research committee purpose

Research Committees

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• Robert S. Fleming 2  

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Many graduate programs require that their students complete a significant research project in their field of study. While these requirements differ between programs and institutions, they frequently involve the successful preparation and completion of a comprehensive research project as well as submitting and defending an appropriate master’s thesis or doctoral dissertation as the culminating requirement of one’s academic program. Variations may exist between the curriculum requirements and expectations of different programs and institutions. It is also important to be aware that the research expectations and deliverables of particular programs and institutions will often also differ by country. Understanding the specifics of each program is an important responsibility of both students completing these requirements and faculty members that supervise and guide their research activities in completing program and degree requirements.

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Fleming, R.S. (2023). Research Committees. In: Preparing for a Successful Faculty Career. Springer Texts in Education. Springer, Cham. https://doi.org/10.1007/978-3-031-50161-6_29

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After admission to candidacy, the student must assemble a research committee. The doctoral research committee has the responsibility to guide the student through the dissertation process and to conduct the final oral defense.

Ph.D.: Each research committee must have at least four members. Two must be from the student's major area of study and one from the minor. For an interdepartmental minor, the minor member must be from outside the major area. If the minor is not pertinent to the topic of the dissertation, the student may petition to substitute another member from outside the major area. The committee chair must be a faculty member in the student's major area. Usually, the committee chair is also the dissertation director. However, it is acceptable for another committee member with particular expertise in the area of study to direct the dissertation. The Nomination of Research Committee, an electronic form, is available in OneStart. All members of Ph.D. research committees must be members of the University Graduate School faculty.

The committee chair and the dissertation director must be endorsed members of the University Graduate School faculty. If a regular member of the University Graduate School faculty has special expertise in the area of the student's research, the research committee chair and the associate dean for graduate studies may petition the University Graduate School to allow the regular faculty member to direct the student's dissertation.

Ed.D.: For 90 credit hour and 60 credit hour Ed.D. programs, research committees must have at least three members. Two of these must be from the major field of study, of which one must be a tenure-line faculty from the core campus. The third member cannot be from the major field of study. One member may be from the faculty of a campus of Indiana University outside the core campus. At least two of the committee members must be tenure-line faculty members. The committee chair must be an associate or full professor in the student's major area of study. The dissertation director must be a regular or endorsed member of the University Graduate School faculty.

In some instances it is possible to include a committee member who is not an Indiana University faculty member, such as a faculty member at another university, on a doctoral committee. To receive approval for such an addition, two conditions must be met:

• the substitute member must have special expertise not available among University Graduate School faculty, either in the substantive area of the study or in the research methodology, and
• the substitute member must supply evidence of published research.

A copy of the Human Subjects Committee approval must be submitted with the Research Committee form. For further information on the Human Subjects approval process, please see the section titled "Use of Human Subjects" below.

Forming a Committee

The procedure for selecting a research committee chair and research committee members varies considerably from student to student. Ideally, the research question that becomes the focus of the dissertation study stems naturally from research experiences, course work, or graduate assistantship assignments that the student has had during the program of studies. Often the advisory committee chair is the student's mentor and becomes the research committee chair. In such a case, the student and chair typically have had discussions about tentative dissertation topics prior to admission to candidacy and prior to the selection of other research committee members.

It is not required that the advisory committee chair be asked to chair the research committee, nor that the advisory committee chair agree to chair the research committee, if asked. Ultimately, the choice of a research chair involves a combination of personal compatibility and compatibility of the research interests of the student and the chair. The student and the committee chair typically confer regarding the selection of other research committee members.

Prospectus/Summary

A one- to two-page dissertation prospectus/ summary must be submitted with the Nomination of Research Committee form. This prospectus/summary should include a clear statement of the questions to be addressed in the study, an outline of the design of the study, the research methods to be used, and a discussion of the contribution of the study to theory and/or to practice. The prospectus/ summary should play an important role in the selection of a research committee. This document allows prospective members to decide whether to participate in the study, based on the area of focus and the integrity of the prospectus. It is generally unwise for faculty members to make a commitment to serve on a student's research committee before a written prospectus/summary is presented for examination.

Dissertation Proposal

After submitting the prospectus/summary, students are next required to submit a dissertation proposal, a document that is considerably more detailed than the prospectus/ summary. The proposal should contain the following elements: a statement of purpose, rationale, literature review, research questions, proposed procedures, the source of data, methods of data collection, methods of data analysis or data reduction, and the contribution of the study to theory and/or to practice. Frequently, students are advised by their research committee to write a draft of the first three chapters of the dissertation (purpose and rationale, literature review, and method) as their research proposal.

A meeting of the research committee must be held to discuss and approve the dissertation proposal. A dissertation proposal approval form is available in the Office of Graduate Studies. When committee approval has been secured, the form must be filed with the Office of Graduate Studies. If the proposed research has changed since submission of the Nomination of Research Committee form, then a new two-page summary must be attached to the Dissertation Proposal Form.

Use of Human Subjects

If the proposed research involves the use of human subjects, a research review form for the use of human subjects must be completed. This form must be approved by the Campus Committee for the Protection of Human Subjects before the data collection begins. Prior to applying for human subjects approval and before the research review form for the use of human subjects can be reviewed, students will need to document that they have been trained to involve humans in research by passing the IU test for using humans in research. The tutorial and test can be found at http://researchadmin.iu.edu/HumanSubjects/index.html . Proof of having passed the test must accompany the application at the time of submission. Failure to provide proof with the application will delay the review until the following month. This applies to all submissions (new, continuation, and/or amendment) regardless of funding or rank of the primary investigator, sponsor, and co-investigators.

If the proposed research does not involve the use of human subjects, the School of Education requiries verification from the Institutional Review Board (IRB) that their oversight is not required.

The Human Subjects Committee office is located at the Carmichael Center 103, 530 E. Kirkwood Avenue, Bloomington, IN 47408, (812) 855-3067, [email protected]. Office hours are 8 a.m. to noon and 1 to 5 p.m., Monday-Friday.

In Indianapolis, students should contact the Office of Research Risk Administration at (317) 274-8289. The research review form for the use of human subjects can be viewed and downloaded from the Web at http://researchadmin.iu.edu/HumanSubjects/index.html.

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Research Committee

The Research Committee shall be responsible for fostering research in neuroradiology, for overseeing researchers and research activities funded by or through the Society. As directed by the Advisory Council, the Research Committee shall be responsible for supervising and judging the application or competition for grants and prizes bestowed by the Society that are research related. The Research Committee shall recommend recipients to the Foundation Board of Trustees, which must approve all grants and monitor the progress of funded individuals or proposals as appropriate.

• Support collaboration amongst basic science (Ph.D scientists) and clinical research (MD scientists) in the Society for educational and research opportunities.
• Develop a strategy for increasing NIH funding for neuroradiology-oriented projects.
• Provide educational and other support activities to encourage research by ASNR members.
• Develop initiatives to enhance the value of the Annual Meeting for neuroimaging investigators, and attract their participation
• Develop a strategy that encourages good quality submissions to the AJNR and to the Foundation-sponsored grants.
• Revise Foundation grant guidelines to enhance greater participation in the wide range of experience of ASNR members.
• Make recommendations to the Foundation regarding the support of research, including specific projects, through Foundation funding of the ASNR.
• Maintain documentation on all current and former funded projects through the Foundation.
• Update and maintain the Research Committee website, such that it is a useful tool for Society members seeking information regarding neuroradiology research.
• Fosters relationships with external organizations in order to advise, recommend, and support clinical trials that assess neuroradiology techniques or procedures.
• Foster collaboration with other organizations involved in Neuroimaging research, including the Radiological Society of North America (RSNA), International Society for Magnetic Resonance in Medicine (ISMRM), Organization for Human Brain Mapping (OHBM), and the Society for Neurosciences (SfN).
• Foster health services research in neuroradiology by collaborating with the Committee for Evidence Based Medicine.).
• To maintain contact with NIH agencies which support neuroradiological research, so as to influence submissions of RFAs and RFPs.

Time Commitment

The committee shall hold conference calls as needed.

Committee Roster

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Research organisations and research ethics committees - ESRC

Our principles: research ethics committees.

All parties involved in research have an active role to play in creating and sustaining a culture of rigorous ethical reflection.

We acknowledge that RECs have many competing obligations, with duties to protect participants, researchers and research organisations which mean they are constantly working to achieve many goals; we encourage RECs to engage with researchers in all stages of a project’s research lifecycle.

The principles below should also be considered during any ongoing monitoring of ESRC-funded projects.

Research should aim to maximise benefit for individuals and society and minimise risk and harm

A REC review of a project should consider the ethical conduct of the research whilst also facilitating high quality ethical research; this includes high-impact activities and new forms of research, for example, co-production. The review should be proportionate to the potential benefits and level of risk of the proposed research. RECs should determine the degree of risk and potential harm that may be tolerable in relation to the potential benefits.

The rights and dignity of individuals and groups should be respected

The primary role of the REC review is to ensure that the research will respect the dignity, rights, welfare and, where possible, the autonomy of participants and all parties involved in and potentially affected by the research.

Wherever possible, participation should be voluntary and appropriately informed

The REC should consider the information provided by the researchers regarding consent and voluntary participation, and evaluate how researchers justify and mitigate risks associated with withholding information and the adequacy of any proposed debriefing.

Participants should, wherever possible, take part in research voluntarily and there should not be any coercion or inappropriate influence.

The REC should be confident that participants will be given sufficient information about the research to enable them to make an informed decision about their participation. REC members should also be aware that there may be instances where this is not practical or desirable (for example, for methodological reasons, or covert or crowd research).

Research should be conducted with integrity and transparency

RECs should ensure that they fulfil their role and responsibilities with integrity and record their decisions and feedback in a transparent way.

Lines of responsibility and accountability should be clearly defined

The remit and responsibilities of the RECs should be clear; RECs should be committed to training and development to enable them to fulfil their role. Where the REC feels that it does not have the expertise to review a proposal, it should seek the help of independent bodies or external members. The REC’s performance is subject to review by the research organisation.

The independence of research should be maintained, and where conflicts of interest cannot be avoided they should be made explicit

RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals.

Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance structure that establishes the right of the REC to pass opinions free of influence.

Secondary RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers.

Further information

Criteria for research ethics committee review

Conflicts of interest, complaints and appeals

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Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research integrity more generally, has been increasingly recognised.

Two types of RECs

It is important to distinguish two types of research ethics committees. The first type is often set up to consider ethical issues that may be relevant to researchers working in specific areas. These might include the ethics of research into genetic modification, climate engineering, dual-use research (e.g., research with military applications), or research using potentially contentious methodologies such as “ human challenge ” trials (where participants are intentionally infected with diseases such as COVID). As these are difficult and complex areas, the main output is often in the form of guidance or position statements that can be applied by researchers, their institutions, funders, and ultimately policymakers. Consequently, these committees are convened at a fairly high level by organisations with an interest in the area of research being considered. They normally include scientific and legal experts alongside those with a specific interest in the topic under consideration (such as patient groups).

But the second, and far more common, type of research ethics committee is those set up by universities, research organisations, or health care providers (such as the NHS) to consider the ethical issues relating to individual, and often very specific, research projects. These Research Ethics Committees — abbreviated as RECs and referred to as Institutional Review Boards (IRBs) in the United States — provide a point-in-time review of a very detailed research protocol before the research is allowed to start. They aim to provide an opinion as to whether the research, if carried out in accordance with the detailed protocol, will meet accepted ethical norms. Exactly what these norms are, and how they can be addressed, is a complex question that may need to take into account guidance created by the first type of ethics committee described above. As such, although RECs still need to have suitably experienced individuals, it is more important that they are also suitably independent from the researcher (and their funder) to ensure they give an ethical opinion that is free from as many conflicts of interest as possible. Scientific or research expertise is important, but so is the voice of non-expert members. Quite often researchers will not be allowed to publish their work if they cannot prove it was reviewed by a REC before it started.

REC review supports research and researchers

REC review is criticised by researchers as being too lengthy, burdensome, or bureaucratic. This is often because it is confused with wider governance processes relating to issues such as data protection, health and safety, financial management, etc. While such issues are important, the fact that they are related to specific, often legally prescribed, arrangements means that they are governance issues that are the responsibility of the research institution (e.g., the university) to review and approve. The distinction between governance approvals , and ethics opinion , is extremely important if the aim is to create systems that provide robust, but proportionate, support to research and researchers. While in some contexts committees are expected to review both governance and ethics issues, there is an increasing recognition that governance is best handled separately by expert research officers, freeing RECs to consider the more complex ethical issues that may arise in any given research project.

Written by Dr Simon Kolstoe, UKRIO Trustee .

Research Review Committee

The Research Review Committee (RRC) is the Department of Psychiatry’s internal grant review committee and helps to ensure that research proposals prepared by investigators affiliated with our Department meet the highest scientific and ethical standards.

Prior to submission to external funding agencies or initiation of internally supported research, the RRC evaluates the scientific and technical merits of all research proposals planned by faculty within the Department, collaborating faculty from outside the Department, fellows, students, and staff. In addition, the RRC provides a preliminary evaluation of potential risks and benefits to human participants and of the welfare of animal subjects. 

All Department faculty and postdoctoral trainees submitting grant applications (as the PI) to external funding agencies must have their proposals reviewed by the RRC (even senior faculty and the Department Chair). For faculty who want to read about our internal submission guidelines and access the RRC materials (policy, coversheet, rating forms, etc.), please visit the faculty intranet site,  Psy Hub . For postdocs interested in submitting a K award, please visit the CARDS SharePoint site.

The RRC requests that investigators submit proposals for review as early as possible and that they work proactively with us throughout the process, especially when questions or special circumstances arise. 

To learn more about the role of the RRC, you can read the committee’s paper in Academic Psychiatry and/or contact one of the RRC Co-Chairs below.

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CORRESPONDENCE TO: Christine Grady, PhD, RN, Department of Bioethics, Clinical Center, National Institutes of Health, Building 10/1C118, Bethesda, MD 20892; e-mail: [email protected]

Corresponding author.

Received 2015 Mar 23; Accepted 2015 Apr 30; Issue date 2015 Nov.

Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research. IRBs were codified in US regulation just over three decades ago and are widely required by law or regulation in jurisdictions globally. Since the inception of IRBs, the research landscape has grown and evolved, as has the system of IRB review and oversight. Evidence of inconsistencies in IRB review and in application of federal regulations has fueled dissatisfaction with the IRB system. Some complain that IRB review is time-consuming and burdensome without clear evidence of effectiveness at protecting human subjects. Multiple proposals have been offered to reform or update the current IRB system, and many alternative models are currently being tried. Current focus on centralizing and sharing reviews requires more attention and evidence. Proposed changes to the US federal regulations may bring more changes. Data and resourcefulness are needed to further develop and test review and oversight models that provide adequate and respectful protections of participant rights and welfare and that are appropriate, efficient, and adaptable for current and future research.

Institutional review boards (IRBs) or equivalent bodies provide a core protection for human participants in biomedical and behavioral research in the United States and > 80 other countries around the world. 1 IRBs are charged with providing an independent evaluation that proposed research is ethically acceptable, checking clinical investigators’ potential biases, and evaluating compliance with regulations and laws designed to protect human subjects.

Independent review of clinical research by an IRB is required for US studies funded by the Department of Health and Human Services (DHHS) and other US federal agencies, as well as for research testing interventions—such as drugs, biologics, and devices—that are under the jurisdiction of the US Food and Drug Administration (FDA) ( Table 1 2 , 3 ). US research institutions can and often do extend federal regulatory requirements to all of their human subjects research. Research conducted outside of the United States but funded by the US government is subject to the same US federal regulations and so requires IRB review or equivalent protections. 4 Research conducted outside of the United States, not under an investigational new drug that submits data to the FDA for a new drug or biologic license application, must comply with Good Clinical Practice guidelines, which include review and approval by an independent review committee and informed consent. 5 Regulations and laws in many other jurisdictions around the world also require review by an independent research ethics committee or IRB. 6 Regulatory bodies in the European Union, Japan, United States, Canada, Australia, and Nordic countries, among others, follow Good Clinical Practice guidelines such as those delineated by the International Conference on Harmonisation, which require approval by an independent ethics committee or IRB. 7 IRBs or research ethics committees, composed of a group of people independent of the specific research, review proposed research plans and related documents before a study can begin and then periodically (usually annually) for the study duration. The goal of IRB review is to assure that the rights and welfare of participating research subjects will be adequately protected in the pursuit of the proposed research study. To be ethically acceptable and comply with regulatory requirements, the IRB determines that risks to subjects are minimized and reasonable in relation to the importance of the knowledge the study is expected to produce, that the process and outcomes of subject selection are fair (including delineated inclusion and exclusion criteria), and that there are adequate plans for obtaining informed consent.

TABLE 1 ] .

Selected US Regulatory Requirements for IRBs (Paraphrased)

CFR = Code of Federal Regulations; IRB = institutional review board.

History of IRBs in the United States

Recognizing that review by impartial others might mitigate conflicting differences in the ethical responsibilities of physician-investigators to research subjects from those of physicians to their patients and, thus, help to protect the rights and welfare of research subjects, James Shannon, MD, Director of the National Institutes of Health (NIH), in 1965 proposed that all NIH research involving human subjects be evaluated by an impartial panel of peers to ensure its ethical integrity. His idea derived, at least in part, from a model that began at the NIH Clinical Center when it opened in 1953, which was a model of group peer review for research involving healthy volunteers. 1 In 1966, US Public Health Service policy requirements for ethical review, which were expanded to all Department of Health Education and Welfare (the DHHS predecessor) research by 1971, were not well enforced. 1 Regulations for the protection of human subjects for DHHS, published in 1974 (45CFR.46), included a requirement for group ethics review and the term “institutional review board” was introduced. The World Medical Association also introduced review by an independent committee for oversight of science and ethics into the 1975 revision of the Declaration of Helsinki. 8 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by the US Congress after revelations of the US Public Health Service syphilis studies at Tuskegee, authored the Belmont Report which explicated ethical principles underlying the conduct of human subjects research. 9 The Commission’s contributions, including integration of the Belmont principles, were incorporated into updated US regulations in 1981. The 1981 DHHS regulations were subsequently adopted by 16 federal agencies (not including the FDA) in 1991 as the Common Rule. The FDA required an IRB beginning in 1981 (Title 21 Code of Federal Regulations, part 56), although some investigators funded by pharmaceutical companies already used oversight committees. 10 The most extensive proposed changes to the Common Rule since 1991 were issued by the DHHS in an Advance Notice of Proposed Rule Making in 2011 in an effort to enhance protections and efficiency. 11 , 12 Public comments were solicited and a Notice of Proposed Rulemaking is under development, but as of this writing has not been published ( Fig 1 ).

Timeline of regulations and guidance regarding IRB review. ANPRM = Advance Notice of Proposed Rule Making; DHEW = US Department of Health, Education, and Welfare; DHHS = Department of Health and Human Services; FDA = US Food and Drug Administration; IRB = institutional review board; NIH = National Institutes of Health.

US regulations at 45CFR.46 subpart E and 21CFR.56.106 require IRBs to be registered with the DHHS Office of Human Research Protections (OHRP), which is responsible for monitoring compliance with the Common Rule. Research institutions that receive DHHS funds file with OHRP an assurance that the institution will comply with federal regulations, called a Federal Wide Assurance. 13 Each assurance has to include at least one internal or external IRB registered with OHRP. The FDA requires registration of IRBs but does not require prospective assurances of compliance; sponsors and investigators include evidence of IRB review when they submit data to the FDA.

Changes to Research

At the time that IRBs were codified in regulation, single-site clinical research was the predominant paradigm. Advances in knowledge, technology, and resources over the subsequent decades have significantly changed the face of research. Growth in public and private spending 14 , 15 as well as evolving scientific opportunities have created novel challenges for IRBs. The majority of clinical trials are now multisite, and some include > 100 sites, often with sites in multiple countries. 16 In addition to multicenter and multinational research, IRBs review, for example, proposals for research with stored samples and data, cell-based and stem cell therapies, emergency research, social science research, and community-based research. IRBs operate under the same regulatory structure and use similar procedures despite a wide range of types of research posing disparate risks to subjects’ rights and welfare. Furthermore, the complexity of oversight has changed with the development of new entities involved in clinical research, such as contract research organizations, data and safety monitoring committees, clinical trial coordinating centers, accrediting associations, and commercial IRBs, among others.

Changes to IRBs

Concurrently, the number of, investment in, and responsibilities of IRBs have continued to increase. Most research institutions, universities, and health-care facilities have at least one IRB, and the majority has more than one. 17 In addition, there are a number of independent or commercial IRBs. 18 Increasingly, IRBs are tasked with responsibilities beyond those required by federal regulation, including, for example, review of conflicts of interest, compliance with privacy regulations, training of investigators, scientific review, and monitoring of clinical trial registration, among others. IRBs do indeed have responsibility for reviewing the science to assess the soundness of the design and the risks and benefits of the proposed research, however, many institutions have a separate scientific review process that precedes and complements IRB review.

Dissatisfaction and concern about what is perceived as an expansive mission and bureaucracy of IRBs has also mounted. Investigators and others criticize the IRB system as dysfunctional and “more concerned with protecting the institution than research participants.” 19 Some claim that IRBs are overburdened 20 and overreaching. Researchers, institutions, and some IRB members complain about burden: excessive paperwork, inflexible interpretation of regulatory requirements, attention to inconsequential details, and “mission creep”—the expanding obligations of IRBs that seem to have little to do with protection of research participants. 21 Fear of regulatory admonition has fueled a focus on compliance with regulations. 22 Some perceive the excessive or “hyper” regulation as seriously affecting or stifling research productivity and adding cost without adding meaningful protections for participants. 23 , 24 Clinical investigators complain that the IRB review process is inefficient and delays their research for what seem like minor modifications. 25 The public hears about problems and fears that research might be unsafe and existing protections ineffective or inadequate. 26 , 27

Charles McCarthy, the first director of the US Office for Protection from Research Risks (the OHRP predecessor) noted, “[IRBs] have become more insightful and sophisticated…But unless [the Human Research Protection System] is considered to be an evolving and expanding mechanism, adapting to the problems of each period of history, it is in danger of becoming fossilized and ineffective.” 28 Flexibility and adaptability are important characteristics not usually attributed to IRBs. The challenge is how to evolve, expand, and adapt IRBs to the current exigencies of research in a rational and meaningful way. As noted by Cohen and Lynch, 29 the system is “ripe for a major course correction.”

Reform: Needs, Attempts, and Challenges

Recognition of the need for a robust system of protecting human research subjects within the changing research landscape has led to various proposals for reform and suggestions for alternative models. 30 ‐ 35

Reform proposals offer changes to address some of the various factors that are problematic for IRBs and for those who use them. Yet, reform efforts have been somewhat paralyzed by the tension between those who find the current system inadequate and those who find it too overreaching. 36 , 37 Nonetheless, many grant that multiple reviews for a single study are duplicative, lead to significant delays in research without adding meaningful protections, and can result in inconsistencies that bias the science. 38 , 39 Additional reasons for considering reform of the current oversight system include inherent conflicts of interest, inadequate resources, the emergence of new research methodologies, and insufficient expertise of members, among others. 40 IRBs also grapple with how to respond to evolving research methods, and high profile cases in which regulators disagree with or disapprove of IRB decisions can fuel uncertainty and anxiety. 41 , 42

Various systems of pre-IRB review have gained traction as a way to improve IRB efficiency: Major issues and gaps can be identified and corrected through prereview before an IRB sees the proposal. Institutions are also adopting a framework that more explicitly recognizes the essential roles of the institution, investigators, and research teams in addition to IRBs in protecting human subjects. 43 Several alternatives to the traditional model of single IRB review or review at each site of a multisite study have been developed and tried ( Table 2 ). 44 ‐ 53 Proposed revisions to the Common Rule include a recommendation for a single IRB of record for domestic multisite trials. 9 More recently, the NIH called for comments on a draft proposal for a single IRB review for NIH-funded multisite trials. 54 NIH is also currently funding several empirical studies of central IRBs with the goal of informing policy development relevant to central IRBs. 55 Despite these significant efforts, many challenges remain in changing the process of IRB review, including questions of liability, cost structures, and incentives, and uncertainty about the relative merits of proposed models. 56

TABLE 2 ] .

Alternative Models for IRB Review

CHOP = Children’s Hospital of Philadelphia; NIAID = National Institute of Allergy and Infectious Diseases; NICHD = National Institute of Child Health and Human Development; NIH = National Institutes of Health; NINDS = National Institute of Neurological Disorders and Stroke; PHERRB = Public Health Emergency Research Review Board. See Table 1 legend for expansion of other abbreviation. (Adapted from the Alternative Models Table in “Summary of the 2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protection.” 31 )

Need for Evidence

Reform proposals often recognize the need for data about what works and for creative and testable ways of achieving the appropriate combination of protecting the rights and welfare of participants with meaningful and efficient IRB review that promotes high quality, relevant, and timely research. Evidence about how well IRBs are functioning, how effective they are, and how they could be more efficient would provide useful guidance for reform efforts. 57 Existing studies describe IRB structure, process, or outcomes and show that IRB judgments are inconsistent, as is their application of a standard set of regulations. 58 , 59 Practices and decisions vary between and within IRBs often without justification, including determinations about risk level, inclusion criteria, and the appropriateness of methods of recruitment and consent. 55 , 60 Despite complaints about inconsistency, independence and local evaluation make some IRB variation inevitable. Moreover, it is difficult to find a study or to identify metrics able to measure how effective IRBs are at ensuring the ethical conduct of research or protecting research participants. 61 Improving effectiveness requires clear and measurable goals for IRBs and ethical justification for regulatory requirements. 62

Many of these factors converge for critics of the IRB system: growing requirements and costs, 63 , 64 bureaucratic burden, vague goals, and limited evidence of effectiveness.

“The available evidence indicates that there are substantial direct and indirect costs associated with IRB oversight of research. IRBs also operate inconsistently and inefficiently, and focus their attention on paperwork and bureaucratic compliance. Despite their prevalence, there is no empirical evidence that IRB oversight has any benefit whatsoever—let alone benefit that exceeds the cost.” 65

Both normative analysis and empirical evidence are needed to understand how to improve the current system and optimize protections for contemporary research. If the goal is primarily to protect research participants from risk, for example, then more analysis of what risks count and more empirical evidence about research risks would provide direction for how we are doing and where the gaps are. As Taylor 66 notes, “whether and how to protect is inescapably normative and inescapably empirical.” In its 2011 report Moral Science: Protecting Human Participants in Human Subjects Research , the President’s Commission recommended that federal agencies involved in the funding of human subjects research “develop systematic approaches to assess the effectiveness of human subject protections and expand support for research related to the ethical and social considerations of human subject protections.” 67

Centralizing IRB Review

Primarily driven by concerns about redundant review, burden, and delay, much attention has been given to the idea of single or central IRB review for multisite studies as an alternative to local IRB review at each site. Multiple reviews also have the possibility of jeopardizing the science by introducing bias. 37 Institutions participating in multisite studies are permitted by federal regulations 68 to use arrangements that centralize or share reviews, yet relatively few employ these options. Many proposals for reforming or updating guidance and regulations have recommended single or central review for multisite studies. 10 , 28 ‐ 31 , 35 Lingering resistance to adopting central or single review for multisite trials appears to be based on concerns about the importance of local context, local accountability and liability, discomfort with relinquishing control over the review, uncertainty about the quality of review by other IRBs, and logistical concerns such as cost-sharing. 30 , 54 There is a paucity of data evaluating how single or central review compares to review at local sites regarding quality of review, satisfaction, resource use, or efficiency.

Conclusions

IRBs have an important role in protecting human research participants from possible harm and exploitation. Independent review by an IRB or equivalent is an important part of a system of protections aiming to ensure that ethical principles are followed and that adequate and appropriate safeguards are in place to protect subjects’ rights and welfare while they contribute to ethically and scientifically rigorous research. Over the four decades since IRBs were codified into regulations, IRB review and oversight has developed and matured as part of a robust system that provides “substantial protections for the health, rights, and welfare of research subjects.” 69 However, during that same period, research methods and opportunities have evolved, the domains of oversight have expanded, and the research enterprise has grown and diversified. The rules, norms, procedures, and even articulation of the goals of IRB review have not kept pace. Although ethical principles underlying research with human subjects have not changed, their implementation and actualization requires refinement and adaptation to respond to changing scientific and social contexts. Data, creativity, regulatory flexibility, and continued dialogue are needed to optimize the implementation of principles and to help shape the future structure, organization, processes, and outcomes of review and oversight by IRBs and related players. These efforts will support progress in clinical research, public trust in the enterprise, and protection of the participants that make research possible.

Acknowledgments

Conflict of interest: None declared.

Role of sponsors: The sponsor had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript.

Other contributions: Views expressed are the author’s and do not necessarily represent those of the National Institutes of Health or the Department of Health and Human Services. The author is grateful for the review and helpful suggestions of Scott Kim, MD, PhD, and Charlotte Holden, JD.

ABBREVIATIONS

Department of Health and Human Services

US Food and Drug Administration

institutional review board

National Institutes of Health

Office of Human Research Protections

FUNDING/SUPPORT: Work on this article was supported by the Clinical Center, Department of Bioethics, in the National Institutes of Health Intramural Research Program.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.

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Institutional Review Boards: Purpose and Challenges

Affiliation.

• 1 Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD. Electronic address: [email protected].
• PMID: 26042632
• PMCID: PMC4631034
• DOI: 10.1378/chest.15-0706

Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research. IRBs were codified in US regulation just over three decades ago and are widely required by law or regulation in jurisdictions globally. Since the inception of IRBs, the research landscape has grown and evolved, as has the system of IRB review and oversight. Evidence of inconsistencies in IRB review and in application of federal regulations has fueled dissatisfaction with the IRB system. Some complain that IRB review is time-consuming and burdensome without clear evidence of effectiveness at protecting human subjects. Multiple proposals have been offered to reform or update the current IRB system, and many alternative models are currently being tried. Current focus on centralizing and sharing reviews requires more attention and evidence. Proposed changes to the US federal regulations may bring more changes. Data and resourcefulness are needed to further develop and test review and oversight models that provide adequate and respectful protections of participant rights and welfare and that are appropriate, efficient, and adaptable for current and future research.

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Timeline of regulations and…

Timeline of regulations and guidance regarding IRB review. ANPRM = Advance Notice…

• McCarthy C. The origins and policies that govern institutional review boards. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:541-550.
• US Code of Federal Regulations. Title 45CFR, part 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html . Accessed January 5, 2015.
• US Code of Federal Regulations. Title 21CFR, part 56. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF... . Accessed January 5, 2015.
• US Code of Federal Regulations. Title 45CFR.46.101 (h). - PubMed
• US Code of Federal Regulations. Title 21 CFR 312.120; guidance for industry and FDA staff FDA acceptance of foreign clinical studies not conducted under an IND frequently asked questions.US Food and Drug Administration website. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf . Accessed April 12, 2015.

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• Volume 35, Issue 6
• Standards for research ethics committees: purpose, problems and the possibilities of other approaches
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• M Czarkowski
• European Forum for Good Clinical Practice, Brussels, Belgium
• H Davies, National Research Ethics Service, 4–8 Maple Street, London W1T 5HD, UK; Hugh.davies{at}nres.npsa.nhs.uk

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields.

https://doi.org/10.1136/jme.2008.027722

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Formation of a Library Committee in Academic and Research Institutions

A Library Committee is a governing body within academic and research institutions tasked with overseeing the library’s development, management, and strategic direction. Typically composed of faculty members, librarians, administrators, and sometimes students, the committee ensures that the library’s resources, services, and policies align with the institution’s educational and research objectives. The Library Committee plays a vital role in shaping the library’s collection, guiding budget allocations, implementing technology, and establishing policies that govern access and usage. Its importance lies in ensuring that the library remains a dynamic, well-managed, and essential resource supporting the entire institution’s academic and research needs. Formation of a Library Committee

Purpose of Forming a Library Committee

A Library Committee serves as a vital governing body within academic and research institutions, overseeing the development and management of the library’s resources, services, and policies. As libraries evolve from physical spaces housing collections of books to dynamic centers of information and technology, the role of the Library Committee becomes increasingly important. The purpose of forming a Library Committee is multifaceted, ensuring that the library remains aligned with the institution’s academic and research objectives while effectively serving the needs of students, faculty, and researchers. By forming a library committee, institutions can:

• Ensuring Alignment with Academic and Research Goals: One of the primary purposes of a Library Committee is to ensure that the library’s resources and services are aligned with the institution’s academic curriculum and research priorities. Faculty, students, and researchers rely on the library to provide access to a wide range of materials, from books and journals to databases and digital tools. A Library Committee, which often includes representatives from different academic departments, ensures that the library’s collection reflects the institution’s current and future needs. The committee plays a key role in guiding the acquisition of new resources, evaluating the relevance and quality of materials, and advising on subscription renewals for journals and databases. By continuously assessing the needs of faculty and students, the Library Committee ensures that the library stays current and supports both teaching and research endeavors.
• Overseeing Budget Allocation and Financial Management: Effective financial management is crucial for the operation of any library. Much of the library’s budget goes toward acquiring new materials, renewing journal subscriptions, investing in technology, and maintaining infrastructure. The Library Committee is responsible for overseeing the allocation of this budget and ensuring that resources are used efficiently. The committee provides guidance on which library areas require priority funding, such as expanding digital collections, acquiring specialized research materials, or upgrading technology. By managing the budget wisely, the Library Committee ensures that the library remains well-equipped to support the academic and research community without exceeding financial constraints. Additionally, the committee often seeks external funding opportunities, such as grants or partnerships, to supplement the library’s budget.
• Formulating and Reviewing Library Policies: A crucial function of the Library Committee is to establish and regularly review policies that govern the library’s operation. These policies cover many areas, including resource access, borrowing privileges, copyright compliance, and data management. By formulating clear and fair policies, the committee ensures that the library operates smoothly and serves the needs of all users. For example, policies on borrowing materials, interlibrary loans, and digital access ensure that students and faculty can access the resources they need fairly and equitably. Additionally, policies related to user behavior and the use of library spaces help maintain a productive and respectful environment for all patrons. The committee also establishes policies to ensure the ethical use of resources, such as adherence to copyright laws and appropriate handling of sensitive research data.
• Encouraging Technological Integration and Digital Transformation: In today’s digital age, libraries are no longer limited to physical collections. They have become digital learning and research centers, providing access to online databases, e-books, digital journals, and research tools. The Library Committee is critical in integrating these technologies, ensuring the library remains relevant and accessible in the modern academic landscape. The committee advises adopting digital platforms, developing online services, and implementing new technologies such as research data management tools, virtual reference systems, and digital repositories. By supporting digital transformation, the Library Committee ensures that the library continues to meet the evolving needs of students and researchers who increasingly rely on remote access to resources and tools.
• Fostering Collaboration and Communication: One of the most important roles of the Library Committee is to foster collaboration between the library, faculty, students, and the institution’s administration. By bringing together representatives from various departments and stakeholders, the committee ensures that the library’s decisions reflect the diverse needs of its users. The committee acts as a conduit for feedback from the academic community, allowing the library to continuously improve its services. For example, faculty members may provide input on new materials required for teaching or research, while students can offer feedback on the usability of digital tools and the accessibility of study spaces. This collaborative approach ensures that the library remains responsive to the needs of its users and continues to evolve in line with institutional goals.
• Supporting Open Access and Research Initiatives: In the academic world, open access to research is increasingly recognized as a means to promote the free exchange of knowledge. The Library Committee often supports open-access initiatives, encouraging faculty and researchers to make their work publicly available through open-access journals or institutional repositories. The committee can help develop policies that promote the use of open-access platforms and ensure compliance with copyright laws. The Library Committee helps enhance the institution’s research output by supporting open access, making it more visible and accessible to a global audience.
• Ensuring Accountability and Long-Term Vision: The Library Committee provides strategic oversight and accountability for the library’s management. Through regular meetings, reviews, and assessments, the committee ensures that the library operates effectively and fulfills its mission to support academic and research success. In addition to addressing immediate issues, the Library Committee shapes the library’s long-term vision. The committee evaluates emerging trends in education, research, and technology, ensuring that the library remains future-proof and capable of adapting to new challenges and opportunities. The committee maintains this forward-looking perspective to ensure the library’s continued relevance and growth in an ever-changing academic environment.

Forming a Library Committee is essential for the effective management and strategic direction of a library within an academic or research institution. The committee ensures that the library’s resources, services, and policies are aligned with the institution’s goals, supporting the academic and research needs of students, faculty, and researchers. From overseeing budget allocation and guiding technological integration to fostering collaboration and promoting open access, the Library Committee is crucial in ensuring that the library remains a vital, dynamic resource for the entire institution. Through its governance, the Library Committee helps libraries adapt to changing demands, ensuring they continue supporting innovation and excellence in teaching, learning, and research.

The formation of a Library Committee in academic and research institutions is a structured process to create a governing body that oversees the library’s resources, policies, and services. The committee ensures that the library aligns with the institution’s academic and research goals and serves the needs of students, faculty, and researchers. Below is a detailed explanation of how such committees are typically formed and how they function.

• Faculty Members: Faculty members from different academic departments are crucial for representing the needs and interests of the teaching and research community. Faculty input ensures that the library’s resources and services support the institution’s curriculum and research activities. Faculty members may vary by discipline to cover a broad spectrum of academic needs, including the humanities, sciences, engineering, and social sciences.
• Librarians: Librarians bring their professional expertise in library science, resource management, cataloging, and user services. Their deep knowledge of library operations, digital resources, and collection management makes them essential committee members. Librarians also provide insights into how technological changes and user behavior trends can affect the library’s role within the institution.
• Administrative Staff: Administrative staff, often from departments like finance, IT, or academic planning, play a crucial role in providing perspectives on budget management, financial planning, and technological infrastructure. They ensure that the library’s strategies align with the institution’s broader operational goals and support budget allocation, data security, and infrastructure needs.
• Student Representatives (Optional): Including student representatives on the committee can provide valuable insights from the primary users of library services. Students can offer feedback on issues like access to study spaces, the usability of digital resources, and the library’s role in supporting their academic success. Engaging students in decision-making fosters a user-centric approach to library management.
• Common roles include: Chairperson: Usually a senior faculty member, librarian, or administrator, the chairperson leads the committee, sets meeting agendas, facilitates discussions, and oversees decision-making. The chairperson plays a vital role in coordinating the work of the committee and ensuring that it remains focused on its strategic goals.
• Secretary: Typically a librarian or administrative staff member, the secretary is responsible for documenting meetings, keeping records, and tracking the implementation of decisions. They ensure that meeting minutes are maintained and that action items are followed up, contributing to the smooth functioning of the committee.
• Subcommittees: In some cases, the library committee may establish subcommittees to handle specific areas of responsibility. For example:
• Policy Subcommittee: Focuses on drafting and revising library policies related to access, usage, and borrowing.
• Budget Subcommittee: Works on financial planning, resource allocation, and prioritizing expenditures for acquisitions and technology upgrades.
• Technology Subcommittee: Manages the library’s digital resources and integration of new technological tools, ensuring that the library remains up-to-date with advancements in digital learning and research tools. Defining these roles early on clarifies each member’s contributions and helps the committee function efficiently.
• Rotating Membership: Rotating members in and out of the committee helps bring new ideas and perspectives while maintaining continuity. This ensures that long-serving members can pass on their institutional knowledge while allowing new members to contribute fresh insights.
• Balanced Representation: Institutions must ensure that the committee maintains balanced representation from various departments, ensuring the library’s services remain relevant across the academic spectrum.
• Succession Planning: The committee should have a plan to replace outgoing members and ensure a smooth transition. Often, this is done through mentorship, where current members help incoming members get up to speed.
• Agenda Setting: The chairperson, in consultation with other members, prepares the agenda for the meeting. The agenda may include reviewing the library’s collection development strategy, evaluating user feedback, planning technology upgrades, or discussing budget allocation.
• Documentation: The secretary keeps a formal record of each meeting, documenting decisions, action items, and deadlines. This ensures accountability and provides a reference for future meetings.
• Decision-Making: The committee uses meetings to make critical decisions about resource acquisitions, budgetary priorities, policy updates, and strategic planning. Meetings provide a platform for open discussion, allowing members to voice concerns, propose new initiatives, and collaborate on problem-solving.
• Submission to the Provost or Dean: The committee’s formation, along with its proposed members and terms of service, is usually submitted to senior leadership, such as the provost, dean, or vice president of academic affairs, for approval.
• Official Endorsement: Once approved, the committee gains the official mandate to make decisions about the library’s operation, resource management, and policy development. This endorsement often comes with a clearly defined reporting structure to senior leadership.
• Faculty and Student Feedback: Regularly soliciting feedback from faculty and students helps the committee make informed decisions that reflect the needs of the library’s users. Surveys, focus groups, and informal meetings can be used to gather input.
• Transparent Decision-Making: The committee should maintain transparency by communicating its decisions and updates through institutional newsletters, email lists, or the library’s website.
• Collaboration with Other Departments: The library committee works closely with departments like IT, finance, and academic services to ensure that library resources align with broader institutional goals.

Forming a library committee is crucial in ensuring that the library remains a vital, well-managed, and strategically aligned resource within academic and research institutions. The committee can effectively oversee the library’s operations and policies by identifying key stakeholders, defining roles and responsibilities, establishing meeting schedules, and securing institutional approval. Through regular communication with the academic community, the committee ensures that the library continues serving the evolving needs of students, faculty, and researchers, enhancing the institution’s educational and research capabilities.

Challenges in Forming a Library Committee in Academic and Research Institutions

Forming a Library Committee in academic and research institutions is crucial for ensuring effective governance and strategic oversight of the library’s resources, services, and policies. However, establishing such a committee is not without its challenges. From selecting the right members to ensuring balanced representation and managing conflicting priorities, several hurdles must be overcome to create a functional and effective Library Committee. Let’s explore the key challenges in forming a Library Committee and how institutions can address them.

• Balancing Expertise and Representation: While faculty members provide academic insights, librarians bring specialized knowledge in library science. Striking the right balance between these roles and including administrators who understand budgeting and resource management can be challenging.
• Ensuring Commitment: The selected individuals must participate in regular meetings, contribute ideas, and make decisions. Faculty and staff often have busy schedules in academic institutions, and ensuring their availability can be a major hurdle.
• Departmental Representation: Some academic disciplines may dominate the committee, leaving other departments underrepresented. For example, science and engineering faculty might focus on technological resources, while humanities scholars may emphasize the importance of physical collections.
• Inclusive Input: Ensuring the committee includes voices from all institution segments, including underrepresented departments and student perspectives, is critical. However, managing this inclusivity while keeping the committee small enough to be effective is a delicate balancing act.
• Resource Allocation: One department may prioritize access to physical resources, while another may focus on expanding digital collections. Conflicting needs can make it difficult to agree on how the library’s budget should be allocated.
• Technology vs. Tradition: While some committee members may push for rapid digital transformation, others may advocate for maintaining traditional resources like print materials and physical archives. Balancing these differing visions is essential to avoid friction and ensure a forward-looking strategy accommodating all stakeholders.
• Engaging Stakeholders: Ensuring the committee regularly solicits feedback from library users, including students and faculty, can be difficult. The committee needs to establish communication channels that allow continuous dialogue with the institution.
• Decision Transparency: Another challenge is maintaining transparency in decision-making. Ensuring library users know the committee’s decisions and understand their rationale requires ongoing effort and clear communication strategies.
• Competing Needs: With limited budgets, the committee may face pressure from different departments to prioritize their needs, whether investing in new technologies, acquiring research databases, or maintaining physical collections.
• Sustainability of Library Services: Managing library services within tight financial constraints while ensuring the sustainability and growth of the library’s resources and services is a complex balancing act. Committee members must be able to negotiate and compromise to make the best use of available funds.
• Varying Expectations: Faculty may expect specialized research resources, while students might prioritize access to study spaces and general collections. Librarians may focus on operational efficiency and the integration of digital tools. Balancing these varying expectations and finding common ground can be difficult.
• Policy Disagreements: Reaching agreement on policies that regulate library access, resource sharing, and technology use may take time, especially when committee members have different priorities.
• Time Commitment: Academic staff and librarians have demanding workloads, and maintaining regular participation in committee meetings can be difficult. Ensuring members remain engaged and committed to the committee’s mission requires careful scheduling and clear communication.
• Turnover and Continuity: The committee may experience turnover as faculty and staff move on or rotate out of the committee. Maintaining continuity and ensuring that institutional knowledge is passed on to new members is important but can be challenging in constant change.
• Approval Process: Securing institutional approval for the committee, including its structure, members, and authority, can involve navigating multiple layers of administration, which may delay the committee’s formation.
• Integrating with Existing Structures: Ensuring that the Library Committee’s work is aligned with other governance bodies within the institution, such as academic councils or finance committees, can be complex. The committee must work within the institution’s governance framework while maintaining its independence in decision-making.

Forming a Library Committee is a critical step in ensuring effective library governance, but it comes with various challenges. From selecting the right members and balancing representation to managing conflicting priorities and budget constraints, institutions must navigate several hurdles to create a successful and functional committee. By addressing these challenges proactively—through clear communication, strategic member selection, and fostering collaboration—the institution can ensure that the Library Committee is an effective body supporting the library’s growth and its role in the academic and research community.

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