What the ANPRM missed: Additional needs for IRB reform

Journal of Law, Medicine and Ethics

Volumn 41, Issue 2, 2013, Pages 390-396

  Lidz, Charles W ^a   Garverich, Suzanne ^b  

^a UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPUTER SECURITY; HUMAN; HUMAN EXPERIMENT; INFORMATION PROCESSING; INFORMED CONSENT; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PEER REVIEW; PROFESSIONAL STANDARD; RESEARCH SUBJECT; UNITED STATES;

COMPUTER SECURITY; DATA COLLECTION; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; PEER REVIEW, RESEARCH; RESEARCH SUBJECTS; UNITED STATES;

EID: 84879731786     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/jlme.12050     Document Type: Article

References (12)

1. U.S. Department of Health and Human Services, Editor, Basic HHS Policy for Protection of Human Research Subjects ("The Common Rule"), in 45CFR46.
2. National Commission for the Protection of Human Subjects, Report and Recommendations for Institutional Review Boards (Washington, D.C.: US Government Printing Office, 1978).
3. G. Koski, An Open Letter to the Human Research Community, 2002, available at (last visited April 23, 2013); E. Gordon, "Trials and Tribulations of Navigating IRBs: Anthropological and Biomedical Perspectives of 'Risk' in Conducting Human Subjects Research, "Anthropological Quarterly 76, no. 2 (2003): 299-320.
4. W. Eaton, "The Reliability of Ethical Reviews: Some Initial Findings, " Canadian Psychologist 24, no. 1 (1983): 14-18; A. Cartwright, "Research Ethics Committees, "BMJ 300, no. 6724 (1990): 607; M. Grodin, B. Zaharoff, and P. Kaminow, "A 12-Year Audit of IRB Decisions, "Quality Review Bulletins 12 (1986): 82-86; M. Giammona and S. Glantz, "Poor Statistical Design in Research on Humans: The Role of Committees on Human Research, "Clinical Research 31 (1983): 572-578; S. J. Ceci, D. Peters, and J. Plotkin, "Human Subjects Review, Personal Values, and the Regulation of Social Science Research, "American Psychologist 40, no. 9 (1985): 994-1002; J. J. Ashford, "Recent Experience of Ethics Committee Review of a Multicenter Research Project, "Journal of Clinical Pharmacology 23 (1987): 373-374; T. Stair et al., "Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial, "Academic Emergency Medicine 8, no. 6 (2001): 636-641; J. Bell, J. Whiton, and S. Connelly, Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects (1998).
5. C. W. Lidz et al., "IRBs: How Closely Do They Follow the Common Rule?" Academic Medicine Academic Medicine 87, no. 7 (2012): 1-6.
6. P. Candilis and C. Lidz, et al., "The Silent Majority: Who Speaks at IRB Meetings, " IRB: Ethics and Human Research 34, no. 4 (2012): 1-12; see Lidz, supra note 6; C. W. Lidz and L. Simon et al., "The Participation of Community Members on Institutional Review Boards, "Journal of Empirical Research in Human Research Ethics 7, no. 1 (2012): 1-8; C. W. Lidz and L. Simon et al., "The Participation of Community Members on Institutional Review Boards, "Journal of Empirical Research in Human Research Ethics 7, no. 1 (2012): 1-8.
7. DHHS Office of the Secretary, "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators - Advance Notice of Proposed Rulemaking, "Federal Register 76, no. 170 (2011): 44, 512-44, 531.
8. See Stair et al., supra note 5; D. E. Hammerschmidt and M. A. Keane, "Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research, "American Journal of the Medical Sciences 304, no. 6 (1992): 348-351.
9. O. Ben-Shahar and C. E. Schneider, "The Failure of Mandated Disclosure, " University of Chicago Law & Economics, Olin Working Paper No. 516, available at (last visited April 8, 2013).
10. D. R. MacKintosh and V. J. Molloy, "Opportunities to Improve Informed Consent, " Applied Clinical Trials (May 2003): 46-48; National Cancer Institute, NCI Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials (1998); M. Hochhauser, "The Informed Consent Form: Document Development and Evaluation, "Drug Information Journal 34, no. 14 (2000): 1309-1317.
11. J. Ziewacz et al., "Crisis Checklists for the Operating Room: Development and Pilot Testing, " Journal of the American College of Surgery 213 (2011): 212-217.
12. W. Waggoner and D. Mayo, "Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms, " IRB 17, no. 1 (1995): 6-9; K. Tarnowski et al., "Readability of Pediatric Biomedical Research Informed Consent Forms, "Pediatrics 85 (1980): 58-62; D. Hammerschmidt and M. Keane, "Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research, "American Journal of the Medical Sciences 304, no. 6 (1992): 348-351.