Hostname: page-component-78c5997874-94fs2 Total loading time: 0 Render date: 2024-11-08T05:05:44.754Z Has data issue: false hasContentIssue false

Symposium on Human Subjects Research: Redux

Published online by Cambridge University Press:  01 January 2021

Extract

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 2002

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

“A Time for Gratitude,” Journal of Law, Medicine & Ethics, 28, no. 4 (2000): 329.CrossRefGoogle Scholar
“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.CrossRefGoogle Scholar
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).+(dated+April+17,+2002).>Google Scholar
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 EdwardGoogle Scholar
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).(last+visited,+October+25,+2002).>Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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).+(dated+July+2002).>Google Scholar
Brainard, J., “Director of Federal Office That Oversees Human Subjects Research Resigns,” Chronicle of Higher Education, Oct. 18, 2002.Google Scholar
See Association for the Accreditation of Human Research Protection Programs, Inc. website at <http://www.aahrpp.org/> (last visited Oct. 24, 2002).+(last+visited+Oct.+24,+2002).>Google Scholar
See National Committee for the Quality Assurance website at <http://www.ncqa.org/communications/news/vahrpaplaunch.htm> (last visited Oct. 24, 2002).+(last+visited+Oct.+24,+2002).>Google Scholar
See National Human Research Protections Advisory Committee, “Charter,” at <http://ohrp.osophs.dhhs.gov/nhrpac/charter.htm> (last revised January 19, 2001).+(last+revised+January+19,+2001).>Google Scholar
See National Human Research Protections Advisory Committee, “Membership Rosters” at <http://ohrp.osophs.dhhs.gov/nhrpac/nhrpacrost.htm> (updated June 4, 2002).+(updated+June+4,+2002).>Google Scholar
Margulies, J., “Bush Administration Allows Research Protections Panel to Expire,” The Chronicle of Higher Education: Daily News, Sept. 18, 2002.Google Scholar
Cooke, R., Dr. Folkman's War: Angiogenesis and the Struggle to Defeat Cancer (New York: Random House, 2001).Google Scholar