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Is research ethics regulation really killing people?

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Overseeing the conduct of medical research is complex and time consuming. In most countries, a significant part of this involves review by human research ethics committees (HRECs). Some researchers argue that a significant part of this oversight by HRECs is unjustified, because it creates significant delays and costs, prevents some research, and can translate into potential harm to patients.16 In the face of such claims, ethics committee review requires robust justification.

HREC processes must prevent more harm than they cause.1 In this article, I discuss and respond to the claim that delays created by the ethics oversight process lead to predictable and avoidable deaths of people who could have benefited from the interventions whose introduction has been slowed down.36

Unfortunately for defending the role of research regulation, there is controversy about its benefits, and only a weak supporting evidence base.7 This is by no means a new concern. In 1975, Gray pointed out that although such review was introduced in 1966 in the United States, “its adequacy and efficiency have not been sufficiently evaluated. Nor have the various revisions and modifications to the policy been based…