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).
GordonE., “Trials and Tribulations of Navigating IRBs: Anthropological and Biomedical Perspectives of ‘Risk’ in Conducting Human Subjects Research,”Anthropological Quarterly76, no. 2 (2003): 299–320.
5.
EatonW., “The Reliability of Ethical Reviews: Some Initial Findings,”Canadian Psychologist24, no. 1 (1983): 14–18.
GiammonaM.GlantzS., “Poor Statistical Design in Research on Humans: The Role of Committees on Human Research,”Clinical Research31 (1983): 572–578.
9.
CeciS. J.PetersD.PlotkinJ., “Human Subjects Review, Personal Values, and the Regulation of Social Science Research,”American Psychologist40, no. 9 (1985): 994–1002.
10.
AshfordJ. J., “Recent Experience of Ethics Committee Review of a Multicenter Research Project,”Journal of Clinical Pharmacology23 (1987): 373–374.
11.
StairT., “Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial,”Academic Emergency Medicine8, no. 6 (2001): 636–641.
12.
BellJ.WhitonJ.ConnellyS., Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects (1998).
13.
LidzC. W., “IRBs: How Closely Do They Follow the Common Rule?”Academic Medicine Academic Medicine87, no. 7 (2012): 1–6.
14.
CandilisP.LidzC., “The Silent Majority: Who Speaks at IRB Meetings,”IRB: Ethics and Human Research34, no. 4 (2012): 1–12.
15.
see Lidz, supra note 6.
16.
LidzC. W.SimonL., “The Participation of Community Members on Institutional Review Boards,”Journal of Empirical Research in Human Research Ethics7, no. 1 (2012): 1–8.
17.
LidzC. W.SimonL., “The Participation of Community Members on Institutional Review Boards,”Journal of Empirical Research in Human Research Ethics7, no. 1 (2012): 1–8.
18.
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 Register76, no. 170 (2011): 44,512–44,531.
19.
Id.
20.
Id.
21.
See Stair, supra note 5.
22.
HammerschmidtD. E.KeaneM. A., “Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research,”American Journal of the Medical Sciences304, no. 6 (1992): 348–351.
23.
Ben-ShaharO.SchneiderC. E., “The Failure of Mandated Disclosure,”University of Chicago Law & Economics, Olin Working Paper No. 516, available at <http://ssrn.com/abstract=1567284> (last visited April 8, 2013).
National Cancer Institute, NCI Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials (1998).
26.
HochhauserM., “The Informed Consent Form: Document Development and Evaluation,”Drug Information Journal34, no. 14 (2000): 1309–1317.
27.
See supra note 10.
28.
ZiewaczJ., “Crisis Checklists for the Operating Room: Development and Pilot Testing,”Journal of the American College of Surgery213 (2011): 212–217.
29.
WaggonerW.MayoD., “Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms,”IRB17, no. 1 (1995): 6–9.
30.
TarnowskiK., “Readability of Pediatric Biomedical Research Informed Consent Forms,”Pediatrics85 (1980): 58–62.
31.
HammerschmidtD.KeaneM., “Institutional Review Board Review Lacks Impact on the Readability of Consent Forms for Research,”American Journal of the Medical Sciences304, no. 6 (1992): 348–351.