The Ethical Analysis of Risk

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45 C.F.R. § 46.111(a).

National Commission, supra note 3.

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Levine , supra note 7, at 42–57.

Levine , “The Role of Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects,” supra note 6, at 2.5–2.44.

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Levine, supra note 7, at 297–98.

National Commission, Research on the Fetus, supra note 19, at 6.

Id. at 73.

Id. at 74.

Levine, supra note 7, at 298.

45 C.F.R.§ 208(a).

National Commission, Research Involving Prisoners, supra note 19, at x.

Id. at xi.

Id. at 20.

Id. at 15.

National Commission, Research Involving Prisoners, supra note 19, at 20.

45 C.F.R. § 46.306(a)(2)(A); 45 C.F.R. § 46.303(d).

National Commission, Research Involving Children, supra note 19.

Levine, supra note 7, at 239.

National Commission, Research Involving Children, supra note 19, at xx.

45 C.F.R. §46.120(i).

National Commission, Research Involving Children, supra note 19, at 20.

Id. at 2.

Id. at 5.

Id. at 5–6.

Id. at 7.

National Commission, Research Involving Children, supra note 19, at 7–8.

Id. at 139.

Id. at 148.

See discussion in the text under the subheading “Ethical Analysis of Entire Protocols” supra.

Id. at 7.

45 C.F.R. § 46.102(i).

National Commission, Research Involving Children, supra note 19, at 2.

National Commission, Research Involving Those Institutionalized as Mentally Infirm, supra note 19.

Id. at 8.

National Commission, Institutional Review Boards, supra note 19, at xx.

Id. at 23.

Id. at 19–20.

National Commission, The Belmont Report, supra note 3.

Levine, “The Boundaries Between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine,” supra note 6, at 1.9–1.10.

Levine, supra note 7, at 250–51.

45 C.F.R. §46.111(a).

45 C.F.R. § 46.208(a).

45 C.F.R. § 46.404–07.

45 C.F.R. § 46.111(a)(1)–(2).

Freedman B. Fuks A. Weijer C. , “Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research,” Clinical Research, 40 (1992): 653–60; Weijer , supra note 1.

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Freedman , supra note 66.

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Freedman , supra note 66.

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45 C.F.R. § 46.102(d).

45 C.F.R. §46.111(a)(1).

45 C.F.R. § 46.111(a)(2).

Freedman B. , “Scientific Value and Validity as Ethical Requirements for Research: A Proposed Explication,” IRB, 9, no. 6 (1987): 7–10.

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45 C.F.R. § 46.102(i).

Freedman B. Fuks A. Weijer C. , “In Loco Parentis. Minimal Risk as an Ethical Threshold for Research upon Children,” Hastings Center Report, 23, no. 2 (1993): 13–19.

45 C.F.R. §46.102(i).

Kopelman L. , “Estimating Risk in Human Research,” Clinical Research, 29, (1981): 1–8.

Freedman Fuks Weijer , supra note 84, at 16.

45 C.F.R. § 46.110(b).

45 C.F.R. § 46.102(i).

Freedman , supra note 78, at 9.

45 C.F.R. § 46.111(b).

Weijer C. , “Research Involving the Vulnerable Sick,” Accountability in Research, 7 (1999): 21–36.

National Bioethics Advisory Commission, Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity (Rockville: National Bioethics Advisory Commission, 1998).