Dataset Information

Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

ABSTRACT: Background:Federal Law requires approval from an Institutional Review Board prior to conducting human subjects research to ensure ethical distribution of benefits and harms. Notwithstanding this role and almost no prescriptive requirements about design or operation, there is little systematic research describing the key attributes of IRBs, as reported by IRB personnel themselves. Methods: Here, 55 IRB directors completed a survey of 77 questions. The goals of the study were to establish what a typical US IRB "looks like," determine whether IRB characteristics can be summarized by a smaller number of overarching components, determine the best predictors of IRB speed and efficiency, and determine whether IRBs differ by high-level qualitative characteristics such as institution type. The above was explored and tested using the general linear model and principal components analysis, and for the former, dependent variables of interest were, a) the time necessary for an IRB to approve a study, and b) efficiency of the review process for full board and expedited reviews. IVs of interest included multiple IRB characteristics. Results: 1) IRB characteristics can be summarized by four key components; 2) IRB speed and efficiency are most strongly determined by tendency to receive biomedical submissions, especially drug-related; and 3) IRBs do vary by institution type on some key variables. Conclusion: These results are the first step toward establishing national norms and building a working model of US IRBs to which other IRBs can compare themselves.

SUBMITTER: Nesom GL

PROVIDER: S-EPMC6905034 | biostudies-literature | 2019 Oct-Dec

REPOSITORIES: biostudies-literature

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Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

Nesom Genevieve L GL Petrof Iraklis I Moore Tyler M TM

AJOB empirical bioethics 20191016 4

<b>Background:</b>Federal Law requires approval from an Institutional Review Board prior to conducting human subjects research to ensure ethical distribution of benefits and harms. Notwithstanding this role and almost no prescriptive requirements about design or operation, there is little systematic research describing the key attributes of IRBs, as reported by IRB personnel themselves. <b>Methods:</b> Here, 55 IRB directors completed a survey of 77 questions. The goals of the study were to esta ...[more]

PMID: 31618119

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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:BackgroundChildren 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.GoalTo evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients).MethodsDescriptive 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.ResultsProtocol 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.ConclusionBoth 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.

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.

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Dataset Information

Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

Publications

Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

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