title: An Assessment of the Human Subjects Protection Review Process for Exempt Research.
abstract: Medical and public health research includes surveys, interviews, and biospecimens - techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of "over-compliance," and makes recommendations for reform.
authors: Jonathan D. Loe, J.D., is a Fellow in Regulatory Science at the University of Arizona. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (History) from the University of Auckland, Auckland, New Zealand. D. Alex Winkelman, J.D., is a clerk for the Honorable Joseph W. Howard of the Arizona Court of Appeals, Division Two. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (English) from the University of Arizona. Christopher T. Robertson, J.D., Ph.D., is Associate Dean for Research and Innovation, Professor of Law, and Faculty Leader of the Regulatory Science Program at the University of Arizona James E. Rogers College of Law. He earned a J.D. from Harvard Law School, Cambridge, Massachusetts, a Ph.D. and M.A. from Washington University, St. Louis, Missouri, and a B.A. (Philosophy) from Southeast Missouri State University, Cape Girardeau, Missouri.
authors: Jonathan D
authors: JD
authors: Loe
authors: Jonathan D. Loe, J.D., is a Fellow in Regulatory Science at the University of Arizona. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (History) from the University of Auckland, Auckland, New Zealand. D. Alex Winkelman, J.D., is a clerk for the Honorable Joseph W. Howard of the Arizona Court of Appeals, Division Two. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (English) from the University of Arizona. Christopher T. Robertson, J.D., Ph.D., is Associate Dean for Research and Innovation, Professor of Law, and Faculty Leader of the Regulatory Science Program at the University of Arizona James E. Rogers College of Law. He earned a J.D. from Harvard Law School, Cambridge, Massachusetts, a Ph.D. and M.A. from Washington University, St. Louis, Missouri, and a B.A. (Philosophy) from Southeast Missouri State University, Cape Girardeau, Missouri.
authors: D Alex
authors: DA
authors: Winkelman
authors: Jonathan D. Loe, J.D., is a Fellow in Regulatory Science at the University of Arizona. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (History) from the University of Auckland, Auckland, New Zealand. D. Alex Winkelman, J.D., is a clerk for the Honorable Joseph W. Howard of the Arizona Court of Appeals, Division Two. He earned a J.D. from the University of Arizona James E. Rogers College of Law, Tucson, Arizona and a B.A. (English) from the University of Arizona. Christopher T. Robertson, J.D., Ph.D., is Associate Dean for Research and Innovation, Professor of Law, and Faculty Leader of the Regulatory Science Program at the University of Arizona James E. Rogers College of Law. He earned a J.D. from Harvard Law School, Cambridge, Massachusetts, a Ph.D. and M.A. from Washington University, St. Louis, Missouri, and a B.A. (Philosophy) from Southeast Missouri State University, Cape Girardeau, Missouri.
authors: Christopher T
authors: CT
authors: Robertson
mesh_terms: D028744:Ethics Committees, Research; D035082:Federal Government; D006805:Human Experimentation; D006801:Humans; D011634:Public Health; D014481:United States