Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-29T10:49:29.491Z Has data issue: false hasContentIssue false
  • English
  • Français

Reviews in Medical Ethics

What the Doctor Didn't Say: The Hidden Truth about Medical Research by Jerry Menikoff and Edward P. Richards

Published online by Cambridge University Press:  01 January 2021

Ana S. Iltis
Get access Rights & Permissions [Opens in a new window]

Extract

What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board (IRB) members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 419 - 424
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Menikoff, J. and Richards, E. P., What the Doctor Didn’t Say: The Hidden Truth about Medical Research (New York: Oxford University Press, 2006): At 15–16.Google Scholar
Id., at 16.Google Scholar
Id., at 49.Google Scholar
Id., at 38.Google Scholar
See Truog, R. D. et al., “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.CrossRefGoogle Scholar
Appelbaum, P., Roth, L. H., and 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., and 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. et al., “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.CrossRefGoogle Scholar
Daugherty, C. et al., “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. and 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.CrossRefGoogle Scholar
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).CrossRefGoogle Scholar
Grimes v. Kennedy Krieger Institute, 366 Md. 29, 782 A.2d 897 (2001).Google Scholar
Institute of Medicine (IOM), Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, National Academy of Sciences, Washington, D.C., 2005.Google Scholar
See Grimes v. Kennedy Krieger Institute, supra note 9, at 103.Google Scholar
Abney v. Amgen, Inc. 443F.3d 540 (6th Cir. 2006).Google Scholar
Mello, M. and 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.CrossRefGoogle Scholar
See Abney v. Amgen, supra note 12; id.Google Scholar
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).Google Scholar
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.CrossRefGoogle Scholar
See Morreim, , supra note 8; Miller, F. G. and Rosenstein, D. L., “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medicine 348, no. 14 (2003): 1383–1386.Google Scholar
See 45 C.F.R. 46.116 (d).Google Scholar
See Menikoff, and Richards, , supra note 1, at 99.Google Scholar
Id., at 65.Google Scholar
Id., at 56.Google Scholar
Id., at 247–248.Google Scholar
Id., at 248.Google Scholar