Evidence-Based Practice of Research Ethics Review?
Beagan, Brenda, McDonald, Michael, Health Law Review
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. …