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2.
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3.
OrrR. D., “Rules is Rules,”American Journal of Bioethics6, no. 3 (2006): 40–41; Food and Drug Administration, 21 CFR § 50, 56, 312, 314, 601, 812, and 814; KipnisK.KingN. M. P. and NelsonR. M., “Trials and Errors: Barriers to Oversight of Research Conducted under the Emergency Research Consent Waiver,”IRB: Ethics & Human Research28, no. 2 (2006): 16–19.
4.
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5.
AbbotL. and GradyC., “A Systematic Review of the Empirical Literature Evaluating IRBs: What we Know and What We Still Need to Learn,”Journal of Empirical Research on Human Research Ethics6, no. 1 (2011): 3–20, at 3.
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MayT.CraigJ. M., and SpellecyR., “IRBs, Hospital Ethics Committees, and the Need for ‘Translational Informed Consent,’”Academic Medicine82, no. 7 (2007): 670–674.
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GreenL. A., “Impact of Institutional Review Board Practice Variation on Observational Health Services Research,”HSR: Health Services Research41, no. 1 (2006): 214–230.
8.
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MaschkeK. J., “Human Research Protections: Time for Regulatory Reform,”Hastings Center Report38, no. 2 (2008): 19–22.
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Id. (Hart).
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See Kelson, supra note 13.
16.
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21.
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29.
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30.
ChoM. K., “Strangers at the Benchside: Research Ethics Consultation,”American Journal of Bioethics8, no. 3 (2008): 4–13; de Melo-MartínI.PalmerL. I., and FinsJ. J., “Viewpoint: Developing a Research Ethics Consultation Service to Foster Responsive and Responsible Clinical Research,”Academic Medicine82, no. 9 (2007): 900–904.
31.
Id. (Cho).
32.
SugarmanJ., “The Role of Institutional Support in Protecting Human Research Subjects,”Academic Medicine75, no. 7 (2000): 687–692.
33.
EllisG., “Keeping Research Subjects Out of Harm's Way,”JAMA282, no. 20 (1999): 1963–1965, at 1964.
34.
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35.
See Martinson, supra note 1.
36.
Anonymous, “Do Researchers Learn to Practice Misbehavior?”Hastings Center Report36, no. 2 (2006): 4–7.