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Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.

ABSTRACT: BACKGROUND:Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., "miscellaneous clinical studies", have no legally mandated timelines for institutional review boards' (IRB) decisions. GOAL:To evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients). METHODS:Descriptive and comparative statistics. Protocol 1 is a prospective, multicenter, cross-sectional screening study of a symptomatic pediatric population at risk for Fabry disease involving genetic testing (NCT02152189). Protocol 2 is a prospective, multicenter, randomized, controlled, open-label, blinded endpoint post-market study to evaluate the effectiveness of stent retrievers (NCT02135926). After having obtained positive initial IRB votes at the main study site, both protocols were subsequently submitted to the remaining IRBs. RESULTS:Protocol 1 was submitted to 19 IRBs. No IRB objected to the study. Median time-to-final vote was 34 (IQR 10-65; range 0 to 130) days. Two IRBs accepted the coordinating center's IRB votes without re-evaluation. Changes to the informed consent documents were asked by 7/19 IRBs, amendments to the protocol by 2. Protocol 2 was submitted to 16 IRBs. Fifteen decisions were made. No IRB objected to the study. Median time-to final vote was 59 (IQR 10 to 65; range 0 to 128) days, which was not statistically significantly different compared with protocol 1 (Wilcoxon test). Two IRBs accepted a previous IRB decision and did not conduct an independent review. Eight/16 IRBs required changes to the informed consent documents; two IRBs recommended an amendment of the protocol. CONCLUSION:Both clinical research protocols involving vulnerable populations were well accepted. IRB workflows and decision times varied substantially. Some IRBs accepted a previous IRB decision without the necessity of another reevaluation process. Requested changes were focused on the informed consent documents. A more standardized approach across jurisdictions is desirable.

SUBMITTER: Kastner B

PROVIDER: S-EPMC4537221 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.

Kästner Bärbel B Behre Simone S Lutz Nadine N Bürger Friederike F Luntz Steffen S Hinderhofer Katrin K Bendszus Martin M Hoffmann Georg F GF Ries Markus M

PloS one 20150814 8

<h4>Background</h4>Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., "miscellaneous clinical studies", have no legally mandated timelines for institutional review boards' (IRB) decisions.<h4>Goal</h4>To evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols ...[more]

PMID: 26275228

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Project description:National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR.

Project description:Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.

Project description:Institutional Review Boards (IRBs) have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined.To explore how and when IRBs view and make decisions about the quality of the science of studies they review.I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding) and interviewed IRB chairs, co-chairs, administrators, and a director from 34 IRBs (response rate = 55%), and an additional 7 members.Interviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how and to what extent to evaluate the science of protocols, whether the science should be 'good enough' (and if so, what that means) versus as good as possible. Federal regulations state that IRBs should ensure that risks are minimized, and commensurate with benefits. Thus, at times IRBs feel that changing the science is ethically necessary. But IRBs also then struggle with whether to adopt a higher threshold (1) that social and thus scientific benefits be maximized and (2) that scientific efforts and resources should not be wasted. Committees face dilemmas - for example, if a 'perfect' study is not feasible. For protocols already approved elsewhere (e.g., by the NIH), IRBs vary in how much they feel they can request alterations, and sometimes make changes nonetheless. Larger institutional contexts and biases can shape these issues, and IRBs differ in how much they are 'pro-research', and have sufficient expertise. IRBs at times also approve studies despite reservations about the science.This study includes interviews with IRBs, but not observations of IRB meetings.IRBs often face ambiguities and conflicting goals in assessing scientific quality. Many IRBs try to improve the science beyond what the regulations mandate. These data have important implications for improving practice, education, research, and policy.

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Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.

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Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.

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