Reviews in Medical Ethics

Menikoff J. Richards E. P. , What the Doctor Didn't Say: The Hidden Truth about Medical Research (New York: Oxford University Press, 2006): At 15–16.

Id., at 16.

Id., at 49.

Id., at 38.

See Truog R. D. , “Is Informed Consent Always Necessary for Randomized, Controlled Trials?” New England Journal of Medicine 340, no. 10 (1999): 448–450; Lantos J. , “The ‘Inclusion Benefit’ in Clinical Trials,” Journal of Pediatrics 134, no. 2 (1999): 130–131.

Appelbaum P. Roth L. H. Lidz C. W. , “The Therapeutic Misconception: Informed Consent in Psychiatric Research,” International Journal of Law and Psychiatry 5, nos. 3–4 (1982): 319–329; Appelbaum P. Roth L. H. Lidz C. W. Benson P. Winslade W. , “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 17, no. 2 (1987): 20–24; Dresser R. , “The Ubiquity and Utility of the Therapeutic Misconception,” Social Philosophy and Policy 19, no. 2 (2002): 271–294; Daugherty C. , “Quantitative Analysis of Ethical Issues in Phase I Trials: A Survey Interview Study of 144 Advanced Cancer Patients,” IRB 22, no. 3 (2000): 6–14.

Daugherty C. , “Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials,” Journal of Clinical Oncology 13, no. 5 (1995): 1062–1072; id. (Dresser); Rayson D. , “Lisa's Stories,” JAMA 282, no. 17 (1999): 1605–1606; Bamberg M. Budwig N. , “Therapeutic Misconceptions: When the Voices of Caring and Research Are Misconstrued as the Voice of Curing,” Ethics and Behavior 2, no. 3 (1992): 165–184; Miller M. “Phase I Cancer Trials: A Collusion of Misunderstanding,” Hastings Center Report 30, no. 4 (2000): 34–43.

Morreim H. E. , “Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities,” Journal of Law, Medicine & Ethics 32, no. 3 (2004): 474–484; Morreim H. E. , “The Clinical Investigator as Fiduciary: Discarding a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 586–598; see, for example, Greenberg v. Miami Children's Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003); Kernke v. Menninger Clinic, Inc., 172 F. Supp. 2ds 1347 (D. Kan. 2001).

Grimes v. Kennedy Krieger Institute , 366 Md. 29, 782 A.2d 897 (2001).

Institute of Medicine (IOM), Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, National Academy of Sciences, Washington, D.C., 2005.

See Grimes v. Kennedy Krieger Institute, supra note 9, at 103.

Abney v. Amgen, Inc. 443F.3d 540 (6th Cir. 2006).

Mello M. Joffe S. , “Compact versus Contract — Industry Sponsors' Obligations to Their Research Subjects,” New England Journal of Medicine 356, no. 26 (2007): 2737–2743, at 2738.

See Abney v. Amgen, supra note 12; id.

See, for example, Ande v. Rock, 647 N.W. 2d 265 (2002); Spenceley v. M.D. Anderson Cancer Center , 938 F.Supp. 398, (S.D. Tex. 1996).

See, for example, Benner P. , “Living Organ Donors: Respecting the Risks Involved in the ‘Gift of Life,’” American Journal of Critical Care 11, no. 3 (2002): 266–268; Ross L. F. , “Donating a Second Kidney: A Tale of Family and Ethics,” Seminars in Dialysis 13, no. 3 (2000): 201–203.

See Morreim , supra note 8; Miller F. G. Rosenstein D. L. , “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medicine 348, no. 14 (2003): 1383–1386.

See 45 C.F.R. 46.116 (d).

See Menikoff Richards , supra note 1, at 99.

Id., at 65.

Id., at 56.

Id., at 247–248.

Id., at 248.