The federal government is in the process of revising the regulations that govern most human subject research in the United States.
In a “Policy Forum” piece in the Aug. 3 issue of Science, bioethics expert Rebecca Dresser, JD, the Daniel Noyes Kirby Professor of Law and professor of ethics in medicine at Washington University in St. Louis, weighs in with recommendations for changes in the oversight process.
Dresser writes that the research oversight system must be based on a fundamental moral judgment. “Human subjects have interests that should not be subordinated to the interests of the patients, researchers, industry stakeholders, and others who gain health and monetary benefits from the research enterprise,” she writes.
Dresser makes three recommendations:
- To promote informed choice, researchers should adopt procedures to evaluate whether prospective subjects understand essential facts about a study.
- Because research subjects accept burdens so that others may benefit, research sponsors and institutions should cover the costs of any study-related injuries.
- To ensure that risks to subjects are justified by the importance of the knowledge a study is expected to produce (this is an existing regulatory requirement), studies should undergo independent and rigorous merit review.
Dresser holds a joint appointment at the law school and at Washington University School of Medicine in St. Louis, teaching law and medical students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction and related topics.
She has written extensively in her field and is the co-author of a casebook on bioethics and law and a book on the ethical treatment of animals. She also is the author of a book on patient advocacy and research ethics. Her most recent work is as editor and contributor to Malignant: Medical Ethicists Confront Cancer (Oxford University Press, 2012).
She is a member of the Recombinant DNA Advisory Committee of the National Institutes of Health and a past member of the President’s Council on Bioethics. She also sits on the Washington University Medical Center Institutional Review Board, as well as the Washington University Embryonic Stem Cell Research Oversight Committee and Alzheimer’s Disease Research Center Ethics Committee.
To view an abstract of the article, visit sciencemag.org/content/337/6094/527.