 |
 |
|
Home |
Current Issue |
Past Issues |
In the Clinic |
ACP Journal Club |
CME |
Collections |
Audio/Video |
Mobile |
Subscribe |
Tools |
Help |
ACP Online
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
16 January 2001 | Volume 134 Issue 2 | Pages 152-157
Clinical research has undergone remarkable and beneficial expansion in the past 25 years, but with this growth has come an unprecedented increase in workload for the human subjects protection system. Recently, a major change in federal oversight of local institutional review boards (IRBs) became evident. Although it was not announced publicly, in 1998 and 1999 federal regulatory actions against local IRBs increased threefold. Particularly notable was the marked increase in regulatory actions taken against the IRBs of academic medical centers (1 in 1997 compared with 14 in 1999). Ironically, this apparent federal crackdown began at the same time that two federal review panels called for major changes in the regulations governing local IRBs. A key factor in the current crisis in the function of local IRBs is the ascendance of multicenter clinical trials as the dominant form of clinical research. Local IRBs were not designed to handle the initial evaluation and ongoing review required by the rapidly increasing number of multicenter clinical trials. Furthermore, local IRB review of the thousands of safety reports from multicenter clinical trials monopolizes resources without promoting patient safety. Instead of rigid enforcement of outmoded regulations that do not contribute to patient safety, the responsibilities of the local IRB in the oversight of multicenter clinical trials must be systematically evaluated.
Author and Article Information
From Denver Health and Hospital Authority and University of Colorado Health Sciences Center, Denver, Colorado.
Presented in part to the National Bioethics Advisory Commission, Washington, D.C., 11 July 2000.
Acknowledgments: The authors thank Andrew Vernon, MD, MPH; Jack Rouff, MSW; and C. Robert Horsburgh, MD, for manuscript review and discussions.
Requests for Single Reprints: William J. Burman, MD, Denver Public Health, 605 Bannock Street, Denver, CO 80204; e-mail, bburman{at}dhha.org.
Current Author Addresses: Drs. Burman, Reves, and Cohn: Denver Public Health, 605 Bannock Street, Denver, CO 80204.
Dr. Schooley: Division of Infectious Diseases, University of Colorado Health Sciences Center, 4200 East Ninth Avenue, Denver, CO 80262. PERSPECTIVE
Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards
Related articles in Annals:
This article has been cited by other articles:
|
|
 |
|
  L Porcu, D Poli, V Torri, E Rulli, M C Di Tullio, M Cinquini, E Bajetta, R Labianca, F Di Costanzo, D Nitti, et al. Impact of recent legislative bills regarding clinical research on Italian ethics committee activity J. Med. Ethics, October 1, 2008; 34(10): 747 - 750. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Saginur, S. F. Dent, L. Schwartz, R. Heslegrave, S. Stacey, and J. Manzo Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review Board J. Clin. Oncol., March 20, 2008; 26(9): 1479 - 1482. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. Fost and R. J. Levine The Dysregulation of Human Subjects Research JAMA, November 14, 2007; 298(18): 2196 - 2198. [Full Text] [PDF]
|
|
|
|
 |
|
 G. K. Sobolski, L. Flores, and E. J. Emanuel Institutional Review Board Review of Multicenter Studies Ann Intern Med, May 15, 2007; 146(10): 759 - 759. [Full Text] [PDF]
|
|
|
|
 |
|
 D. G. Graham, M. S. Spano, and B. Manning The IRB Challenge for Practice-based Research: Strategies of the American Academy of Family Physicians National Research Network (AAFP NRN) J Am Board Fam Med, March 1, 2007; 20(2): 181 - 187. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. M Califf Clinical trials bureaucracy: unintended consequences of well-intentioned policy Clinical Trials, December 1, 2006; 3(6): 496 - 502. [Abstract] [PDF]
|
|
|
|
 |
|
 L. Hilbrich and P. Sleight Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials Eur. Heart J., September 2, 2006; 27(18): 2158 - 2164. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. L DeMets, N. Fost, and M. Powers An Institutional Review Board dilemma: responsible for safety monitoring but not in control Clinical Trials, April 1, 2006; 3(2): 142 - 148. [Abstract] [PDF]
|
|
|
|
 |
|
 L. B Dunn, P. J Candilis, and L. W. Roberts Emerging Empirical Evidence on the Ethics of Schizophrenia Research Schizophr Bull, January 1, 2006; 32(1): 47 - 68. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R Dal-Re, R Ortega, and E Morejon Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation? J. Med. Ethics, June 1, 2005; 31(6): 344 - 350. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. DeMets, R. Califf, D. Dixon, S. Ellenberg, T. Fleming, P. Held, D. Julian, R. Kaplan, R. Levine, J. Neaton, et al. Issues in regulatory guidelines for data monitoring committees Clinical Trials, April 1, 2004; 1(2): 162 - 169. [Abstract] [PDF]
|
|
|
|
 |
|
 J Lynn When does quality improvement count as research? Human subject protection and theories of knowledge Qual. Saf. Health Care, February 1, 2004; 13(1): 67 - 70. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. D. Scott Research-Related Injury: Problems and Solutions J. Law Med. Ethics, September 1, 2003; 31(3): 419 - 428. [PDF]
|
|
|
|
|
|
I. Berlin and D. A. Gorelick The French Law on "Protection of Persons Undergoing Biomedical Research": Implications for the U.S. J. Law Med. Ethics, September 1, 2003; 31(3): 434 - 441. [PDF]
|
|
|
|
|
|
R. McWilliams, J. Hoover-Fong, A. Hamosh, S. Beck, T. Beaty, and G. Cutting Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study JAMA, July 16, 2003; 290(3): 360 - 366. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Humphreys, J. Trafton, and T. H. Wagner The Cost of Institutional Review Board Procedures in Multicenter Observational Research Ann Intern Med, July 1, 2003; 139(1): 77 - 77. [Full Text] [PDF]
|
|
|
|
|
|
C. A. Coyne, R. Xu, P. Raich, K. Plomer, M. Dignan, L. B. Wenzel, D. Fairclough, T. Habermann, L. Schnell, S. Quella, et al. Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group J. Clin. Oncol., March 1, 2003; 21(5): 836 - 842. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. C. Bevan Towards the regulation of Research Ethics Boards/Pour une reglementation des Comites d'ethique de la recherche Can J Anesth, November 1, 2002; 49(9): 900 - 906. [Full Text] [PDF]
|
|
|
|
 |
|
 M. C. Christian, J. L. Goldberg, J. Killen, J. S. Abrams, M. S. McCabe, J. K. Mauer, and R. E. Wittes A Central Institutional Review Board for Multi-Institutional Trials N. Engl. J. Med., May 2, 2002; 346(18): 1405 - 1408. [Full Text] [PDF]
|
|
|
|
|
|
R. Steinbrook Improving Protection for Research Subjects N. Engl. J. Med., May 2, 2002; 346(18): 1425 - 1430. [Full Text] [PDF]
|
|
|
|
|
|
J. E. Siegel, A. Vaughn, and E. Baszczewski The Crisis in Local Institutional Review Boards Ann Intern Med, March 5, 2002; 136(5): 410 - 410. [Full Text] [PDF]
|
|
|
|
|
|
A. M. Sugar The Crisis in Local Institutional Review Boards Ann Intern Med, March 5, 2002; 136(5): 410 - 410. [Full Text] [PDF]
|
|
|
|
|
|
S. Nagy-Agren The Crisis in Local Institutional Review Boards Ann Intern Med, March 5, 2002; 136(5): 410 - 411. [Full Text] [PDF]
|
|
|
|
|
|
W. J. Burman, R. T. Schooley, M. A. Morse, R. M. Califf, and J. Sugarman The Role of Local Institutional Review Boards in Protecting Human Research Subjects JAMA, June 6, 2001; 285(21): 2713 - 2713. [Full Text] [PDF]
|
|
|
|
|
|
M. A. Morse, R. M. Califf, and J. Sugarman Monitoring and Ensuring Safety During Clinical Research JAMA, March 7, 2001; 285(9): 1201 - 1205. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. J. Levine Institutional Review Boards: A Crisis in Confidence Ann Intern Med, January 16, 2001; 134(2): 161 - 163. [Full Text] [PDF]
|
|
Article
