Informing governance through evidence-based research on REBs: challenges and opportunities.

• Author: Owen, Michael
• Position: Research Ethics Boards

In 2004, Joan Sieber made a passionate call for research that would inform our understanding of the workings of Institutional Review Boards (IRBs) or Research Ethics Boards (REBs). Although there is a rich scholarship on the ethical conduct of research involving human subjects, she argued, "Ethical decision making by scientists and institutional review boards should not be based on hunches and anecdotes. ... These questions should be answered through empirical research." (1) More recently, in a study of IRBs and their knowledge of regulations governing pediatric research, Strousytup et al argued that IRBs "need to open up and allow themselves to be looked at. ..." (2) Michael McDonald claimed an

"urgent need for well-grounded research on the tensions between having standards of performance, monitoring, accreditation and processes that are sensitive to the needs, concerns and rights of research subjects and that stimulate and facilitate research. ... For too long ..., these fundamental questions have been debated in an a priori manner or simply by resort to anecdotal evidence." (3) Scholars question whether REBs create bureaucratic impediments to the conduct of high quality and innovative research, provide researchers with value--added service and advice that might enhance the protection of participants or ensure that participants are better informed of the risks, harms, and benefits for themselves, for others and for science. (4) These sorts of questions are the kind that could and should be addressed through empirical work.

At a July 2008 retreat of Canadian Network for the Governance of Ethical Health Research Involving Humans, we sought to refine the empirical research agenda identified by Sieber (5) and others. (6) In our discussions we identified many ways in which scholars have turned their attention to the role of REBs within the research enterprise and ways in which REBs themselves are engaging in quality improvement assessments as well as action research (7) on their practices and impacts on the researchers and organizations that they serve. In this paper, we consider some of the challenges to studying REBs and address briefly five areas of interest to the Network members. These areas of interest are not intended to provide a comprehensive overview of the issues affecting the conduct of research on REBs and their processes. (8) By considering these issues, we hope to add some insights on the challenges of conducting research on REBs and urge others to empirically test our assumptions and those of others, with a view to developing robust evidence-based research that will inform and improve the ways in which REBs and research ethics administration are governed.

We have not, for example, addressed the structure and functions of REBs in developing countries (9) or the challenges faced by Canadian REBs in assessing research studies being conducted in developing countries. Nor have we considered the issue of quality assurance studies, which legitimately may be conducted by a REB or its governing organization. Other forms of evaluation, such as site visits by the National Council on Ethics in Human Research [NCEHR] or audits conducted by accreditation agencies such as the Association for Accreditation of Human Research Ethics Programs, Inc. [AAHRPP] or regulatory agencies such as Health Canada are also excluded from our consideration. The contributions of these forms of assessment to the literature on the governance of REBs are, potentially, significant and could be the topic of further research.

Much of the scholarly and applied research in which REBs are the "research subject" can be summarized as follows:

* assessments of the validity of anecdotal reports about the length of time it takes REBs to review protocols; (10)

* identifying ways to improve the quality of service to the research community; (11)

* evaluations of whether the REB process actually protects human participants through the interpretation of national policies and regulations; (12)

* assessments and the identification of the educational and professional development needs of REB chairs, members, researchers as well as administrative support staff and how such educational programs have improved the quality of the REB processes and the conduct of research; (13)

* variability across research ethics boards and evaluations of the decision-making processes of research ethics boards; (14)

* examinations of the ways in which REB members apply ethical judgment on protocols such as the proportional assessment of risks and harms; (15)

* evaluations of the impact of the REB processes on researchers and the conduct of research, (16) and, more recently;

* evaluations of the impact of accreditation on the governance of REBs. (17)

Research on research ethics boards in these few areas constitute the tip of the ice-berg--the possible topics areas for research on research ethics boards internal processes such as research ethics board's decision-making and its impact on medical, clinical (18), socio-behavioural (19), humanities and arts research and practice (20), and governance (21) are nearly endless and highly contested.

1. REBs as subjects of research--issues and potential challenges

   More and more researchers, REBs and governing organizations are studying or commissioning research and quality assurance assessments of REBs, their processes and their governance structures. This trend raises the question of what it means for REBs to be arbiters of the very research that evaluates their functioning. REBs have had to evaluate how such research could be conducted while preserving the confidentiality and anonymity of key informants. Are REBs being forced to be more critically reflective of their own processes? At the same time, we argue, they must strike a...