Clinical research and the physician–patient relationship: the dual roles of physician and researcher

doi:10.1017/CBO9780511545566.034

29 - Clinical research and the physician–patient relationship: the dual roles of physician and researcher

Published online by Cambridge University Press: 30 October 2009

Nancy M. P. King and

Larry R. Churchill

Edited by

Peter A. Singer and

A. M. Viens

Show author details

Nancy M. P. King: Affiliation:
Professor Wake Forest University USA
Larry R. Churchill: Affiliation:
Professor Vanderbilt University, Vanderbilt USA
Peter A. Singer: Affiliation:
University of Toronto
A. M. Viens: Affiliation:
University of Oxford

Book contents

Get access

Summary

Dr. F, an oncologist in a small community practice, has been asked by a pharmaceutical company to conduct early-phase clinical trials involving several new investigational chemotherapeutic agents that do not yet have FDA approval. These would be very small phase I trials, with the possibility of conducting some phase I/II and phase II trials in the future as well. The reimbursement he will receive for the research will substantially increase the income of his practice, provided that he is able to recruit and retain a sufficient number of subjects. “More importantly, though,” Dr. F thinks to himself, “I have so little to offer many of my sickest patients now. The best thing about doing clinical research is being able to offer them something new, that just might be their best hope.”

Dr. G treats patients with hemophilia. Although treatments have improved dramatically in recent years, hemophilia is a devastating, and devastatingly expensive, chronic disease. Because she has high hopes about promising experimental technologies, she also conducts research. She prides herself on the research partnerships she develops with patient–subjects who seek to contribute to the development of better treatments. Recently, however, she has received inquiries from patients with hemophilia from around the world who want to enroll in her research because the experimental interventions are provided free of charge. These patients tell her that they cannot afford standard therapies, and that enrolling in her research is their only hope for treatment. Dr. G is troubled by this reasoning, and discusses it with a colleague, who responds, “Lots of people enroll in research to get treatment.[…]

Type: Chapter
Information: The Cambridge Textbook of Bioethics , pp. 214 - 221

DOI: https://doi.org/10.1017/CBO9780511545566.034 [Opens in a new window]

Publisher: Cambridge University Press

Print publication year: 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.)

Book purchase

Temporarily unavailable

References

Abigail Alliance v. Eschenbach [2006] US App. LEXIS 10874 (D.C. Cir. 2006).

Appelbaum, P. S. (1996). Commentary: examining the ethics of human subjects research. Kennedy Inst Ethics J 6: 283–7.CrossRef Google Scholar

Appelbaum, P. S. (2002). Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioethics 2: 22–3.CrossRef Google Scholar PubMed

Appelbaum, P. S., Roth, L. H., and Lidz, C. (1982). The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5: 319–29.CrossRef Google Scholar PubMed

Appelbaum, P. S., Roth, L. H., Lidz, C. W., Benson, P., and Winslade, W. (1987). False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17: 20–4.CrossRef Google Scholar PubMed

Appelbaum, P. S., Lidz, C. W., and Grisso, T. (2004). Therapeutic misconception in clinical research: frequency and risk factors. IRB, Ethics Hum Res 26: 1–5.CrossRef Google Scholar PubMed

Brody, H. and Miller, F. G. (2003). The clinician–investigator: unavoidable but manageable tension 13. Kennedy Inst Ethics J 13: 329–36.CrossRef Google Scholar

Capron, A. M. (1974). Informed consent in catastrophic disease research and treatment. U Penn Law Rev 123: 340–61.CrossRef Google Scholar PubMed

Chen, D. and Miller, F. (2003). Clinical research and the physician–patient relationship. Ann Int Med 138: 669–72.CrossRef Google Scholar PubMed

Churchill, L. R. (1980). Physician–investigator, patient–subject: exploring the logic and the tension. J Med Philos 5: 215–24.CrossRef Google Scholar PubMed

Churchill, L. R., Collins, M. L., King, N. M. P., Pemberton, S. G., and Wailoo, K. A. (1998). Genetic research as therapy: implications of “gene therapy” for informed consent. J Law Med Ethics 26: 38–47.CrossRef Google Scholar PubMed

Coleman, C. (2005). Duties to subjects in clinical research 58. Vand Law Rev 58: 387–449.Google Scholar

Daugherty, C., Ratain, M. J., Grochowski, E., et al. (1995). Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13: 1062–72.CrossRef Google Scholar PubMed

Daugherty, C., Banik, D., Janish, L., et al. (2000). Quantitative analysis of ethical issues in phase I trials: a survey of 144 advanced cancer patients. IRB, Ethics Hum Res 22: 6–14.CrossRef Google Scholar PubMed

Dresser, R. (2000). When Science offers Salvation. New York: Oxford University Press.Google Scholar

Dresser, R. (2002). The ubiquity and utility of the therapeutic misconception. Soc Philos Pol 19: 271–94.CrossRef Google Scholar PubMed

Easter, M. M., Henderson, G. E., Davis, A. M., Churchill, L. R., and King, N. M. P. (2007). The many meanings of care in clinical research. In The View from Here: Social Science and Bioethics, ed. DeVries, R., Turner, L., Orfali, K. and Bosk, C.. Oxford: Blackwell for Sociology of Health and Illness.Google Scholar

Estrada v. Jacques (1984) 321 S.E.2d 240 (N.C. Ct. App. 1984).

Evans, E. E. and London, A. J. (2006). Equipoise and the criteria for reasonable action. J Law Med Ethics 34: 441–50.CrossRef Google Scholar PubMed

Freedman, B. (1987). Equipoise and the ethics of clinical research. N Engl J Med 317: 141–5.CrossRef Google Scholar PubMed

Freedman, B. (1990). Placebo-controlled trials and the logic of clinical purpose. IRB, Rev Hum Subj Res 12: 1.Google Scholar PubMed

Freedman, B., Weijer, C., and Glass, K. C. (1996a). Placebo orthodoxy in clinical research. I. Empirical and methodological myths. J Law Med Ethics 24: 243–51.CrossRef Google Scholar

Freedman, B., Weijer, C., and Glass, K. C. (1996b). Placebo orthodoxy in clinical research. II. Ethical, legal and regulatory myths. J Law Med Ethics 24: 252–9.CrossRef Google Scholar

Glass, K. C. and Waring, D. (2002). Effective trial design need not conflict with good patient care. Am J Bioethics 2: 25.CrossRef Google Scholar

Gray, B. (1975). Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research. New York: John Wiley.Google Scholar

Grimes v. Kennedy Krieger Institute (2001) 782 A.2d 807 (Md. 2001).

Hellman, D. (2002). Evidence, belief, and action: the failure of equipoise to resolve the ethical tension in the randomized clinical trial. J Law Med Ethics 30: 375–9.CrossRef Google Scholar PubMed

Henderson, G. E., Davis, A. M., King, N. M. P., et al. (2004a). Uncertain benefit: investigators' views and communications in early phase gene transfer trials. Mol Ther 10: 225–31.CrossRef Google Scholar

Henderson, G. E., Davis, A. M., and King, N. M. P. (2004b). Vulnerability to influence: a two-way street. Am J Bioethics 4: 50–2.CrossRef Google Scholar

Henderson, G. E., Easter, M. M., Zimmer, C., et al. (2006). Therapeutic misconception in early phase gene transfer trials. Soc Sci Med 62: 239–53. [Epub 5 July 2005.]CrossRef Google Scholar PubMed

Horng, S. and Grady, C. (2003). Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB, Ethics Hum Res 25: 11–16.CrossRef Google Scholar PubMed

Horng, S., Emanuel, E. J., Wilfond, B., et al. (2002). Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 347: 2134–40.CrossRef Google Scholar PubMed

Horng, S., and Emanuel, E. J., Wilfond, B., et al. (2003). Authors reply. N Engl J Med 348: 1497.Google Scholar

Horstmann, E., McCabe, M. S., Grochow, L., et al. (2005). Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352: 895–904.CrossRef Google Scholar PubMed

Joffe, S., and Weeks, J. C. (2002). Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst 94: 1847–53.CrossRef Google Scholar PubMed

Joffe, S., Cook, E. F., Cleary, P. D., et al. (2001). Quality of informed consent in cancer clinical trials: a cross–sectional survey. Lancet 358: 1772–7.CrossRef Google Scholar PubMed

Kass, N. E., Sugarman, J., Faden, R.et al. (1996). Trust: the fragile foundation of contemporary biomedical research. Hastings Cent Rep 26: 25–9.CrossRef Google Scholar PubMed

King, N. M. P., Henderson, G. E., Churchill, L. R., et al. (2005). Consent forms and the therapeutic misconception: the example of gene transfer research. IRB, Ethics Hum Res 27: 1–8.CrossRef Google Scholar PubMed

Klanica, K. (2005). Conflicts of interest in medical research: how much conflict should exceed legal boundaries?J Biolaw Bus 8: 35–45.Google Scholar PubMed

Lemmens, T. and Miller, P. B. (2002). Avoiding a Jekyll-and-Hyde approach to the ethics of clinical research and practice. Am J Bioethics 2: 14–17.CrossRef Google Scholar PubMed

Levinsky, N. G. (2002). Nonfinancial conflicts of interest in research. N Engl J Med 347: 759–61.CrossRef Google Scholar PubMed

Miller, F. G. and Brody, H. (2002). What makes placebo-controlled trials unethical?Am J Bioethics 2: 3.CrossRef Google Scholar PubMed

Miller, F. G. and Brody, H. (2003). A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 33: 19–28.CrossRef Google Scholar PubMed

Miller, F. G. and Rosenstein, D. L. (2003). The therapeutic orientation to clinical trials. N Engl J Med 348: 1383–6.CrossRef Google Scholar PubMed

Miller, M. (2000). Phase I cancer trials. A collusion of misunderstanding. Hastings Cent Rep 30: 34–43.CrossRef Google Scholar PubMed

Miller, P. B. and Weijer, C. (2003). Rehabilitating equipoise. Kennedy Inst Ethics J 13: 93–118.CrossRef Google Scholar PubMed

Miller, P. B. and Weijer, C. (2006). Fiduciary obligation in clinical research. J Law Med Ethics 34: 424–40.CrossRef Google Scholar PubMed

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Office for Protection from Research Risks.Google Scholar

Nuremberg Code (1949). Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2. Washington, DC: US Government Printing Office, pp. 181–2. (http://www.hhs.gov/ohrp/references/nurcode.htm).Google Scholar

Re Cincinnati Radiation Litigation [1995] 874 F. Supp. 796 (S.D. Ohio 1995).

TD v. New York State Office of Mental Health (1996) 650 N.Y.S.2d 173.

Toth v. Community Hospital at Glen Cove [1968] 22 N.Y.2d 255; 239 N.E.2d 368; 292 N.Y.S.2d 440 (N.Y. Ct. App.1968).

World Medical Association (1964). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [revised 1975, 1983, 1989, 1996, 2000]. Washington, DC: World Medical Association (http://www.wma.net/e/policy/b3.htm).