Evidence-based practice of research ethics review?

• Author: Beagan, Brenda

Introduction

In a recent editorial in the Journal of the American Medical Association, Jeremy Sugarman argues that, "The time is ripe for evidence-based ethics. Similar to evidence-based medicine, an evidence-based ethics would emphasize the importance of data in informing discussions and decision-making about the ethical issues inherent to clinical medicine and research." (1) The Consortium to Examine Clinical Research Ethics headed by Ezekiel Emanuel puts the gathering and use of such evidence into a larger governance perspective by observing that the current US system of oversight for research involving humans "does not systemically assess performance or outcomes." (2) They note particularly the lack of validated measures for evaluating such outcomes and cite the Institute of Medicine's call for the development of an "independent body to develop measures and collect performance data." (3) These recommendations for developing an evidence-based ethics for human subjects protection are quite similar to those made in the first systematic examination of Canadian governance of health research involving human subjects--a study in which both authors of this paper were involved. Based on the research findings in that study, we noted particularly the need for experimentation and research to fill gaps in knowledge, such as appropriate standards for performance-focussed review. (4)

In this paper we explore the need for and barriers to evidence-based ethics for human subjects protection. We present a new analysis of interviews gathered for our earlier study with key informants involved in ethics review or its governance in Canada. While our informants believed that their own review committees were effective, they could offer very little support for this belief. When queried further about the desirability of collecting evidence of effectiveness (or ineffectiveness), contrasting opinions were expressed about needing to trust the integrity of researchers and lack of trust in ethics reviews conducted by other committees. We believe that these contrasting themes of trust and distrust in the context of scant empirical evidence help illuminate the need for and barriers to evidence-based approaches.

Evidence-based practice (EBP), "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients," (5) has become standard in virtually all health professions. (6) EBP rests on an assumption that while clinical expertise is essential, it is not sufficient for good patient care. Systematic observation and critical appraisal of research literature following specific rules of evidence are thought to reduce the biases that may influence practice grounded solely in experience and unsystematic clinical observation. (7) The criteria for ranking levels of evidence vary from one source to another, (8) but the overall pattern is consistent, with systematic reviews, meta-analyses, and randomised controlled trials positioned as the best level of evidence for or against an intervention. While expert opinion and committee consensus are considered valid contributions to evidence-based practice in health care, they are not seen as particularly rigorous or persuasive forms of evidence.

Important critiques of EBP in health care raise fundamental questions about what counts as evidence, the role of patient preferences and values, the role of clinical experience and expertise, the implications of practice contexts, and even the epistemological grounding of approaches that systematically privilege some forms of knowing over others. (9) Although qualitative research has historically fared poorly in EBP, recently there has been a proliferation of guidelines for critical appraisal of qualitative research studies. (10) While on the one hand some have argued that such systematic approaches to critical appraisal violate core assumptions of naturalistic research paradigms, on the other hand it is clear that within scholarly communities there are--and must be--ways to assess the quality of research. Thus, however we may choose to categorise types of evidence, even those who dispute the conceptual underpinnings of EBP generally agree with the idea that available evidence should somehow be evaluated and incorporated into practice.

To conceptualise ethical review of human subjects research grounded in critical evaluation of existing evidence, it is essential to focus on the fundamental ends or goals of research ethics. Like Brody, (11) we see a relatively broad international consensus on these basic ends, emerging out of a shared concern about cases of abuse of subjects in research. (12) The consensus is expressed in numerous professional, national and international statements, guidelines and regulations of primarily clinical research. In our earlier work on Canadian governance, (13) we expressed this consensus in terms of three primary goals: (1) promoting socially beneficial research; (2) protecting human subjects from unnecessary harms, including affronts to dignity; and (3) maintaining trust between the research community and society as a whole. Public trust in research depends in part on the successful fulfilment of the first two goals but adds important elements of representation, accountability and legitimation to them. An evidence-based research ethics would focus on how well particular research projects are likely to and actually do fulfill these three goals. As a process, it would involve the collection and assessment of information about the achievement of these goals as well as the effective dissemination of the information to the research community (researchers, their institutions and research sponsors) and the general public (in particular populations from which research subjects are drawn).

The Goals of Ethical Review

The empirical research methods used for our study have been reported on in detail elsewhere. (14) The results reported here are based on qualitative interviews with 43 participants, all members or Chairs of Research Ethics Boards (REBs), or members of policy-setting national organizations in Canada. The consensus reflected in research ethics literature concerning the goals or objectives of...