Symposium on Human Subjects Research: Redux

“A Time for Gratitude,” Journal of Law, Medicine & Ethics, 28, no. 4 (2000): 329.

“Risks, Benefits, and Conflicts of Interest in Human Research: Ethical Evolution in the Changing World of Science,” Journal of Law, Medicine & Ethics, 28, no. 4 (2000): 330–31.

See Koski G. , “An Open Letter to the Human Research Community,” available at <http://ohrp.osophs.dhhs.gov/humansubjects/qip/oltr.pdf> (dated April 17, 2002).

Letter from Patrick J. McNeilly , Ph.D. and Carome Michael M.D. , Division of Compliance, Office for Protection from Research Risks, Department of Health and Human Services, to Edward

Miller D.M.D. Van Dang Chi M.D. Ph.D., Johns Hopkins University School of Medicine (July 19, 2001), at <http://ohrp.osophs.dhhs.gov/detrm_letrs/jul01a.pdf>(last visited, October 25, 2002).

An “assurance” is a formal written binding commitment submitted to and approved by the federal government in which an institution agrees to comply with applicable regulations governing research with human subjects and describes the procedures through which compliance will be achieved.

See 45 C.F.R. §; 46.103 (2002). Among the effects of the government's suspension of an institution's assurance is the termination of federal funding of research projects involving human subjects at the institution.

See Curry D. , “U.S. Restricts Research at Johns Hopkins After a Volunteer's Death,” The Chronicle of Higher Education, Aug. 3, 2001, at A25.

See, e.g., Office for Human Research Protections, “Compliance Determination Letters,” available at <http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/jul2002.htm> (dated July 2002).

Brainard J. , “Director of Federal Office That Oversees Human Subjects Research Resigns,” Chronicle of Higher Education, Oct. 18, 2002.

See Association for the Accreditation of Human Research Protection Programs, Inc. website at <http://www.aahrpp.org/> (last visited Oct. 24, 2002).

See National Committee for the Quality Assurance website at <http://www.ncqa.org/communications/news/vahrpaplaunch.htm> (last visited Oct. 24, 2002).

See National Human Research Protections Advisory Committee, “Charter,” at <http://ohrp.osophs.dhhs.gov/nhrpac/charter.htm> (last revised January 19, 2001).

See National Human Research Protections Advisory Committee, “Membership Rosters” at <http://ohrp.osophs.dhhs.gov/nhrpac/nhrpacrost.htm> (updated June 4, 2002).

Margulies J. , “Bush Administration Allows Research Protections Panel to Expire,” The Chronicle of Higher Education: Daily News, Sept. 18, 2002.

Id.

Cooke R. , Dr. Folkman's War: Angiogenesis and the Struggle to Defeat Cancer (New York: Random House, 2001).