The regulation of clinical research: What's love got to do with it?

Abstract

The central philosophical pillar of the current system of research regulation in the United States today is that clinical investigators cannot and should not be trusted to protect the interests of the people whom they recruit to participate in research. That distrust of researchers is coupled with a starry-eyed idealism about trustworthiness of clinicians. In my opinion, the distrust of researchers and the complacency about clinicians are both misplaced. The result of these twin errors is that people are overprotected in research studies and inadequately protected in clinical care. Patients outside of research studies are exposed to many types of risks from innovative therapy and from practice variation. Researchers who try to study these risks in a risk-reducing way are hampered by burdensome regulations. We need a fundamental theoretical and conceptual change. The change would require us to acknowledge 2 things. First, research can be done in a way that does not harm (and might help) current patients. Second, researchers as moral agents can balance their moral obligations to patients with their obligations to science just as clinicians balance their fiduciary obligations to patients with other interests.

Keywords: IRB; OHRP; ethics; minimal risk; neonatology; oxygen‐saturation; regulation; research.