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In their article, “The job of ‘ethics committees’”, Andrew Moore and Andrew Donnelly argue that current guidance documents provide that institutional research review committees (hereafter, institutional review boards (IRBs)) perform two different and distinct functions, namely, a regulative review and an ethical review. They argue for separating those functions and for eliminating the ethics review role from IRBs. Instead, they want IRBs to focus exclusively on determining whether research proposals conform to governing regulations.
In their argument, Moore and Donnelly correctly note that regulatory requirements and ethical requirements can conflict. That point is correct, but hardly surprising. After all, regulations are general and the research proposals are specific, so an individual proposal may not conform to the general formulation of the rule and yet be consistent with ethics. Thus, a rule may generally be regarded as expressing a relevant moral consideration while providing a conclusion that does not appropriately reflect an ethical determination in the specific case. This inconsistency need not amount to what Moore and Donelly characterise as a ‘repellent’ or an ‘unconscionable’ review decision (p. 13).
Moore and Donnelly are also concerned that IRB decisions may differ from each other in their review of the same proposal. Again, they are correct in recognising that such inconsistent outcomes would be less likely if IRBs were to focus exclusively on whether proposals conformed to the regulations.
That said, I reach the opposite conclusion. As I see it, IRBs present us with a good example of when the possibility of inconsistency is a relatively small consideration in comparison to the important values that are served by IRBs considering their protocol reviews in light of ethics and conforming to regulations. Allow me to explain.
The authors and endorsers of research ethics …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.
↵i Aristotle (1971). The Nichochean Ethics of Aristotle. Ross, WD, translator. London: Oxford University Press.
↵ii E.g., Kenneth Kipnis, Nancy King, Robert Nelson. An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial, 2006, AJOB 6:18–21.
↵iii E.g., The OHRP and SUPPORT, N Engl J Med 2013;368:e36.
↵iv E.g., Farmer P, Campos NG. New malaise: bioethics and human rights in the global era. J Law Med Ethics 2004;32:243–51.
↵v E.g., Marcia Angel, The Ethics of Clinical Research in the Third World, 1997, NEJM 337(12):847–849
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