- Research, Practice, and Innovative Therapy:On the Theoretical Model of Robert J. Levine
Shimon Tashiro is Project Assistant Professor at the University of Tokyo Center for Biomedical Ethics and Law in Japan. Dr Tashiro is a member of the Institutional Review Board of National Hospital Organization Sendai Medical Center. His research interests focus primarily on research ethics, such as issues on the distinction between research and practice, the ethics of innovative therapy and the ethics of RCTs. He is also interested in end-of-life care, professional ethics, and the history of bioethics.
Thanks to Hitoshi Arima, Reidar Lie, Joseph Milium, and an anonymous reviewer for the Asian Bioethics Review for helpful comments on earlier drafts of this paper.
1. See Tashiro, S. (2008) Ishi no shiten kara mita kenkyu rinri: kanazawa daigaku fuzoku byoin mudan rinsyo shiken sosho o jirei to shite (Research Ethics from the Perspective of Japanese Doctors: the Case of Kanazawa University Hospital), Nichibei no iryo: seido to rinri (Medicine in the United States and Japan: Institutions and Ethics), ed. Y. Sugita, Osaka University Press, Osaka, 129-50.
2. More precisely, the defendant in this court case was the government because this hospital was one of the national university's hospitals and the physicians working there were hired by the government. Also, the plaintiff was the patient's family member because the patient herself had died from cancer right after this trial. However, for the sake of simplicity, I assume that the defendant is the hospital and physicians, and the plaintiff is the patient herself in this paper.
3. In Japan, the Guidelines for Good Clinical Practice (the GCP rules) based on the Pharmaceutical Affairs Act have covered only clinical trials for drug approval (Chiken) since 1997. It means there is no law which regulates clinical trials using already approved drugs. There has been the non-binding ethical guideline based on administrative guidance (Gyosei shido) since 2003.
4. Robert Truog and his colleagues discuss a similar case. See Truog, R., et al. (1999) Is Informed Consent Always Necessary for Randomized, Controlled Trials?, The New England Journal of Medicine, 340 (10), 804-7. They insist that one does not need to obtain informed consent from his/her subjects in randomised controlled trials of two approved drugs. However, I take a different position as I show in this paper. I agree with Rebecca Dresser's critics of their paper. See Dresser, R. (2002) The Ubiquity and Utility of the Therapeutic Misconception, Social Science and Policy, 19 (2), 288-90.
5. This topic is related to various issues in research ethics, including risk-benefit analysis, ethics of innovative therapy, ethics of surgical research, the problem of clinical equipoise, and therapeutic misconception. See Freedman, B., A. Fuks, and C. Weijer (1992) Demarcating Research and Treatment: A Systematic Approach for the Analysis of the Ethics of Clinical Research, Clinical Research, 40, 653-60; King, N.M.P. (1995) Experimental Treatment: Oxymoron or Aspiration?, Hastings Center Report, 25 (4), 6-15; Margo, C.E. (2001) When is Surgery Research? Toward an Operational Definition of Human Research, Journal of Medical Ethics, 27, 40-3; Miller F., and H. Brody (2003) A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials, Hastings Center Report, 33 (3), 19-28; Henderson, G.E., et al. (2007) Clinical Trials and Medical Care: Defining the Therapeutic Misconception, PLoS Medicine, 4 (11), 1735-8.
6. The PLoS Medicine Editors (2007) How can We Draw the Line between Clinical Care and Medical Research?, PLoS Medicine, 4 (11), 1707-8.
7. Schüklenk, U., and R. Ashcroft (2000) International Research Ethics, Bioethics14 (2), 158-72.
8. Hallowell, N., et al. (2009) Distinguishing Research from Clinical Care in Cancer Genetics: Theoretical Justifications and Practical Strategies, Social Science and Medicine, 68, 2010.
9. See Jonsen, A. (1998) The Birth of Bioethics, Oxford University Press, New York, 99-106.
10. Levine, R.J. (1978) The Boundaries between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine, The Belmont Report, Appendix Volume 1, DHEW Pub. No. (OS) 78-0013, U.S. Printing Office, Washington, D.C., 1-1-44.