The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council. In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of research ethics issues. According to the TCPS (...) 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice”. Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge. (shrink)

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered (...) with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs).Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts.Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets. (shrink)

Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon (...) the view one has of the world. A person who is naive about medical facts may, for example, interpret chest pain upon exertion as a sign that he is “overdoing it”; were he more medically knowledgeable, the same symptom might be interpreted as a possible indicator of coronary artery disease. The naive interpretation calls for rest; the informed interpretation calls for medical attention as well. (shrink)

Although well established in developed countries, Ethics review boards in the academia, and specifically for social and behavioral sciences (SBS) research, is a relatively new, and still a controversy inducing endeavor. This study explores the establishment and functioning of ERBs in Israeli academia, serving as a case study for the challenges and progress made in ensuring ethical research practices in non-medical related spheres. A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS researchers, who (...) each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges. Open, semi structured In-depth interviews were conducted in order to facilitate a critical reflective stance among the various participants, exploring their experiences, behaviors and the meanings they assign to ERB processes. Our research revealed two major themes. The first is the developmental trajectories in the construction processes of ERBs in Israel, comprised of the following stages: Initiation, expansion, opposition, and acceptance and assimilation. The second was a typology of participation throughout the ERBs’ construction process. Inspired by Merton’s strain theory, this typology includes conformists, ritualists, ideologists, control-freaks, and insurgents. The findings expose a unique perspective into the initiation, establishment, and development of ERBs, which can shed light on the role of ERBs in general, as well as point out how resistance to ERBs, as well as the different reasons for championing them, affected not only ERBs form and their legitimacy, but also their interaction with researchers. (shrink)

: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...) determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risks encountered and more attuned to the priorities of trial subjects. (shrink)

The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct (...) by some investigators. The authors contend that, by fostering a climate in which investigators perceive that they receive fair and unbiased treatment, IRBs optimize the likelihood of collegial compliance with appropriate participant protections. (shrink)