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A fundamental stipulation of the Code of Federal Regulations for the protection of human research subjects, Title 45 Part 46 (45 CFR 46), is that institutional review boards (IRBs) have a membership diverse in race, gender and cultural backgrounds with sensitivity to issues such as community attitudes.1 The purpose of a diverse membership is to promote respect for the IRB's advice and counsel in safeguarding the rights and welfare of human subjects. To that end, 45 CFR 46 requires that each IRB include at least one member whose primary concerns are in scientific areas, one member who is not otherwise affiliated with the institution and one member whose primary concerns are in non-scientific areas.2 IRB members whose primary concerns are in non-scientific areas are referred to in conversation and in the literature as non-scientists, laypersons, public members or public representatives and community members or community representatives.3,4,5 We think the term non-scientist is most consistent with the regulatory intent and refer to them as such in this study. Non-scientist members are often clerics, lawyers, or laypersons and may also fill the requirement for non-affiliated members if they or members of their family are not otherwise affiliated with the institution.
The National Institutes of Health (NIH) Office of Human Subjects Research (OHSR) conducted this study to learn more about the roles and experiences of the non-scientist members in the fourteen IRBs of the NIH Intramural Research Program (IRP) and to assess how educational activities for non-scientist members can be improved. Additionally the study was conducted to learn how non-scientist members’ perceptions of their roles and experiences compare with the perceptions of scientist IRB members. The NIH IRP consists of the Clinical Research Center and NIH campus in Bethesda, MD, and sites in Baltimore, MD and Research Triangle Park, NC.
OHSR mailed a questionnaire to the 28 non-scientist members of the NIH's fourteen IRBs. The survey consisted of five sections. The first two sections contained questions to elicit members’ perceptions of their roles and experiences on the IRB. The third section assessed members’ needs and desires for additional education. A multiple choice scale offered five ordered responses either for strength of agreement (strongly agree, agree, unsure, disagree, strongly disagree) or frequency (always, often, sometimes, rarely, never). The fourth section requested demographic information including sex, education level, employment status and time served on the IRB. Section five asked for open-ended responses to questions about the most important qualities of effective non-scientist IRB members and how the NIH could better assist non-scientist members in their roles. Questions were framed to elicit agreement and disagreement to avoid bias.
All 135 NIH scientist IRB members and chairs were surveyed anonymously via an online questionnaire. The survey consisted of five sections including questions about scientist members’ perceptions of non-scientists’ roles using the same multiple choice scale for strength of agreement or frequency as described above. Basic demographic information such as NIH institute of employment and time served on the IRB was requested. Scientist members were also asked to provide open-ended responses about the most important qualities of effective non-scientist IRB members and how the NIH could better assist non-scientist members in their roles.
Non-scientist IRB member responses were linked to personal identifiers by code but identifiers were removed and all linkages broken at the conclusion of the study. All scientist member responses were anonymous and not linkable to personal identifiers. This research was determined to be exempt from IRB review (by the NIH Deputy Director for Intramural Research).
Responses to questions from non-scientists and scientists were compared for significance of difference using a two-sided Pearson chi-square test or a two-sided Fisher's exact test. If the expected number in any cell of a contingency table was less than five, a two-tailed Fisher's exact test was used. For descriptive purposes, ordered responses (strongly agree, agree, unsure, disagree or strongly disagree) were compared with unordered categories (non-scientist or scientist). For the purpose of detecting statistical differences in agreement, “strongly agree” or “strongly disagree” responses were combined with “agree” or “disagree” responses. Analyses for statistical differences in agreement were performed while including and excluding “unsure” responses. Separate P values are reported for each analysis, either including or excluding “unsure” responses. A two-sided P value less than 0.05 indicated statistical significance. Statistical analyses were performed using SPSS for Windows version 14.0 (SPSS Inc., Chicago, IL).
Selected demographic data and comparisons with published literature are given in Table 1. Twenty-five of the twenty-eight non-scientist IRB members completed questionnaires (89% response rate) and each of the fourteen NIH IRBs were represented by respondents. Sixty-four percent of non-scientist respondents were not affiliated with the NIH other than by IRB membership and non-affiliated member responses were not statistically different from affiliated members. Respondents were 60% female and no differences between male and female responses were observed. Ninety-two percent of non-scientist members had completed at least a bachelor's degree and 76% had an advanced degree including a law degree or non-science-related masters degree or Ph.D. Twenty percent had less than a year of experience on an IRB, 36% had 1−3 years, 12% 4−6 years and 28% longer than six years.
Non-scientist IRB members were asked questions pertaining to their main roles. Seventy-two percent of respondents agreed (28% strongly) that the main role of non-scientist IRB members is to review and make recommendations about the informed consent document (Table 2). Eighty-one percent of non-affiliated non-scientists agreed compared to 56% of affiliated members, but this difference did not reach significance (P=0.355). Although most believed their main role was to review the informed consent, 92% felt they made other important contributions (8% were unsure). For example, non-scientist members were asked at what frequency they asked questions concerning scientific design, informed consent process and human subjects’ issues unrelated to the informed consent document. Seventy-six percent answered that they sometimes or often asked questions about the scientific design of protocols and 84% answered they sometimes or often asked about the informed consent. Only 44% reported they often ask questions concerning the protection of human subjects that are unrelated to the informed consent document and one respondent reported never asking questions unrelated to the informed consent document.
Non-scientist IRB members were asked if they believed they had unique roles on their IRB and, if so, what those roles might be. Sixty percent agreed that non-scientist IRB members represent community values, views and norms (12% strongly) but 24% were unsure (Table 2). Eleven (69%) non-affiliated members agreed compared to four (44%) affiliated members but this did not reach significance (P=0.263). Eighty-eight percent agreed (24% strongly) that one of the reasons for having non-scientist IRB members is to make the conduct of research accountable to the public. Twenty percent agreed (one member strongly) that non-scientist IRB members are more capable of representing the interests of human research subjects than are scientist members while 40% were unsure.
Members were asked to choose from a list of roles commonly attributed to non-scientists and to agree or disagree if they felt these roles described them (Table 3). Overall, 68% percent described their role as laypersons, 28% as representatives of the public, 16% as representatives of the community and 16% as advocates for research subjects. Non-scientist responses were also stratified by each member's affiliation with the NIH (Table 3). Nearly twice as many nonaffiliated non-scientist members described themselves as laypersons as did affiliated non-scientist members, but this difference did not show statistical significance (P=0.087). Agreement with the description of members’ roles as public representatives, community representatives and research advocates did not differ between affiliated and nonaffiliated non-scientists.
Members were asked how frequently they felt uncomfortable participating in IRB deliberations and if they felt their opinions were valued by other members or investigators. Ninety-six percent of non-scientist members reported that they were active participants most of the time and 92% answered that their IRB chairperson encouraged their participation. Thirty-six percent of members reported that they sometimes felt uncomfortable participating in IRB discussions, forty-percent answered that they sometimes felt uncomfortable asking questions about scientific design and 12% that they sometimes felt uncomfortable asking questions about human subjects protections. Regarding their perception of being valued on the IRB, 92% of non-scientists felt that scientist IRB members took their comments and suggestions seriously. Eighty percent believed that principal investigators took their comments and suggestions seriously, though 20% were unsure.
When non-scientists were asked if they were adequately prepared by the NIH for service as IRB members, 72% agreed that they had been adequately prepared, 12% disagreed and 16% were unsure. Fifty-eight percent answered that they wanted more education on the protection of human subjects than they had received, 21% did not and 21% were unsure. Non-scientists were asked to choose in which areas additional education would make them more effective IRB members. Thirty-seven percent desired additional education on the Belmont Report, 45% on 45 CFR 46 and 62% the NIH IRB review standards.
Eighty-four of 135 scientist IRB members completed questionnaires (62% response rate) and each of the fourteen NIH IRBs were represented by respondents. Nineteen percent of scientist member respondents had less than a year of experience on an IRB, 47% had 1−3 years, 17% had 4−6 years and 17% had longer than six years. Questions were asked of both non-scientist and scientist IRB members to assess qualitative and statistical differences in responses (Table 2). Results did not change when affiliated non-scientist member responses were either included in or excluded from the analyses.
Forty-seven percent of scientist respondents answered that the main role of non-scientist IRB members is to review and make recommendations about the informed consent document compared to 72% of non-scientists (P=0.037). Ninety-seven percent felt that non-scientists made important contributions above and beyond their review of the informed consent document, similar to the non-scientists’ responses.
Eighty-one percent answered that non-scientist IRB members represent community values, views and norms (19% strongly) compared to 60% of non-scientists (P=0.056). Ninety-three percent of scientist members agreed (33% strongly) that a reason for having non-scientist IRB members is to make the conduct of research accountable to the public, similar to non-scientist responses (88%). Seventy-two percent of scientist IRB members disagreed that non-scientist members are more capable of representing the interests of research subjects. This was significantly different from non-scientists who mostly disagreed (40%) or were unsure (40%), (P=0.009).
Ninety percent agreed that an IRB's ability to protect human research subjects is improved by having members whose primary concerns are in non-scientific areas, but 50% disagreed that having more non-scientist members would further improve this ability. All but one scientist IRB member agreed that contributions made by non-scientist members are respected by other IRB members. All scientists reported that they take comments and suggestions made my non-scientist members seriously compared to 92% of non-scientists who felt they were taken seriously (8% were unsure). Eighty percent felt that comments and suggestions made by non-scientists are taken seriously by investigators, 18% were unsure and two scientists disagreed.
Non-scientist and scientist IRB members were asked what they thought were the three most important qualities of effective non-scientist IRB members. Among members who returned the survey, 21 non-scientists (84%) and 77 scientist members (92%) answered this open response question. The most frequently cited quality of effective non-scientist IRB members was “assertiveness” by 43% of non-scientists and 36% of scientists. IRB members further described the quality of assertiveness as having self-confidence, a willingness to ask questions and the ability to speak up. Twenty-nine percent of non-scientists and 8% of scientist members suggested that “having a scientific background” and “having the ability to understand the science” were important qualities. The ability to review the informed consent form for clarity, readability and comprehension from a lay perspective was cited by 14% of non-scientists and 13% of scientists. Fourteen percent of non-scientists and nine percent of scientists suggested that “having the ability to advocate for human subjects” and “represent the perspective of human subjects” were important qualities of non-scientist members. Additionally, six percent of scientists responded that an important quality was “having the ability to bring a different perspective” and “to see something that scientists may take for granted.”
The requirement for inclusion on IRBs of at least one member whose primary concerns are in nonscientific areas flows from the conviction that prospective review of research by a diverse group of individuals is most likely to protect human subjects and promote ethically sound research. The regulations specify that the IRB should be sufficiently qualified through the experience, expertise and diversity of its members to promote respect for its advice and counsel. From a practical standpoint, however, it is a challenge to determine to what extent non-scientists fulfill the requirements specified by the regulations and how IRBs draw on and implement non-scientists’ diverse viewpoints and experiences.
It has been observed in our study and by others, that non-scientist IRB members often consider review of the informed consent document as their primary or most important role.6,7,8 In our study, nearly three-quarters of non-scientists thought review of the informed consent document was their primary role, and less than half answered that they often inquire about human subjects protections issues unrelated to the informed consent. Why do non-scientist IRB members consider review of the informed consent document their primary role? Review of research requires a wide range of judgments by IRB members, including, for example, whether risks are “reasonable” and whether there exist “adequate” provisions to protect subjects. Non-scientists may perceive that scientific expertise is required to make such judgments. In an open response question, one-third of non-scientists cited that having a scientific background was an important quality of effective non-scientist IRB members. Review of the informed consent document could be perceived as requiring the least scientific expertise and therefore, non-scientists are drawn to this role. Although most non-scientists disagreed that a science background was necessary to be an effective IRB member, effectiveness may be perceived as fulfillment of their primary role, review of the informed consent document. The consequence of non-scientist members limiting their review to consent documents is the potential loss of their points of view on other fundamental regulatory elements (Table 4).
Non-scientist and non-affiliated IRB members are often described as “public members,” “community members,” and “public” or “community representatives”.9,10,11,12 Federal regulations do not use these terms, therefore it is fair to ask if non-scientist or non-affiliated members can or should fulfill any of these roles. In our study, two-thirds of non-scientists and more than three-fourths of scientist IRB members agreed that non-scientists represent community views. Nearly one-third described non-scientists’ roles as public representatives and about one-fifth described their roles as community representatives. We encourage use of the terms “non-scientist” and “non-affiliated” members to describe IRB members whose interests are primarily in non-scientific areas and members who are not otherwise affiliated with the NIH, respectively. We do not use the terms community or public representative because it is unclear what views or which community they may represent. In contrast to published studies where a majority of non-scientist members described themselves as representing or giving a voice to human subjects13 or serving as advocates for human subjects,14 only 16% of NIH non-scientist members described this as their role. The role of non-scientists in the review process is important for several reasons, including that their viewpoints flow from intellectual processes and life experiences that differ from scientist IRB members.
Nearly all scientist and non-scientist IRB members agreed that a role of non-scientist IRB members is to make the conduct of research accountable to the public. This seems to be consistent with the intention of those who wrote the regulations to include non-scientist and non-affiliated members who could be perceived as potential “whistle blowers“ (Charles R. McCarthy, PhD, personal communication, 2002). This role was not seen as exclusive for non-affiliated members. Prior to the codification of the policy for the protection of human subjects into federal regulations (45 CFR 46) in 1974, the rights and welfare of research subjects were assessed by an investigator's institutional associates, a group composed of affiliated scientists.15 However, a response to unethical treatment of human research subjects was implementation of 45 CFR 46 which codified requirements for diversification of membership and views on IRBs.16 It was felt by the authors of the regulations that non-scientists, whether affiliated or not, had the ability to fully appreciate risks associated with the study without being blinded by the lure of scientific advancement.
Overall our results suggest that non-scientist members are active participants in NIH's IRBs and that their points of view are taken seriously and valued by other members. We think these are important indicators of NIH IRBs’ attempts to fulfill the spirit and the letter of regulations to protect research subjects. We identified some room for improvement in several areas. Although most non-scientist respondents thought they had been adequately prepared for their IRB service, many wanted additional education. In the NIH IRP, all new members complete required computer-based training programs on basic ethical and regulatory aspects of human subjects protections and specific requirements for research in the IRP. Also, they attend an orientation session with OHSR senior staff. Currently, there is no IRP educational program designed specifically for non-scientist members. Although it is not clear to us that such a program is necessary, our study suggests that some of these members may view their role too narrowly by, for example, focusing on the informed consent document. As the IRP prepares for accreditation of its human research protection program, self-evaluation of its IRB educational activities, including consideration of the results of this study, will occur.
The involvement of non-scientist and unaffiliated members in the IRB review process has strong ethical and regulatory grounding. Identifying good candidates, educating them about IRBs and promoting an environment in which their considered advice is respected and implemented are all important aspects of protecting human research subjects.