Research Exceptionalism

Abstract

Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research.

Pragmatic randomized trials in drug development pose new ethical questions: a systematic review

“…The authors advocate a rejection of the research-treatment distinction because it additionally fails 'to identify which activities warrant ethical review and to determine when patients are at risk and in need of oversight protection' [12]. Kass et al argue that labeling certain activities as 'research' currently indicates that these activities are subject to more-stringent regulation, despite the fact that they might involve similar or even less risk than routine practice -a view coined as 'research exceptionalism' by Wilson and Hunter [13].…”

Why should ethics approval be required prior to publication of health promotion research?

“…16 Similarly, although doctors were once considered capable of judging the ethics of their own research, the dominant view now is that ethics committees -even with their limitations in expertise and resources -are, as disinterested collectives, both more objective and more capable of making these assessments. 1,3 Health promotion investigators may also raise the point that we have already made above, namely that most of what they do is low risk and that obtaining ethical approval will either add unnecessary time or costs to an intervention without being justified by a risk-benefit calculation. In response, we claim that just because research is low risk, this does not make it no risk.…”

“…In this regard we agree with Wilson and Hunter that one of the key factors that distinguishes research from other risky activities -and that justifies relatively stringent regulation -is that research relies heavily on public trust, both for its funding and for public participation. 3 A second, related point is that research ethics approval processes can help to ensure that a research project is well designed -a foundation for ethical research. 8(p10,1.1) Despite the name 'ethics review', the HREC approval process also involves oversight of the methodological and other scientific aspects of a proposed project.…”

The ethics of disease eradication

“…This article provides an initial answer, by examining whether there is anything that is ethically exceptional about eradication [10]. If there is, we should expect eradication policies to be subject to sui generis ethical considerations; if there is not, we should expect standard approaches to the ethics of public health policy to be sufficient.…”