An Argument for the Necessity of Voting Student IRB Members by Dr. Dennis Cooley
Anyone who has served on or administered an Institutional Review Board (IRB) should be more than familiar with the proper composition of such a body according to federal law. IRBs are required to have members:
with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. 1
Among the other mandates are suggestions on appropriate input. The IRB is encouraged to “invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.”2 Of course, these individuals are not necessarily voting members, but they do provide important information and insights that other board members might not have when making decisions about some human participant research.
Federal regulations are silent about IRB student membership—both undergraduate and graduate—leaving it to the various institutions’ best judgment. The result is that student members appear to be relatively rare. The University of Washington (UW) is among the small number of institutions with student voting members.3 According to UW, since the university encourages students to participate in various ways in research, the institution considers it “appropriate and desirable” to have student members with the same rights and responsibilities as any other member.4
The Office of Human Research Protections (OHRP) has at least thought about student membership in its Guidebook and elsewhere.5 “When students are likely to be participating in research, IRBs should consider including a student member or consulting with students where appropriate.”6 What remains unclear is what OHRP desires the student’s academic status to be, i.e., undergraduate or graduate, what background or credentials the student to have, and especially interesting is what “including” and “consulting” mean.
Combining OHRP’s advice and UW’s IRB policy provides a useful foundation for an argument in favor of student IRB membership. I contend that in institutions in which graduate and undergraduate students are used for human participants, voting membership for these two groups is not only a good idea but obligatory as well.7 8 I will begin with the general justifications for student members, and then proceed to several objections to seating students on an IRB.
Why Student Voting Members are a Necessity
There are four reasons students should be members of certain IRBs: the right to representation, undue influence and coercion management, to provide necessary information, and as a method to educate future researchers. First, the right to representation has a long history in the Western World beginning in medieval parliaments and running through contemporary society. 9 The argument for a right to representation can be summarized by saying, as Frankena did, that if you believe “every human being is equally entitled to the best life he is capable of”, then it follows that “everyone should have a representative among those who determine what will be done or not done.” 10 Frankena’s argument rightly assumes that since people can neither be experts in every area that affects their lives nor everywhere at once, they need to have representatives who are willing to act in their interests.11
In addition, there is precedent in federal regulations for certain groups being represented on IRB’s. IRB’s are not to be composed entirely of one sex whenever possible, nor are they to consist only of one profession’s members.12 Furthermore, at least one scientist and one non-scientist are required, as well as a community member from outside the institution who is not related to anyone affiliated with the institution.13 If these classes ought to be represented in the research studies’ evaluations, then students, who are many experiments’ subjects and persons worthy of moral concern, deserve to be represented as well. To make decisions repeatedly which affect a specific population without allowing that group to have an adequate voice in the matter shows a marked disregard for the inherent worth of the group’s members, especially when doing the same for race or sex would not be morally permissible.14 For example, if a male only IRB approved studies that were to be performed on women and qualified women were available to serve on the board, there would be a justified outcry over the process, even if the research itself proved to be ethical.
The reason the student representative should be a student rather than someone else becomes clearer once the representative’s duties are enumerated. According to Pitkin, almost everyone wants a discrete, independent, and wise representative who will both act in the group’s interests and represent them in a responsive matter. 15 Among these and other functions, a representative must:
provide for a degree of popular control…provide for leadership and responsibility in decision making…ensure that decision makers are responsive to the interests and opinions of the [community]…endow the [body] with a particular kind of legitimacy [and] provide channels of communication.16
Although students are not prisoners, the prisoner representative’s required characteristics are useful to show the features student IRB members should have. Prisoner representatives should “be skilled and knowledgeable enough to be effective but not so unlike the rest of the IRB as to be marginalized.” 17Entailed in these requirements are a knowledge base not only of federal, state, and local regulations and policies, but a particular understanding of the subject pool and the conditions in which the study will be conducted. For example, the representative should be able to generate an accurate assessment of the actual risks to prisoners and effectively convey that information to other board members.18 Moreover, the representative must make independent decisions based upon these rights and interests of the prisoners represented.19 Student board members must have the same skills and abilities when reviewing protocols using students for research.
Although non-student representatives could fulfill many of the functions, they do so to a lesser degree due to their inability to fully represent the group. A student is student community representative in three widely recognized ways: as an agent who acts on another’s behalf–in this case the student body–as a person sharing some of the represented class’ characteristics, and as a person who symbolizes the represented class’ identity or qualities.20 Non-student representatives are clearly able to represent students in the first manner, but fail to fulfill the latter two. Intuitively, given that students have all three characteristics, ceteris paribus, representation by them over non-students would be more useful to the board.
Adding evidentiary weight to the above intuition are the unique features students bring to IRB review. Student members evaluate the entire protocol in light of the student community, as well as the appropriate policy, regulations, and other relevant guidance. Student members, using their unique features, make decisions based upon the overall project and its components which might be hidden from the study’s participants who too often have enough information merely to satisfy the informed consent’s demands. For example, a student with appropriate knowledge and sensitivity to the student community might have raised concerns that those institutional decision-makers involved in William Sheldon’s research of college men and women’s personality traits that required the subjects to be photographed in the nude failed to do until it was far too late.21
The need for student representation by students can be seen especially when the study involves deceit requiring waiver of some informed consent elements. In these situations, the potential participants do not have sufficient information to make a fully informed decision affecting their lives. Student IRB members have all the information in addition to knowing the student community’s interests; therefore, student members are often better able to decide on a study’s permissibility for the student community as a whole and those who might participate, even though only the latter are directly affected by the research.
Besides the right to be represented, students are not as independent as some human participants because there is a clear power differential between investigators and students.22 Beecher, for example, states that students by their very nature are “captive groups” who are susceptible to subtle coercion.23 Oakes agrees with this assessment arguing that they are vulnerable group members ethically similar to children, racial or ethnic minorities, and adults with decisional impairments. 24 Oakes also claims that when participation in research and grades are tied together, “an element of coercion and conflict of interest obtains.”25Student subjects often do what professors say because they want to please the latter, they fear that their grades, potential letters of recommendation, and other opportunities will be affected negatively if they do not,26 they are merely complying with an authority a la Milgram, or for some other non-rational reason that those with more life experience would find illegitimate. 27
Questions of coercion and undue influence on students used in research arise so often that OHRP includes guidance to resolve issues surrounding it. The federal office states that if the research is a course requirement, then non-research alternatives involving comparable time and effort need to be offered. In those cases in which extra credit or other reward can be earned by students, the benefit must be reasonable and there has to be alternative and comparable means to receiving the reward.28
Evaluating protocols without student member participation might be more expedient, but it poses ethical concerns that need not exist. The fact of the matter is that some faculty and other researchers fail to recognize that students are more easily manipulated than many other participants. As a result, the students are unwittingly treated as convenient research pool members for researchers with limited budgets and research and publishing needs rather than as human persons deserving respect for who they are.29 With student membership, students’ viewpoints can be expressed about whether or not they are being exploited in some way that other IRB members are generally unable to recognize or that the study has some other prohibited consequence to it.
In addition to representation rights and mitigation of coercion and undue influence, students bring distinctive resources to decision making processes that justify their full IRB membership. Since student members are more inculcated in their contemporaries’ culture than are other board members and share unique features with them, student members have valuable insight into the group’s general communication needs and abilities, internal and external pressures, and any other issue that might affect the study’s propriety. For example, more specific knowledge of the subject pool is useful in regard to whether payments or other rewards will lead to situations in which student participants consent without fully considering participation risks. Furthermore, Oakes states that many informed consent forms are inadequate because the “reading levels are too high, jargon too common, and potential risks woefully underestimated.”30 Student members can evaluate consents to determine if their readability, logical flow of ideas, headings and subheadings’ organization, type style and text size, and other relevant features31 are consistent with student potential participants’ ability to understand sufficiently for informed consent requirements. Since an informed consent’s emphasis is on how well the potential study participants know the information, then presenting it in language readily comprehensible to the subject pool is better than merely assuming the language has those features. Given that non-student members’ society and culture is significantly different than students’ in ways about which the former often are uninformed or do not fully comprehend, it follows that student members are more likely than non-students to provide information necessary to making an ethical decision.
The fourth and final reason for student inclusion is to educate future researchers and to help change the culture on many campuses. Since most of the institutions with studies being conducted on undergraduate and graduate students are teaching institutions, it is part of their mission to educate their students to perform their best in their chosen fields, especially those involving human participant research. Graduate students and some undergraduates will be researchers who need to know how to perform ethical research. As part of their employment, they might serve terms on their employers’ IRB; hence, the experience they receive as students will serve them well and allow their employer’s IRB to benefit from having an experienced member. Even if the former student never serves on another review board, she still needs to be an ethical researcher and institution citizen. Membership helps students hone their skills doing human subject research in permissible ways. IRB membership improves graduate students abilities for analyzing research projects, introduces them to being members of the community of scholars, and makes them better able to mentor others in the proper conduct of research.
Although few IRBs are mismanaged, many research institutions have a culture in which investigators blame the board for preventing their valuable research from taking case because of arcane regulations and idiosyncratic practices. The problem arises in many cases due to a lack of information on both the IRB and researchers’ part. If care is taken in the student member’s selection, he can also act as a liaison to explain to other students and interested parties the IRB’s duties, processes, and compliance concerns, as well as a conduit to the IRB from the investigators. The benefit from someone within the research community discussing the IRB with those who find the review process little more than a hindrance to their work is the latter becomes more likely to understand why IRB polices must be followed. Moreover, if the misconceptions about IRBs are eliminated or prevented early in students’ careers, then a culture of collaboration is more likely to replace the current one. This community interaction will assist in promoting “respect for its advice and counsel in safeguarding the rights and welfare of human subjects”32 that often cannot be achieved when researchers believe that IRB members do not understand or care about the nature of their field and research.
Although it might initially be daunting to convince administrators, current IRB members, and others of the need to include voting student members, the consequences of doing so are well worth the effort. The overall result of student IRB membership is movement away from the principle investigators and students’ power differential relationship to one based more on collaboration. Following the lead of the Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research’s work updating regulations on prisoners, collaboration can be beneficial to all research stakeholders. Collaboration can show the strengths and weaknesses of a protocol, help design the study to local conditions, and satisfy the interest that potential subjects have in being consulted in research that will affect their community.33 This in turn will prevent some of the negative results of research which at the time seems permissible to researchers, IRBs, and others, but once exposed to the public, generates enormous controversy and problems for many innocent people. The ultimate end of inclusion is a better research environment for all.
There were a number of concerns that arise when IRBs consider adding students as voting members. First, some current members might wonder whether students will take their charge as seriously as it deserves. Students are very busy with their private and academic lives, which might interfere with their abilities to attend meetings or review protocols. Related to the time constraints is a concern that students would not be responsible enough to evaluate study proposals with the gravitas they deserve or maintain confidentiality and discretion when such is warranted. If these defects occur, then the inadequate reviews would violate 45 CFR 46.107 (a).
Other IRB members could be unsure whether students will have an adequate understanding of the review process to ensure that the review was complete as mandated by regulations.34 Of all the potential problems, this one seems to pose the most concern for the reason that IRBs must be very careful to comply with federal, state, and institutional policies. First, of course, members must protect human participants’ welfare and rights. Second they are obligated to maximize utility, respect all people affected by the research in the appropriate ways, and to pursue some form of distributive justice as found in the Belmont Report. Third, following all relevant policies protects the institution from an OHRP or other relevant regulatory agency visit and the negative consequences that arise from it. If students are unable to review protocols adequately, on these grounds, they should not be voting members.
In addition, one of the most pressing administrative concerns plaguing some IRBs is reaching a quorum to conduct business. With student members, it might become harder to achieve the mandated majority because students have busy schedules which can interfere with them attending a meeting held during regular business hours. Moreover, if they cannot come, then other board members with their own conflicting commitments would have to ensure that they set aside their other duties and appointments to be there; thereby creating unnecessary difficulties for non-student members. Less flexibility in turn might cause more reluctance to serve on boards that already have trouble attracting members.
There could also be an unexpressed reluctance on some senior faculty and others’ part to accept students as members with equal voting rights. Students might be thought to be less qualified due to the fact that they are far less experienced than senior faculty members who have been in their profession for a long time. The latter have had much greater training in their fields and have encountered more relevant situations than students, which it could be argued, places them at a distinct advantage over others. Although representative democracy is mandatory in many circumstances, when dealing with human subject research, older, wiser heads should prevail without the unnecessarily permitting students to be involved in discussions or voting.
Although these potential problems are obstacles to be overcome, they are neither insurmountable nor exclusive to students being voting members. An IRB should only be comprised of individuals who are qualified to perform their tasks. It is the relevant officials’ responsibility to ensure that each appointed member is able to do her job; hence, great care should be taken in potential members’ recruitment and screening regardless of what group she represents. If a student, staff, faculty, or outside candidate is not properly trained, then she should not be appointed. Furthermore, if a member cannot fulfill her responsibilities, then there should be procedures in place to remove her from the board. However, without adequate empirical evidence, it would be unjustified to claim that students are inherently inferior in their abilities to fulfill federal and other regulations to many faculty, prisoner representatives, and community members.
A final argument against including students as members is grounded upon the premise that their membership is not required if their interests can be represented adequately by a qualified non-student. After all, the federal government mandates only that there be sufficient expertise on the board to be able to make an informed decision about the research. Even Subpart C of 45 CFR 46 states that a prisoner representative can take the place of a prisoner on the board. The Committee on Clinical Research Involving Children recommends merely that IRBs should have adequate expertise with research on children and consult when appropriate with experts, parents, and other stakeholders who can provide information the IRB needs.35 It does not require that a child, parent, or other stakeholder have a vote on the board. If federally recognized vulnerable groups, such as children, do not have the right to representation, then it would seem presumptuous to demand it for students.
Although I believe the three reasons for student membership can adequately overcome this objection, a few words also can be said about its inherent weaknesses. First, the mere fact that something is not required by federal regulations does not entail that it should not be required. At one time, there was inadequate representation for prisoner research, research on women, minorities, and so on until people finally changed the system to be more inclusive. The same unethical oversight, I contend, is occurring in regard to students. Second, permitting a prisoner representative to be a non-prisoner is limited by qualified prisoners’ availability. If a prisoner and non-prisoner are equally qualified in the skills to do an adequate job of representing prisoners, then choosing a non-prisoner over a prisoner would be as morally problematic as an IRB composed solely of men making decisions about research on women. Prisoners have more insight into what it is to be incarcerated at that time than does someone who is not under the same constraints and does not have the unique experiences and feelings a current prisoner has. A qualified prisoner would be able to “appreciate and articulate an accurate and sensitive assessment of the actual risk to prisoner subjects” 36 because of their situation. Therefore, actual prisoners are more representative, and therefore better members than are non-prisoners. The case for actual student members is much the same as that of prisoners. Well meaning though they may be, a non-student representative will never have the features the best representatives have, e.g. being a student familiar with the community of students’ interests as a community member.
If we wish to provide the best research review and oversight, then it seems reasonable to conclude that students should be voting members of IRBs. Besides demonstrating the proper respect to research participants by incorporating adequate representation and exploitation mitigation, there is just too much benefit with little to no cost from having them fully represent their groups.
1 United States of America. Code of Federal Regulations Title 45: Department of Health and Human Services Part 46: Protection of Human Subjects. Revised June 2005.
2 See ref. 1, 45 CFR 46.107 (f).
3 University of Washington (UW). IRB Member Composition. (December 2007). http://www.washington.edu/research/hsd/irb_comp.html.
4 See ref 3, Ibid.
6 See ref 5, Ibid.
7 In institutions with research on undergraduates and without graduate programs, undergraduate IRB membership is obligatory.
8 North Dakota State University Institutional Review Board for the Protection of Human Subjects Guidelines. (August 2007) http://www.ndsu.nodak.edu/research/irb/rcatt_irb_guidelines.php.
9 Birch, A.H. Representation. New York, NY: Praeger Publishers, Inc, 1971.
10 Frankena, WK. Two Notes on Representation. In: Pennock, JR, Chapman, JW. Representation. New York: Atherton Press, 1968, p. 49-51: 51.
11 Diggs, BJ. Practical Representation. In: Pennock, JR, Chapman, JW. Representation. New York: Atherton Press, 1968, p. 28-37.
12 See ref. 1. 45 CFR 46.107 (b).
13 See ref 1, 45 CFR 46.107 (c&d).
14 Of course, deception in some experiments can be justified but the participants should be apprised after the research is performed.
15 Pitkin, HF. The Concept of Representation. Berkeley, CA: University of California Press, 1967: 209.
16 See ref. 9, 107-8.
17 Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Board on Health Sciences Policy, Institute of Medicine of the National Academies. Ethical Considerations for Research Involving Prisoners. Gostin, LO, Vanchieri, C, Pope, A. (Editors) Washington, D.C.: The National Academies Press, 2007: 83.
18 See ref. 17, 141.
19 Secretary’s Advisory Committee on Human Research Protections (SACHRP). Office for Human Research Subjects Protections. Appendix A. (December 2007). http://www/hhs.gov/ohrp/sachrp/sachrpltrtohhssecApdA.html.
20 See ref 9, 15.
21 Prescott, HM. Using the Student Body: College and University Students as Research Subjects in the United States during the Twentieth Century. Journal of the History of Medicine and Allied Sciences 2002; 57(1): 3-38.
22 Oakes, JM. Risks and Wrongs in Social Science Research: An Evaluator’s Guide to the IRB. Evaluation Review 2002; 26(5): 443-479.
23 Beecher, HK. Research and the Individual: Human Studies. Little, Brown: Boston. MA: Little, Brown, 1970: 77.
24 See ref. 22, 456.
25 See ref 22, 461.
26 Tickle, JJ, Heatherton TF. 2002. Research Involving College Students. In: Bankert, EA, Amdur, RJ. Institutional Review Board Management and Function. Boston, MA: Jones & Bartlett Publishers: Boston, 2002, p 384-5.
27 See ref. 5; ref. 21, 37; and Roberts, LW, Geppert, CMA, Coverdale, J., Louie, A., Edenharder, K. Editorial: Ethical and Regulatory Considerations in Education Research. Academic Psychiatry 2005; 29: 1-5.
29 Cohen, JM. “Extra Credit for Research Subjects” IRB 1982; 4: 10-11.
30 See ref. 22, 464.
31 Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine of the National Academies. Ethical Conduct of Clinical Research Involving Children. Field. MJ, E. Behrman, RE. (Editors) Washington, D.C.: The National Academies Press, 2004, 162.
32 See ref 1, 45 CFR 46.107 (a)
33 See ref 17, 129-30.
34 See ref 1, 45 CFR 46.107 (a).
35 See ref 31, 253.
36 See ref 17, 141.