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Informed Consent in Research – Types, Templates and Examples

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Informed Consent in Research

Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of participants.

Types of Informed Consent in Research

There are different types of informed consent in research , which may vary depending on the nature of the study, the type of participants, and the context. Some of the common types of informed consent in research include:

Written Consent

This is the most common type of informed consent, where participants are provided with a written document that explains the study and its requirements. The document typically includes information about the purpose of the study, procedures involved, risks and benefits, confidentiality, and participant rights. Participants are asked to sign the document as an indication of their willingness to participate.

Oral Consent

In some cases, oral consent may be used when a written document is not practical or feasible. Oral consent involves explaining the study and its requirements to participants verbally and obtaining their consent. This method may be used for studies with illiterate or visually impaired participants or when conducting research remotely.

Implied Consent

Implied consent is used in studies where participants’ actions are taken as an indication of their willingness to participate. For example, a participant may be considered to have given implied consent if they show up for a scheduled appointment for the study.

Opt-out Consent

This method is used when participants are given the opportunity to decline participation in a study. Participants are provided with information about the study and are given the option to opt-out if they do not wish to participate. This method is commonly used in population-based studies or surveys.

Assent is used in studies involving minors or participants who are unable to provide informed consent due to cognitive impairment or disability. Assent involves obtaining the agreement of the participant to participate in the study, along with the consent of a legally authorized representative.

Informed Consent Format in Research

Here’s a basic format for informed consent that can be customized for specific research studies:

• Introduction : Begin by introducing yourself and the purpose of the study. Clearly state that participation is voluntary and that participants can withdraw at any time without penalty.
• Study Overview : Provide a brief overview of the study, including its purpose, methods, and expected outcomes.
• Procedures : Describe the procedures involved in the study in clear, concise language. Include information about the types of data that will be collected, how they will be collected, and how long the study will take.
• Risks and Benefits : Outline the potential risks and benefits of participating in the study. Be honest and upfront about any discomfort, inconvenience, or potential harm that may be involved, as well as any potential benefits.
• Confidentiality and Privacy : Explain how participant data will be collected, stored, and used, and what measures will be taken to ensure confidentiality and privacy.
• Voluntary Participation: Emphasize that participation is voluntary and that participants can withdraw at any time without penalty. Explain how to withdraw from the study and who to contact if participants have questions or concerns.
• Compensation and Incentives: If applicable, explain any compensation or incentives that will be offered to participants for their participation.
• Contact Information: Provide contact information for the researcher or a representative from the research team who can answer questions and address concerns.
• Signature : Ask participants to sign and date the consent form to indicate their voluntary agreement to participate in the study.

Informed Consent Templates in Research

Here is an example of an informed consent template that can be used in research studies:

Introduction

You are being invited to participate in a research study. Before you decide whether or not to participate, it is important for you to understand why the research is being done, what your participation will involve, and what risks and benefits may be associated with your participation.

Purpose of the Study

The purpose of this study is [insert purpose of study].

If you agree to participate, you will be asked to [insert procedures involved in the study].

Risks and Benefits

There are several potential risks and benefits associated with participation in this study. Some of the risks include [insert potential risks of participation]. Some of the benefits include [insert potential benefits of participation].

Confidentiality

Your participation in this study will be kept confidential to the extent allowed by law. All data collected during the study will be stored in a secure location and only accessed by authorized personnel. Your name and other identifying information will not be included in any reports or publications resulting from this study.

Voluntary Participation

Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you choose not to participate or if you withdraw from the study, there will be no negative consequences.

Contact Information

If you have any questions or concerns about the study, you can contact the investigator(s) at [insert contact information]. If you have questions about your rights as a research participant, you may contact [insert name of institutional review board and contact information].

Statement of Consent

By signing below, you acknowledge that you have read and understood the information provided in this consent form and that you freely and voluntarily consent to participate in this study.

Participant Signature: _____________________________________ Date: _____________

Investigator Signature: ____________________________________ Date: _____________

Examples of Informed Consent in Research

Here’s an example of informed consent in research:

Title : The Effects of Yoga on Stress and anxiety levels in college students

Introduction :

We are conducting a research study to investigate the effects of yoga on stress and anxiety levels in college students. We are inviting you to participate in this study.

If you agree to participate, you will be asked to attend four yoga classes per week for six weeks. Before and after the six-week period, you will be asked to complete surveys about your stress and anxiety levels. Additionally, we will measure your heart rate variability at the beginning and end of the six-week period.

Risks and Benefits:

There are no known risks associated with participating in this study. However, the benefits of practicing yoga may include decreased stress and anxiety levels, increased flexibility and strength, and improved overall well-being.

Confidentiality:

All information collected during this study will be kept strictly confidential. Your name will not be used in any reports or publications resulting from this study.

Voluntary Participation:

Participation in this study is completely voluntary. You are free to withdraw from the study at any time without penalty.

Contact Information:

If you have any questions or concerns about this study, you may contact the principal investigator at (phone number/email address).

By signing this form, I acknowledge that I have read and understood the above information and agree to participate in this study.

Participant Signature: ___________________________

Date: ___________________________

Researcher Signature: ___________________________

Importance of Informed Consent in Research

Here are some reasons why informed consent is important in research:

• Protection of participants’ rights : Informed consent ensures that participants understand the nature and purpose of the research, the risks and benefits of participating, and their rights as participants. It empowers them to make an informed decision about whether to participate or not.
• Ethical responsibility : Researchers have an ethical responsibility to respect the autonomy of participants and to protect them from harm. Informed consent is a crucial way to uphold these principles.
• Legality : Informed consent is a legal requirement in most countries. It is necessary to protect researchers from legal liability and to ensure that research is conducted in accordance with ethical standards.
• Trust : Informed consent helps build trust between researchers and participants. When participants understand the research process and their role in it, they are more likely to trust the researchers and the study.
• Quality of research : Informed consent ensures that participants are fully informed about the research and its purpose, which can lead to more accurate and reliable data. This, in turn, can improve the quality of research outcomes.

Purpose of Informed Consent in Research

Informed consent is a critical component of research ethics, and it serves several important purposes, including:

• Respect for autonomy: Informed consent respects an individual’s right to make decisions about their own health and well-being. It recognizes that individuals have the right to choose whether or not to participate in research, based on their own values, beliefs, and preferences.
• Protection of participants : Informed consent helps protect research participants from potential harm or risks that may arise from their involvement in a study. By providing participants with information about the study, its risks and benefits, and their rights, they are able to make an informed decision about whether to participate.
• Transparency: Informed consent promotes transparency in the research process. It ensures that participants are fully informed about the research, including its purpose, methods, and potential outcomes, which helps to build trust between researchers and participants.
• Legal and ethical requirements: Informed consent is a legal and ethical requirement in most research studies. It ensures that researchers obtain voluntary and informed agreement from participants to participate in the study, which helps to protect the rights and welfare of research participants.

Advantages of Informed Consent in Research

The advantages of informed consent in research are numerous, and some of the most significant benefits include:

• Protecting participants’ autonomy: Informed consent allows participants to exercise their right to self-determination and make decisions about whether to participate in a study or not. It also ensures that participants are fully informed about the risks, benefits, and implications of participating in the study.
• Promoting transparency and trust: Informed consent helps build trust between researchers and participants by providing clear and accurate information about the study’s purpose, procedures, and potential outcomes. This transparency promotes open communication and a positive research experience for all parties involved.
• Reducing the risk of harm: Informed consent ensures that participants are fully aware of any potential risks or side effects associated with the study. This knowledge enables them to make informed decisions about their participation and reduces the likelihood of harm or negative consequences.
• Ensuring ethical standards are met : Informed consent is a fundamental ethical requirement for conducting research involving human participants. By obtaining informed consent, researchers demonstrate their commitment to upholding ethical principles and standards in their research practices.
• Facilitating future research : Informed consent enables researchers to collect high-quality data that can be used for future research purposes. It also allows participants to make an informed decision about whether they are willing to participate in future studies.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Permission Letter To Conduct Research: How To Draft It Right!

In this article, I’ll share my insights and provide you with a step-by-step guide, including customizable templates , to craft your own effective permission letter for research.

Key Takeaways Understand the purpose and importance of a permission letter for research. Learn the essential components to include in your letter. Get a step-by-step guide to writing a compelling permission letter. Benefit from a customizable template to streamline your writing process. Discover practical tips from my personal experience to enhance your letter.

Understanding the Importance of a Permission Letter for Research

A permission letter for research is a crucial document that formally requests authorization to conduct a study in specific locations or collect data from a particular group.

It serves as a formal agreement between the researcher and the authority or individuals involved, ensuring that the research is conducted ethically and legally.

Step-by-Step Guide to Writing Your Permission Letter

Step 1: start with contact information and date.

Always begin your letter by stating your contact information at the top, followed by the date. This should include your name, address, phone number, and email address.

Step 2: Address the Recipient Properly

Address the recipient by their proper title and name. If you’re unsure, a general “To Whom It May Concern” can suffice, but personalized greetings are always more impactful.

Step 3: Introduce Yourself and Your Affiliation

Introduce yourself, your position, and your affiliation. This sets the context and establishes your credibility.

Step 4: Clearly State the Purpose of Your Letter

Be clear and concise about your intent to seek permission for research. Mention the research topic and why the specific site or group is essential for your study.

Step 5: Provide Details of Your Research

Explain the scope of your research, the methodology you’ll use, and the expected duration. Transparency is key to gaining trust and approval.

Step 6: Assure Ethical Compliance

Highlight your commitment to ethical standards, including how you’ll ensure participant confidentiality and data protection.

Step 7: Request for Approval

Politely request permission to proceed with your research, expressing your willingness to comply with any required protocols or guidelines.

Step 8: Include Contact Information for Follow-up

Offer your contact information again, encouraging the recipient to reach out with any questions or requests for further details.

Step 9: Close with a Professional Salutation

End your letter with a professional closing, such as “Sincerely,” followed by your name and signature.

Template for a Permission Letter To Conduct Research

[Your Name] [Your Address] [City, State, Zip Code] [Phone Number] [Email Address] [Date]

[Recipient’s Name or Title] [Organization’s Name] [Address] [City, State, Zip Code]

Dear [Recipient’s Name or Title],

I am writing to request permission to conduct research at [location/site/group], as part of my [research project/study] on [topic]. My name is [Your Name], and I am a [Your Position] at [Your Institution or Organization].

The purpose of my research is to [briefly state the objective]. I believe that [location/site/group] is essential for my study because [reason]. The research will involve [describe the methodology], and I anticipate it will take approximately [duration] to complete.

I assure you that all research activities will adhere to the highest ethical standards. Participant confidentiality and data protection will be strictly maintained throughout the research process.

Your approval to conduct this research would be greatly appreciated. I am more than willing to adhere to any specific protocols or requirements you may have. Please feel free to contact me at [Your Phone Number] or [Your Email Address] if you have any questions or need further information.

Thank you for considering my request. I look forward to your positive response.

[Your Name] [Your Signature, if sending a hard copy]

Personal Tips from My Experience

• Personalize Your Letter:  Tailoring the letter to the recipient shows respect and attention to detail.
• Be Concise but Thorough:  Provide enough detail to inform but not so much that it overwhelms the reader.
• Follow-Up:  Don’t hesitate to follow up if you haven’t received a response within a reasonable time frame.
• Show Appreciation:  Always express gratitude for the recipient’s time and consideration.

I hope this guide helps you craft an effective permission letter for your research. I’d love to hear about your experiences or any additional tips you might have. Please share your thoughts and questions in the comments below!

Related Posts

• Free Templates for Research Permission Letters
• 3 Must-Have Templates for Requesting Permission Easily
• Sample Letter To Request To Attend A Conference: Free & Effective

Frequently Asked Questions (FAQs)

Q: What is a permission letter to conduct research?

Answer : A permission letter to conduct research is a formal request to obtain permission from an organization or individual to conduct research on a particular topic. This type of letter is commonly used by students, researchers, and scholars who require permission to carry out their research.

Q: Why is a permission letter to conduct research important?

Answer : A permission letter to conduct research is important because it shows that the researcher has obtained the necessary permissions to conduct their research. It also provides a clear understanding of the scope and nature of the research and how it will be conducted, which can help to prevent misunderstandings or legal issues.

Q: Who should I address my permission letter to?

Answer : You should address your permission letter to the individual or organization that has the authority to grant permission for your research. This could be the head of the organization, a department manager, or an individual who is responsible for the area that you wish to conduct research in.

Q: What should I include in my permission letter to conduct research?

Answer : Your permission letter to conduct research should include an introduction that outlines your research topic and objectives, an explanation of why you need permission, an overview of your research methodology, details on the timeline and logistics of your research, and a formal closing that thanks the recipient for their time and consideration.

Q: How do I ensure that my permission letter to conduct research is effective?

Answer : To ensure that your permission letter to conduct research is effective, make sure that it is clear, concise, and polite. Provide detailed information about your research and the nature of your request, and address any potential concerns or objections that the recipient may have. Finally, proofread your letter carefully to ensure that it is free from errors and typos.

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Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Child assent ages 3-6
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• Parent permission
• Brief protocol for exempt research including data management and security questionnaire
• Child assent 12-14
• Introductory psychology subject pool general consent template
• Introductory psychology subject pool exempt consent template

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How To Write An Info/Consent Document

What is a consent form.

A consent form is a document which provides prospective research participants with the information necessary to make an informed decision about whether to take part in research or not. It may or may not include a signature section. It will be referred to as the  info/consent document .

What’s the difference between a consent form and an information letter?

• Some researchers like to separate the information (found in an information letter) from the signature section (which they term the consent form) – this is your decision and is NOT required by the Research Ethics Board (REB), but DO NOT REPEAT the same information in both places.
• You MUST provide the participant with a copy of the info/consent letter regardless of how you document consent.

General instructions

• Write in a conversational tone.
• Who is your audience? Speak directly to them. The language should be at grade 8-level.
• Directly address the participant. ‘You’ are invited, not ‘the participant’ is invited. 
• Avoid legalistic language (e.g. you hereby agree, you certify that, etc.)
• Use bullet point lists to increase readability.
• Use a readable font such as Arial, Courier, or Verdana. Use a minimum 12 point font.
• The REB will NOT proof read for spelling and grammar.
• The bodyshould provide a plain-language description of what the participant will experience. If you need to include more than a couple of sentences, add the description of the procedure as an appendix.

What are the biggest review problems I can avoid?

• Inconsistency between the info/consent document, recruitment documents, and the REB application.
• Unnecessary repetition of information between information letters and consent documents.
• Missing required elements.
• Cut and paste errors.
• CONFIDENTIALITY – a person’s identity is kept confidential. The data you collect will be shared when you publish it.
• ANONYMITY – data are anonymous ONLY when a person’s identity has never been associated with it.
• We will use your name in the final report.
• Your name will not be released with any of the data.
• We will not collect any identifiers other than your signature on the consent form.

Readability

Give a draft to someone who is NOT in your academic discipline to proof read. Have them circle every word which is not entirely clear. Remove these words.

There is a feature in Word to test ‘Readability’ . It is best used on individual paragraphs and is NOT fool-proof. But it will give you an idea.

• In Word, go to “File”→”Options” → “Proofing”, then click ”Show Readability Statistics”. After Spell Check has been completed, Word displays readability information.
• The Flesch Reading Ease scale has a maximum value of 100, with higher numbers representing greater reading ease (approximately 60-70 is a good target). 
• The Flesch-Kindcaid Grade Level is an approximation of the grade-level of education necessary for someone to understand the document (e.g., a value of 8 means Grade 8). 
• If you want to determine the readability for an individual paragraph, highlight the paragraph, run Spell Check and then click “No” when the message pops up “Word finished checking the selection. Do you want to continue checking the remainder of the document?”
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How to obtain informed consent for research

1 University of Messina, “G. Martino” Hospital, Messina, Italy

Amelia Licari

2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

Short abstract

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].

Educational aims

• To provide a comprehensive overview of issues in obtaining informed consent in clinical research.
• To describe the process of obtaining informed consent in clinical trials.
• To highlight the circumstances under which informed consent can be waived.
• To review the setting of obtaining informed consent from “vulnerable populations”.

The informed consent process

The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].

Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).

The information about the research should be given by a physician or by other individuals ( i.e.  researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.

Informed consent: when is it not necessary?

After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].

The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].

The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.

RCTs based on infeasibility of informed consent

Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].

Table 1

Conditions to be met in emergency clinical study

Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].

RCTs that omit informed consent only for control groups

In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].

In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].

In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].

In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].

All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].

RCTs that omit informed consent entirely

Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].

Special needs: vulnerable patients

A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].

Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].

Physical vulnerability

For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].

Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].

Table 2

Conditions to be met in research studies involving pregnant women and fetuses

Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.

Table 3

Consent signature requirements for pregnant women and children

# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].

Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].

Table 4

Studies that may involve prisoners

Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].

Psychological vulnerability

Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].

Social vulnerability

Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.

Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].

Special needs: children

Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].

Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.

In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and ​ and2 2 summarise the parental and assent permission requirements, respectively.

Flow chart of parental permission requirements.

Flow chart of child assent requirements.

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.

Self-evaluation questions

• a) Diagnosis
• b) Risks and benefits of treatment
• c) Alternatives to treatment
• d) Family’s wishes
• a) When a minor is considered as emancipated
• b) When a patient is found to be incompetent
• c) When immediate treatment is necessary to prevent death or permanent impairment
• d) When the subject is aged >18 years
• a) Minor is married or divorced
• b) Minor on active duty in the US armed forces
• c) Minor is considered self-sufficient by a court
• d) Minor having a son

Suggested answers

• All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent.
• Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
• When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
• Participation of vulnerable patients in clinical trials is regulated by specific law dispositions.

Conflict of interest: None declared.

Sample Consent Forms

Consent form templates.

These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here .

Summary of Changes to the Regulations for Informed Consent:  Revised Common Rule Changes to Informed Consent and Waiver Requirements

Summary of Changes to Consent Documents:

• Informed Consent Documents – Version 2.0 Summary of Changes
• Informed Consent Documents – Version 2.1 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 4/10/2023 Summary of Changes

Concise Summary examples can be found here .

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary
• Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).

• Informed Consent Short Form Guidance
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template
• Sample HIPAA Authorization Template in Spanish ( Certification )

• Consent Letter: Writing Guide, Types, [+12 Consent Samples]

Receiving Consent in today’s society is a huge deal and that’s why it’s important that companies seek user licence before doing anything with their data. Defined as an agreement to do something or for something to happen, consent letter and approval is an integral part of the everyday environment.

There are three ways in which consent can be obtained ; Explicit Consent, Implicit Consent and Opt-out Consent;

• Explicit Consent

Explicit consent often commonly referred to as direct consent means that the respondent is presented with a clear option on whether they agree or disagree with disclosing their personal information. Explicit consent is usually required when the nature of the information to be collected is sensitive.

• Implicit Consent

Implicit or indirect consent is expressed as consent drawn from the respondents actions. implict con could come in two forms: whether the respondent consents to giving personal information or providing information of a body/organisation in a way that it directly benefits you.

A ready example is providing references on you resume to your new employers which infers that your referees have given their consent to be contacted by your prospective employers.

• Opt-out Consent

Opt-out consent is simply giving the respondent a chance to decline consent. A failure to do so by the respondent means that they gave granted permission. Businesses are fond of using this way of receiving consent because they realize customers do not take the pains to read the end user agreements before signing up.

For clarity sake, the key features of these three ways are; Explicit consent is an express direct concession to a thing, Implicit consent also referred to as implied consent is consent inferred from your actions and current circumstance while opt-out consent underlines the art of giving consent by not declining to give consent to a thing or an agreement.

Sign up on Formplus to create your customised online consent form with our easy-to-use form builder.

What is a Consent Letter?

A consent letter is simply a letter written to request for permission from a person or a group of people. While the respondent gives you their consent, you must also be transparent about the purpose for which you are requesting a consent. The information offered via your consent form or consent letter must be used solely for its intended purpose.

 How to Write a Consent Letter

• Consent Letter Content/Descriptions

The consent form should contain a heading. For instance a Parental Consent Form seeking consent from a parent to allow their wards to participate in a project. It could come with a preview explaining all that is expected of the respondent.

• Duration of Participation

The duration under which the participant is expected to make themselves available as provided in the form should be clearly spelt out. e.g Date of commencement of field trip and expected date of return. 

• Names of Parties Involved  

A consent form should contain the names, addresses and details of both parties involved. In the case of a photography consent form, the details of the photographer are a necessity.

• Compensation/ Contract/Rules Agreement

The contract/rules of engagement should be spelt out in easy to understand language. Any inconvenience or risk to be experienced during the duration of the project the consent is being issued on should be clearly spelt out to the recipient. In the same light, all compensations and benefits accrued should also be mentioned.

The most important detail on consent forms. The respondent indicates their consent by submitting their signatures to the online approval. Collecting electronic signatures via online forms is made easy with Formplus.

What is a Consent Form? 

A consent form is a form that provides content or evidence that a procedure was agreed to. The main purpose of the informed consent process is to protect the interests of the individual drawing the form. 

The consent form provides answers for all possible questions that pertain to a procedure and clearly state that the respondent has the option to not participate. This Form provides evidence of a participant’s agreement to be involved in a project.

For any topic for research, it is the responsibility of the researcher to educate participants on the purpose, procedures, risks and benefits of a study before going ahead to obtain their consent. Participants are to be kept in the loop of things.

Why Use An Online Consent Form

An online consent form can be used for a variety of reasons: for generating leads, distributing surveys, collecting payments amongst others. The model consent form includes personal information of clients as well as other key details.

Advantages of Receiving Consent forms online

There are several perks to receiving consent forms online. Here’s why you should prioritize online forms over its offline counterpart.

• Electronic forms are easier to fill out that on paper as such your forms are completed in record time.
• Because of the ease of filling them out, response rates improve in leaps and bounds.
• Editing the received forms can be done easily without extra cost.
• Questions can also be added to the existing forms with relative ease and re-submitted.
• Online consent forms are more secure with the introduction of passwords and encryption.
• Online forms increase helps in the ease and effectiveness of data collection.

TYPES OF CONSENT FORMS

There are various types of consent forms and in this discourse, we’ll be delving into a few of them to broaden your understanding of how forms work. Most other forms stem from these four.

• Parental Consent Form

A parental consent form basically covers the legal notification parents/guardians give so that their minors/wards can participate in certain activities. In a scenario where a minor is to undergo treatment, get a piercing or even get married, the parent/guardian must give consent through a parental consent form. The parent/guardian also exercises the right to approve or disapprove certain curricula in the education of a minor. Parental consent forms have backing by law and are essentially why they are used without fail.

• Medical Consent Form

A medical consent form is a form used in the industry of medicine to obtain consent for a medical procedure. Contained in a medical form must be the information carefully stated on the risks of procedures relating solely to research as well as full disclosure.

In medical practice, consent for a person to be treated before the commencement of any medical procedures. The patient ultimately holds the cards on the final decision on whether or not they’d be treated or donate an organ, whichever the case may be. Except of course in extreme cases like when the patient is in a coma.

• Consent Form for Research or Informed Consent

Also referred to as informed consent, it is best explained as a form used to express voluntary agreement to participate in research. The subjects used in the study must participate willingly and not under duress. Contained in the consent form is information on the rights of the subject, the procedures to be undergone, the purpose of the research, the risks as well as the benefits accrued to the subject at the expiration of the research.

• Consent Form for Education

This form is used to record consent for the school to collect information to assist in determining the student’s eligibility for and participation in the educational procedures of an institution. The parent/guardian is privy to this form to determine on behalf of the minor whether they are fit to take certain classes. 

Top 12 Online Consent Form Templates

• General Consent Form Template

This is an all-purpose consent form template containing the personal details of the respondent as well as their signature and the activity for which they consent to. It is a minimalist form designed to collect exact details of the respondents as well as their consent.

• Guarantor Consent Form Template 

For a property owner expecting a new tenant, there is a need for the intending tenant to present a guarantor. The name of the guarantor, their address as well as a declaration of their intention to stand as guarantor are the key components that form this template.

• Parental Consent Form Template

Let Parents or Guardians sign-off their approval for their under-18 kids to perform or do certain tasks that requires adult permission with this parental consent form template. The parent/guardian can give a medical history of the minor and more importantly make a declaration on the status of the minors participation in any activity.

• Photography Consent Form Template  

This form is to be completed by individual (parent/guardian if individual is less than 16 years of age) before the photograph is taken. Details of the form include names and addresses of the individual as well as the photographers details.

• Model Release Consent Form Template

Use the Model Release Form template if you are going to work with models, studios, media companies, or fashion brands. You can use this form template as a legal document (or use access) between you, the photographer or the person who owns the image right property. 

• RSVP Consent Form Template

Use this customizable RSVP form template by Formplus to manage guests reservation. This RSVP form template can be used to collect Name, Email, Phone Number, collect more information about your guests and most importantly, confirm their attendance.

• Contact Form Template

Receive customer inquiries, support requests, and more with this online contact form template. Start with this simple customer contact form template, and then customize it to fit your needs.

• Blood Donation Consent Form Template

In addition to basic personal details such as names and addresses, the blood donation form template contains key fields such as blood group as well as if the applicant has had any diseases or allergies. It can be used by Nonprofits and clubs for Blood donation drives.

• Enrollment Form Template

The enrollment form template collects important details from an applicant seeking to enrol. There are fields to input basic details such as the level of qualification attained by the applicant and any documents for identification. There is also a section where the applicant can provide the necessary references. 

• Petition Form Template

This is a simple to use template designed to collect signatures from people who agree with your cause. It collects basic details such as names and addresses as well as the all important signature. There is also a field for respondents to leave their comments regarding the petition.

• Rental Application Form Template

This application form template can be used by an individual with property available for lease. Key fields to be filled out contained in the form include; the ownership of a pet, if the prospective tenant has ever filed for bankruptcy and a document of identification to be uploaded. This template covers all the angles giving the property owner full information.

• Child Travel Consent Form Template

This template is useful for travel requests for school children. It contains key elements such as the name of the supervisor-in-charge, the reason for the trip, duration as well as estimated travel cost and exact destination. 

• Interview Consent Form Template

This online interview consent form template allows interviewee sign off their consent to use the interview data for research or report for journalist. With premium features like short text fields, upload, e-signature, etc., Formplus Builder is the perfect tool to create your preferred online consent forms without coding experience.

Can’t find your preferred consent form template ? Sign up to Formplus to create your customised online consent form with our easy-to-use form builder.

Why use Formplus Builder to Create an Online Consent Form? 

• Data Storage & Security  

Formplus currently provides an enviable data storage platform for all users. You can also store received data in your preferred cloud storage option. With unlimited file uploads, users can submit files, photos, or videos via your online forms without any restriction to the size or number of files that can be uploaded.

• E-Signatures

Collecting electronic signatures via online forms is made easy with Formplus. The online signature field is very responsive and easy to use on any device – laptop, tablet, or smartphone. Users can sign and submit forms in minutes, without printing out paper forms.

• Upload Fields

The Formplus builder lets you receive files (could be photos or video) via your consent forms.

• Email Invitation/Social Sharing

On the Formplus builder, you get to select from our wide range of sharing options how best you want to reach your users. Forms can be filled from any device including mobile. Customize the confirmation emails sent to your respondents upon form submission on the Formplus Builder.

• Private Forms

With the Formplus builder, you can make a form private to control who can submit entries to your form. Formplus forms are GDPR compliant and can be used to collect user consent and opt-ins.

• Form Security and Encryption

All Formplus forms are SSL enabled, making sure that all connections between your web browser and our servers are secure 100% of the time. To add an extra layer of security in your forms, you can use CAPTCHA to keep your form data safe from spammers and bots.

The Formplus form builder is ideal for building powerful consent forms to help you collect the information you need. Build your consent form within minutes. Style it using various customisation options or leave it as default if you wish.

Connect to Formplus, Get Started Now - It's Free!

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Writing A Consent Form

Below are some useful tips on writing a consent form for your proposed subject population. The procedures for obtaining consent should be documented on the Consent tab of the protocol application.

Coercion  - The subject must be given the opportunity to consent or not consent without the intervention of any element of force, fraud, trickery, duress, coercion, or undue influence on the subject’s decision. Payments & credits should be pro-rated & not withheld until completion. Any payment or class credit must be appropriate to the tasks involved and the subject population.

Compensation  - Compensation payments must be pro-rated or provided in full even if a subject withdraws from the study early. If the payment includes a  lottery , participants must be at least 18 years of age to participate and be entered into the lottery and payment (e.g. prorating) cannot be withheld until the completion of the study. A participant may withdraw from a study and still be entered into a lottery. Approximate odds of winning need to be included in the consent form.

Class Credit  - Any project where class credit is involved must be open to all members of the class AND there must be a non-research option to obtain the same credit for the same amount of effort. The Psych & Geography pools are currently the only pools at UCSB whose procedures are codified and do not need to be documented in this form. All other use of class credit & non research alternatives must be documented in the ORahs protocol application on the Consent tab.

Elements of Consent  - Consent forms should include all the required elements of informed consent and additional elements (if applicable), unless a waiver of consent is requested, justified, and approved by the IRB.

Identifiable data  - Consent for using identifiable data (e.g., video recordings) must be obtained, unless a waiver is requested, justified, and approved by the HSC. If participants are to be recorded or photographed, they must be informed as to how this media may be used (e.g., used in conferences, presentations, publications, shared with other researchers). The use of check boxes is recommended for varying levels of consenting to participate. If there are informational risks to the participant, additional safeguards may need to be put in place. These should be described in the risk tab and discussed in the participant consent. The disposition of identifiable data should be described in the consent form. Identifiable data may be retained indefinitely or destroyed. The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared.

Language  - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms. For studies involving multiple subject populations (e.g., children and adults), multiple consent forms are required and must be tailored to the reading and comprehension level(s) of the subject populations to be enrolled.

Translation  - If the subject population involves individuals who speak a different language, consent forms should be translated into the target language and translated back into English by two different individuals to ensure that the appropriate concepts are being conveyed. Using a translator app, such as Google translate should not be used to translate consent forms.

Other Helpful Hints  -

• Avoid using terms such as "agree to" or "certify understanding".
• Only use the consent form that is approved in the ORahs application.
• Think about how you would explain this project in a conversation with someone who was not familiar with your research or field.
• If social security numbers are required to process payment to human subjects participants, then this should be included in the consent form.
• Any alterations or changes to the approved protocol must be reviewed and approved by the HSC prior to initiation.

Consent forms must be signed by the subject, and/or by the parent or legal guardian UNLESS a waiver of documentation or consent is requested, justified & approved. Signed consent forms must be stored securely in your UCSB Department.

 For information on requesting a waiver of documentation or consent, visit the  Waiver of Consent or Documentation page .

Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

• Reliance Consultation
• Consent Cover Letter Template
• Office for the Protection of Research Subjects (OPRS)
• Forms, Guidance, Resources

Download File

This template should be used as a consent document for simple survey or questionnaire research.  This document should be used when a signature will  not  be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey.  Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions.  To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form.

Related Documents

• Information Sheet Template

Related Research Topics

• Consent Templates
• Electronic Consent
• Electronic Signatures and Waivers of Documentation of Consent

Related Glossary Items

• Waiver of Documentation of Consent

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How to Write Consent Letter? Format and Samples

Table of Contents

A consent letter is a document written by a person or a party, seeking permission from another. Consent letters are important as they are legally required to obtain permission to initiate an action. This article sheds light on the types and format of consent letters.

Guidelines for Writing a Consent Letter

Given below are certain guidelines which will help you write an effective consent letter:

• The letter or email should have a clear heading regarding the consent.
• Clearly describe the requirements (if any).
• Ensure that relevant names and other details such as addresses and contact information of respective parties are included in the letter.
• Mention the duration of the program or participation.
• Explain the rules of the contract.
• The most important part is the signature on the consent letter. This is where the respondent accepts the consent.
• End the letter in a professional tone.

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Types of Consent Letter

There are three distinct types of consent an organization may collect:

• Explicit Consent: This type of consent is also known as direct consent. In this type of consent letter, an individual provides a positive indication that they agree to their personal data being shared. This includes option like of ticking an opt-in box, or an action that signifies agreement, such as oral confirmatio, or the provision of contact details where the individual has been clearly informed that by giving these details they agree to their data being shared.
• Implicit Consent: This type of consent is also known as indirect consent. It is described from the action of the respondents. This is when someone gives their contact information (e.g., email address, phone number, etc.) but does not explicitly say they want to receive marketing messages or mail. An example of implicit consent is when a customer makes a purchase and provides their email at checkout.
• Opt-out Consent: Opt-out consent is a method of obtaining consent where organizations provide the choice to decline consent. Businesses use this method of obtaining consent because they recognize that customers do not take the time to read the end-user agreements before signing up.

Format of Consent Letter

The format of a consent letter varies according to the purpose. Let’s have a look at the general format.

________________________________________________________________________________________________________________

Recipient’s Name/ Designation

Name of the Organization

Subject: Consent to (purpose)

Salutation (Dear Sir/Madam,)

Body of the letter: Explain the purpose or reason for which you are providing consent. Mention  all the necessary and relevant details, including date, event, place, name, etc.

Mobile Number/ Email ID

Consent Letter Samples

Let us go through the samples of some of the most commonly used consent letters.

Parental Consent Letter to Attend a Field Trip

Whomsoever it may concern,

Indian High School,

Subject: Consent Acceptance Letter for Field Trip

Dear Sir/Madam,

I, Rahul Khanna, am the legal parent of Trevor Fernandes. I hereby acknowledge that I have granted my consent for my son, Rohit Khanna, to join the school’s field trip on September 10th, 2022. I have read and comprehended the school’s terms and conditions. I’ve also instructed my ward to follow all safety precautions to avoid mishaps and to observe the school’s rules and regulations.

Any inquiries regarding this consent can be directed to me via my mobile number.

(Signature)

Rahul Khanna

Consent Form for Credit Report Authorization

Whomsoever concerned,

XYZ Financial Services,

Subject: Credit Report Authorization Consent Form

I, Rohit Khanna, hereby authorize XYZ Financial Services to do a background check and/or consumer credit report on me. I have attached the necessary documents, including my PAN card number and Bank Account number for the purpose of verification of my credit score.

Rohit Khanna

[email protected]

Consent Letter for Internship Acceptance

Contact Details

Subject: Letter for Internship Acceptance

Dear Rohit Khanna,

We are pleased to offer you internship programme with ABC Bank for a period of 3 months. You will be provided with an honorarium of Rs. 10000 per month.

Please note that any information collected from you during the course of your internship will be kept confidential at all times.

We appreciate your interest in ABC Bank.

Yours sincerely,

Branch Manager

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Frequently Asked Questions (FAQs)

What are the types of Consent letter?

There are many types of consent letters but the majority of those letters are for these four types:

• Parental consent form
• Medical consent form
• Consent form for research
• Consent form for education

What is a consent letter?

A consent letter is a formal letter written to request or provide consent to intitate a particular course of action.

What is opt-out consent?

In this type of consent, organizations provide the option to deny consent. Not choosing to subscribe to newsletters, unticking a previously ticked checkbox, not consenting to save personal details, rejecting the use of cookies, etc. are some examples of opt-out.

Ramzeena Althaf

Ramzeena is a free thinker, an avid reader and tenacious when it comes to writing. An ardent Scrabble lover, she loves sharing exam updates and related topics for aspirants

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• Consent Letter

Receiving Consent in today’s era is a big matter, which is why it’s critical to obtain suitable permission and carry out the necessary activities within the established boundaries. A consent letter and its approval is an essential aspect of everyday life. It is defined as an agreement or arrangement to do something or for something to happen. This article on how to write a consent letter will offer you a general idea of what you should include in a consent letter as well as sample consent letters for your convenience.

What is a Consent Letter?

A consent letter is a formal written document in which one person or party requests permission from another person or party. If the respondent offers consent, you must also be transparent about why you are obtaining consent. It is necessary to write a consent letter in order to obtain authorization to begin an action. A letter of consent, as opposed to a simple letter of permission, has legal significance.

Types of Consent Letters

Consent can be received in three ways: explicit consent, implicit consent, and opt-out consent.

• Explicit Consent – This is also referred to as direct consent. The respondent is given a clear alternative or a statement in which they can agree or disagree with a request. When the nature of the information to be gathered is sensitive, explicit consent is usually necessary.
• Implicit Consent – Because it is derived from the respondents’ actions, implicit consent is also known as indirect consent. Giving references on your resume to your new employers, for example, implies that your referees have agreed to be contacted by your prospective employers.
• Opt-out Consent – Another form of acquiring consent is opt-out consent, in which organizations provide the option to deny consent. Businesses use this method of obtaining consent because they recognize that customers do not take the time to read the end-user agreements before signing up.

Guidelines to Write a Consent Letter

Here are some pointers for crafting an effective consent letter:

• Make certain that the formal letter/email has a clear consent heading.
• Describe the respondents’ specifications/requirements (if any).
• Indicate the length of the program or participation.
• Ensure that the letter includes relevant names and other facts such as addresses and contact information for the respective parties.
• Explain the project’s engagement (or contract) rules. Any benefits and/or compensation must be made known to participants.
• The most significant aspect of the consent letter is the signature. This is the point at which the respondent acknowledges the consent.
• Proofread your consent letter and close it in a professional tone.

Format for a Consent Letter

The format of a consent letter might vary depending on the situation and purpose. However, if the appropriate alterations are made, this general structure is applicable to everybody.

(Recipient Name/Designation)

Receiver’s Address

Subject: Consent to ___ (state the purpose/reason for the consent)

Salutation or Greeting: (Dear Sir/Madam)

Body of the letter: (Explain why you are providing/requesting consent). Don’t forget to include all pertinent information, such as the date, event, location, and name. Finish the letter by signing off and beginning to accept the consent’s terms and conditions.

Contact Details: (Mobile number or Email ID)

Consent Letter Samples

Some of the most frequent applications for consent letter types are as follows:

Sample 1 – Parental Consent Letter to attend a Field Trip

Whomsoever it may concern,

ABC Higher Secondary School,

Subject: Consent Acceptance Letter for Field Trip

Dear Sir/Madam,

I, John Fernandes, am the legal parent of Trevor Fernandes. I hereby acknowledge that I have granted my consent for my son to join the school’s field trip on July 15, 2022. Also, I have read and comprehended all of the school’s terms and conditions. I’ve also instructed my ward to follow all safety precautions to avoid mishaps and to observe the school’s rules and regulations.

Any inquiries about this consent can be directed to me via my mobile number.

(Signature)

John Fernandes

Explore More Sample Letters

• Leave Letter
• Letter to Uncle Thanking him for Birthday Gift
• Joining Letter After Leave
• Invitation Letter for Chief Guest
• Letter to Editor Format
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• Authorization Letter

Sample 2 – Credit Report Authorization/Consent Form

Whomsoever concerned,

ABC Financial Services,

Subject: Credit Report Authorization Consent Form

By my signature below I, John Jacob, hereby authorize ABC Financial Services to obtain a Background Check and/or Consumer Credit Report on me. I have attached the necessary documents, including my PAN card number and Bank Account number for the purpose of verification of my credit score.

[email protected]

• Application For Character Certificate

Sample 3 – Medical Consent Form

I, the parent/guardian of ________________

Give permission to the medical personnel/staff/volunteers participating in the activities during the period __________ to administer any relevant treatment or medication to the named participant, when/if necessary. I understand that I shall be notified, as soon as possible, or the hospital visit and any treatment given by the hospital.

Relationship to the patient

Sample 4 – Research Consent Form

Name of the Department:

I confirm that I have read and understood the information about the project as provided in the participant information sheet. I confirm that I have had the opportunity to ask questions and the researcher has answered any questions about the study to my satisfaction. Yes, I understand that my participation is voluntary and that I am free to withdraw from the project at any time without having to give a reason and without any consequences.

I understand that I can withdraw my data from the study anytime.

Researcher’s Name

Frequently Asked Questions on Consent Letter

Q1. What is a consent letter?

Answer. A consent letter is a formal letter that is intended to request or offer consent to begin a specific course of action. Make sure the objective, terms, and conditions are all clear.

Q2. What exactly is opt-out consent?

Answer. Organizations provide the option to deny consent in this sort of consent. The respondent’s failure to decline the consent suggests that they have already given permission for the collection of information or the delivery of advertisements.

Q3. What are the different types of consent letters?

Answer. There are many different types of consent letters, but the majority of them fall into one of four categories:

• Parental consent form
• Medical consent form
• Consent form for research
• Consent form for education

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