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December 2001

Human Studies, Institutional Review Boards, and the Protection of Human Subjects

Arch Ophthalmol. 2001;119(12):1849-1850. doi:10.1001/archopht.119.12.1849

THE PRINCIPLE that physicians must place the safety and welfare of their patients above all other considerations applies just as surely when physicians are recruiting and studying subjects in clinical investigations as it does when they are caring for the sick. Patient research in one form or another has been conducted for millennia but only in the last several decades and only in certain countries have regulations been promulgated that guide the ethical conduct of human experimentation. At present in the United States, human studies are regulated by the Code of Federal Regulations1 and the revised Declaration of Helsinki.2