Skip to main content Accessibility help
×
Hostname: page-component-78c5997874-v9fdk Total loading time: 0 Render date: 2024-11-02T21:52:21.905Z Has data issue: false hasContentIssue false

25 - Research ethics

Published online by Cambridge University Press:  30 October 2009

Eric M. Meslin
Affiliation:
Professor Indiana University, Indianapolis
Bernard M. Dickens
Affiliation:
Faculty of Law University of Toronto
Peter A. Singer
Affiliation:
University of Toronto
A. M. Viens
Affiliation:
University of Oxford
Get access

Summary

Dr. A is a family practitioner with a special interest in the treatment of chronic obstructive pulmonary disease. He receives a letter from the coordinator of a study to evaluate a promising new treatment for this condition. The letter invites Dr. A to submit the names of potentially eligible patients. He will be paid $100 for each name provided.

Dr. B, a psychiatrist in private practice, is approached by a pharmaceutical company to assist with a clinical trial to test the efficacy of a new drug in the treatment of acute psychosis. The study will enroll acutely psychotic patients with no history of psychosis (or of treatment with antipsychotic drugs) through physicians' offices and emergency departments. Patients enrolled in the study will be randomly assigned to receive the new medication or a placebo and will remain in hospital for eight weeks. During this time, they will not be permitted to receive antipsychotic medications other than the study drug. Informed consent will be obtained from each participant or a proxy. Patients may be withdrawn from the study if their medical condition worsens substantially.

What is research ethics?

Research involving human subjects can raise difficult and important ethical and legal questions. The field of research ethics is devoted to the systematic analysis of such questions to ensure that study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole.

Type
Chapter
Information
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.)

References

Appelbaum, P., Roth, L., Lidz, C., Benson, P., and Winslade, W. (1987). False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 2: 20–4.CrossRefGoogle Scholar
Benatar, S. R. (2002). Reflections and recommendations on research ethics in developing countries. Soc Sci Med 54: 1131–41.CrossRefGoogle ScholarPubMed
Childress, J. F., Meslin, E. M., and Shapiro, H. T. (eds.) (2005). Belmont Revisited: Ethical Principles for Research with Human Subjects. Washington, DC: Georgetown University Press.Google Scholar
CIOMS (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences.Google Scholar
Deleury, E. and Croubau, D. (1994). Le droit des personnes physiques. Cowansville, QC: Éditions Yvon Blais, pp. 119–20.Google Scholar
Dickens, B. M. (1994). Medical records – patient's right to receive copies – physician's fiduciary duty of disclosure: McInerney v. MacDonald. Can Bar Rev 73: 234–42.Google Scholar
Elliott, C. and Weijer, C. (1995). Cruel and unusual treatment. Saturday Night 110: 31–4.Google Scholar
Freedman, B. (1987a). Scientific value and validity as ethical requirements for research: a proposed explanation. IRB, Rev Hum Subj Res 17: 7–10.Google Scholar
Freedman, B. (1987b). Equipoise and the ethics of clinical research. N Engl J Med 317: 141–5.CrossRefGoogle Scholar
Freedman, B. and Shapiro, S. (1994). Ethics and statistics in clinical research: towards a more comprehensive examination. J Stat Plann Inference 42: 223–40.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Freedman, B., Glass, K. C., and Weijer, C. (1996b). Placebo orthodoxy in clinical research. II: Ethical, legal and regulatory myths. J Law Med Ethics 24: 252–9.CrossRefGoogle Scholar
Hellman, S. and Hellman, D. (1991). Of mice but not men: problems of the randomized clinical trial. N Engl J Med 324: 1584–9.CrossRefGoogle Scholar
Hjorth, M., Holmberg, E., Rodjer, S., and Westin, J. (1992). Impact of active and passive exclusions on the results of a clinical trial in multiple myeloma. Br J Haematol 80: 55–61.CrossRefGoogle ScholarPubMed
Human Genome Organization (1996). Statement on the principled conduct of genetic research. Genome Dig 3: 2–3.Google Scholar
International Committee of Medical Journal Editors (1997). Uniform requirements for manuscripts submitted to biomedical journals. Can Med Assoc J 156: 270–7.Google Scholar
Kane, J. M. (1996). Schizophrenia. N Engl J Med 334: 34–1.CrossRefGoogle ScholarPubMed
Levine, R. J. (1988). Ethics and Regulation of Clinical Research. New Haven; CT: Yale University Press.Google ScholarPubMed
Levine, R. J. (1994). The impact of HIV infection on society's perception of clinical trials. Kennedy Inst Ethics J 4: 93–8.CrossRefGoogle ScholarPubMed
Lind, S. E. (1990). Finder's fees for research subjects. N Engl J Med 323: 192–5.CrossRefGoogle ScholarPubMed
Meslin, E. M. (1994). Toward an ethic in dissemination of new knowledge in primary care research. In Disseminating Research/Changing Practice: Research Methods for Primary Care, ed. Dunn, E. V.. Vol. 6, Thousand Oaks, CA: Sage, pp. 32–44.Google Scholar
Meslin, E. M., Sutherland, H. J., Lavery, J. V., and Till, J. E. (1995). Principlism and the ethical appraisal of clinical trials. Bioethics 9: 399–418.CrossRefGoogle ScholarPubMed
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 (1947). Article 1. Washington, DC: Government Printing Office (http://www.ushmm.org/research/doctors/Nuremberg_Code.htm).Google Scholar
Reicken, H. W. and Ravich, R. (1982). Informed consent to biomedical research in Veteran's administration hospitals. JAMA 248: 344–50.CrossRefGoogle Scholar
Silva, M. C. and Sorrell, J. M. (1988). Enhancing comprehension of information for informed consent: a review of empirical research. IRB, Rev Hum Subj Res 10: 1–5.Google ScholarPubMed
Sutherland, H. J., Meslin, E. M.Till, J. E. (1994). What's missing from current clinical trials guidelines? A framework for integrating science, ethics and the community. J Clin Ethics 5: 297–303.Google Scholar
Truman v. Thomas (1980), 611 Pacific (2d) 902 (Sup Ct Calif).
United Nations (1958). International Covenant on Civil and Political Rights. New York: United Nations.Google Scholar
US Department of Health and Human Services (1991). Code of Federal Regulations Title 45 part 46: Protection of Human Subjects, revised 1991. Washington, DC: Government Printing Office.Google Scholar
US Office for Protection from Research Risk (1993). Protecting Human Subjects: Institutional Review Board Guidebook. Washington, DC: Office for Protection from Research Risk.Google Scholar
Weijer, C. (1995). The breast cancer research scandal: addressing the issues. CMAJ 152: 1195–7.Google ScholarPubMed
Weijer, C. (1996). Evolving ethical issues in selection of subjects for clinical research. Camb Q Healthc Ethics 5: 334–45.CrossRefGoogle ScholarPubMed
Weijer, C., Shapiro, S.Fuks, A., Glass, K. C., and Skrutkowska, M. (1995). Monitoring clinical research: an obligation unfulfilled. CMAJ 152: 1973–80.Google ScholarPubMed
Weijer, C., Freedman, B., Fuks, A., et al. (1996). What difference does it make to be treated in a clinical trial? A pilot study. Clin Invest Med 19: 179–83.Google Scholar
White House Advisory Committee on Human Radiation Experiments (1995). Final Report [doc no 061-000-00-848-9]. Washington, DC: Government Printing Office.
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).

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×