nonscientist irb members at the nih

Nonscientist IRB Members at the NIHAuthor(s): Robert D. Allison, Lura J. Abbott and Alison WichmanSource: IRB: Ethics and Human Research, Vol. 30, No. 5 (Sep. - Oct., 2008), pp. 8-13Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/20460692 .

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BY ROBERT D. ALLISON, LuRA J. ABBOTT, AND ALISON WICHMAN

Nonsci'entist IRB M embers at the NIH I

A fundamental stipulation of the federal regulations governing research with humans is that nstitutional Review Boards (IRBs) have a mem

bership diverse in race, gender, and cultural backgrounds and be sensitive to issues such as community attitudes.' 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, the regulations require 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 nonscientific areas. Nonscientist members are often clerics, lawyers, or laypersons and may also fill the requirement for nonaffiliated members if they or mem bers of their family are not otherwise affiliated with the institution. IRB members whose primary concerns are in nonscientific areas are referred to in conversation and in the literature as nonscientists, laypersons, public mem bers or representatives, and community members or rep resentatives.3 However, we think the term nonscientist is more consistent with the regulatory intent and thus use that term rather than those listed above.

The Office of Human Subjects Research (OHSR) at the National Institutes of Health (NIH) conducted a study to learn more about the roles and experiences of the nonscientist members in the 14 IRBs of the NIH Intramural Research Program and to assess how educa tional activities for nonscientist members can be improved. The study was also conducted to learn how nonscientist members' perceptions of their roles and experiences compare with the perceptions of scientist IRB members. The NIH Intramural Research Program consists of the Clinical Research Center and NIH cam pus in Bethesda, Maryland, and sites in Baltimore, Maryland, and Research Triangle Park, North Carolina.

Study Methods

OHSR conducted two surveys: one that involved a questionnaire mailed to the z8 nonscientist mem

bers of the NIH's 14 IRBs, and another that involved an online questionnaire sent to all 13 5 NIH scientist IRB members and IRB chairs. The mailed survey of nonscien tist IRB members consisted of five sections. The first two sections contained questions to elicit members' percep tions of their roles and experiences on the IRB. The third section assessed members' needs and desires for addition al education. A multiple choice scale offered five ordered responses either for strength of agreement (strongly agree, agree, unsure, disagree, strongly disagree) or fre quency (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 nonscientist IRB members and how the NIH could better assist nonscientist members in their roles. Questions were framed to elicit agreement and dis agreement in order to avoid bias. Nonscientist IRB mem ber responses were linked to personal identifiers by code, but identifiers were removed and all linkages were bro ken at the conclusion of the study.

The online survey of the 13 5 NIH scientist IRB mem bers and IRB chairs consisted of five sections that includ ed questions about scientist members' perceptions of nonscientists' 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 nonscientist IRB members and how the NIH could better assist nonscientist members in their roles. Responses to the online form were emailed to us without any information that would identify the sender, so all sci entist member responses were anonymous and not link able to personal identifiers.

Robert D. Allison, Lura J. Abbott, and Alison Wichman, "Nonscientist IRB Members at the NIH," IRB: Ethics & Human Research 30, no. 5 (2008): 8-13.

- SEPTEMBER-OCTOBER 2008 IRB: ETHICS & HUMAN RESEARCH



Table 1. Demographics: Comparisons with Published Literature

Study Reference Allison et al. 2008 Porter 1987 Sengupta et al. 2003 Anderson 2006

Total Studied # 25 198 32 16

Nonscientists % (nonaffiliated %) 100% (64%) 100% (100%) 47% (53%) 100% (100%)

Population (# IRBs) NIH, Intramural Research 200 institutions with Academic institutions in Five universities, Program, Bethesda, MD (14) Multiple Project Assurances Northeast, West Coast, five hospitals

Midwest and South (11) and one research

organization

Gender (% females) 60% 42% 66% 69%

Education % ? bachelors (% 2 graduate degree) 92% (76%) 95% (72%) 100% (72%) 100% (38%)

Time on IRB - years 28% 2-4; 40% ? 4 38% 2-4 8.4 (mean) 4.5 (mean)

Responses from all respondents 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 (nonscientist or sci entist). 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 agree ment 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 per formed using SPSS for Windows, version 14.0 (SPSS Inc., Chicago, Illinois).

Study Results

'able 1 shows selected demographic data and com I parisons with published literature. Twenty-five of

the z8 nonscientist IRB members completed question naires (89% response rate), and each of the 14 NIH IRBs were represented by respondents. Sixty-four per cent of nonscientist respondents were not affiliated with the NIH other than by IRB membership, and nonaffiliat ed member responses were not statistically different from affiliated members. Respondents were 6o% female, and no differences between male and female responses were observed. Ninety-two percent of nonscientist members had completed at least a bachelor's degree, and 76% had an advanced degree, such as a law degree, nonscience

related master's degree, or doctoral degree. Twenty per cent had less than a year of experience on an IRB, 36% had one to three years, i z% had four to six years, and 28 % had longer than six years.

O Nonscientist Members. Nonscientist IRB members were asked questions pertaining to their main roles. Seventy-two percent agreed (z78% strongly) that the main role of nonscientist IRB members is to review and make recommendations about the informed consent doc ument (Table 2). Eighty-one percent of nonaffiliated nonscientists agreed, compared to 56% of affiliated non scientist members, but this difference did not reach sta tistical significance (p = 0.355). Although most believed their main role was to review the informed consent doc ument, 92% felt they made other important contribu tions (8% were unsure). For example, nonscientist mem bers 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 said they some times or often asked questions about the scientific design of protocols, and 84% said they sometimes or often asked about the informed consent process. Only 44% reported they often ask questions concerning the protec tion of human subjects that are unrelated to the informed consent document, and one respondent report ed never asking questions unrelated to the informed con sent document.

Nonscientist IRB members were also asked if they believed they had unique roles on their IRB and, if so, what those roles might be. Sixty percent agreed that nonscientist IRB members represent community values, views, and norms (12% strongly), but 24% were unsure (Table z). Eleven (69%) nonaffiliated members agreed

IRB: ETHICS & HUMAN RESEARCH SEPTEMBER-OCTOBE



Table 2. Selected Responses of Nonscientist and Scientist IRB Members

Nonscientists (N = 25) Scientists (N = 84) Agree Disagree Unsure Agree Disagree Unsure P1 P2

1. The main role of nonscientists is to review the informed consent document 72% 28% 0% 46.5% 50% 3.5% 0.057 0.037

2. Nonscientists make important contributions in addition to their review of the informed consent document 92% 0% 8% 97% 2% 1% 0.176 1.00

3. Nonscientists are more capable of representing the interests of research subjects than scientists 20% 40% 40% 13% 72% 15% 0.009 0.142

4. Nonscientists make the conduct of research accountable to the public 88% 4% 8% 93% 3.5% 3.5% 0.823 1.00

5. Nonscientists represent community views and values 60% 16% 24% 81% 5% 14% 0.058 0.056

6. The IRB's ability to protect research subjects would be improved if it had more nonscientist members 28% 24% 48% 19% 50% 31% 0.071 0.100

7. IRB members respect and take seriously nonscientists' contributions 92% 0% 8% 99% 1% 0% 0.051 1.00

8. Investigators respect nonscientists' contributions 80% 0% 20% 80% 18% 2% 1.00 1.00

9. A science background is necessary to be an effective nonscientist IRB member 4% 84% 12% 1 % 89% 10% 0.571 0.400

P1 is the p value for whether nonscientists and scientists differed in any response category.

P2 is the p value for whether nonscientists differed in response to either "agree" and "disagree" when "unsure" responses were excluded from the calculation.

compared to four (44%) affiliated members, but this did not reach statistical significance (p = o.z63). Eighty-eight percent agreed (24% strongly) that one of the reasons for having nonscientist IRB members is to make the con duct of research accountable to the public. Twenty per cent agreed (one member strongly) that nonscientist IRB members are more capable of representing the interests of human research subjects than scientist members are, while 40% were unsure.

Respondents were asked to choose from a list of roles commonly attributed to nonscientists and to agree or dis agree if they felt these roles described them (Table 3). Overall, 68% percent described their role as layperson, 28% as representative of the public, 16% as representa tive of the community, and 16% as advocate for research subjects. Nonscientist responses were also stratified by

each member's affiliation with the NIH. Nearly twice as many nonaffiliated nonscientist members described them selves as laypersons as did affiliated nonscientist mem bers, but this difference did not show statistical signifi cance (p = 0.087). Agreement with the description of members' roles as public representatives, community rep resentatives, and research advocates did not differ between affiliated and nonaffiliated nonscientists.

Nonscientist IRB member respondents were asked how frequently they felt uncomfortable participating in IRB deliberations, and whether they felt their opinions were valued by other members or investigators. Ninety six percent reported that they were active participants most of the time, and 9z% answered that their IRB chairperson encouraged their participation. Thirty-six percent reported that they sometimes felt uncomfortable

participating in IRB discus sions, 40% said that they sometimes felt uncomfort able asking questions about scientific design, and i z% said that they sometimes felt uncomfortable asking ques tions about human subjects protections. Regarding their perception of being valued on the IRB, 9z% of nonsci

Table 3. Roles of Nonscientist IRB Members

Overall (N = 25) Affiliated (N = 9) Nonaffiliated (N = 16)

Agree Disagree Agree Disagree Agree Disagree p

Layperson 68% 32% 44% 56% 81% 19% 0.087 Public Representative 28% 72% 22% 78% 31% 69% 0.682 Community Representative 16% 84% 11% 89% 19% 81% 1.00 Research Subject Advocate 16% 84% 11% 89% 19% 81% 1.00

IRB: ETHICS & HUMAN RESEARCH



entists felt that scientist IRB members took their com ments and suggestions seriously. Eighty percent believed that principal investigators took their comments and suggestions seriously, though zo% were unsure. When nonscientists were asked if they were adequate

ly prepared by the NIH for service as IRB members, 72% agreed that they had been adequately prepared, iz% disagreed, and 16% were unsure. Fifty-eight per cent answered that they wanted more education on the protection of human subjects than they had received, while 21 % did not, and2 1 were unsure. Nonscientists were asked to choose in which areas additional educa tion would make them more effective IRB members. Thirty-seven percent desired additional education on the Belmont Report, 45 % on the regulations governing research with humans, and 6z% on the IRB review stan dards at the NIH (data not shown).

0 Scientist Members. Eighty-four of 13 5 scientist IRB members responded to the questionnaire (6z% response rate), and each of the 14 NIH IRBs were repre sented by respondents. Scientist IRB members include all IRB chairs; the IRB chair response rate was 1oo%. Nineteen percent of scientist member respondents had less than a year of experience on an IRB, 47% had one to three years, 17% had four to six years, and 17% had longer than six years. Questions were asked of both nonscientist and scientist IRB members to assess qualita tive and statistical differences in responses (Table z). Results did not change when affiliated nonscientist mem ber responses were either included in or excluded from the analyses.

Forty-seven percent of scientist respondents said that the main role of nonscientist IRB members is to review and make recommendations about the informed consent document, compared to 72% of nonscientists (p = 0.037). Ninety-seven percent of scientist respondents felt that nonscientist IRB members made important contri butions above and beyond their review of the informed consent document, a finding that was similar to the non scientists' responses.

Eighty-one percent of scientist respondents said that nonscientist IRB members represent community values, views, and norms (19% strongly), compared to 6o% of nonscientists (p = 0.056). Ninety-three percent of scien tist members agreed (33 % strongly) that a reason for having nonscientist IRB members is to make the conduct of research accountable to the public, similar to nonsci entist responses (88%). Seventy-two percent of scientist IRB members disagreed that nonscientist members are

more capable of representing the interests of research subjects. This was significantly different from nonscien tists, who mostly disagreed (40%) or were unsure (40%)

(p = 0.009). Ninety percent of scientist respondents agreed that an

IRB's ability to protect human research subjects is improved by having members whose primary concerns are in nonscientific areas, but 5o% disagreed that having more nonscientist members would further improve this ability. All but one scientist IRB member agreed that contributions made by nonscientist members are respect ed by other IRB members. All scientists reported that they take comments and suggestions made by nonscien tist members seriously, compared to 92?/% of nonscien tists reporting that they felt they were taken seriously (8% were unsure). Eighty percent of scientist IRB mem bers felt that comments and suggestions made by nonsci entists are taken seriously by investigators, while 8% were unsure, and two disagreed.

X Effectiveness of Nonscientist IRB Members. Nonscientist and scientist IRB members were asked what they thought were the three most important qualities of effective nonscientist IRB members. Among members who returned the survey, zi nonscientists (84%) and 77 scientist members (9z%) answered this open-response question. The most frequently cited quality of effective nonscientist IRB members was "assertiveness," an answer given by 43 % of nonscientists and 36% of scien tists. IRB members further described the quality of assertiveness as indicating self-confidence, a willingness to ask questions, and the ability to speak up. Twenty nine percent of nonscientists and 8% of scientist mem bers suggested that "having a scientific background" and "having the ability to understand the science" were important qualities. The ability to review the informed consent document for clarity, readability, and compre hension from a lay perspective was cited by 14% of nonscientists and 13 % of scientists. Fourteen percent of nonscientists 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 nonscientist members. Additionally, six percent of scientists responded that an important quality was "having the ability to bring a dif ferent perspective" and "to see something that scientists may take for granted."

IRB: ETHICS & HUMAN RESEARCH SEPTEMBER-OCTOBE



Discussion

The regulatory requirement that IRBs must have at

1least 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 speci fy 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 prac tical standpoint, however, it is a challenge to determine to what extent nonscientists fulfill the requirements spec ified by the regulations and how IRBs draw on and implement nonscientists' diverse viewpoints and experi ences.

Nonscientist and nonaffiliated IRB members are often described as "public members," "community members," and "public" or "community representatives."4 In our study, two-thirds of nonscientists and more than three fourths of scientist IRB members agreed that nonscien tists represent community views. Nearly one-third described nonscientists' role as public representative, and about one-fifth described their role as community repre sentative. Yet because federal regulations do not use these terms, it is reasonable to ask whether nonscientist or nonaffiliated members can or should fulfill any of these roles. We encourage use of the terms "nonscien tist" and "nonaffiliated" members to describe IRB mem bers whose interests are primarily in nonscientific areas and members who are not otherwise affiliated with the NIH, respectively. We do not use the terms community or public representative because what views or which community an individual may represent is unclear.

In contrast to published studies where a majority of nonscientist members described themselves as represent ing or giving a voice to human subjects5 or as serving as advocates for human subjects,6 only 16% of NIH non scientist members described this as their role. Nearly all scientist and nonscientist IRB members agreed that a role of nonscientist IRB members is to make the conduct of research accountable to the public. This suggests that all respondents-whether affiliated with the IRB's insti tution or not-believe that nonscientist members may be better situated to fully appreciate risks associated with the study without being blinded by the lure of scientific advancement.

Review of research requires a wide range of judg ments by IRB members, including, for example, whether risks are reasonable and whether adequate provisions

are in place to protect subjects. Nonscientists may per ceive that scientific expertise is required to make such judgments. In an open-response question, one-third of nonscientists cited that having a scientific background was an important quality to be an effective nonscientist IRB member. Review of the informed consent document could be perceived as requiring the least scientific expert ise and, thus, nonscientists may be drawn to this role. Indeed, our study and others suggest that nonscientist IRB members often consider review of the informed con sent document as their primary or most important role.7 In our study, nearly three-quarters of nonscientists thought review of the informed consent document was their primary role, and less than half answered that they often inquire about human subjects protection issues unrelated to the informed consent document. This is a curious finding, especially since most nonscientist respondents did not agree that it is necessary for an IRB member to have a scientific background to be an effec tive member. Moreover, only 14% of nonscientist mem bers said that to be an effective IRB member required the ability to review informed consent documents for clarity, readability, and comprehension from a lay per spective.

Our study results suggest that nonscientist members actively participate on the NIH's IRBs and that their points of view are taken seriously and valued by other members. These findings are important indicators of IRB members' attempts to fulfill the spirit and the letter of regulatory requirements to protect research subjects. However, we identified some room for improvement in several areas. Although most nonscientist respondents thought they had been adequately prepared for their IRB service, many wanted additional education. In the NIH Intramural Research Program, all new IRB members to this program are required to complete computer-based training on basic ethical and regulatory aspects of human subjects protections and specific requirements for research in the intramural program. In addition, they are required to attend an orientation session conducted by OHSR senior staff. However, there currently is no edu cational program in place in the Intramural Research Program designed specifically for nonscientist IRB mem bers. Although it is not clear to us that such a program is necessary, our study suggests that some of these mem bers may view their role too narrowly by, for example, focusing on the informed consent document. The involvement of nonscientist 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 sub jects. As the Intramural Research Program prepares for accreditation of its human research protection program, it will evaluate its IRB educational activities, especially in light of the results of this study.

Disclosure

The views expressed are those of the authors and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. This research was determined to be exempt from IRB review by the NIH Deputy Director for Intramural Research.

* Robert D. Allison, MD, MPH, is a former intern, Office of Human Subjects Research, Office of the Director, National Institutes of Health, Bethesda, MD, and currently is Research Fellow, Department of Transfusion Medicine, NIH Clinical Center, Bethesda, MD; Lura J.

Abbott, DPA, MS, CIP, is Senior Health Science Administrator, Office of Human Subjects Research, Office of the Director, National Institutes of Health, Bethesda, MD; and Alison Wichman, MD, is Chair, National Heart, Lung, and Blood Institute Institutional Review Board, National Institutes of Health, Bethesda, MD.

References

i. Department of Health and Human Services, Protection of Human Subjects, 45 CFR 46.

2. See ref. 1.

3. Porter JP. How unaffiliated/nonscientist members of institutional review boards see their roles. IRB: A Review of Human Subjects Research 1987;956:1-6; Sengupta S and Lo B. The roles and experi ences of nonaffiliated and nonscientist members of institutional review boards. Academic Medicine 2oo3;78(2):2i2-2i8; Anderson EE. A

qualitative study of nonaffiliated, nonscientist institutional review

board members. Accountability in Research 2006;13:135-155. 4. See ref. 3, Porter 1987, Sengupta and Lo 2003; Porter JP. What

are the ideal characteristics of unaffiliated/nonscientist IRB members? IRB: A Review of Human Subjects Research 198658(3 ):i-6; Hayes G,

Hayes S, Dykstra T. A survey of university institutional review boards:

Characteristics, policies, and procedures. IRB: Ethics & Human

Research i995;i7(3):i-6. 5. See ref. 3, Sengupta and Lo 2003. 6. See ref. 3, Porter 1987, Sengupta and Lo 2003; see ref. 4, Porter

1986. 7. See ref. 3, Porter 1987.




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