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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

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Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Ethical Issues in Research

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Addressing ethical issues in your research proposal

This article explores the ethical issues that may arise in your proposed study during your doctoral research degree.

What ethical principles apply when planning and conducting research?

Research ethics are the moral principles that govern how researchers conduct their studies (Wellcome Trust, 2014). As there are elements of uncertainty and risk involved in any study, every researcher has to consider how they can uphold these ethical principles and conduct the research in a way that protects the interests and welfare of participants and other stakeholders (such as organisations).  

You will need to consider the ethical issues that might arise in your proposed study. Consideration of the fundamental ethical principles that underpin all research will help you to identify the key issues and how these could be addressed. As you are probably a practitioner who wants to undertake research within your workplace, consider how your role as an ‘insider’ influences how you will conduct your study. Think about the ethical issues that might arise when you become an insider researcher (for example, relating to trust, confidentiality and anonymity).  

What key ethical principles do you think will be important when planning or conducting your research, particularly as an insider? Principles that come to mind might include autonomy, respect, dignity, privacy, informed consent and confidentiality. You may also have identified principles such as competence, integrity, wellbeing, justice and non-discrimination.  

Key ethical issues that you will address as an insider researcher include:

• Gaining trust
• Avoiding coercion when recruiting colleagues or other participants (such as students or service users)
• Practical challenges relating to ensuring the confidentiality and anonymity of organisations and staff or other participants.

(Heslop et al, 2018)

A fuller discussion of ethical principles is available from the British Psychological Society’s Code of Human Research Ethics (BPS, 2021).

You can also refer to guidance from the British Educational Research Association and the British Association for Applied Linguistics .

Ethical principles are essential for protecting the interests of research participants, including maximising the benefits and minimising any risks associated with taking part in a study. These principles describe ethical conduct which reflects the integrity of the researcher, promotes the wellbeing of participants and ensures high-quality research is conducted (Health Research Authority, 2022).  

Research ethics is therefore not simply about gaining ethical approval for your study to be conducted. Research ethics relates to your moral conduct as a doctoral researcher and will apply throughout your study from design to dissemination (British Psychological Society, 2021). When you apply to undertake a doctorate, you will need to clearly indicate in your proposal that you understand these ethical principles and are committed to upholding them.  

Where can I find ethical guidance and resources? 

Professional bodies, learned societies, health and social care authorities, academic publications, Research Ethics Committees and research organisations provide a range of ethical guidance and resources. International codes such as the Universal Declaration of Human Rights underpin ethical frameworks (United Nations, 1948).  

You may be aware of key legislation in your own country or the country where you plan to undertake the research, including laws relating to consent, data protection and decision-making capacity, for example, the Data Protection Act, 2018 (UK).  If you want to find out more about becoming an ethical researcher, check out this Open University short course: Becoming an ethical researcher: Introduction and guidance: What is a badged course? - OpenLearn - Open University  

You should be able to justify the research decisions you make. Utilising these resources will guide your ethical judgements when writing your proposal and ultimately when designing and conducting your research study. The Ethical Guidelines for Educational Research (British Educational Research Association, 2018) identifies the key responsibilities you will have when you conduct your research, including the range of stakeholders that you will have responsibilities to, as follows:   

• to your participants (e.g. to appropriately inform them, facilitate their participation and support them)
• clients, stakeholders and sponsors
• the community of educational or health and social care researchers
• for publication and dissemination
• your wellbeing and development

The National Institute for Health and Care Research (no date) has emphasised the need to promote equality, diversity and inclusion when undertaking research, particularly to address long-standing social and health inequalities. Research should be informed by the diversity of people’s experiences and insights, so that it will lead to the development of practice that addresses genuine need. A commitment to equality, diversity and inclusion aims to eradicate prejudice and discrimination on the basis of an individual or group of individuals' protected characteristics such as sex (gender), disability, race, sexual orientation, in line with the Equality Act 2010.  

The NIHR has produced guidance for enhancing the inclusion of ‘under-served groups’ when designing a research study (2020). Although the guidance refers to clinical research it is relevant to research more broadly.  

You should consider how you will promote equality and diversity in your planned study, including through aspects such as your research topic or question, the methodology you will use, the participants you plan to recruit and how you will analyse and interpret your data.    

What ethical issues do I need to consider when writing my research proposal?

You might be planning to undertake research in a health, social care, educational or other setting, including observations and interviews. The following prompts should help you to identify key ethical issues that you need to bear in mind when undertaking research in such settings.  

1.     Imagine you are a potential participant. Think about the questions and concerns that you might have:

• How would you feel if a researcher sat in your space and took notes, completed a checklist, or made an audio or film recording?
• What harm might a researcher cause by observing or interviewing you and others?
• What would you want to know about the researcher and ask them about the study before giving consent?
• When imagining you are the participant, how could the researcher make you feel more comfortable to be observed or interviewed? 

2.     Having considered the perspective of your potential participant, how would you take account of concerns such as privacy, consent, wellbeing and power in your research proposal?  

[Adapted from OpenLearn course: Becoming an ethical researcher, Week 2 Activity 3: Becoming an ethical researcher - OpenLearn - Open University ]  

The ethical issues to be considered will vary depending on your organisational context/role, the types of participants you plan to recruit (for example, children, adults with mental health problems), the research methods you will use, and the types of data you will collect. You will need to decide how to recruit your participants so you do not inappropriately exclude anyone.  Consider what methods may be necessary to facilitate their voice and how you can obtain their consent to taking part or ensure that consent is obtained from someone else as necessary, for example, a parent in the case of a child. 

You should also think about how to avoid imposing an unnecessary burden or costs on your participants. For example, by minimising the length of time they will have to commit to the study and by providing travel or other expenses. Identify the measures that you will take to store your participants’ data safely and maintain their confidentiality and anonymity when you report your findings. You could do this by storing interview and video recordings in a secure server and anonymising their names and those of their organisations using pseudonyms.  

Professional codes such as the Code of Human Research Ethics (BPS, 2021) provide guidance on undertaking research with children. Being an ‘insider’ researching within your own organisation has advantages. However, you should also consider how this might impact on your research, such as power dynamics, consent, potential bias and any conflict of interest between your professional and researcher roles (Sapiro and Matthews, 2020).  

How have other researchers addressed any ethical challenges?

The literature provides researchers’ accounts explaining how they addressed ethical challenges when undertaking studies. For example, Turcotte-Tremblay and McSween-Cadieux (2018) discuss strategies for protecting participants’ confidentiality when disseminating findings locally, such as undertaking fieldwork in multiple sites and providing findings in a generalised form. In addition, professional guidance includes case studies illustrating how ethical issues can be addressed, including when researching online forums (British Sociological Association, no date).

Watch the videos below and consider what insights the postgraduate researcher and supervisor provide  regarding issues such as being an ‘insider researcher’, power relations, avoiding intrusion, maintaining participant anonymity and complying with research ethics and professional standards. How might their experiences inform the design and conduct of your own study?

Postgraduate researcher and supervisor talk about ethical considerations

Your thoughtful consideration of the ethical issues that might arise and how you would address these should enable you to propose an ethically informed study and conduct it in a responsible, fair and sensitive manner. 

British Educational Research Association (2018)  Ethical Guidelines for Educational Research.  Available at:  https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018  (Accessed: 9 June 2023).

British Psychological Society (2021)  Code of Human Research Ethics . Available at:  https://cms.bps.org.uk/sites/default/files/2022-06/BPS%20Code%20of%20Human%20Research%20Ethics%20%281%29.pdf  (Accessed: 9 June 2023).

British Sociological Association (2016)  Researching online forums . Available at:  https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf  (Accessed: 9 June 2023).

Health Research Authority (2022)  UK Policy Framework for Health and Social Care Research . Available at:  https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/uk-policy-framework-health-and-social-care-research/#chiefinvestigators  (Accessed: 9 June 2023).

Heslop, C., Burns, S., Lobo, R. (2018) ‘Managing qualitative research as insider-research in small rural communities’,  Rural and Remote Health , 18: pp. 4576.

Equality Act 2010, c. 15.  Available at:   https://www.legislation.gov.uk/ukpga/2010/15/introduction   (Accessed: 9 June 2023).

National Institute for Health and Care Research (no date)  Equality, Diversity and Inclusion (EDI) . Available at:  https://arc-kss.nihr.ac.uk/public-and-community-involvement/pcie-guide/how-to-do-pcie/equality-diversity-and-inclusion-edi  (Accessed: 9 June 2023).

National Institute for Health and Care Research (2020)  Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project.  Available at:   https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435  (Accessed: 9 June 2023).

Sapiro, B. and Matthews, E. (2020) ‘Both Insider and Outsider. On Conducting Social Work Research in Mental Health Settings’,  Advances in Social Work , 20(3). Available at:  https://doi.org/10.18060/23926

Turcotte-Tremblay, A. and McSween-Cadieux, E. (2018) ‘A reflection on the challenge of protecting confidentiality of participants when disseminating research results locally’,  BMC Medical Ethics,  19(supplement 1), no. 45. Available at:   https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0279-0

United Nations General Assembly (1948)  The Universal Declaration of Human Rights . Resolution A/RES/217/A. Available at:  https://www.un.org/en/about-us/universal-declaration-of-human-rights#:~:text=Drafted%20by%20representatives%20with%20different,all%20peoples%20and%20all%20nations . (Accessed: 9 June 2023).

Wellcome Trust (2014)  Ensuring your research is ethical: A guide for Extended Project Qualification students . Available at:  https://wellcome.org/sites/default/files/wtp057673_0.pdf  (Accessed: 9 June 2023).

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Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

Promoting Ethical Conduct in Science

Do U.S. research institutions meet or exceed federal mandates for instruction in responsible conduct of research? A national survey

 Read about U.S. research instutuins follow federal manadates for ethics in research 

Learn more about NIEHS Research

Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

Ethical considerations in research: Best practices and examples

To conduct responsible research, you’ve got to think about ethics. They protect participants’ rights and their well-being - and they ensure your findings are valid and reliable. This isn’t just a box for you to tick. It’s a crucial consideration that can make all the difference to the outcome of your research.

In this article, we'll explore the meaning and importance of research ethics in today's research landscape. You'll learn best practices to conduct ethical and impactful research.

Examples of ethical considerations in research

As a researcher, you're responsible for ethical research alongside your organization. Fulfilling ethical guidelines is critical. Organizations must ensure employees follow best practices to protect participants' rights and well-being.

Keep these things in mind when it comes to ethical considerations in research:

Voluntary participation

Voluntary participation is key. Nobody should feel like they're being forced to participate or pressured into doing anything they don't want to. That means giving people a choice and the ability to opt out at any time, even if they've already agreed to take part in the study.

Informed consent

Informed consent isn't just an ethical consideration. It's a legal requirement as well. Participants must fully understand what they're agreeing to, including potential risks and benefits.

The best way to go about this is by using a consent form. Make sure you include:

• A brief description of the study and research methods.
• The potential benefits and risks of participating.
• The length of the study.
• Contact information for the researcher and/or sponsor.
• Reiteration of the participant’s right to withdraw from the research project at any time without penalty.

Anonymity means that participants aren't identifiable in any way. This includes:

• Email address
• Photographs
• Video footage

You need a way to anonymize research data so that it can't be traced back to individual participants. This may involve creating a new digital ID for participants that can’t be linked back to their original identity using numerical codes.

Confidentiality

Information gathered during a study must be kept confidential. Confidentiality helps to protect the privacy of research participants. It also ensures that their information isn't disclosed to unauthorized individuals.

Some ways to ensure confidentiality include:

• Using a secure server to store data.
• Removing identifying information from databases that contain sensitive data.
• Using a third-party company to process and manage research participant data.
• Not keeping participant records for longer than necessary.
• Avoiding discussion of research findings in public forums.

Potential for harm

​​The potential for harm is a crucial factor in deciding whether a research study should proceed. It can manifest in various forms, such as:

• Psychological harm
• Social harm
• Physical harm

Conduct an ethical review to identify possible harms. Be prepared to explain how you’ll minimize these harms and what support is available in case they do happen.

Fair payment

One of the most crucial aspects of setting up a research study is deciding on fair compensation for your participants. Underpayment is a common ethical issue that shouldn't be overlooked. Properly rewarding participants' time is critical for boosting engagement and obtaining high-quality data. While Prolific requires a minimum payment of £6.00 / $8.00 per hour, there are other factors you need to consider when deciding on a fair payment.

First, check your institution's reimbursement guidelines to see if they already have a minimum or maximum hourly rate. You can also use the national minimum wage as a reference point.

Next, think about the amount of work you're asking participants to do. The level of effort required for a task, such as producing a video recording versus a short survey, should correspond with the reward offered.

You also need to consider the population you're targeting. To attract research subjects with specific characteristics or high-paying jobs, you may need to offer more as an incentive.

We recommend a minimum payment of £9.00 / $12.00 per hour, but we understand that payment rates can vary depending on a range of factors. Whatever payment you choose should reflect the amount of effort participants are required to put in and be fair to everyone involved.

Ethical research made easy with Prolific

At Prolific, we believe in making ethical research easy and accessible. The findings from the Fairwork Cloudwork report speak for themselves. Prolific was given the top score out of all competitors for minimum standards of fair work.

With over 25,000 researchers in our community, we're leading the way in revolutionizing the research industry. If you're interested in learning more about how we can support your research journey, sign up to get started now.

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What Are the Ethical Considerations in Research Design?

When I began my work on the thesis I was always focused on my research. However, once I began to make my way through research, I realized that research ethics is a core aspect of the research work and the foundation of research design.

Research ethics play a crucial role in ensuring the responsible conduct of research. Here are some key reasons why research ethics matter:

Let us look into some of the major ethical considerations in research design.

Ethical Issues in Research

There are many organizations, like the Committee on Publication Ethics , dedicated to promoting ethics in scientific research. These organizations agree that ethics is not an afterthought or side note to the research study. It is an integral aspect of research that needs to remain at the forefront of our work.

The research design must address specific research questions. Hence, the conclusions of the study must correlate to the questions posed and the results. Also, research ethics demands that the methods used must relate specifically to the research questions.

Voluntary Participation and Consent

An individual should at no point feel any coercion to participate in a study. This includes any type of persuasion or deception in attempting to gain an individual’s trust.

Informed consent states that an individual must give their explicit consent to participate in the study. You can think of consent form as an agreement of trust between the researcher and the participants.

Sampling is the first step in research design . You will need to explain why you want a particular group of participants. You will have to explain why you left out certain people or groups. In addition, if your sample includes children or special needs individuals, you will have additional requirements to address like parental permission.

Confidentiality

The third ethics principle of the Economic and Social Research Council (ESRC) states that: “The confidentiality of the information supplied by research subjects and the anonymity of respondents must be respected.” However, sometimes confidentiality is limited. For example, if a participant is at risk of harm, we must protect them. This might require releasing confidential information.

Risk of Harm

We should do everything in our power to protect study participants. For this, we should focus on the risk to benefit ratio. If possible risks outweigh the benefits, then we should abandon or redesign the study. Risk of harm also requires us to measure the risk to benefit ratio as the study progresses.

Research Methods

We know there are numerous research methods. However, when it comes to ethical considerations, some key questions can help us find the right approach for our studies.

i. Which methods most effectively fit the aims of your research?

ii. What are the strengths and restrictions of a particular method?

iii. Are there potential risks when using a particular research method?

For more guidance, you can refer to the ESRC Framework for Research Ethics .

Ethical issues in research can arise at various stages of the research process and involve different aspects of the study. Here are some common examples of ethical issues in research:

Institutional Review Boards

The importance of ethics in research cannot be understated. Following ethical guidelines will ensure your study’s validity and promote its contribution to scientific study. On a personal level, you will strengthen your research and increase your opportunities to gain funding.

To address the need for ethical considerations, most institutions have their own Institutional Review Board (IRB). An IRB secures the safety of human participants and prevents violation of human rights. It reviews the research aims and methodologies to ensure ethical practices are followed. If a research design does not follow the set ethical guidelines, then the  researcher will have to amend their study.

Applying for Ethical Approval

Applications for ethical approval will differ across institutions. Regardless, they focus on the benefits of your research and the risk to benefit ratio concerning participants. Therefore, you need to effectively address both in order to get ethical clearence.

Participants

It is vital that you make it clear that individuals are provided with sufficient information in order to make an informed decision on their participation. In addition, you need to demonstrate that the ethical issues of consent, risk of harm, and confidentiality are clearly defined.

Benefits of the Study

You need to prove to the panel that your work is essential and will yield results that contribute to the scientific community. For this, you should demonstrate the following:

i. The conduct of research guarantees the quality and integrity of results.

ii. The research will be properly distributed.

iii. The aims of the research are clear and the methodology is appropriate.

Integrity and transparency are vital in the research. Ethics committees expect you to share any actual or potential conflicts of interest that could affect your work. In addition, you have to be honest and transparent throughout the approval process and the research process.

The Dangers of Unethical Practices

There is a reason to  follow ethical guidelines. Without these guidelines, our research will suffer. Moreover, more importantly, people could suffer.

The following are just two examples of infamous cases of unethical research practices that demonstrate the importance of adhering to ethical standards:

• The Stanford Prison Experiment (1971) aimed to investigate the psychological effects of power using the relationship between prisoners and prison officers. Those assigned the role of “prison officers” embraced measures that exposed “prisoners” to psychological and physical harm. In this case, there was voluntary participation. However, there was disregard for  welfare of the participants.
• Recently, Chinese scientist He Jiankui announced his work on genetically edited babies . Over 100 Chinese scientists denounced this research, calling it “crazy” and “shocking and unacceptable.” This research shows a troubling attitude of “do first, debate later” and a disregard for the ethical concerns of manipulating the human body Wang Yuedan, a professor of immunology at Peking University, calls this “an ethics disaster for the world” and demands strict punishments for this type of ethics violation.

What are your experiences with research ethics? How have you developed an ethical approach to research design? Please share your thoughts with us in the comments section below.

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The ethics and integrity of research with schools, families and communities

• Perspective Article
• Published on: September 24, 2024

• Communities

DR KAREN BOARDMAN, HEAD OF DEPARTMENT, DEPARTMENT OF EARLY YEARS EDUCATION, EDGE HILL UNIVERSITY, UK

Silvia cont, research assistant, department of early years education, edge hill university, uk, chris davey, headteacher, blessed sacrament primary school, uk , introduction: the issues of maintaining research integrity and addressing ethical educational research dilemmas .

Concerns surrounding the ethics and integrity of research with schools, families and communities is one of many enduring debates within educational research. We already know that it is essential that researchers carefully consider all the ethical issues that relate to research, from conception to dissemination (informed consent, participation, privacy, vulnerability, truth, etc.), in order to guide robust meaningful research. Moreover, considering these ethical issues is relevant for all stakeholders to feel protected and have increased trust in the research process. Therefore, this paper aims to offer the reader an overview of how research circles (RCs), as a tool for participatory action research (Persson, 2009), can be used as an ethical methodological research approach with educational settings, families and communities.

The main principles guiding RCs include democracy, empowerment, social context and agency (see Figure 1 ). The first principle refers to the democratic nature of RCs, as all involved participants are equals (Högdin and Kjellman, 2014). Given that our key aim is ‘to carry out research together with – not on – the participants’ (Svensson, 2002, cited in Bergman, 2014, p. 7), including everyone as equal partners in each RC project is vital. The second principle is the empowering nature of RCs, which is rooted in the reciprocal dialogue among participants at each stage and the source of their knowledge and learning (Freire et al., 2018). The third principle is the specific social context and related issues underpinning collaborative knowledge creation with RC participants – the context is what matters. Our RC models are considered a bridge between educational practice and theory (Lundgren, 1999) to support all stakeholders.

As such, all stakeholders within their individual social context are agents actively involved in making collaborative choices regarding the research phases (including the initial research idea, the number and elaboration of research questions, data collection, analysis, report writing and dissemination formats).

Figure 1: RC principles for research integrity

Following these principles, our RC models provide the distinct advantage of navigating and mitigating common ethical issues and maintaining the integrity of the whole research process – starting from the initial research idea and including the report-writing phases and final dissemination. The mutual participatory nature of our RC projects helps to ensure that all ethical issues, such as the lack of truly informed participant consent, confidentiality breaches (Cohen et al., 2007) or the research itself being imposed onto all participants (Coghlan and Brydon-Miller, 2014), are readily sustained. 

The most important feature of our RC projects is research integrity, meaning that the focus of any research has strong moral grounding, including honesty, completeness and uniqueness, and considers all stakeholder viewpoints – agency and intentionality.

Therefore, it is essential that viewpoints, actions and the effectiveness of the provision include all stakeholders’ honest voices. Here, the RC principle of the ‘circle as a collaborative space’ aids all stakeholders in understanding and adhering to the research integrity principles of openness, sensitivity and scientific impartiality (Cohen et al., 2007). This is obviously easier said than done. The main principles of democracy, agency and power of knowledge (Holmstrand et al., 2008 support the many ongoing ethical issues within our RC projects.

The next section will illustrate one particular RC case study, exploring the impact on children’s development of a specialist autism provision within a UK primary school.

The research circle as an ethical research method: An exploration of the impact of specialist autism provision within a UK primary school

The aim of this RC was to explore the impact of the newly implemented autism spectrum disorder (ASD) specialist provision at the school, in response to the growing needs of parents and families in the local community. Children are referred to the provision by the local authority, as no specialised provision is currently available in this area. Children attend the provision five days a week, from 9am to 2.30pm. The provision is physically and structurally connected to the mainstream primary school; however, the children are accommodated in separate units with distinct curricula and professional staff.

Participants  

Participants in this study are the children attending the autism provision, the parents, carers and families of children attending the provision, the educators who teach in the mainstream school and the educators within the specialised provision. All stakeholders were involved in the RC meetings and discussions prior to and after ethical approval, to ensure that all voices and opinions were shared.

Methodology 

Assessment of children’s progress

The educators within the autism provision have identified social communication and social interaction as the two areas that the school wishes to assess. An assessment criterion called ‘B Squared’ evaluated the children’s social communication and interaction at three time points: at the beginning of the study period, at a six-month interval and finally at the end of the 12-month RC study. These observations were carried out as part of the general activities within a natural classroom setting by educators with whom the children were comfortable and familiar. 

Assessment of parents’ experience of the provision

A survey incorporating a questionnaire with open and closed questions was shared with parents/carers of the children attending the provision, to ascertain their views on the effectiveness of the autism provision. A random selection of completed questionnaires was identified to conduct five approximately one-hour interviews. Focus group workshops (FGW) were scheduled for parents, carers and families to further discuss their views on the effectiveness of the provision. 

Assessment of school staff

A survey was conducted with the mainstream school staff to ascertain their views on the effectiveness of the provision, along with a follow-up FGW. 

Assessment of the autism provision staff

A survey was conducted with the autism provision staff to ascertain their views on the effectiveness of the provision, along with a follow-up FGW.

Data analysis 

Data was collated by a research assistant. Themes were explored using thematic analysis (Clarke and Braun, 2021) as part of the RC. 

The main findings highlighted how this new autism provision successfully impacted on the children’s development and the wellbeing of the families. However, an enhanced focus on supporting children’s communication, alongside further collaboration, integration and networking opportunities with the primary school and local community, were identified. The findings have been shared with all stakeholders in two formats:

• a research report for autism provision staff and mainstream school staff
• a leaflet written in plain English, accessible to children’s parents, families and carers.

Ethics and integrity of research with schools, families and communities

The collaborative nature of our RC, informed by the principles of democracy, empowerment, social context and agency, ensured that we adhered to the more traditional ethical dilemmas of educational research (e.g. ethical clearance, anonymity, privacy, confidentiality, informed consent, participation, vulnerability and truth) (Ramrathan et al., 2017), and as such prevented the occurrence of ethical dilemmas usually linked to educational research (power dynamics and boundaries, ownership of data, findings dissemination and publication and social action for social change) (Brydon-Miller and Banks, 2019).

Here are some examples of how the RC principles maintained the integrity of the collective process:

• As part of the ethical approval process, all RC stakeholders had several meetings, ensuring that everyone, including participants, was informed in advance about the nature of the research. Participants’ active involvement in the RC allowed them to make even more informed decisions regarding their willingness to participate in the research when reading the participant information sheet and the consent form. This process was transparent for everyone.
• The RC stakeholders’ involvement was not just limited to research design. For example, the school stakeholders administered the parents, setting and school staff questionnaires based on participants’ availability and access. This active involvement in collecting their data helped to reset power dynamics , so that RC participants were no longer considered passive sources of information for researchers. 
• All stakeholders were actively involved in the life of the RC. Data analysis was also informed by input to RC members, who had access to a summary of the main research findings (anonymous at this stage). RC meetings explored the topic of ownership of the data. RC stakeholders also guaranteed the trustworthiness of the findings. 
• Lastly, the dissemination and publication of findings were also decided based on RC stakeholders’ needs and the context. RC participants suggested that the dissemination materials needed to include practical recommendations in a staff research report and parents’ leaflet format.

Practical applications 

Focusing on this RC approach, we hope, will demonstrate to teachers, families and communities that RCs are a safe space where they are protected from ethical issues and research integrity is maintained. Within this model, they can: 

• Find the time to come together and discuss the issues relevant to their setting as the starting point for developing an RC project.
• Democratically participate and contribute as active agents alongside teachers/ researchers to carry out RC principles, making collective decisions about the RC project through recurrent circle meetings – listening and talking to each other and being open to exploring the ethical dilemmas in social contexts.
• Be empowered to contribute their professional/practice-based knowledge with all RC participants within an equal learning community, creating new knowledge as the basis for their professional/personal practice development – developing their agency.
•  Put into practice the RC outcomes and continue with the collaborative nature of true research integrity – all voices to be equally heard, including communities, families and children.

The research ethical dilemmas were democratically discussed with all the RC stakeholders, considering the setting and context ( Figure 1 ). RC stakeholders were involved as active agents , enthusiastically sharing inputs and contributing to all the research phases, from the proposal of the initial idea for the research to dissemination. RC is, therefore, an ethical ‘mediating arena’ (Persson, 2009, p. 10), where participants are empowered to create new knowledge through a reflective, dialogic and emancipatory construction process (Persson, 2009; Foster-Fishman et al., 2005).

• Bergman L (2014) The research circle as a resource in challenging academics’ perceptions of how to support students’ literacy development in higher education. Canadian Journal of Action Research 15(2): 3–20.
• Brydon-Miller M and Banks S (2019) Ethics in participatory research. In: Ethics in Participatory Research for Health and Social Well-Being: Cases and Commentaries. London: Routledge, pp. 1–30.
• Clarke V and Braun V (2021) Thematic Analysis: A Practical Guide. London and Thousand Oaks, CA: SAGE.
• Coghlan D and Brydon-Miller M (2014) Research Circles. In: Coghlan D and Brydon-Miller M (eds) The SAGE Encyclopaedia of Action Research. London: SAGE Publications, pp. 686-688.
• Cohen L, Manion L and Morrison K (2007) Research Methods in Education. London and New York: Routledge.
• Foster-Fishman P, Nowell B, Deacon Z et al. (2005) Using methods that matter: The impact of reflection, dialogue, and voice. American Journal of Community Psychology 36(3–4): 275–291.
• Freire P, Ramos MB, Macedo DP et al. (2018) Pedagogy of the Oppressed, 50th anniversary ed. London: Bloomsbury Academic.
• Högdin S and Kjellman C (2014) Research circles: A method for the development of knowledge and the creation of change in practice. Saber e Educar 19: 24–37.
• Holmstrand L et al. (2008) The Research Circle Approach: A Democratic Form for Collaborative Research in Organizations. In: Shani A, Mohrman S, Pasmore W et al. (eds) Handbook of Collaborative Management Research. London, SAGE Publications, pp. 183-200.
• Lundgren M (1999) How are research circles used in schools? – some reflections. In: HSS 99 – Högskolor och Samhälle i Samverkan, Dalarna University, Sweden, 16–18 March 1999.
• Persson S (2009) Research Circles: A Guidebook. Malmö: Centre for Diversity in Education.
• Ramrathan L, Le Grange L and Shawa LB (2017) Ethics in educational research. In: Ramrathan L, Le Grange L and Higgs P (eds) Education Studies for Initial Teacher Education. South Africa: Juta, pp. 432–443.

From this issue

Issue 22: Autumn 2024

September 2024

Impact Articles on the same themes

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• Original Research

Leading quality use of research in schools

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Criticality in evidence-informed teaching: Expansive learning with Rosenshine

How teacher-led research can meaningfully contribute to appraisals

Teacher inquiry questions: A trust-wide shift

From well-intentioned to evidence-informed: Making the shift on a large scale

• Teacher Reflection

Using research to embed an evidenced-informed pastoral curriculum to support whole school behaviour policies

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• Open access
• Published: 19 September 2024

Current status and influencing factors of nurses’ knowledge and attitudes towards clinical research ethical in China: a province-wide cross-sectional survey

• Na Zhang 1 ,
• Qinqin Cheng 2 ,
• Tingwei Luo 4 ,
• Zhiqiang Zhang 4 ,
• Sishan Jiang 4 ,
• Hongwen Qin 5 &
• Lihui Zhu 1  

BMC Nursing volume  23 , Article number:  671 ( 2024 ) Cite this article

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Nurses’ competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research.

A cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses’ knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression.

A total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P  < 0.001, R2 = 18.0%); degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether the respondent has ever participated in an ethics training were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P  < 0.001, R2 = 17.3%).

Conclusions

Nurses in a Chinese province scored low on the cognitive dimension of clinical research ethics, but their attitudes were at a relative high level, with many influencing factors. Degree, technical title, and grade of hospital, all affect cognitive and attitude scores. It is also worth noting that whether the hospital has an ethics committee affects the attitude scores, but has no effect on the cognitive scores.Nursing administrators and educators should consider providing effective and targeted strategies (e.g., ongoing training, scholarly seminars, and scholarly exchanges) to enhance nurses’ knowledge and competence in clinical research ethics to protect subject rights as well as to ensure the quality of clinical research.

Peer Review reports

Clinical research refers to scientific research in the field of medicine to study the physiology, pathology, pharmacology and other aspects of humans, patients or volunteers through observation and experiments. Its purpose is to improve medical practice, optimize treatment options, improve the quality of care, and promote the development of medical science [ 1 ]. Clinical research plays a vital role in disease prevention and treatment and in maintaining the health of the population. Nurses can better carry out clinical research, which is the basis for promoting the development of nursing disciplines and an important means of improving the quality of clinical care [ 2 , 3 ]. Nursing personnel can disseminate new methods, theories, concepts, and new standards of nursing practice through research. With the rapid development of clinical research in recent years, clinical research is now gradually exploring towards the experimental stage. At this stage, the main research object is the patient, and taking the patient as the research object involves many complex ethical issues, such as how to respect the patient’s rights and protect the patient’s interests in clinical research [ 3 ]. Therefore, the benchmark issue of ethics will be an important issue facing the clinical research process in the future.

Medical and nursing journals are probably the most important way for nursing staff to disseminate their new ideas, methods, etc. These journals can play an important role in promoting compliance with ethical principles in clinical research among caregivers [ 4 , 5 ]. A growing number of medical and nursing journals require physicians or nurses to publish studies that have addressed ethical issues and have been approved by Institutional Review Boards (IRBs) [ 6 , 7 ]. However, not every journal emphasizes the requirement to address ethical issues. An online review of 767 articles from leading European otolaryngology journals by an academic [ 8 ] found that 49.9% of the articles lacked an ethics committee approval statement and 42.9% lacked informed consent disclosure. Another researcher [ 9 ]conducted an ethical review of 32 stepped wedge clustered randomized trials and found that only 24 trials (75%) passed the research ethics committee review and only 16 (50%) reported informed consent of the study participants, with only one-third of the studies overall complying with the requirements. A number of studies by Chinese scholars have shown [ 10 , 11 ] that nursing staff research capacity is poor in mainland China and publish articles of lower quality, which is reflected in their impact factors and citation reports, and that one possible reason for the lower quality of articles is the lack of ethical concerns of nursing staff during the research process. These nursing research findings from the East and West suggest that clinical research ethics should receive widespread attention and focus from nursing workers. Although countries have actively explored ethical issues in clinical research and have published guidelines and management norms related to clinical research ethics [ 12 ], ethical awareness during the implementation of the study has not really penetrated into the research work of nursing workers, and therefore may still not be able to adequately protect the subjects.

Nurses, as the main body of conducting nursing clinical research, are the actual operators of the research and the close contacts of the subjects [ 13 ], and their comprehensive ethical level of ethical knowledge, ethical attitudes and ethical implementation have a direct impact on the quality of clinical research and the safety of the subjects.The theory of knowledge, attitude and practice believes that individuals can eventually develop healthy behaviors by acquiring health knowledge and building positive attitudes [ 14 ]. Therefore, attention must be paid to cultivating and improving cognitive awareness and attitudes. At present, developed countries such as the United States, the United Kingdom and France have constructed a systematic and comprehensive medical ethics education and training model, and the form of education is appropriate, but the medical workers’ medical ethics knowledge and practice still need to be improved. Surveys show that medical interns, medical officers, residents and consultants in Nigeria generally have inadequate knowledge of medical ethics; truthfully obtaining informed consent has become a major medical ethical challenge for medical workers in Europe [ 15 , 16 ]. However, at this stage, there are fewer investigations related to ethical perceptions of nursing workers during clinical research. In China, research on research ethics is underdeveloped, and the cities with more ethical studies are mainly Beijing, Shanghai, Zhejiang and Jiangsu. The studies mainly focused on clinical researchers and medical staff in a certain province or hospital with regard to the ethical review of clinical research, ethical knowledge and training needs [ 17 , 18 ]. The investigation of nursing staff’s ethical knowledge and attitude towards clinical research is still insufficiently concerned. As an important member of the nursing staff to promote the high quality development of hospital research, only by mastering the knowledge related to clinical research ethics and correctly understanding the connotation, can they better practice ethical behavior. Therefore, this study aims to understand the level of nurses’ clinical research ethics knowledge and attitudes through a cross-sectional survey, analyze the factors affecting nurses’ clinical research knowledge and attitudes, and provide precise suggestions for nurses to carry out targeted training related to clinical research ethics.

The study used a cross-sectional design and convenience sampling approach.

Participant selection and setting

From April 2023 to September 2023, we conducted a cross-sectional survey involving 304 participants recruited from registered nurses in Hunan Province, China. The inclusion criteria consisted of the following: (1) being a registered nurse and (2) proficiency in the Chinese language. Exclusion criteria included: (1) nurses undergoing training, internships, or further education, and (2) nurses on maternity leave, sick leave, or engaged in further training during the survey period. Hunan Province comprises 14 prefecture-level cities. The research sample was selected through convenience sampling from 20 hospitals across 8 cities in Hunan Province, namely Changsha, Zhuzhou, Chenzhou, Changde, Zhangjiajie, Hengyang, and Shaoyang. The sample size was calculated using G-Power with a confidence interval of 95% and an alpha of 0.05. The estimated target sample size was 138.

Data collection

Convenience sampling method was used to recruit the sample for this study. The formal questionnaire was edited to form an electronic questionnaire, a link was generated and posted on social media, and the team members or the head of the hospital Ethics committee office sent invitation messages to different hospitals in various cities in Hunan Province. Nurses in these hospitals can scan the QR code on social media to fill in the questionnaire, and sign the informed consent before filling in the questionnaire. Whether to fill in the questionnaire is completely voluntary.The survey link was available for one week (15 September 2023 to 21 September 2023). In total, 320 nurses completed the survey. Based on the total number of survey items, we estimated that it would take approximately 10 min to complete all items. To ensure the quality of the data, we decided to exclude questionnaires with very short (3 min) or long (20 min) completion duration, leaving 304 valid questionnaires. All questionnaires were completed through an online survey and an electronic data collection tool, Questionnaire Star ( www.wjx.cn ).

Demographic questionnaire

We used a self-designed questionnaire to collect nurses’ individual and unit characteristics. Nurses’ individual characteristics including gender, age, degree,, technical title, working years, number of clinical research projects participated in one year, number of clinical research projects chaired in one year, whether you have attended any training on ethics knowledge. Unit characteristics including grade of hospital(China’s hospital level refers to the hospital level according to the “hospital grading management standards”. It is divided into one, two and three levels; each level is further divided into A, B and C, of which three levels of hospitals are added to the special level, with a total of three levels and ten levels. Hospital grade is based on hospital functions, facilities, technical strength and other indicators of hospital qualification assessment) and whether the hospital has an ethics committee.

Clinical research ethics knowledge, attitude questionnaire

According to the references [ 18 , 19 , 20 ]and combining the opinions of clinical professionals and researchers, the questionnaire on ethical knowledge and attitude of clinical research was prepared by ourselves after group discussion. The questionnaire was also administered to 30 nurses in Hunan to test the reliability and validity of the questionnaire, which was finally formed into a questionnaire containing a total of 19 items in 2 dimensions: knowledge (13 items) and attitude (6 entries). The Cronbach’s alpha coefficient for the total dimension of the questionnaire was 0.835, and the Cronbach’s alpha coefficients for the knowledge dimension and attitude dimension were 0.922 and 0.812, respectively. The knowledge dimension included contents related to ethical concepts, the basic principles of medical ethics, the contents of the Declaration of Helsinki of the World Medical Assembly and the Measures for Ethical Review of Biomedical Research Involving Human Beings (2016), and the setup of ethics committees, Knowledge of Good Clinical Practice (GCP) for Drug Clinical Trials, and cases of ethical problems in clinical research projects, etc. The Clinical Research Ethics Questionnaire has a total score of 100 points, with questions 1–8 being single choice questions worth 7 points each, questions 9–11 being multiple choice questions worth 10 points each, and questions 12–13 being situational judgment single choice questions worth 7 points each. Higher scores indicate better knowledge of clinical research ethics. The attitude dimension includes the attitude towards the fulfilment of the duties of the ethics committee, the importance of ethical review and the need for GCP certificate for clinical research, etc. Each item is scored on a Likert 5-point scale, with “strongly disagree, basically disagree, not sure, relatively agree, strongly agree” scoring from 1 to 5. The higher the score, the better the subject’s attitude towards the ethics of clinical research is. The standard score was used to calculate knowledge and attitude of the questionnaire, which was average score/total score×100% [ 22 ].

Data analysis

The data collected was transferred to the statistic software SPSS for analysis. All data were analysed by SPSS 26.0. Categorical variable data (demographic and other characteristics of nurse) were presented as numbers and percentages, while continuous variables (knowledge, attitude total score) were expressed as means and standard deviation (SD). Multiple linear regression analysis was used to determine the relevant factors affecting nurses’ knowledge and attitude towards clinical research ethics.The total score of knowledge and attitude for each factor was set as the dependent variables, while univariate analysis found that statistically significant variables were used as independent variables.When processing multiple regression analysis, the nominal variables were set as dummy variables, such as whether the hospital has an ethics committee(yes=(0, 0), no=(1, 0), unclear=(0, 1)). A p value of < 0.05 was considered statistically significant.

Ethical considerations

The study was approved by the Hunan Children’s Hospital Research Ethics (Reference number: HCHLL-2024-09).

Sample characteristics

Among 304 participants, 92.4% ( n  = 281) were female. The majority were under 39 years of age. The mean age was (34 ± 8.56) years. Most (60.4%) of the participants ( n  = 225) had a bachelor’s degree or higher. The majority were of intermediate title. Regarding unit characteristics, half (67.4%) of the participants’ hospitals belonged to tertiary Grade 3B and above. Nearly half of the participants’ hospitals (49.7%) had an ethics committee. Other general information characteristics are shown in Table  1 .

Nurses’ clinical research ethics knowledge and attitude score

In this study, 304 nurses had total scores of 63.08 and 27.35 for clinical research ethics knowledge and attitude, with standard scores of 63.08 and 91.17, respectively, with moderate knowledge scores and good attitude scores. The scores of each dimension and each entry are shown in Tables  1 and 2 .

One-way analysis of nurses’ clinical research ethics knowledge and attitude scores

Table  3 presented clinical research ethics knowledge and attitude for different general characteristics.Clinical research ethics knowledge and attitude in participants with a PhD/Postdoctoral degree were significantly higher than in those below this level ( p <0.001, p  = 0.001). The level of clinical research ethics knowledge and attitude was significantly higher working in Grade 2 A or above hospitals compared to those working in hospitals below Grade 2 A( p <0.001, p <0.001). The clinical research ethics knowledge and attitude of the participants with senior titles were significantly higher than those of the participants with junior and intermediate titles ( P  = 0.001, P  < 0.001).The higher the number of participants who presided over the number of clinical research projects in one year, the higher the scores of clinical research ethics knowledge and attitude ( P  < 0.001, P  < 0.001).Clinical research ethics knowledge and attitude showed a significant difference with whether the hospital has an ethics committee ( p <0.001, p  < 0.001),and whether to participate in training related to ethical knowledge ( p  < 0.001, p =0.008). However, other characteristics of nurses had no obvious impact ( p  > 0.05).

Multiple regression analysis of nurses’ clinical research ethics knowledge and attitude scores

The results of multiple linear regression analysis, as shown in Table  4 , showed that degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year and whether to participated in training related to ethical knowledge were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P  < 0.001), which explained 18% of the variance. Degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether to articipate in training related to ethical knowledge were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P  < 0.001), which explained 17.3% of the variance.

To the best of our knowledge, This is the first study to examine the current status of nurses’ ethical knowledge and attitudes toward clinical research and their associated factors in different levels of hospitals in China. The results of this study not only help nursing managers to understand the ethical knowledge and attitudes of nurses in clinical research, but also lay the foundation for further research.

This study shows that the standardized total score of nurses’ knowledge of clinical research ethics was 63.08, which was in the middle level. It is related to the overall low educational level of the Chinese nurse population, the low number of clinical research projects carried out, and the serious lack of continuing education and training.In 2010, the state promulgated the Guiding Principles for Ethical Review of Drug Clinical Trials [ 23 ], and major hospitals across the country constructed and perfected the ethical review procedures for drug clinical trials based on this principle and the Code for Quality Management of Drug Clinical Trials [ 24 ]. In contrast, clinical research involving human beings has only gradually begun to regulate the ethical review of scientific research since the promulgation of the Measures for Ethical Review of Biomedical Research Involving Human Beings in 2016, but the needs and development paths of hospitals of different regions and grades are different, leading to differences in the importance attached to ethical review of scientific research. Clinical research programs in nursing primarily focus on nurses with postgraduate backgrounds. Over the past three years, there has been a gradual increase in the number of nurses in this group. Typically engaged in clinical nursing duties, they often have limited participation in conferences and studies concerning research ethics, leading to a lack of knowledge in this area.Therefore, in this group, there are still cases in which the papers published by nursing research are reviewed as research proposals, and the research proposals tend to emphasize science rather than ethics [ 25 ], and thus lack the knowledge related to research ethics. knowledge of ethics-related aspects. The cognitive dimension scores were consistent with the results of most scholars‘ [ 26 , 27 ]studies.

In the cognitive dimensions, the situational judgement questions based on ethical controversies that often arise in the course of clinical research had the lowest scores. The score of the first situational judgment question was 2.39 ± 0.19, and the score of the second was 2.16 ± 0.18. These results indicate that nurses have insufficient thinking and experience about possible ethical disputes in clinical research practice, which may be related to the few clinical studies carried out by hospitals or the lack of attention to relevant research ethical issues in the process of carrying out clinical research. While entries such as the definition of ethics, the Chinese name of GCP, and the content involved in an informed consent form had higher scores. This may be related to the gradual emphasis on nursing scientific research and the more basic scientific research ethics education and knowledge training carried out by hospitals.Therefore, we need to further strengthen the training of research ethics for nursing staff. In particular, hospitals or schools should increase the content of research ethics when setting up basic nursing education training courses, so as to improve the operation level of clinical research ethics of nursing staff, so that they can correctly analyze and deal with various ethical conflicts they may face, so that nursing scientific research and ethics can promote each other and coordinate development.

The attitude dimension scores in this study were good and consistent with the findings of scholars from Ghana and Ethiopia [ 28 , 29 ]. China’s National Health Commission, in order to further regulate clinical research, issued the Guidelines for the Construction of Ethical Review Committees for Clinical Research Involving Human Beings in October 2019 [ 4 ] and required that clinical research involving human beings be comprehensively filed in the Medical Research Registration and Filing Information System from September 2020, and the Opinions on Strengthening the Ethical Governance of Science and Technology issued by the Central Committee of the Communist Party of China (CPC) and the State Council of China in April 2023 [ 29 ] proposing that emphasis be placed on education and training in science and technology ethics, and that not only are universities encouraged to offer ethics-related courses, but that ethics training should also be actively carried out after entry into the workforce, thereby enhancing the ethical awareness of research-related personnel. A series of documents have been issued to encourage hospital ethics committees to rigorously review the ethical issues in the whole process of clinical research, and to require hospitals and universities to strengthen ethical training in clinical research. In addition, in recent years, more and more high-quality nursing journals require contributors to provide ethical approval numbers and informed consent, etc [ 30 , 31 ]. , which is also an important basis for reflecting academic standards. With the support of the national policy, the gatekeeping of the hospital ethics committee and the personal experience of contributing to make research ethics in the spotlight, so the nurses have a more positive attitude towards the ethical issues of clinical research. Therefore, the nursing management department needs to pay attention to this issue, to actively improve and standardise the ethical system of clinical research, to strengthen the relevant knowledge and skills training and inspection, and to promote the standardised development of nursing clinical research ethics in mainland China.

In this study, we found that the level of nurses’ knowledge and attitude towards clinical research ethics were related to their degree, grade of hospital, technical title, number of clinical research projects chaired in one year, and whether the respondent has ever participated in an ethics training. The higher the degree, the better the knowledge and attitude of the nurses, which is consistent with the results of previous studies [ 32 ]. Nurses with a master’s degree have a systematic background of clinical research knowledge, and they have learnt a more scientific research design method, and they pay attention to randomised, blinded and other research methods in nursing research. Both research knowledge and research practice are richer than those of other academic groups. They are also strict with themselves and can take the initiative to participate in research-related training and learning according to their research direction to expand their knowledge field, so they have a more solid grasp of research ethics knowledge and a more positive attitude towards ethical work in clinical research. Nurses with a bachelor’s degree or lower accounted for 67.7% of the nurses in this study, accounting for a larger proportion. This phenomenon should attract the attention of the nursing management department, which should further cultivate highly educated nursing talents, encourage nurses to participate in continuing education to improve their own ability and professionalism, and also suggest that targeted training in ethics courses should be conducted at different levels according to different educational backgrounds.

The higher the hospital ranking, the higher the level of clinical research ethics knowledge and attitudes, which is consistent with the results of many similar studies [ 33 , 34 ]. The higher the hospital ranking, the more importance was given to the ranking of hospitals and disciplines in terms of scientific and technological(S&T) impact. S&T impact is determined by the total ranking of S&T inputs, S&T outputs, and academic impact. Therefore, the higher the hospital ranking, the more importance the nursing discipline places on clinical research outputs and the more resources and platforms available to the nursing discipline, so the clinical research is also very important. The higher the level of the hospital, the more resources and platforms nursing can use, so the experience of clinical research is richer, and the knowledge of research ethics is better mastered, which leads to a more positive attitude towards the ethical work in clinical research.

The higher the technical title, the better the knowledge and attitude, which is consistent with the findings of Famuyide M, Ayoub NM [ 26 , 35 ]and others, who found that the ethical knowledge, belief and behaviour of the researchers tended to increase as the title increased. At present, more and more nurses in hospitals need scientific research achievements to promote their titles, and nurses with higher technical titles have more research outputs, more experience in clinical research, more opportunities to participate in research ethics training, and more systematic and comprehensive reserves of ethical knowledge in clinical research, and thus their ethical awareness has become stronger, and they pay more attention to ethical issues in clinical research.

Nurses who chaired more clinical research projects had better ethical knowledge and attitudes, consistent with the results of previous studies [ 36 ]. When hosting clinical research projects, nurses must have really experienced various ethical reviews in the whole process from project declaration, project implementation and project completion, and the ethical materials required for the research projects have been examined and approved by the research department and the ethics committee, so that nurses’ ethical knowledge has been strengthened and their ethical thinking and awareness have been improved when they hosted the clinical research projects over and over again. The results of this study show that nurses who has ever participated in an ethics training have higher scores of ethical knowledge and attitude consistent with the results of many studies [ 37 , 38 ]. Medical ethics training is a key aspect of improving medical staff’s cognitive level, analysing and dealing with ethical dilemmas [ 39 ], and clinical research ethics training can be taught from various aspects such as the basis of ethical review, procedures, and how to apply for ethical review of scientific research, etc., so the more training you participate in, the more comprehensive the knowledge you acquire, and the more positive the ethical attitudes are. Therefore, nursing managers should pay attention to the ethical atmosphere and education to improve the enthusiasm of nurses to participate in ethical training, and then translate the value theory of research ethics into clinical ethical norms, and play a guiding and warning role in clinical practice [ 40 ].

The most important finding in the present study was that the cognitive score was not related to whether the hospital had an ethics committee, but the attitude score was. The reason for this may be that hospitals with ethics committees have more comprehensive ethical review systems and can regularly conduct publicity and ethical lectures for the entire medical staff, thus improving their attitudes towards clinical research ethics, but the improvement of ethical knowledge requires one’s own proactive understanding and study. However, a survey of 73 hospitals in China on the implementation of ethical review systems and review programmes found that most of the hospitals had problems such as irrational structure of the ethics committee members, imperfect ethical review process and lack of consistency in the review contents [ 41 ]. Therefore, we need to strengthen the construction of ethics committees in Chinese hospitals and develop a more standardised review mechanism [ 42 ], so as to ensure the quality of clinical research projects and better protect the rights and interests of subjects.

Limitations

There are some limitations that must be considered: (1) the cross-sectional survey makes it difficult to identify the causal relationships between the variables; (2) the N was not large enough to detect significant differences ; (3) the participants were all nurses from one province and (4)the content of questionnaire items is not wide enough. Therefore, the differences in clinical research ethics knowledge and attitudes of nurses in hospitals in different provinces and regions of China need to be explored. It is recommended that a more scientific and comprehensive questionnaire should be set up next, and a larger sample and multi-center investigation and research should be conducted in each province. In the future, the level of nurses’ knowledge, attitude and practice towards clinical research ethics can also be explored from the theory of knowledge, attitude and practice(KAP) the facilitating and inhibiting factors affecting knowledge, attitude and practice can be analysed. This will provide a reference for nurses to carry out personalized training on clinical research ethics, and suggest precise countermeasures to improve the level of knowledge and attitude of all Chinese nurses towards clinical research ethics.

Nurses in one province in China scored low on the cognitive dimension of clinical research ethics but high on the attitudinal dimension. Nurses scored highest on the “content of informed consent” and lowest on the two “situational judgement questions”. In addition to degree, technical title, grade of hospital, number of clinical research projects chaired in one year and whether to participate in training related to ethical knowledge. Whether the hospital has an ethics committee was associated with the nurses’ attitude towards clinical research ethics .

Therefore, nursing managers know which aspects of nurses’ knowledge need to be strengthened in terms of clinical research ethics knowledge. In order to improve nurses’ knowledge of clinical research ethics, nursing managers need to give full consideration to these low-scoring entries and the influencing factors when setting up training courses on clinical research ethics, and explore effective training modes and targeted strategies according to different situations in order to ensure the effectiveness of training implementation. It is hoped that in the future, nursing managers in different levels of hospitals can set up specialized, systematic, standardized and procedural clinical research ethics training courses according to their own weaknesses and needs, and evaluate the effectiveness of the training afterwards. We still need to conduct deeper research in this area.

Data availability

Data is provided within the manuscript or supplementary information files.

Aijing L, Juan L, Yulei LCX, Guoping Y. Survey and analysis of public awareness of clinical research in China. J Cent South Univ. 2023;48(1):130–7.

Google Scholar  

Sadoughi F, Azadi T, Azadi T. Barriers to using electronic evidence based literature in nursing practice:a systematised review. Health Info Libr J. 2017;34(3):187–99.

Article   PubMed   Google Scholar  

Cleary M, Sayers J, Watson R. Essentials of building a career in nursing research. Nurse Res. 2016;23(6):9–13.

Schick-Makaroff K, Storch JL. Guidance for ethical Leadership in nursing codes of Ethics: an integrative review. Nurs Leadersh (Tor Ont). 2019;32(1):60–73.

Migliore LA, Killian JM. Ethical considerations for nursing Research with Military populations. Annu Rev Nurs Res. 2018;36(1):107–29.

Luan Jia D, Qiangting L, Yue Z, Yilin L, Jie S, Fei L, Na C, Ximin X, Wenhong. Du Liang. Construction of quality evaluation index system for medical clinical research papers. China Sci Technol J Res. 2023;34(02):144–55.

Furuya-Kanamori L, Xu C, Hasan SS, Doi SA. Quality versus Risk-of-Bias assessment in clinical research. J Clin Epidemiol. 2021;129:172–5.

Murphy S, Nolan C, O’Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clin Otolaryngol. 2015;40(1):36–40.

Article   CAS   PubMed   Google Scholar  

Taljaard M, Hemming K, Shah L, Giraudeau B, Grimshaw JM, Weijer C. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: results from a systematic review. Clin Trials. 2017;14(4):333–41.

Peng J, Hui ZY. Nursing research in three regions in China: a bibliometric study. Int Nurs Rev. 2011;58(1):21–5.

Zhang J, Yan QY, Yue S. Nursing research capacity and its management in China: a systematic review. J Nurs Manag. 2020;28(2):199–208.

Shrestha B, Dunn L. The declaration of Helsinki on Medical Research involving human subjects: a review of Seventh Revision. J Nepal Health Res Counc. 2020;17(4):548–52.

Li Fengsan Y. The role of ethics committees in the protection of subject/patient rights and interests under the new situation. Chin J Clin Pharmacol. 2020;36(19):3165–8.

Mo L, Urbauer DL, Bruera E, Hui D. Recommendations for Palliative and Hospice Care in NCCN guidelines for treatment of Cancer. Oncologist. 2021;26(1):77–83.

Fadare J, ODesalu, Olufemi O. Knowledge of medical ethics among Nigerian medical doctors. Nigerian Med Journal: J Nigeria Med Association. 2021; (53): 226–30.

Boer MCD, Zanin A, Latour JM, Brierley J. Paediatric residents and fellows Ethics (PERFEct) survey: perceptions of European trainees regarding ethical dilemmas. Eur J Pediatr. 2022;181(2):561–70.

Pakizekho S, Barkhordari-Sharifabad M. The relationship between ethical leadership, conscientiousness, and moral courage from nurses’ perspective. BMC Nurs. 2022;21(1):164.

Lv Yue, Li Tianzhi, Hou Huiru, A preliminary study of medical ethics knowledge cognition and education for healthcare workers in geriatric wards. China Medical Ethics. 2018; 31(1): 124–127.

Taghadosi M, Valiee S, Aghajani M. Nursing faculty’s point of view regarding noncompliance with ethics in academic environments: a qualitative study. BMC Nurs. 2021;20(1):15.

Article   PubMed   PubMed Central   Google Scholar  

Gelling L, Ersser S, Heaslip V, Tait D, Trenoweth S. Ethical conduct of nursing research. J Clin Nurs. 2021;30(23–24):e69–71.

PubMed   Google Scholar  

Ali R, Piscitello G. Improving knowledge, attitudes, and skills of Medical clinicians and trainees in Clinical Medical Ethics. Am J Hosp Palliat Care. 2022;39(12):1467–74.

Zhu L, Zhang N, Hu Y, Xu Y, Luo T, Xiang Y, Jiang S, Zhang Z, Chen M, Xiong Y. Influencing factors of knowledge, attitude and behavior in children’s palliative care among pediatric healthcare workers: a cross-sectional survey in China. BMC Palliat Care. 2023;22(1):67.

Xie Jiangchuan X, Linli C, Liya P, Xinmei M, Pan C. Common protocol deviations and improvement measures in drug clinical trials. China Pharm. 2022;33(13):1554–8.

Cao Liya X, Linli X, Jiangchuan P, Xinmei M, Pan C. Key points and analysis of on-site verification of drug clinical trial data after the implementation of the 2020 version of the code of practice for the Quality Management of Drug Clinical trials. Chin J New Drugs. 2023;32(3):264–9.

Alba B. Factors that impact on emergency nurses’ ethical decision-making ability. Nurs Ethics. 2018;25(7):855–66.

Hoseinialiabadi P, Omidi A, Arab M. Knowledge and attitude toward professional ethics: a study among Iranian medical and nursing students. J Educ Health Promot. 2022;11:7.

Famuyide M, Compretta C, Ellis M. Neonatal nurse practitioner ethics knowledge and attitudes. Nurs Ethics. 2019;26(7–8):2247–58.

Asare P, Ansah EW, Sambah F. Ethics in healthcare: knowledge, attitude and practices of nurses in the Cape Coast Metropolis of Ghana. PLoS ONE. 2022;17(2):e0263557.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Kassa H, Murugan R, Zewdu F. Assessment of knowledge, attitude and practice and associated factors towards palliative care among nurses working in selected hospitals, Addis Ababa, Ethiopia. BMC Palliat Care. 2014;13(1):6.

Couture V, Roy MC, Dez E, Laperle S, Bélisle-Pipon JC. Ethical Implications of Artificial Intelligence in Population Health and the Public’s role in its governance: perspectives from a Citizen and Expert Panel. J Med Internet Res. 2023;25:e44357.

Du Meichen OY, Yanqiong L. Comparison and evaluation of ethical quality of nursing literature among Chinese scholars at home and abroad. J Nurs. 2019;34(15):98–101.

Xie Wenhong P, Yongyi. Zhang Guangqing.Analysis of the status of research ethical behavior of nursing science and technology journal authors and strategies for improvement. Sci Technol Communication. 2022;14(7):11–5.

Azakir B, Mobarak H, Al NS. Knowledge and attitudes of physicians toward research ethics and scientific misconduct in Lebanon. BMC Med Ethics. 2020;21(1):39.

Storaker A, Heggestad AKT, Sæteren B. Ethical challenges and lack of ethical language in nurse leadership. Nurs Ethics. 2022;29(6):1372–85.

Zhu Linghong H, Xiumin Z, Jingni. A survey on the current status of clinical research ethics awareness among medical staff at all levels of hospitals in Qinghai Province. China Med Ethics. 2017;30(6):753–6.

Ayoub NM, Qandil AM, McCutchan JA. Knowledge, attitudes, and Practice Regarding Research Ethics Committees among Health Care Faculty at two public universities in Jordan. J Empir Res Hum Res Ethics. 2019;14(4):372–82.

Germán NH, Rosemarie B. A survey in Mexico about ethics dumping in clinical research. BMC Med Ethics. 2019;20(1):38.

Robichaux C, Grace P, Bartlett J, Stokes F, Saulo Lewis M, Turner M. Ethics Education for nurses: foundations for an Integrated Curriculum. J Nurs Educ. 2022;61(3):123–30.

Liu Junlin Y. Reflections on the influencing factors of research ethics identity of medical postgraduates in China and their educational programs and assessment. Sci Technol Manage Res. 2023;43(8):127–32.

Kang JS. Ethics and Industry interactions: impact on Specialty Training, Clinical Practice, and Research. Rheum Dis Clin North Am. 2020;46(1):119–33.

Paumgartten FJR. Equipoise, placebo in clinical trials and Brazilian code of Medical Ethics. Rev Assoc Med Bras. 1992;67(4):490–5.

Article   Google Scholar  

Lei F, Du L, Dong M. Reflections on medical journals’ response to medical ethics in the context of artificial intelligence. J Editing. 2023;35(3):263–7.

Leung SOC, Chan CC, Shah S. Development of a Chinese version of the modified Barthel Index validity and relia- bility. Clin Rehabil. 2007;21(10):912–22.

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Acknowledgements

We express our deep gratitude to nurses from Hunan Province for their willingness and cooperation in the study.

This work was supported by Scientific Research Program of Hunan Provincial Health Commission, China (grant number 20200634), Research Project of the Hunan Provincial Nursing Association, China(grant number HNKY202203), Scientific Research Program of Hunan Provincial Health Commission, China (grant number D202314058012) and Research project of Chinese Nursing Association, China (grant number ZHKY202305).

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Zhang, N., Cheng, Q., Lu, W. et al. Current status and influencing factors of nurses’ knowledge and attitudes towards clinical research ethical in China: a province-wide cross-sectional survey. BMC Nurs 23 , 671 (2024). https://doi.org/10.1186/s12912-024-02332-x

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Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts

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• Marie-Josée Drolet   ORCID: orcid.org/0000-0001-8384-4193 1 ,
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In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

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Introduction

Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted ). University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity), insufficient access to research funds, and within a market economy that values productivity and speed often to the detriment of quality or rigour – this research context creates a perfect recipe for breaches in research ethics, like research misbehaviour or misconduct (i.e., conduct that is ethically questionable or unacceptable because it contravenes the accepted norms of responsible conduct of research or compromises the respect of core ethical values that are widely held by the research community) (Drolet & Girard, 2020 ; Sieber, 2004 ). Problematic ethics and integrity issues – e.g., conflicts of interest, falsification of data, non-respect of participants’ rights, and plagiarism, to name but a few – have the potential to both undermine the credibility of research and lead to negative consequences for many stakeholders, including researchers, research assistants and personnel, research participants, academic institutions, and society as a whole (Drolet & Girard, 2020 ). It is thus evident that the academic community should be able to identify these different ethical issues in order to evaluate the nature of the risks that they pose (and for whom), and then work towards their prevention or management (i.e., education, enhanced policies and procedures, risk mitigation strategies).

In this article, we define an “ethical issue” as any situation that may compromise, in whole or in part, the respect of at least one moral value (Swisher et al., 2005 ) that is considered socially legitimate and should thus be respected. In general, ethical issues occur at three key moments or stages of the research process: (1) research design (i.e., conception, project planning), (2) research conduct (i.e., data collection, data analysis) and (3) knowledge translation or communication (e.g., publications of results, conferences, press releases) (Drolet & Ruest, accepted ). According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods. Many of these issues are related to breaches of research ethics norms, misbehaviour or research misconduct. Bruhn et al., ( 2002 ) developed a typology of misbehaviour and misconduct in academia that can be used to judge the seriousness of different cases. This typology takes into consideration two axes of reflection: (a) the origin of the situation (i.e., is it the researcher’s own fault or due to the organizational context?), and (b) the scope and severity (i.e., is this the first instance or a recurrent behaviour? What is the nature of the situation? What are the consequences, for whom, for how many people, and for which organizations?).

A previous detailed review of the international literature on ethical issues in research revealed several interesting findings (Beauchemin et al., 2021 ). Indeed, the current literature is dominated by descriptive ethics, i.e., the sharing by researchers from various disciplines of the ethical issues they have personally experienced. While such anecdotal documentation is relevant, it is insufficient because it does not provide a global view of the situation. Among the reviewed literature, empirical studies were in the minority (Table  1 ) – only about one fifth of the sample (n = 19) presented empirical research findings on ethical issues in research. The first of these studies was conducted almost 50 years ago (Hunt et al., 1984 ), with the remainder conducted in the 1990s. Eight studies were conducted in the United States (n = 8), five in Canada (n = 5), three in England (n = 3), two in Sweden (n = 2) and one in Ghana (n = 1).

Further, the majority of studies in our sample (n = 12) collected the perceptions of a homogeneous group of participants, usually researchers (n = 14) and sometimes health professionals (n = 6). A minority of studies (n = 7) triangulated the perceptions of diverse research stakeholders (i.e., researchers and research participants, or students). To our knowledge, only one study has examined perceptions of ethical issues in research by research ethics board members (REB; Institutional Review Boards [IRB] in the USA), and none to date have documented the perceptions of research ethics experts. Finally, nine studies (n = 9) adopted a qualitative design, seven studies (n = 7) a quantitative design, and three (n = 3) a mixed-methods design.

More studies using empirical research methods are needed to better identify broader trends, to enrich discussions on the values that should govern responsible conduct of research in the academic community, and to evaluate the means by which these values can be supported in practice (Bahn, 2012 ; Beauchemin et al., 2021 ; Bruhn et al., 2002 ; Henderson et al., 2013 ; Resnik & Elliot, 2016; Sieber 2004 ). To this end, we conducted an empirical qualitative study to document the perceptions and experiences of a heterogeneous group of Canadian researchers, REB members, and research ethics experts, to answer the following broad question: What are the ethical issues in research?

Research Methods

Research design.

A qualitative research approach involving individual semi-structured interviews was used to systematically document ethical issues (De Poy & Gitlin, 2010 ; Hammell et al., 2000 ). Specifically, a descriptive phenomenological approach inspired by the philosophy of Husserl was used (Husserl, 1970 , 1999 ), as it is recommended for documenting the perceptions of ethical issues raised by various practices (Hunt & Carnavale, 2011 ).

Ethical considerations

The principal investigator obtained ethics approval for this project from the Research Ethics Board of the Université du Québec à Trois-Rivières (UQTR). All members of the research team signed a confidentiality agreement, and research participants signed the consent form after reading an information letter explaining the nature of the research project.

Sampling and recruitment

As indicated above, three types of participants were sought: (1) researchers from different academic disciplines conducting research (i.e., theoretical, fundamental or empirical) in Canadian universities; (2) REB members working in Canadian organizations responsible for the ethical review, oversight or regulation of research; and (3) research ethics experts, i.e., academics or ethicists who teach research ethics, conduct research in research ethics, or are scholars who have acquired a specialization in research ethics. To be included in the study, participants had to work in Canada, speak and understand English or French, and be willing to participate in the study. Following Thomas and Polio’s (2002) recommendation to recruit between six and twelve participants (for a homogeneous sample) to ensure data saturation, for our heterogeneous sample, we aimed to recruit approximately twelve participants in order to obtain data saturation. Having used this method several times in related projects in professional ethics, data saturation is usually achieved with 10 to 15 participants (Drolet & Goulet, 2018 ; Drolet & Girard, 2020 ; Drolet et al., 2020 ). From experience, larger samples only serve to increase the degree of data saturation, especially in heterogeneous samples (Drolet et al., 2017 , 2019 ; Drolet & Maclure, 2016 ).

Purposive sampling facilitated the identification of participants relevant to documenting the phenomenon in question (Fortin, 2010 ). To ensure a rich and most complete representation of perceptions, we sought participants with varied and complementary characteristics with regards to the social roles they occupy in research practice (Drolet & Girard, 2020 ). A triangulation of sources was used for the recruitment (Bogdan & Biklen, 2006 ). The websites of Canadian universities and Canadian health institution REBs, as well as those of major Canadian granting agencies (i.e., the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, Fonds de recherche du Quebec), were searched to identify individuals who might be interested in participating in the study. Further, people known by the research team for their knowledge and sensitivity to ethical issues in research were asked to participate. Research participants were also asked to suggest other individuals who met the study criteria.

Data Collection

Two tools were used for data collecton: (a) a socio-demographic questionnaire, and (b) a semi-structured individual interview guide. English and French versions of these two documents were used and made available, depending on participant preferences. In addition, although the interview guide contained the same questions, they were adapted to participants’ specific roles (i.e., researcher, REB member, research ethics expert). When contacted by email by the research assistant, participants were asked to confirm under which role they wished to participate (because some participants might have multiple, overlapping responsibilities) and they were sent the appropriate interview guide.

The interview guides each had two parts: an introduction and a section on ethical issues. The introduction consisted of general questions to put the participant at ease (i.e., “Tell me what a typical day at work is like for you”). The section on ethical issues was designed to capture the participant’s perceptions through questions such as: “Tell me three stories you have experienced at work that involve an ethical issue?” and “Do you feel that your organization is doing enough to address, manage, and resolve ethical issues in your work?”. Although some interviews were conducted in person, the majority were conducted by videoconference to promote accessibility and because of the COVID-19 pandemic. Interviews were digitally recorded so that the verbatim could be transcribed in full, and varied between 40 and 120 min in duration, with an average of 90 min. Research assistants conducted the interviews and transcribed the verbatim.

Data Analysis

The socio-demographic questionnaires were subjected to simple descriptive statistical analyses (i.e., means and totals), and the semi-structured interviews were subjected to qualitative analysis. The steps proposed by Giorgi ( 1997 ) for a Husserlian phenomenological reduction of the data were used. After collecting, recording, and transcribing the interviews, all verbatim were analyzed by at least two analysts: a research assistant (2nd author of this article) and the principal investigator (1st author) or a postdoctoral fellow (3rd author). The repeated reading of the verbatim allowed the first analyst to write a synopsis, i.e., an initial extraction of units of meaning. The second analyst then read the synopses, which were commented and improved if necessary. Agreement between analysts allowed the final drafting of the interview synopses, which were then analyzed by three analysts to generate and organize the units of meaning that emerged from the qualitative data.

Participants

Sixteen individuals (n = 16) participated in the study, of whom nine (9) identified as female and seven (7) as male (Table  2 ). Participants ranged in age from 22 to 72 years, with a mean age of 47.5 years. Participants had between one (1) and 26 years of experience in the research setting, with an average of 14.3 years of experience. Participants held a variety of roles, including: REB members (n = 11), researchers (n = 10), research ethics experts (n = 4), and research assistant (n = 1). As mentioned previously, seven (7) participants held more than one role, i.e., REB member, research ethics expert, and researcher. The majority (87.5%) of participants were working in Quebec, with the remaining working in other Canadian provinces. Although all participants considered themselves to be francophone, one quarter (n = 4) identified themselves as belonging to a cultural minority group.

With respect to their academic background, most participants (n = 9) had a PhD, three (3) had a post-doctorate, two (2) had a master’s degree, and two (2) had a bachelor’s degree. Participants came from a variety of disciplines: nine (9) had a specialty in the humanities or social sciences, four (4) in the health sciences and three (3) in the natural sciences. In terms of their knowledge of ethics, five (5) participants reported having taken one university course entirely dedicated to ethics, four (4) reported having taken several university courses entirely dedicated to ethics, three (3) had a university degree dedicated to ethics, while two (2) only had a few hours or days of training in ethics and two (2) reported having no knowledge of ethics.

• Ethical issues

As Fig.  1 illustrates, ten units of meaning emerge from the data analysis, namely: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. To illustrate the results, excerpts from verbatim interviews are presented in the following sub-sections. Most of the excerpts have been translated into English as the majority of interviews were conducted with French-speaking participants.

Ethical issues in research according to the participants

Research Integrity

The research environment is highly competitive and performance-based. Several participants, in particular researchers and research ethics experts, felt that this environment can lead both researchers and research teams to engage in unethical behaviour that reflects a lack of research integrity. For example, as some participants indicated, competition for grants and scientific publications is sometimes so intense that researchers falsify research results or plagiarize from colleagues to achieve their goals.

Some people will lie or exaggerate their research findings in order to get funding. Then, you see it afterwards, you realize: “ah well, it didn’t work, but they exaggerated what they found and what they did” (participant 14). Another problem in research is the identification of authors when there is a publication. Very often, there are authors who don’t even know what the publication is about and that their name is on it. (…) The time that it surprised me the most was just a few months ago when I saw someone I knew who applied for a teaching position. He got it I was super happy for him. Then I looked at his publications and … there was one that caught my attention much more than the others, because I was in it and I didn’t know what that publication was. I was the second author of a publication that I had never read (participant 14). I saw a colleague who had plagiarized another colleague. [When the colleague] found out about it, he complained. So, plagiarism is a serious [ethical breach]. I would also say that there is a certain amount of competition in the university faculties, especially for grants (…). There are people who want to win at all costs or get as much as possible. They are not necessarily going to consider their colleagues. They don’t have much of a collegial spirit (participant 10).

These examples of research misbehaviour or misconduct are sometimes due to or associated with situations of conflicts of interest, which may be poorly managed by certain researchers or research teams, as noted by many participants.

Conflict of interest

The actors and institutions involved in research have diverse interests, like all humans and institutions. As noted in Chap. 7 of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2018),

“researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (i.e., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour” (p. 92).

The sources of these conflicts are varied and can include interpersonal conflicts, financial partnerships, third-party pressures, academic or economic interests, a researcher holding multiple roles within an institution, or any other incentive that may compromise a researcher’s independence, integrity, and neutrality (TCPS2, 2018). While it is not possible to eliminate all conflicts of interest, it is important to manage them properly and to avoid temptations to behave unethically.

Ethical temptations correspond to situations in which people are tempted to prioritize their own interests to the detriment of the ethical goods that should, in their own context, govern their actions (Swisher et al., 2005 ). In the case of researchers, this refers to situations that undermine independence, integrity, neutrality, or even the set of principles that govern research ethics (TCPS2, 2018) or the responsible conduct of research. According to study participants, these types of ethical issues frequently occur in research. Many participants, especially researchers and REB members, reported that conflicts of interest can arise when members of an organization make decisions to obtain large financial rewards or to increase their academic profile, often at the expense of the interests of members of their research team, research participants, or even the populations affected by their research.

A company that puts money into making its drug work wants its drug to work. So, homeopathy is a good example, because there are not really any consequences of homeopathy, there are not very many side effects, because there are no effects at all. So, it’s not dangerous, but it’s not a good treatment either. But some people will want to make it work. And that’s a big issue when you’re sitting at a table and there are eight researchers, and there are two or three who are like that, and then there are four others who are neutral, and I say to myself, this is not science. I think that this is a very big ethical issue (participant 14). There are also times in some research where there will be more links with pharmaceutical companies. Obviously, there are then large amounts of money that will be very interesting for the health-care institutions because they still receive money for clinical trials. They’re still getting some compensation because its time consuming for the people involved and all that. The pharmaceutical companies have money, so they will compensate, and that is sometimes interesting for the institutions, and since we are a bit caught up in this, in the sense that we have no choice but to accept it. (…) It may not be the best research in the world, there may be a lot of side effects due to the drugs, but it’s good to accept it, we’re going to be part of the clinical trial (participant 3). It is integrity, what we believe should be done or said. Often by the pressure of the environment, integrity is in tension with the pressures of the environment, so it takes resistance, it takes courage in research. (…) There were all the debates there about the problems of research that was funded and then the companies kept control over what was written. That was really troubling for a lot of researchers (participant 5).

Further, these situations sometimes have negative consequences for research participants as reported by some participants.

Respect for research participants

Many research projects, whether they are psychosocial or biomedical in nature, involve human participants. Relationships between the members of research teams and their research participants raise ethical issues that can be complex. Research projects must always be designed to respect the rights and interests of research participants, and not just those of researchers. However, participants in our study – i.e., REB members, researchers, and research ethics experts – noted that some research teams seem to put their own interests ahead of those of research participants. They also emphasized the importance of ensuring the respect, well-being, and safety of research participants. The ethical issues related to this unit of meaning are: respect for free, informed and ongoing consent of research participants; respect for and the well-being of participants; data protection and confidentiality; over-solicitation of participants; ownership of the data collected on participants; the sometimes high cost of scientific innovations and their accessibility; balance between the social benefits of research and the risks to participants (particularly in terms of safety); balance between collective well-being (development of knowledge) and the individual rights of participants; exploitation of participants; paternalism when working with populations in vulnerable situations; and the social acceptability of certain types of research. The following excerpts present some of these issues.

Where it disturbs me ethically is in the medical field – because it’s more in the medical field that we’re going to see this – when consent forms are presented to patients to solicit them as participants, and then [these forms] have an average of 40 pages. That annoys me. When they say that it has to be easy to understand and all that, adapted to the language, and then the hyper-technical language plus there are 40 pages to read, I don’t understand how you’re going to get informed consent after reading 40 pages. (…) For me, it doesn’t work. I read them to evaluate them and I have a certain level of education and experience in ethics, and there are times when I don’t understand anything (participant 2). There is a lot of pressure from researchers who want to recruit research participants (…). The idea that when you enter a health care institution, you become a potential research participant, when you say “yes to a research, you check yes to all research”, then everyone can ask you. I think that researchers really have this fantasy of saying to themselves: “as soon as people walk through the door of our institution, they become potential participants with whom we can communicate and get them involved in all projects”. There’s a kind of idea that, yes, it can be done, but it has to be somewhat supervised to avoid over-solicitation (…). Researchers are very interested in facilitating recruitment and making it more fluid, but perhaps to the detriment of confidentiality, privacy, and respect; sometimes that’s what it is, to think about what type of data you’re going to have in your bank of potential participants? Is it just name and phone number or are you getting into more sensitive information? (participant 9).

In addition, one participant reported that their university does not provide the resources required to respect the confidentiality of research participants.

The issue is as follows: researchers, of course, commit to protecting data with passwords and all that, but we realize that in practice, it is more difficult. It is not always as protected as one might think, because professor-researchers will run out of space. Will the universities make rooms available to researchers, places where they can store these things, especially when they have paper documentation, and is there indeed a guarantee of confidentiality? Some researchers have told me: “Listen; there are even filing cabinets in the corridors”. So, that certainly poses a concrete challenge. How do we go about challenging the administrative authorities? Tell them it’s all very well to have an ethics committee, but you have to help us, you also have to make sure that the necessary infrastructures are in place so that what we are proposing is really put into practice (participant 4).

If the relationships with research participants are likely to raise ethical issues, so too are the relationships with students, notably research assistants. On this topic, several participants discussed the lack of supervision or recognition offered to research assistants by researchers as well as the power imbalances between members of the research team.

Lack of Supervision and Power Imbalances

Many research teams are composed not only of researchers, but also of students who work as research assistants. The relationship between research assistants and other members of research teams can sometimes be problematic and raise ethical issues, particularly because of the inevitable power asymmetries. In the context of this study, several participants – including a research assistant, REB members, and researchers – discussed the lack of supervision or recognition of the work carried out by students, psychological pressure, and the more or less well-founded promises that are sometimes made to students. Participants also mentioned the exploitation of students by certain research teams, which manifest when students are inadequately paid, i.e., not reflective of the number of hours actually worked, not a fair wage, or even a wage at all.

[As a research assistant], it was more of a feeling of distress that I felt then because I didn’t know what to do. (…) I was supposed to get coaching or be supported, but I didn’t get anything in the end. It was like, “fix it by yourself”. (…) All research assistants were supposed to be supervised, but in practice they were not (participant 1). Very often, we have a master’s or doctoral student that we put on a subject and we consider that the project will be well done, while the student is learning. So, it happens that the student will do a lot of work and then we realize that the work is poorly done, and it is not necessarily the student’s fault. He wasn’t necessarily well supervised. There are directors who have 25 students, and they just don’t supervise them (participant 14). I think it’s really the power relationship. I thought to myself, how I saw my doctorate, the beginning of my research career, I really wanted to be in that laboratory, but they are the ones who are going to accept me or not, so what do I do to be accepted? I finally accept their conditions [which was to work for free]. If these are the conditions that are required to enter this lab, I want to go there. So, what do I do, well I accepted. It doesn’t make sense, but I tell myself that I’m still privileged, because I don’t have so many financial worries, one more reason to work for free, even though it doesn’t make sense (participant 1). In research, we have research assistants. (…). The fact of using people… so that’s it, you have to take into account where they are, respect them, but at the same time they have to show that they are there for the research. In English, we say “carry” or take care of people. With research assistants, this is often a problem that I have observed: for grant machines, the person is the last to be found there. Researchers, who will take, use student data, without giving them the recognition for it (participant 5). The problem at our university is that they reserve funding for Canadian students. The doctoral clientele in my field is mostly foreign students. So, our students are poorly funded. I saw one student end up in the shelter, in a situation of poverty. It ended very badly for him because he lacked financial resources. Once you get into that dynamic, it’s very hard to get out. I was made aware of it because the director at the time had taken him under her wing and wanted to try to find a way to get him out of it. So, most of my students didn’t get funded (participant 16). There I wrote “manipulation”, but it’s kind of all promises all the time. I, for example, was promised a lot of advancement, like when I got into the lab as a graduate student, it was said that I had an interest in [this particular area of research]. I think there are a lot of graduate students who must have gone through that, but it is like, “Well, your CV has to be really good, if you want to do a lot of things and big things. If you do this, if you do this research contract, the next year you could be the coordinator of this part of the lab and supervise this person, get more contracts, be paid more. Let’s say: you’ll be invited to go to this conference, this big event”. They were always dangling something, but you have to do that first to get there. But now, when you’ve done that, you have to do this business. It’s like a bit of manipulation, I think. That was very hard to know who is telling the truth and who is not (participant 1).

These ethical issues have significant negative consequences for students. Indeed, they sometimes find themselves at the mercy of researchers, for whom they work, struggling to be recognized and included as authors of an article, for example, or to receive the salary that they are due. For their part, researchers also sometimes find themselves trapped in research structures that can negatively affect their well-being. As many participants reported, researchers work in organizations that set very high productivity standards and in highly competitive contexts, all within a general culture characterized by individualism.

Individualism and performance

Participants, especially researchers, discussed the culture of individualism and performance that characterizes the academic environment. In glorifying excellence, some universities value performance and productivity, often at the expense of psychological well-being and work-life balance (i.e., work overload and burnout). Participants noted that there are ethical silences in their organizations on this issue, and that the culture of individualism and performance is not challenged for fear of retribution or simply to survive, i.e., to perform as expected. Participants felt that this culture can have a significant negative impact on the quality of the research conducted, as research teams try to maximize the quantity of their work (instead of quality) in a highly competitive context, which is then exacerbated by a lack of resources and support, and where everything must be done too quickly.

The work-life balance with the professional ethics related to work in a context where you have too much and you have to do a lot, it is difficult to balance all that and there is a lot of pressure to perform. If you don’t produce enough, that’s it; after that, you can’t get any more funds, so that puts pressure on you to do more and more and more (participant 3). There is a culture, I don’t know where it comes from, and that is extremely bureaucratic. If you dare to raise something, you’re going to have many, many problems. They’re going to make you understand it. So, I don’t talk. It is better: your life will be easier. I think there are times when you have to talk (…) because there are going to be irreparable consequences. (…) I’m not talking about a climate of terror, because that’s exaggerated, it’s not true, people are not afraid. But people close their office door and say nothing because it’s going to make their work impossible and they’re not going to lose their job, they’re not going to lose money, but researchers need time to be focused, so they close their office door and say nothing (participant 16).

Researchers must produce more and more, and they feel little support in terms of how to do such production, ethically, and how much exactly they are expected to produce. As this participant reports, the expectation is an unspoken rule: more is always better.

It’s sometimes the lack of a clear line on what the expectations are as a researcher, like, “ah, we don’t have any specific expectations, but produce, produce, produce, produce.” So, in that context, it’s hard to be able to put the line precisely: “have I done enough for my work?” (participant 3).

Inadequate ethical Guidance

While the productivity expectation is not clear, some participants – including researchers, research ethics experts, and REB members – also felt that the ethical expectations of some REBs were unclear. The issue of the inadequate ethical guidance of research includes the administrative mechanisms to ensure that research projects respect the principles of research ethics. According to those participants, the forms required for both researchers and REB members are increasingly long and numerous, and one participant noted that the standards to be met are sometimes outdated and disconnected from the reality of the field. Multicentre ethics review (by several REBs) was also critiqued by a participant as an inefficient method that encumbers the processes for reviewing research projects. Bureaucratization imposes an ever-increasing number of forms and ethics guidelines that actually hinder researchers’ ethical reflection on the issues at stake, leading the ethics review process to be perceived as purely bureaucratic in nature.

The ethical dimension and the ethical review of projects have become increasingly bureaucratized. (…) When I first started working (…) it was less bureaucratic, less strict then. I would say [there are now] tons of forms to fill out. Of course, we can’t do without it, it’s one of the ways of marking out ethics and ensuring that there are ethical considerations in research, but I wonder if it hasn’t become too bureaucratized, so that it’s become a kind of technical reflex to fill out these forms, and I don’t know if people really do ethical reflection as such anymore (participant 10). The fundamental structural issue, I would say, is the mismatch between the normative requirements and the real risks posed by the research, i.e., we have many, many requirements to meet; we have very long forms to fill out but the research projects we evaluate often pose few risks (participant 8). People [in vulnerable situations] were previously unable to participate because of overly strict research ethics rules that were to protect them, but in the end [these rules] did not protect them. There was a perverse effect, because in the end there was very little research done with these people and that’s why we have very few results, very little evidence [to support practices with these populations] so it didn’t improve the quality of services. (…) We all understand that we have to be careful with that, but when the research is not too risky, we say to ourselves that it would be good because for once a researcher who is interested in that population, because it is not a very popular population, it would be interesting to have results, but often we are blocked by the norms, and then we can’t accept [the project] (participant 2).

Moreover, as one participant noted, accessing ethics training can be a challenge.

There is no course on research ethics. […] Then, I find that it’s boring because you go through university and you come to do your research and you know how to do quantitative and qualitative research, but all the research ethics, where do you get this? I don’t really know (participant 13).

Yet, such training could provide relevant tools to resolve, to some extent, the ethical issues that commonly arise in research. That said, and as noted by many participants, many ethical issues in research are related to social injustices over which research actors have little influence.

Social Injustices

For many participants, notably researchers, the issues that concern social injustices are those related to power asymmetries, stigma, or issues of equity, diversity, and inclusion, i.e., social injustices related to people’s identities (Blais & Drolet, 2022 ). Participants reported experiencing or witnessing discrimination from peers, administration, or lab managers. Such oppression is sometimes cross-sectional and related to a person’s age, cultural background, gender or social status.

I have my African colleague who was quite successful when he arrived but had a backlash from colleagues in the department. I think it’s unconscious, nobody is overtly racist. But I have a young person right now who is the same, who has the same success, who got exactly the same early career award and I don’t see the same backlash. He’s just as happy with what he’s doing. It’s normal, they’re young and they have a lot of success starting out. So, I think there is discrimination. Is it because he is African? Is it because he is black? I think it’s on a subconscious level (participant 16).

Social injustices were experienced or reported by many participants, and included issues related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when one researcher is a woman.

If you do international research, there are things you can’t talk about (…). It is really a barrier to research to not be able to (…) address this question [i.e. the question of inequalities between men and women]. Women’s inequality is going to be addressed [but not within the country where the research takes place as if this inequality exists elsewhere but not here]. There are a lot of women working on inequality issues, doing work and it’s funny because I was talking to a young woman who works at Cairo University and she said to me: “Listen, I saw what you had written, you’re right. I’m willing to work on this but guarantee me a position at your university with a ticket to go”. So yes, there are still many barriers [for women in research] (participant 16).

Because of the varied contextual characteristics that intervene in their occurrence, these social injustices are also related to distributive injustices, as discussed by many participants.

Distributive Injustices

Although there are several views of distributive justice, a classical definition such as that of Aristotle ( 2012 ), describes distributive justice as consisting in distributing honours, wealth, and other social resources or benefits among the members of a community in proportion to their alleged merit. Justice, then, is about determining an equitable distribution of common goods. Contemporary theories of distributive justice are numerous and varied. Indeed, many authors (e.g., Fraser 2011 ; Mills, 2017 ; Sen, 2011 ; Young, 2011 ) have, since Rawls ( 1971 ), proposed different visions of how social burdens and benefits should be shared within a community to ensure equal respect, fairness, and distribution. In our study, what emerges from participants’ narratives is a definite concern for this type of justice. Women researchers, francophone researchers, early career researchers or researchers belonging to racialized groups all discussed inequities in the distribution of research grants and awards, and the extra work they need to do to somehow prove their worth. These inequities are related to how granting agencies determine which projects will be funded.

These situations make me work 2–3 times harder to prove myself and to show people in power that I have a place as a woman in research (participant 12). Number one: it’s conservative thinking. The older ones control what comes in. So, the younger people have to adapt or they don’t get funded (participant 14).

Whether it is discrimination against stigmatized or marginalized populations or interest in certain hot topics, granting agencies judge research projects according to criteria that are sometimes questionable, according to those participants. Faced with difficulties in obtaining funding for their projects, several strategies – some of which are unethical – are used by researchers in order to cope with these situations.

Sometimes there are subjects that everyone goes to, such as nanotechnology (…), artificial intelligence or (…) the therapeutic use of cannabis, which are very fashionable, and this is sometimes to the detriment of other research that is just as relevant, but which is (…), less sexy, less in the spirit of the time. (…) Sometimes this can lead to inequities in the funding of certain research sectors (participant 9). When we use our funds, we get them given to us, we pretty much say what we think we’re going to do with them, but things change… So, when these things change, sometimes it’s an ethical decision, but by force of circumstances I’m obliged to change the project a little bit (…). Is it ethical to make these changes or should I just let the money go because I couldn’t use it the way I said I would? (participant 3).

Moreover, these distributional injustices are not only linked to social injustices, but also epistemic injustices. Indeed, the way in which research honours and grants are distributed within the academic community depends on the epistemic authority of the researchers, which seems to vary notably according to their language of use, their age or their gender, but also to the research design used (inductive versus deductive), their decision to use (or not use) animals in research, or to conduct activist research.

Epistemic injustices

The philosopher Fricker ( 2007 ) conceptualized the notions of epistemic justice and injustice. Epistemic injustice refers to a form of social inequality that manifests itself in the access, recognition, and production of knowledge as well as the various forms of ignorance that arise (Godrie & Dos Santos, 2017 ). Addressing epistemic injustice necessitates acknowledging the iniquitous wrongs suffered by certain groups of socially stigmatized individuals who have been excluded from knowledge, thus limiting their abilities to interpret, understand, or be heard and account for their experiences. In this study, epistemic injustices were experienced or reported by some participants, notably those related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when a researcher is a woman or an early career researcher.

I have never sent a grant application to the federal government in English. I have always done it in French, even though I know that when you receive the review, you can see that reviewers didn’t understand anything because they are English-speaking. I didn’t want to get in the boat. It’s not my job to translate, because let’s be honest, I’m not as good in English as I am in French. So, I do them in my first language, which is the language I’m most used to. Then, technically at the administrative level, they are supposed to be able to do it, but they are not good in French. (…) Then, it’s a very big Canadian ethical issue, because basically there are technically two official languages, but Canada is not a bilingual country, it’s a country with two languages, either one or the other. (…) So I was not funded (participant 14).

Researchers who use inductive (or qualitative) methods observed that their projects are sometimes less well reviewed or understood, while research that adopts a hypothetical-deductive (or quantitative) or mixed methods design is better perceived, considered more credible and therefore more easily funded. Of course, regardless of whether a research project adopts an inductive, deductive or mixed-methods scientific design, or whether it deals with qualitative or quantitative data, it must respect a set of scientific criteria. A research project should achieve its objectives by using proven methods that, in the case of inductive research, are credible, reliable, and transferable or, in the case of deductive research, generalizable, objective, representative, and valid (Drolet & Ruest, accepted ). Participants discussing these issues noted that researchers who adopt a qualitative design or those who question the relevance of animal experimentation or are not militant have sometimes been unfairly devalued in their epistemic authority.

There is a mini war between quantitative versus qualitative methods, which I think is silly because science is a method. If you apply the method well, it doesn’t matter what the field is, it’s done well and it’s perfect ” (participant 14). There is also the issue of the place of animals in our lives, because for me, ethics is human ethics, but also animal ethics. Then, there is a great evolution in society on the role of the animal… with the new law that came out in Quebec on the fact that animals are sensitive beings. Then, with the rise of the vegan movement, [we must ask ourselves]: “Do animals still have a place in research?” That’s a big question and it also means that there are practices that need to evolve, but sometimes there’s a disconnection between what’s expected by research ethics boards versus what’s expected in the field (participant 15). In research today, we have more and more research that is militant from an ideological point of view. And so, we have researchers, because they defend values that seem important to them, we’ll talk for example about the fight for equality and social justice. They have pressure to defend a form of moral truth and have the impression that everyone thinks like them or should do so, because they are defending a moral truth. This is something that we see more and more, namely the lack of distance between ideology and science (participant 8).

The combination or intersectionality of these inequities, which seems to be characterized by a lack of ethical support and guidance, is experienced in the highly competitive and individualistic context of research; it provides therefore the perfect recipe for researchers to experience ethical distress.

Ethical distress

The concept of “ethical distress” refers to situations in which people know what they should do to act ethically, but encounter barriers, generally of an organizational or systemic nature, limiting their power to act according to their moral or ethical values (Drolet & Ruest, 2021 ; Jameton, 1984 ; Swisher et al., 2005 ). People then run the risk of finding themselves in a situation where they do not act as their ethical conscience dictates, which in the long term has the potential for exhaustion and distress. The examples reported by participants in this study point to the fact that researchers in particular may be experiencing significant ethical distress. This distress takes place in a context of extreme competition, constant injunctions to perform, and where administrative demands are increasingly numerous and complex to complete, while paradoxically, they lack the time to accomplish all their tasks and responsibilities. Added to these demands are a lack of resources (human, ethical, and financial), a lack of support and recognition, and interpersonal conflicts.

We are in an environment, an elite one, you are part of it, you know what it is: “publish or perish” is the motto. Grants, there is a high level of performance required, to do a lot, to publish, to supervise students, to supervise them well, so yes, it is clear that we are in an environment that is conducive to distress. (…). Overwork, definitely, can lead to distress and eventually to exhaustion. When you know that you should take the time to read the projects before sharing them, but you don’t have the time to do that because you have eight that came in the same day, and then you have others waiting… Then someone rings a bell and says: “ah but there, the protocol is a bit incomplete”. Oh yes, look at that, you’re right. You make up for it, but at the same time it’s a bit because we’re in a hurry, we don’t necessarily have the resources or are able to take the time to do things well from the start, we have to make up for it later. So yes, it can cause distress (participant 9). My organization wanted me to apply in English, and I said no, and everyone in the administration wanted me to apply in English, and I always said no. Some people said: “Listen, I give you the choice”, then some people said: “Listen, I agree with you, but if you’re not [submitting] in English, you won’t be funded”. Then the fact that I am young too, because very often they will look at the CV, they will not look at the project: “ah, his CV is not impressive, we will not finance him”. This is complete nonsense. The person is capable of doing the project, the project is fabulous: we fund the project. So, that happened, organizational barriers: that happened a lot. I was not eligible for Quebec research funds (…). I had big organizational barriers unfortunately (participant 14). At the time of my promotion, some colleagues were not happy with the type of research I was conducting. I learned – you learn this over time when you become friends with people after you enter the university – that someone was against me. He had another candidate in mind, and he was angry about the selection. I was under pressure for the first three years until my contract was renewed. I almost quit at one point, but another colleague told me, “No, stay, nothing will happen”. Nothing happened, but these issues kept me awake at night (participant 16).

This difficult context for many researchers affects not only the conduct of their own research, but also their participation in research. We faced this problem in our study, despite the use of multiple recruitment methods, including more than 200 emails – of which 191 were individual solicitations – sent to potential participants by the two research assistants. REB members and organizations overseeing or supporting research (n = 17) were also approached to see if some of their employees would consider participating. While it was relatively easy to recruit REB members and research ethics experts, our team received a high number of non-responses to emails (n = 175) and some refusals (n = 5), especially by researchers. The reasons given by those who replied were threefold: (a) fear of being easily identified should they take part in the research, (b) being overloaded and lacking time, and (c) the intrusive aspect of certain questions (i.e., “Have you experienced a burnout episode? If so, have you been followed up medically or psychologically?”). In light of these difficulties and concerns, some questions in the socio-demographic questionnaire were removed or modified. Talking about burnout in research remains a taboo for many researchers, which paradoxically can only contribute to the unresolved problem of unhealthy research environments.

Returning to the research question and objective

The question that prompted this research was: What are the ethical issues in research? The purpose of the study was to describe these issues from the perspective of researchers (from different disciplines), research ethics board (REB) members, and research ethics experts. The previous section provided a detailed portrait of the ethical issues experienced by different research stakeholders: these issues are numerous, diverse and were recounted by a range of stakeholders.

The results of the study are generally consistent with the literature. For example, as in our study, the literature discusses the lack of research integrity on the part of some researchers (Al-Hidabi et al., 2018 ; Swazey et al., 1993 ), the numerous conflicts of interest experienced in research (Williams-Jones et al., 2013 ), the issues of recruiting and obtaining the free and informed consent of research participants (Provencher et al., 2014 ; Keogh & Daly, 2009 ), the sometimes difficult relations between researchers and REBs (Drolet & Girard, 2020 ), the epistemological issues experienced in research (Drolet & Ruest, accepted; Sieber 2004 ), as well as the harmful academic context in which researchers evolve, insofar as this is linked to a culture of performance, an overload of work in a context of accountability (Berg & Seeber, 2016 ; FQPPU; 2019 ) that is conducive to ethical distress and even burnout.

If the results of the study are generally in line with those of previous publications on the subject, our findings also bring new elements to the discussion while complementing those already documented. In particular, our results highlight the role of systemic injustices – be they social, distributive or epistemic – within the environments in which research is carried out, at least in Canada. To summarize, the results of our study point to the fact that the relationships between researchers and research participants are likely still to raise worrying ethical issues, despite widely accepted research ethics norms and institutionalized review processes. Further, the context in which research is carried out is not only conducive to breaches of ethical norms and instances of misbehaviour or misconduct, but also likely to be significantly detrimental to the health and well-being of researchers, as well as research assistants. Another element that our research also highlighted is the instrumentalization and even exploitation of students and research assistants, which is another important and worrying social injustice given the inevitable power imbalances between students and researchers.

Moreover, in a context in which ethical issues are often discussed from a micro perspective, our study helps shed light on both the micro- and macro-level ethical dimensions of research (Bronfenbrenner, 1979 ; Glaser 1994 ). However, given that ethical issues in research are not only diverse, but also and above all complex, a broader perspective that encompasses the interplay between the micro and macro dimensions can enable a better understanding of these issues and thereby support the identification of the multiple factors that may be at their origin. Triangulating the perspectives of researchers with those of REB members and research ethics experts enabled us to bring these elements to light, and thus to step back from and critique the way that research is currently conducted. To this end, attention to socio-political elements such as the performance culture in academia or how research funds are distributed, and according to what explicit and implicit criteria, can contribute to identifying the sources of the ethical issues described above.

Contemporary culture characterized by the social acceleration

The German sociologist and philosopher Rosa (2010) argues that late modernity – that is, the period between the 1980s and today – is characterized by a phenomenon of social acceleration that causes various forms of alienation in our relationship to time, space, actions, things, others and ourselves. Rosa distinguishes three types of acceleration: technical acceleration , the acceleration of social changes and the acceleration of the rhythm of life . According to Rosa, social acceleration is the main problem of late modernity, in that the invisible social norm of doing more and faster to supposedly save time operates unchallenged at all levels of individual and collective life, as well as organizational and social life. Although we all, researchers and non-researchers alike, perceive this unspoken pressure to be ever more productive, the process of social acceleration as a new invisible social norm is our blind spot, a kind of tyrant over which we have little control. This conceptualization of the contemporary culture can help us to understand the context in which research is conducted (like other professional practices). To this end, Berg & Seeber ( 2016 ) invite faculty researchers to slow down in order to better reflect and, in the process, take care of their health and their relationships with their colleagues and students. Many women professors encourage their fellow researchers, especially young women researchers, to learn to “say No” in order to protect their mental and physical health and to remain in their academic careers (Allaire & Descheneux, 2022 ). These authors also remind us of the relevance of Kahneman’s ( 2012 ) work which demonstrates that it takes time to think analytically, thoroughly, and logically. Conversely, thinking quickly exposes humans to cognitive and implicit biases that then lead to errors in thinking (e.g., in the analysis of one’s own research data or in the evaluation of grant applications or student curriculum vitae). The phenomenon of social acceleration, which pushes the researcher to think faster and faster, is likely to lead to unethical bad science that can potentially harm humankind. In sum, Rosa’s invitation to contemporary critical theorists to seriously consider the problem of social acceleration is particularly insightful to better understand the ethical issues of research. It provides a lens through which to view the toxic context in which research is conducted today, and one that was shared by the participants in our study.

Clark & Sousa ( 2022 ) note, it is important that other criteria than the volume of researchers’ contributions be valued in research, notably quality. Ultimately, it is the value of the knowledge produced and its influence on the concrete lives of humans and other living beings that matters, not the quantity of publications. An interesting articulation of this view in research governance is seen in a change in practice by Australia’s national health research funder: they now restrict researchers to listing on their curriculum vitae only the top ten publications from the past ten years (rather than all of their publications), in order to evaluate the quality of contributions rather than their quantity. To create environments conducive to the development of quality research, it is important to challenge the phenomenon of social acceleration, which insidiously imposes a quantitative normativity that is both alienating and detrimental to the quality and ethical conduct of research. Based on our experience, we observe that the social norm of acceleration actively disfavours the conduct of empirical research on ethics in research. The fact is that researchers are so busy that it is almost impossible for them to find time to participate in such studies. Further, operating in highly competitive environments, while trying to respect the values and ethical principles of research, creates ethical paradoxes for members of the research community. According to Malherbe ( 1999 ), an ethical paradox is a situation where an individual is confronted by contradictory injunctions (i.e., do more, faster, and better). And eventually, ethical paradoxes lead individuals to situations of distress and burnout, or even to ethical failures (i.e., misbehaviour or misconduct) in the face of the impossibility of responding to contradictory injunctions.

Strengths and Limitations of the study

The triangulation of perceptions and experiences of different actors involved in research is a strength of our study. While there are many studies on the experiences of researchers, rarely are members of REBs and experts in research ethics given the space to discuss their views of what are ethical issues. Giving each of these stakeholders a voice and comparing their different points of view helped shed a different and complementary light on the ethical issues that occur in research. That said, it would have been helpful to also give more space to issues experienced by students or research assistants, as the relationships between researchers and research assistants are at times very worrying, as noted by a participant, and much work still needs to be done to eliminate the exploitative situations that seem to prevail in certain research settings. In addition, no Indigenous or gender diverse researchers participated in the study. Given the ethical issues and systemic injustices that many people from these groups face in Canada (Drolet & Goulet, 2018 ; Nicole & Drolet, in press ), research that gives voice to these researchers would be relevant and contribute to knowledge development, and hopefully also to change in research culture.

Further, although most of the ethical issues discussed in this article may be transferable to the realities experienced by researchers in other countries, the epistemic injustice reported by Francophone researchers who persist in doing research in French in Canada – which is an officially bilingual country but in practice is predominantly English – is likely specific to the Canadian reality. In addition, and as mentioned above, recruitment proved exceedingly difficult, particularly amongst researchers. Despite this difficulty, we obtained data saturation for all but two themes – i.e., exploitation of students and ethical issues of research that uses animals. It follows that further empirical research is needed to improve our understanding of these specific issues, as they may diverge to some extent from those documented here and will likely vary across countries and academic research contexts.

Conclusions

This study, which gave voice to researchers, REB members, and ethics experts, reveals that the ethical issues in research are related to several problematic elements as power imbalances and authority relations. Researchers and research assistants are subject to external pressures that give rise to integrity issues, among others ethical issues. Moreover, the current context of social acceleration influences the definition of the performance indicators valued in academic institutions and has led their members to face several ethical issues, including social, distributive, and epistemic injustices, at different steps of the research process. In this study, ten categories of ethical issues were identified, described and illustrated: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. The triangulation of the perspectives of different members (i.e., researchers from different disciplines, REB members, research ethics experts, and one research assistant) involved in the research process made it possible to lift the veil on some of these ethical issues. Further, it enabled the identification of additional ethical issues, especially systemic injustices experienced in research. To our knowledge, this is the first time that these injustices (social, distributive, and epistemic injustices) have been clearly identified.

Finally, this study brought to the fore several problematic elements that are important to address if the research community is to develop and implement the solutions needed to resolve the diverse and transversal ethical issues that arise in research institutions. A good starting point is the rejection of the corollary norms of “publish or perish” and “do more, faster, and better” and their replacement with “publish quality instead of quantity”, which necessarily entails “do less, slower, and better”. It is also important to pay more attention to the systemic injustices within which researchers work, because these have the potential to significantly harm the academic careers of many researchers, including women researchers, early career researchers, and those belonging to racialized groups as well as the health, well-being, and respect of students and research participants.

Al-Hidabi, Abdulmalek, M. D., & The, P. L. (2018). Multiple Publications: The Main Reason for the Retraction of Papers in Computer Science. In K. Arai, S. Kapoor, & R. Bhatia (eds), Future of Information and Communication Conference (FICC): Advances in Information and Communication, Advances in Intelligent Systems and Computing (AISC), Springer, vol. 886, pp. 511–526

Allaire, S., & Deschenaux, F. (2022). Récits de professeurs d’université à mi-carrière. Si c’était à refaire… . Presses de l’Université du Québec

Aristotle (2012). Aristotle’s Nicomachean Ethics . Chicago: The University of Chicago Press

Google Scholar  

Bahn, S. (2012). Keeping Academic Field Researchers Safe: Ethical Safeguards. Journal of Academic Ethics , 10 , 83–91. https://doi.org/10.1007/s10805-012-9159-2

Article   Google Scholar  

Balk, D. E. (1995). Bereavement Research Using Control Groups: Ethical Obligations and Questions. Death Studies , 19 , 123–138

Beauchemin, É., Côté, L. P., Drolet, M. J., & Williams-Jones, B. (2021). Conceptualizing Ethical Issues in the Conduct of Research: Results from a Critical and Systematic Literature Review. Journal of Academic Ethics , Early Online. https://doi.org/10.1007/s10805-021-09411-7

Berg, M., & Seeber, B. K. (2016). The Slow Professor . University of Toronto Press

Birchley, G., Huxtable, R., Murtagh, M., Meulen, R. T., Flach, P., & Gooberman-Hill, R. (2017). Smart homes, private homes? An empirical study of technology researchers’ perceptions of ethical issues in developing smart-home health technologies. BMC Medical Ethics , 18 (23), 1–13. https://doi.org/10.1186/s12910-017-0183-z

Blais, J., & Drolet, M. J. (2022). Les injustices sociales vécues en camp de réfugiés: les comprendre pour mieux intervenir auprès de personnes ayant séjourné dans un camp de réfugiés. Recueil annuel belge d’ergothérapie , 14, 37–48

Bogdan, R. C., & Biklen, S. K. (2006). Qualitative research in education: An introduction to theory and methods . Allyn & Bacon

Bouffard, C. (2000). Le développement des pratiques de la génétique médicale et la construction des normes bioéthiques. Anthropologie et Sociétés , 24 (2), 73–90. https://doi.org/10.7202/015650ar

Bronfenbrenner, U. (1979). The Ecology of Human development. Experiments by nature and design . Harvard University Press

Bruhn, J. G., Zajac, G., Al-Kazemi, A. A., & Prescott, L. D. (2002). Moral positions and academic conduct: Parameters of tolerance for ethics failure. Journal of Higher Education , 73 (4), 461–493. https://doi.org/10.1353/jhe.2002.0033

Clark, A., & Sousa (2022). It’s time to end Canada’s obsession with research quantity. University Affairs/Affaires universitaires , February 14th. https://www.universityaffairs.ca/career-advice/effective-successfull-happy-academic/its-time-to-end-canadas-obsession-with-research-quantity/?utm_source=University+Affairs+e-newsletter&utm_campaign=276a847f 70-EMAIL_CAMPAIGN_2022_02_16&utm_medium=email&utm_term=0_314bc2ee29-276a847f70-425259989

Colnerud, G. (2015). Ethical dilemmas in research in relation to ethical review: An empirical study. Research Ethics , 10 (4), 238–253. DOI: https://doi.org/10.1177/1747016114552339

Davison, J. (2004). Dilemmas in Research: Issues of Vulnerability and Disempowerment for the Social Workers/Researcher. Journal of Social Work Practice , 18 (3), 379–393. https://doi.org/10.1080/0265053042000314447

DePoy, E., & Gitlin, L. N. (2010). Introduction to Research . St. Louis: Elsevier Mosby

Drolet, M. J., & Goulet, M. (2018). Travailler avec des patients autochtones du Canada ? Perceptions d’ergothérapeutes du Québec des enjeux éthiques de cette pratique. Recueil annuel belge francophone d’ergothérapie , 10 , 25–56

Drolet, M. J., & Girard, K. (2020). Les enjeux éthiques de la recherche en ergothérapie: un portrait préoccupant. Revue canadienne de bioéthique , 3 (3), 21–40. https://doi.org/10.7202/1073779ar

Drolet, M. J., Girard, K., & Gaudet, R. (2020). Les enjeux éthiques de l’enseignement en ergothérapie: des injustices au sein des départements universitaires. Revue canadienne de bioéthique , 3 (1), 22–36. https://www.erudit.org/fr/revues/bioethics/2020-v3-n1-bioethics05237/1068761ar/

Drolet, M. J., & Maclure, J. (2016). Les enjeux éthiques de la pratique de l’ergothérapie: perceptions d’ergothérapeutes. Revue Approches inductives , 3 (2), 166–196

Drolet, M. J., Pinard, C., & Gaudet, R. (2017). Les enjeux éthiques de la pratique privée: des ergothérapeutes du Québec lancent un cri d’alarme. Ethica – Revue interdisciplinaire de recherche en éthique , 21 (2), 173–209

Drolet, M. J., & Ruest, M. (2021). De l’éthique à l’ergothérapie: un cadre théorique et une méthode pour soutenir la pratique professionnelle . Québec: Presses de l’Université du Québec

Book   Google Scholar  

Drolet, M. J., & Ruest, M. (accepted). Quels sont les enjeux éthiques soulevés par la recherche scientifique? In M. Lalancette & J. Luckerhoff (dir). Initiation au travail intellectuel et à la recherche . Québec: Presses de l’Université du Québec, 18 p

Drolet, M. J., Sauvageau, A., Baril, N., & Gaudet, R. (2019). Les enjeux éthiques de la formation clinique en ergothérapie. Revue Approches inductives , 6 (1), 148–179. https://www.erudit.org/fr/revues/approchesind/2019-v6-n1-approchesind04618/1060048ar/

Fédération québécoise des professeures et des professeurs d’université (FQPPU). (2019). Enquête nationale sur la surcharge administrative du corps professoral universitaire québécois. Principaux résultats et pistes d’action . Montréal: FQPPU

Fortin, M. H. (2010). Fondements et étapes du processus de recherche. Méthodes quantitatives et qualitatives . Montréal, QC: Chenelière éducation

Fraser, D. M. (1997). Ethical dilemmas and practical problems for the practitioner researcher. Educational Action Research , 5 (1), 161–171

Fraser, N. (2011). Qu’est-ce que la justice sociale? Reconnaissance et redistribution . La Découverte

Fricker, M. (2007). Epistemic Injustice: Power and the Ethics of Knowing . Oxford University Press

Giorgi, A. (1997). De la méthode phénoménologique utilisée comme mode de recherche qualitative en sciences humaines: théories, pratique et évaluation. In J. Poupart, L. H. Groulx, J. P. Deslauriers, et al. (Eds.), La recherche qualitative: enjeux épistémologiques et méthodologiques (pp. 341–364). Boucherville, QC: Gaëtan Morin

Giorgini, V., Mecca, J. T., Gibson, C., Medeiros, K., Mumford, M. D., Connelly, S., & Devenport, L. D. (2016). Researcher Perceptions of Ethical Guidelines and Codes of Conduct. Accountability in Research , 22 (3), 123–138. https://doi.org/10.1080/08989621.2014.955607

Glaser, J. W. (1994). Three realms of ethics: Individual, institutional, societal. Theoretical model and case studies . Kansas Cuty, Sheed & Ward

Godrie, B., & Dos Santos, M. (2017). Présentation: inégalités sociales, production des savoirs et de l’ignorance. Sociologie et sociétés , 49 (1), 7. https://doi.org/10.7202/1042804ar

Hammell, K. W., Carpenter, C., & Dyck, I. (2000). Using Qualitative Research: A Practical Introduction for Occupational and Physical Therapists . Edinburgh: Churchill Livingstone

Henderson, M., Johnson, N. F., & Auld, G. (2013). Silences of ethical practice: dilemmas for researchers using social media. Educational Research and Evaluation , 19 (6), 546–560. https://doi.org/10.1080/13803611.2013.805656

Husserl, E. (1970). The crisis of European sciences and transcendental phenomenology . Evanston, IL: Northwestern University Press

Husserl, E. (1999). The train of thoughts in the lectures. In E. C. Polifroni, & M. Welch (Eds.), Perspectives on Philosophy of Science in Nursing . Philadelphia, PA: Lippincott. 247 – 62. 43

Hunt, S. D., Chonko, L. B., & Wilcox, J. B. (1984). Ethical problems of marketing researchers. Journal of Marketing Research , 21 , 309–324

Hunt, M. R., & Carnevale, F. A. (2011). Moral experience: A framework for bioethics research. Journal of Medical Ethics , 37 (11), 658–662. https://doi.org/10.1136/jme.2010.039008

Jameton, A. (1984). Nursing practice: The ethical issues . Englewood Cliffs, Prentice-Hall

Jarvis, K. (2017). Dilemmas in International Research and the Value of Practical Wisdom. Developing World Bioethics , 17 (1), 50–58. DOI: https://doi.org/10.1111/dewb.12121

Kahneman, D. (2012). Système 1, système 2: les deux vitesses de la pensée . Paris: Flammarion

Keogh, B., & Daly, L. (2009). The ethics of conducting research with mental health service users. British Journal of Nursing , 18 (5), 277–281. https://doi.org/10.12968/bjon.2009.18.5.40539

Lierville, A. L., Grou, C., & Pelletier, J. F. (2015). Enjeux éthiques potentiels liés aux partenariats patients en psychiatrie: État de situation à l’Institut universitaire en santé mentale de Montréal. Santé mentale au Québec , 40 (1), 119–134

Lynöe, N., Sandlund, M., & Jacobsson, L. (1999). Research ethics committees: A comparative study of assessment of ethical dilemmas. Scandinavian Journal of Public Health , 27 (2), 152–159

Malherbe, J. F. (1999). Compromis, dilemmes et paradoxes en éthique clinique . Anjou: Éditions Fides

McGinn, R. (2013). Discernment and denial: Nanotechnology researchers’ recognition of ethical responsibilities related to their work. NanoEthics , 7 , 93–105. https://doi.org/10.1007/s11569-013-0174-6

Mills, C. W. (2017). Black Rights / White rongs. The Critique of Racial Liberalism . Oxford University Press

Miyazaki, A. D., & Taylor, K. A. (2008). Researcher interaction biases and business ethics research: Respondent reactions to researcher characteristics. Journal of Business Ethics , 81 (4), 779–795. DOI https://doi.org/10.1007/s10551-007-9547-5

Mondain, N., & Bologo, E. (2009). L’intentionnalité du chercheur dans ses pratiques de production des connaissances: les enjeux soulevés par la construction des données en démographie et santé en Afrique. Cahiers de recherche sociologique , 48 , 175–204. https://doi.org/10.7202/039772ar

Nicole, M., & Drolet, M. J. (in press). Fitting transphobia and cisgenderism in occupational therapy, Occupational Therapy Now

Pope, K. S., & Vetter, V. A. (1992). Ethical dilemmas encountered by members of the American Psychological Association: A national survey. The American Psychologist , 47 (3), 397–411

Provencher, V., Mortenson, W. B., Tanguay-Garneau, L., Bélanger, K., & Dagenais, M. (2014). Challenges and strategies pertaining to recruitment and retention of frail elderly in research studies: A systematic review. Archives of Gerontology and Geriatrics , 59 (1), 18–24. https://doi.org/10.1016/j.archger.2014.03.006

Rawls, J. (1971). A Theory of Justice . Harvard University Press

Resnik, D. B., & Elliott, K. C. (2016). The Ethical Challenges of Socially Responsible Science. Accountability in Research , 23 (1), 31–46. https://doi.org/10.1080/08989621.2014.1002608

Rosa, H. (2010). Accélération et aliénation. Vers une théorie critique de la modernité tardive . Paris, Découverte

Sen, A. K. (2011). The Idea of Justice . The Belknap Press of Harvard University Press

Sen, A. K. (1995). Inegality Reexaminated . Oxford University Press

Sieber, J. E. (2004). Empirical Research on Research Ethics. Ethics & Behavior , 14 (4), 397–412. https://doi.org/10.1207/s15327019eb1404_9

Sigmon, S. T. (1995). Ethical practices and beliefs of psychopathology researchers. Ethics & Behavior , 5 (4), 295–309

Swazey, J. P., Anderson, M. S., & Lewis, K. S. (1993). Ethical Problems in Academic Research. American Scientist , 81 (6), 542–553

Swisher, L. L., Arsalanian, L. E., & Davis, C. M. (2005). The realm-individual-process-situation (RIPS) model of ethical decision-making. HPA Resource , 5 (3), 3–8. https://www-s3-live.kent.edu/s3fs-root/s3fs-public/file/RIPS_DecisionMaking_0.pdf

Tri-Council Policy Statement (TCPS2) (2018). Ethical Conduct for Research Involving Humans . Government of Canada, Secretariat on Responsible Conduct of Research. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf

Thomas, S. P., & Pollio, H. R. (2002). Listening to Patients: A Phenomenological Approach to Nursing Research and Practice . New York: Springer Publishing Company

Wiegand, D. L., & Funk, M. (2012). Consequences of clinical situations that cause critical care nurses to experience moral distress. Nursing Ethics , 19 (4), 479–487. DOI https://doi.org/10.1177/0969733011429342

Williams-Jones, B., Potvin, M. J., Mathieu, G., & Smith, E. (2013). Barriers to research on research ethics review and conflicts of interest. IRB: Ethics & Human Research , 35 (5), 14–20

Young, I. M. (2011). Justice and the Politics of difference . Princeton University Press

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Acknowledgements

The team warmly thanks the participants who took part in the research and who made this study possible. Marie-Josée Drolet thanks the five research assistants who participated in the data collection and analysis: Julie-Claude Leblanc, Élie Beauchemin, Pénéloppe Bernier, Louis-Pierre Côté, and Eugénie Rose-Derouin, all students at the Université du Québec à Trois-Rivières (UQTR), two of whom were active in the writing of this article. MJ Drolet and Bryn Williams-Jones also acknowledge the financial contribution of the Social Sciences and Humanities Research Council of Canada (SSHRC), which supported this research through a grant. We would also like to thank the reviewers of this article who helped us improve it, especially by clarifying and refining our ideas.

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Drolet, MJ., Rose-Derouin, E., Leblanc, JC. et al. Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts. J Acad Ethics 21 , 269–292 (2023). https://doi.org/10.1007/s10805-022-09455-3

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5 Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, Oxfordshire, UK

6 Coventry and Warwickshire Partnership NHS Trust, Coventry, UK

Quality improvement (QI) provides a rigorous and innovative approach to improving patient's lives in the healthcare system. Still, it can pose challenges in understanding what ethical considerations apply to some projects to minimise the possibility of patient harm or prevent other ethical wrongs and potential staff burden. While many commentaries discuss the extent to which QI ethics should match research ethics, there is minimal literature regarding what QI project teams should do when considering ethics at the planning stage. This paper provides a practical walkthrough of some of the ethical considerations across the breadth of QI projects, starting from some of the key questions when planning a QI project and a guide for the different ethical considerations that may apply.

Introduction

The Health Foundation describes quality improvement (QI) as the systematic approach that uses techniques to improve healthcare quality. 1 QI projects vary in scale and can include individual-level, group-level and organisational-level tests of change that can involve large groups of staff, patients and their carers/families in one or across various healthcare settings. Following the Institute of Healthcare Improvement’s model involves a diagnostic stage to establish what the team is trying to accomplish, whether an improvement is possible, and what changes may result in an improvement. Following this diagnostic stage, one or more change ideas are tested using a Plan, Do, Study, Act cycle through an iterative process. 2 It is important to note that other QI approaches are utilised in healthcare, but this paper adopted the IHI model for QI to develop this guidance.

Although QI can create significant benefits, it can also shape patients’ care in ways that raise ethical questions concerning respect, dignity, harm and justice. In particular, QI in healthcare can involve changes in care delivery and have unanticipated adverse outcomes and cause harm to patients. 3 These harms vary from time spent completing unnecessary surveys to physical and psychological harm. Relatedly, the risk of changing care delivery must be measured on a risk/benefit basis and weighed against the increased risk to patients compared with usual care. 4 Poorly justified and delivered QI projects that are unlikely to yield positive results may not be ethically justified when considering the burden to patients. 5 As such, careful consideration needs to be paid to ensure that QI projects are delivered in fair and equitable ways and whether they might infringe on patients’ dignity or autonomy. Similarly, family/carer involvement, especially those who may be directly involved in care delivery, are at risk of potential harm from the consequences associated with conducting a poorly conceived and/or poorly delivered QI project.

As well as the potential patient harm and burden that may arise from a QI project, potential staff harm and burden also requires consideration. Typically, staff lead QI projects in their locality or service and are responsible for their completion. As such, they may accrue operational and emotional burdens from carrying out a project that detracts from direct patient contact or carries a perceived element of controlled or even uncontrolled risk.

Despite the potential associated benefits and costs of QI, there is much confusion over identifying the appropriate ethical considerations for QI and how to address these in a justifiable and practically feasible manner. In general, QI projects do not typically require the same ethical approval as research projects. 6 Any ethical rules in place for the conduct of QI activities are often unclear. 4 Furthermore, some QI projects do not require patient consent and clinician participation is not always voluntary. 7 These challenges are further compounded by the wide variation in QI projects and the extent to which ethical considerations must be applied.

The extent to which ethical oversights need to be established has led to many commentaries on the differences and similarities between ethics in QI and research. 6 8–10 This has been stimulated further by recent work in research ethics that has scrutinised the ethical obligations that arise within a ‘learning health system’. 11 12 The consensus is that QI activities cut across the established demarcation between clinical ethics and research ethics and that distinctive ethical requirements arise for implementing QI projects. While well-established ethical guidance is available for research activities, there is a paucity of information on how to conduct QI projects in an ethically defensible manner, despite the emergence of detailed, practical guidance for implementation research more generally. 13 The Healthcare Quality Improvement Partnership produced ethical guidance designed to differentiate between research, QI and clinical audit, and how these projects should be reviewed and monitored. 14 While this report provided helpful guidance for identifying some of the possible ethical issues, it does not provide clear, practical guidance that focuses on the day-to-day tasks associated with carrying out various stages of an ethical QI project and the ethical judgements that need to be made within these stages.

A lack of clear ethical guidance in a QI project can lead to ethical considerations being side-lined, ignored or addressed in a cursory manner, potentially giving rise to harms or the undermining of trust and accountability in healthcare settings. 15 Also, as healthcare staff often work in high-pressured environments, many might be tempted to adopt a pragmatic ‘get it done’ approach to QI projects and unintentionally miss critical ethical considerations. Furthermore, this lack of clear guidance for ethics in QI can lead to teams modifying projects to fit within a QI context to circumvent research ethics review requirements that often take a considerable amount of time. This practice is questionable because QI projects are not absent of ethical issues that ought to be attended to prior to being implemented.

This paper sets out a practical guide and ‘walkthrough’, tailored explicitly for ethical considerations in QI projects. This guidance was borne out of our collective experiential knowledge of supporting and leading QI projects in a mental healthcare setting. As such, the key questions and guidance are a composite of the experience of both managing ethical challenges across many projects with teams and QI project oversight meetings. First, we held a series of meetings to identify key themes, successes and lessons learnt from our experiences. Next, we selected QI project examples that would best illustrate how to apply our suggested guidance. Finally, we discussed the guidance with different QI leads and QI researchers locally to ensure that the key questions and guidance were fit for purpose and revised when necessary.

Unlike previous guidance, this paper provides a granularity of detail to guide novice and experienced QI teams through addressing the ethical dimensions of their projects, with due consideration for all parties involved. Furthermore, we intentionally designed the guidance to be as generalisable as possible and applicable, irrespective of the particular person implementing the QI project, whether this is a front-line clinician, executive leadership, or QI leads. Finally, the guidance is grounded in QI projects to maximise its usefulness to all involved in this work.

First, we set out a list of key questions to assist in identifying the range of ethical considerations that could present themselves when conducting a QI project. Next, we provid practical guidance that sets out the typical stages in a QI project and associated actions. Finally, we provide different QI examples and how these ethical considerations apply alongside the QI activities. Following this, we pull out some of the key themes and discuss their importance in a QI project context.

Key questions when conducting QI projects

As a QI project can vary considerably in the extent to which ethical considerations apply, teams must understand how their projects raise ethical considerations that they need to attend to, throughout the project, from planning through to implementation. These questions should consider the categories of patient and family/carer, staff involvement and burden, mental capacity and consent, accessing data, and whether there is a possibility of harm to any of the parties involved in the project. Box 1 provides some of the possible key questions when planning a QI project.

Questions when starting a QI project

Scope of the project.

• Is the project relating to the exercise or organisation of front-line healthcare provision or supporting healthcare duties?
• Are all relevant staff involved in scoping the project?

Patient and family/carer engagement

• Have you considered whether the method for engagement is suitable for all the project participants, given the overarching aim or specific QI project’s objectives?
• Do the patients and/or family members and carers understand the purpose of the QI project and their role in the project?
• Will there be any qualitative or quantitative data collection directly from patients and/or family members and carers?
• If so, how will these data be collected and by whom?

Staff engagement

• Is there a registered team member to provide oversight of the project and adhere to any local governance requirements?
• Are all relevant staff involved in all stages of the project?
• Are staff provided with appropriate time, support and training to lead or support a QI project?
• Are the staff members’ views or experiences being collected, documented and analysed/considered as part of the project?
• Have all concerns about the project and its feasibility been addressed? (These may include staffing capacity and capability concerns and concerns around the relative risk related to a proposed test of change).

Informed Consent

• If the project directly involves patients and/or family members and carers, who will facilitate the provision of informed consent?
• Who will assess mental capacity to give consent?
• Will consent/agreement be required from the lead clinician?
• How will consent be documented? By whom?
• If the project directly involves collecting data from staff, are staff fully informed about the project and what it will involve for them?

Accessing patient data

• Will the project require accessing identifiable patient information?
• Are relevant information governance procedures followed or advice needed?
• Does patient participation need to be recorded in their record? Who will take responsibility for this?
• How will the data be curated and analysed?

Possible distress and harm

• Is there any possibility of causing physical and/or psychological harm?
• Is there a risk of causing harm to the patient or vicarious trauma to the researcher or staff involved?
• Was the involvement itself, traumatic? If so, is there a plan to support the patients, family members, carers or staff members?

Key ethical considerations when conducting QI projects

When planning the breadth and extent to which ethical considerations apply to any given QI project, the next step is to consider the list of actions required at every project stage. Box 2 provides suggested actions throughout all project stages, focusing on what staff should do when conducting QI projects and incorporating them into their daily activities (see box 2 ). These align with the questions posed in box 1 .

Guidance for addressing ethical considerations in quality improvement (QI) projects

Stage and suggested actions, the impetus for the project.

• Attend a series of meetings with relevant gatekeepers and stakeholders to discuss the motivations for starting the project and the anticipated benefits to improve healthcare delivery.
• Where possible, include an evidence base (literature or data or both) to discuss the rationale behind why this work is important.
• Identify and explore the benefits and opportunities for QI capability building.
• Establish senior leader buy-in to protect time for staff to lead QI projects, if necessary.

Validity and value of the project

• Scope the evidence base for the tests of change considered.
• Ensure that the tests of change align with the project aims and that all those involved understand and contribute (where appropriate) to the diagnostic stage of the project.
• Ensure that measures are valid, reliable and have an evidence base.
• Establish a measurement strategy capable of reliably evaluating whether tests of changes are successful in improving patient care.
• Designate a QI lead (typically a clinician) to ensure that the project is viable and considered.
• Ensure that the project adheres to any local ethical oversights.

Staff, patient and family/carer engagement

• Engage staff, patient and family/carer viewpoints throughout the project to ensure that their insights inform whether the project is feasible and remains patient-centred (where appropriate).
• Empower and engage relevant staff taking ownership and leading the project.
• Remind all those involved about the importance of their engagement, the expectations regarding their involvement, and ensure they are credited throughout the project and beyond.
• Ensure staff are broadly on board with the project’s benefits and that they are fully informed about the impact on their day-to-day duties (eg, any additional time that may impact the amount of patient care provided).
• Consider the methodological approach when collecting views and whether they reflect all viewpoints and maximise their contributions.
• Ensure that accessible language used is understandable to the intended audience. Possibly pilot for all materials associated with a project (eg, questionnaires).
• Ensure that the questions will give insight into current practice.
• For QI, the questions should focus on improvement (ie, knowledge, perceptions and suggestions) and focus less on personal experience unless collecting data on direct experience is judged as critical to evaluating any improvement.
• Ensure that when collecting the views of patients and families/carers that it recognises the relevant sensitivities and vulnerabilities—start with a lighter opening question to serve as an ice breaker, gradually deepen the questions, and check if the patient is ok to return to the ward/their daily life.
• Ensure that engaging with patients is considered with minimal disruption to their current routine.
• Ensure flexibility when engaging with staff (eg, establishing protected time for their QI activities).
• Provide a comfortable and neutral space that allows staff and/or patients to have open and candid discussions.
• Be mindful of environmental considerations for more confidential and/or sensitive discussions.
• Be mindful of body posture and non-verbal cues when engaging staff, patients and family/carers about their views.
• Engage collaborative discussions in group settings and be inclusive but focused on integrating ideas into a project.

Informed consent

• Discuss patient recruitment with staff to be aware of any issues that may arise.
• Consult established guidance on producing information sheets and/or provide consent forms in the research ethics context.
• Patients and relevant family/carers should be prebriefed before the project takes place and understand the nature of the aims.
• Gain informed consent before patient involvement.
• Ensure that they understand what is happening and fully understand their right to withdraw and ask questions.
• Any relevant parent/carer needs to receive communication about the projects, including a right to object or ask any questions.
• Obtain consent from the clinical lead to indicate who may be willing to participate and who may not be suitable.
• Collect informed consent for staff and families/carers, when applicable.
• Create an appropriate procedure to anonymise the identity of each patient when necessary.
• Record consent and participation in patients’ records, where appropriate.

Patient information and data collection

• Collate the required information for measuring baseline and effectiveness of tests of change.
• Wherever possible, collect from existing data sources and avoid creating an additional burden on the staff’s time.
• Ensure that those accessing staff, patient and family/carer identifiable information have received the necessary training.
• Access any data using appropriate computer equipment (approved equipment or via agreed remote desktop access).
• Ensure that software used to explore/analyse data is safe and free from possible data breaches.
• Store all data in a secure location (eg, a secure drive within the organisation).
• Ensure that all data curation, handling and dissemination align with local data policies and are compliant with the Data Protection Act (2018).

Welfare and safeguarding

• Consider possible harm and burdens that might accrue to all those involved at all project stages.
• Ensure a risk assessment is in place if the staff, patients or family/carers involved become distressed or provide a disclosure during any part of the project (eg, collecting views, qualitative evaluation).
• Ensure that all parties involved know procedures to signpost individuals to relevant services (eg, a web link or print out to agreed internal and external services).
• All staff involved must receive safeguard training and understand local safeguarding policies.
• Ensure appropriate professional indemnity is in place, particularly when QI teams engage with services outside their immediate work environment.
• When collecting patient and/or family/carer views, consider including a staff member to act as a familiar face and comply with the safeguarding requirements above.
• There should be wellness checks with all parties involved when entering any potentially sensitive or difficult activity in a project.
• Record all sensitive activities with direct patient involvement on the electronic patient record.
• For sensitive discussions, interviews and focus groups, staff should be debriefed with an appropriate colleague (eg, a supervisor or manager) as part of the wellness check and to discuss the outcomes.

Application of ethical considerations to QI project examples

The extent to which ethical considerations apply to different QI projects varies drastically from project to project. For some projects, it is a matter of changing an administrative process that can impact patient outcomes further down the line. At the other extreme, it can involve exploring sensitive topics that may cause distress and harm to those involved. Table 1 provides examples of the different types of projects and what ethical considerations may be applied.

QI, quality improvement.

Boxes 1 and 2 , table 1 illuminate the numerous ethical considerations throughout any QI project, from inception to completion and beyond. The following section elaborates on some of the more pertinent ethical considerations in QI projects that pose particular complexities and are worthy of further reflection.

Patient, family/carer and staff views are essential to conducting ethical and safe QI projects that maximise the chances of improving healthcare. Incorporating patient and staff views ensures that any QI work is fit for purpose and patient-centred, reflecting their needs, and ensuring that their involvement is ‘with’ or ‘by’ patients and staff, rather than ‘to’ or ‘for’ them. 16 QI projects give rise to wide-ranging ethical considerations that concern all parties involved, as they typically experiment with changes in healthcare delivery that may be embedded into practice. Below, we discuss requirements to engage the different groups and how this is important in propagating ethical practice.

QI projects are unique from most research in two aspects. First, staff lead many of the QI projects as an integral part of their day. Second, any staff member at any level of the organisation can lead a QI project. Across all QI projects, healthcare organisations should also consider designating a senior leader to oversee whether QI projects are viable and maintain ethical monitoring, a point made in previous guidance. 14 Organisations may designate a leader in each service or directorate, create a dedicated team or assign these responsibilities to an existing team.

The QI leadership teams typically support these teams in simultaneously learning (if they are new to QI) and implementing a project in their service. This approach leads to two significant ethical considerations regarding the role of the staff leading the QI project. First, the extent to which their time is justifiable, especially for those who incur additional tasks that detract from patient care, typically in their current role. 17 The second is a possible emotional burden for staff conducting QI projects with an element of perceived risk (eg, reducing the length of stay that could increase readmission if the project is unsuccessful). These considerations are essential in all QI projects, especially when projects do not have total staff investment when starting a project. 18

Besides direct staff engagement, their engagement as stakeholders interested in the project and gatekeepers for their patient populations are equally important. Gatekeeper examples can include a broad range of audiences, such as carers and families of those that do not have mental capacity, the nursing or clinical lead (eg, Ward Manager or Matron), members of any advocacy team, and clinical medical leads (eg, consultant) or regulators (eg, specific boards with regulatory responsibilities). Decisions around allowing access to their group(s) should broadly follow three critical criteria:

• Minimising the risk of harm and maximising benefit from the QI project—both in their immediate service, relevant linked services and the wider community.
• Ensure that there are likely to be distinct benefits from the QI that align with organisational aims and/or current priorities.
• There will be a reasonable level of resource and support, depending on their commitment and what the QI project entails.

A valuable approach to staff engagement is collaborating with them throughout the project to design and carry out activities to achieve the aims. Relatedly, particular leadership behaviours encourage staff collaboration and engagement. These behaviours include compassionate and inclusive leadership that encourages psychologically safe practice and candid discourse at all stages of a QI project. 19–21 Both staff collaboration and leadership behaviours are vital for multiple reasons.

• Staff input is especially crucial for QI project focus, diagnosis and suitability of a QI project that positively influences patient treatment and experience.
• Leadership engagement will directly impact whether projects are embedded in routine practice and sustained.
• Leadership and staff collaboration can find opportunities to decrease work burden in related aspects of patient care (eg, increased efficacy from reducing duplication).
• Leadership can highlight safeguards regarding staff involvement in a project (eg, burden) and its impact on their patient population (eg, staff cover and protected time).

From a cultural perspective, collaboration with staff empowers them to shift from passive recipients to active contributors and QI project leaders. Furthermore, successful collaborations provide opportunities to gain their insights through open dialogue and balancing these with data-informed and research-informed approaches to maximise QI projects' effectiveness. Providing support to the staff who lead a QI project offers them an opportunity to simultaneously learn and implement QI practice, leading to individual and organisational capability building.

Patient engagement

The primary purpose of QI projects is to provide changes that result in increased quality of patient care, focusing on patients' lived experience in living with particular conditions and the impact of received care. Seeking patient engagement offers the opportunity to illuminate the value of a project to them, providing insights provide opportunities for codesigning and redesigning QI projects. Furthermore, patient involvement keeps the patient at the centre of QI efforts.

Despite the benefits, patient engagement is complex and has many ethical challenges. Without proper consideration, patriarchal approaches to patient engagement can lead to negative consequences, including leaving them disempowered and damaging therapeutic relationships. 22 Also, the extent to which patients can engage may vary based on their current health status and capacities. QI projects should provide a flexible approach to patient engagement that reflects their varying degrees of capacity. Examples of approaches include patient attendance at project meetings, one-off discussions or repeated discussions to explore their views throughout a project, and the extent to which they engage in the codesign of various aspects of the project (eg, preparation of material, inputting on change ideas).

Successful patient engagement requires organisational support and collaboration with staff to ensure safe and successful input from patients. This collective effort provides opportunities to ensure that the approach is ‘fit for purpose’ and will empower patients to contribute. As discussed in box 1 , patients should understand the importance of their input and feel safe to speak up even if they disagree with a suggested course of action. They should also understand their role and associated expectations and receive appropriate credit for their contributions.

Family/carer engagement

Patient care can often be influenced and directly supported by family and/or carer engagement in formal and informal settings. Families and carers also provide an opportunity to advocate and bridge the gap between patients and the healthcare system, particularly when patients may not have mental capacity. Furthermore, families and carers offer lived experience and experiential knowledge to support patients and possibly inform changes in formal healthcare practice.

Like patient engagement, family/carer engagement considerations must be weighed against numerous ethical considerations—for example, the balance between the value of their insights and whether they provide effective patient care. Also, considerations regarding patient-centred care and issues relating to confidentiality (eg, balancing family/carer engagement alongside patient engagement and whether this reflects the patient’s wishes). Like patient engagement, staff should understand the role of family/carer engagement to ensure they feel empowered to contribute and incorporate their involvement wherever appropriate. Furthermore, families and carers should realise the importance of their contributions, understand expectations and credit them throughout the project.

Safeguarding and welfare

Welfare and safeguarding are paramount to all concerned when conducting a QI project and should be the priority at all stages. This can include (but is not limited to) handling patient and staff data, issues relating to the privacy and confidentiality of patient and staff identities, and the adverse effects resulting from the project.

A sensible starting point for any QI project is to devise a protocol for handling safeguarding issues and ensure that those conducting QI projects are suitably trained. In particular, at points of the project where the risk of a safeguarding issue is much greater. For example, exploring experiences based on sensitive topics or possibly resurfacing previous trauma or uncovering a new safeguarding disclosure. Any drafted protocol must align with current safeguarding practices and should be codesigned with a designated safeguarding representative. All parties involved in the project should be familiar with this process to provide seamless support should a safeguarding issue arise. All those conducting QI should receive relevant safeguarding training and refreshers as part of their mandated training. This is particularly important for organisations that employ QI Leads. For individual projects, all those involved in QI projects should be aware of any local safeguarding procedures.

As well as the immediate safeguarding issues when conducting a QI project with patient engagement, it is also vital to consider any possible long-term effects. Any protocol should provide welfare checks and subsequent support procedures for all those involved. In particular, for sensitive topics, a mandatory supportive review should be available to all those involved in the project. A sufficiently trained person should facilitate the review and be removed from the project itself. If any further distress or issues arise, all those involved should be signposted/referred to any other relevant professional services or internal services. Practical approaches include recording the extent to which patients were involved in the project and associated documents.

Limitations

The proposed guidance has several limitations worth considering. First, the evidential basis for this guidance is mainly grounded in one mental health trust and the authors' experiences. Therefore, differences in ethical oversight may influence the usefulness of the proposed guidance. For example, some healthcare organisations may have pre-existing ethical governance frameworks in place or have already established processes with internal research and development teams or ethics committees. Second, the current QI capacity and capabilities between healthcare organisations may also vary drastically. For example, some healthcare organisations may have dedicated QI teams. Some may have external support with no dedicated teams, and others may have QI integrated into other teams, such as audit teams and research and development teams. Due to the diverse nature of QI projects (as illustrated in table 1 ) and QI capabilities between healthcare organisations, this paper is designed for teams to shape, reflect and use this guidance at their discretion depending on what applies to their QI project rather than being a prescriptive framework.

The extent to which QI projects require ethical approval varies considerably and, in some cases, align substantially with similar research projects. It is sometimes difficult for those in the QI field to know the extent to which ethical considerations are required, and this ambiguity can cause confusion and potential harm. This paper has shown how QI projects give rise to ethical considerations that demand attention, regardless of whether QI and research ethics ought to be treated as distinctive or overlapping activities. There are residual questions about whether QI should be subject to ethical oversight and ethics review processes, as is the case in research activities. However, we leave these questions for future analysis.

Instead, this paper sought to provide task-oriented guidance accessible to busy healthcare staff in their day-to-day duties, distinctively supplementing previous guidance documents. It aids those conducting QI projects, shifting mindsets from a ‘get it done’ mentality to a more considered ethical QI practice approach. Furthermore, we sought to explore the ethical considerations for conducting QI projects for all involved, including carers/patients and staff who support and lead these projects, focusing on the importance of engagement. In the first instance, those undertaking QI projects need to think proactively about the ethical considerations in their work before implementing QI tests of change. The key questions outlined aim to help guide what type of ethical considerations are essential for each project. Next, we outline practical guidance for various stages in a QI project and associated actions. Finally, we discuss QI project examples and the ethical considerations applied to each project.

Incorporating the key questions and guidance provides QI teams (and researchers in QI) to ensure considered, proportionate, and ethical practice in future QI projects, given the impact these projects (and their evaluation) can have on patient’s healthcare staff.

Acknowledgments

We would like to thank the teams at Oxford Healthcare Improvement Centre at the Oxford Health NHS Foundation Trust, and the Risk and Safety Group at the Department of Experimental Psychology at the University of Oxford for their contributions and feedback on this manuscript.

Twitter: @dfhunt1981

Contributors: All authors contributed to idea development. DFH and JB drafted the initial manuscript. MD and GH contributed to refining the manuscript.

Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests: None declared.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review: Not commissioned; externally peer reviewed.

Ethics statements

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• Health Topics A-Z

Effects on Research

At a glance.

Learn more about the ethics and policies that have had and effect on research conducted by the Public Health Ethics Program sponsored by Tuskegee University and CDC.

After the U.S Public Health Service's (USPHS) Untreated Syphilis Study at Tuskegee, the government changed its research practices.

In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed.

Regulations and standards

In addition to the Commission's recommendations, since 1974 researchers are required to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards (IRBs). IRBs decide whether research protocols meet ethical standards.

The rules and policies for human subjects research have been reviewed and revised many times since they were first approved. Efforts to promote the highest ethical standards in research are ongoing.

Ethics Advisory Board and policies

An Ethics Advisory Board was formed in the late-1970s to review ethical issues of biomedical research. As a result, the 1979 publication known as The Belmont Report summarized the three ethical principles that should guide human research: respect for persons ; beneficence ; justice. From 1980-1983, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research reported "every two years on the adequacy and uniformity of the Federal rules and policies, and their implementation, for the protection of human subjects in biomedical and behavioral research." In 1991, federal departments and agencies (16 total) adopted the Federal Policy for the Protection of Human Subjects .

In October 1995, President Bill Clinton created a National Bioethics Advisory Commission, funded and led by the Department of Health and Human Services. The commission's task was to review current regulations, policies, and procedures. Also, to ensure all possible safeguards are in place to protect research volunteers. It was succeeded by the President's Council on Bioethics , which was established in 2001, and then the Presidential Commission for the Study of Bioethical Issues established in 2009.

Syphilis Study

The Untreated Syphilis Study at Tuskegee was conducted between 1932 and 1972 to observe the natural history of untreated syphilis.