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Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders

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Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders by Erin R othw ell, Karen J. M aschke, Jeffrey R. B o t k in , A aron G o LDENBERC, THOMAS H . MURRAY, AND SUZANNE M . RlVERA Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders lthough biobanks in the United States are these institutions’ IRBs address protections for human a significant resource for genetic and other subjects of biobank-related research may help in the Ahealth-related research in collecting, storing, development of ethically sound policies that permit and and sharing human biospecimens and associated data encourage biospecimen and data sharing within and for systematic access and use (herein referred to as across all institutions where human subjects research is “biobanking”), they raise unique ethical and policy conducted, not only those in the CTSA consortium. challenges on a wide range of issues.1 Conflicting guidance from government agencies, research organi­ Study Methods zations, and professional bodies on issues related to ata for this paper are drawn from a larger multi­ informed consent, privacy and confidentiality, and the Dmethod study of biobanking at a representative return of individual genetic research results to biobank sample of IRBs at CTSA member institutions. As part participants has often left investigators and institutional of this NIH-funded project, we collected both quantita­ review boards (IRBs) unclear about how to develop tive and qualitative data about biobanking policies and biobanking policies in a way that protects biobank practices from the IRBs at these institutions. This paper participants while advancing research. Differences in focuses on the qualitative data from in-depth telephone institutions’ biobanking policies and procedures may interviews with zz IRB leaders (directors and adminis­ impede biobanks’ efforts to share biospecimens and trators) from 17 CTSA-affiliated institutions (five of the associated data with researchers at other institutions, interviews had two respondents). IRB leaders for these which is crucial for the genetic research enterprise. interviews were recruited from institutions selected For this study, we sought to learn about IRBs’ poli­ because of the leaders’ responses to our study’s quanti­ cies and procedures for collecting, storing, and shar­ tative survey of 51 IRBs at CTSA member institutions. ing biospecimens and associated data, how they were This survey asked a number of questions regarding developed, and how they are revised. We also wanted IRB policies related to collecting, storing, and sharing to obtain the perspectives of IRB leaders about their human biospecimens. From these quantitative survey IRBs’ policies and human subjects protection practices. results, we identified 31 IRBs that tended to provide di­ We targeted IRBs at institutions that are members of vergent responses on eight key survey questions (Table the National Institutes of Health’s (NIH’s) Clinical 1, available, along with Table z, on the IRB: Ethics & and Translational Science Awards (CTSA) consortium. Human Research website). “Divergent responses” rep­ There are more than 6o medical research institutions in resent more extreme responses to these eight questions the CTSA consortium, including leading academic med­ (i.e., selecting “always” or “never” on selected policy ical centers, institutions with a diverse population of options). By choosing IRBs with divergent responses, adult and pediatric patients, and institutions with inves­ we sought to identify IRBs that have clear policies tigators that conduct genetic research.2 The goal of the reflecting differences of opinions in the field about the CTSA program is to speed the translation of research most appropriate human subjects protections. Once discoveries into improved health.3 Understanding how the institutions were identified, the same IRB leaders who completed the previous quantitative survey were Rothwell E, Maschke KJ, Botkin JR, et al. Biobanking research and human subjects protections: Perspectives of IRB leaders, IRB: Ethics & Human sent an email inviting them to participate in an in-depth Research 2015;37(2):8-13. March-April 2015 IRB: Ethics & Human Research interview. All respondents were emailed a minimum of were considered widely accepted procedures that are two times, and then a research assistant initiated three systematically applied to all studies and are developed follow-up phone calls. Out of the 31 IRBs, 17 agreed and approved by institutional administrators. Guid­ to participate. Reasons for not participating were not ances are sets of best practices that are supported by collected due to the lack of response to emails or tele­ consensus. Most respondents reported that their institu­ phone calls. tion distinguishes between guidance and policy and The interviews took place between January 2013 that they preferred to develop guidance for biobanking. and March 2013. After a respondent(s) gave verbal Reasons for this approach included perceptions about informed consent, an investigator on our project with how rapidly the biobanking landscape changes regard­ experience in qualitative research conducted a semi- ing issues related to consent and subtleties related to structured interview to obtain information about 1) the identifiability of biospecimens and associated data. the given IRB’s biobanking policies, 2) how the IRB’s One respondent noted that biobanking is “a field that biobanking policies were developed and by whom, 3) changes so quickly so we can be more flexible in devel­ the IRB’s process for revising human protection polices oping guidance,” as opposed to having to develop and related to biobanking, and 4) how flexible the IRB change policies. Another respondent pointed out that was about revising biobanking policies. We also asked questions about the history and/or ongoing discussions I r Bs at institutions in the CTSA consortium at the IRB of specific procedures relevant to biobank­ ing such as consent approaches, sharing biospecimens, shared common uncertainties and challenges about and biobank participants’ withdrawing their materials human subjects protections for biobank-related from research. The interview questions were tailored to research. include the responses provided in the previous quantita­ tive survey. Interview questions are listed in Table 2. “somebody’s always coming up with some new twist Each interview lasted an average of 50 minutes, and that the policy might not have considered.” all of the interviews were audiorecorded. The record­ Several respondents noted that their institutions ings were transcribed verbatim, and one member of relied on workgroups as the primary mechanism for the research team verified the transcripts for accuracy. developing guidance for their investigators about Content analysis was used to analyze the data. A biobanking. When asked what sources of information distinguishing feature of content analytic approaches institutions used to develop biobanking guidance and is the use of a consistent set of codes to designate data policies, most respondents said their institution relied segments that contain similar material.4 After the first on guidance from the Office for Human Research three interviews, the transcripts of those interviews Protections (OHRP), the Association for the Accredita­ and the semistructured interview guide were reviewed tion of Human Research Protection Programs (AAH- to develop an initial coding template.5 This template RPP), and their institution’s office of legal counsel. was then used to systematically code the first three Other sources of information included the National transcripts, allowing for the addition of new codes that Cancer Institute’s best practices recommendations for might have been missed with the initial development biorepositories,7 guidance and policies at other research of the codebook.6 All coded data were reviewed and institutions, and feedback from their own investigators verified by a second independent reviewer. No discrep­ who conduct biobanking-related research. Respondents ancies emerged, and the remaining interviews were then reported that guidance-development meetings involved conducted and coded using the same coding template. an iterative process and included IRB members and Additional information about study methods and cod­ administrators, experienced investigators, ethicists, and ing can be obtained on request from the first author. legal counsel. They acknowledged the importance of obtaining input from the community about human sub­ Study Results jects protections in biobanking but noted the difficulty Process for Developing Guidance for Biobank­ of obtaining such input. One respondent admitted that ing. Interviews all started with asking the respondents “maybe we didn’t do a good enough job engaging them to describe their IRB’s process for the development of [the community].” Some respondents said they ob­ policies, guidance, or practices. For this study, policies tained community input by having individuals from the IRB: Ethics & H uman Research March-A pril 2015 9 community serve on some of their IRB committees. mens are ever really deidentified. Responses along ■ Biobanking versus Other Human Subjects Pro­ these lines included one respondent’s question “Are tection Policies. Most respondents reported that their they truly anonymous?” as well as these remarks from institution’s process for developing guidance about other respondents: “The Nature article recently demon­ biobanking encompassed additional considerations strated how easy it is
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