Reforming Human Subject Research
Ezekiel J. Emanuel, M.D., Ph.D., and Jerry Menikoff, M.D., J.D.
New England Journal of Medicine
July 25, 2011
Since 1991, there has been almost no change to the Common Rule. Yet research with humans has substantially increased in volume, with more international and multisite studies, more health-services research, and more research with biospecimens.
Protecting Research Subjects with Diminished Capacity – Balancing Research Needs with Ethical Concerns, Center policy brief, Summer 2006
Assessing Social Issues of Research, Summer McGee, The Bioethics Channel, May 19, 2011