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Protecting Participants in Clinical Trials
A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.
Protecting Human Research Participants
A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.
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More Information
You may find that the informed consent process and conversations with your medical team are sufficient in helping you arrive at a decision. Or you may wish to gather more outside information before making up your mind. Other good sources of information include:
- local hospitals
- Institutional Review Boards
- patient advocacy and support groups
- health plans
- NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615
- library and Internet research
You can also search the National Library of Medicine's PubMed database for additional articles on informed consent and clinical trials.
Keep in mind that everyone's information needs are different. You should do whatever makes you feel most comfortable as you make this important decision.
Includes sources used in this Guide as well as background reading:
Broome M. "Consent (Assent) for Research with Pediatric Patients." Working manuscript.
Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute. "Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials." August 1998.
Davis T et. al. "Informed Consent for Clinical Trials: A Comparative Study of Standard versus Simplified Forms." Journal of the National Cancer Institute 1998 May 6; 90 (9): 668-74.
Faden R, Beauchamp T. A History and Theory of Informed Consent (New York: Oxford UP, 1986). Chapter 8, "The Concepts of Informed Consent and Competence," and Chapter 9, "Understanding."
Grossman SA et. al."Are Informed Consent Forms that Describe Clinical Oncology Research Protocols Readable by Most Patients and Their Families?" Journal of Clinical Oncology 1994 Oct; 12 (10): 2211-5.
Jimison HB et. al. "The Use of Multimedia in the Informed Consent Process." Journal of the American Medical Information Association 1998 May-Jun; 5 (3): 245-56.
Kodish E et. al. "Informed Consent in the Childrens Cancer Group: Results of Preliminary Research." Cancer 1998 June 15; 82 (12): 2467-81.
National Cancer Institute. "Informed Consent: New Recommendations to Simplify, Improve Quality." Fact sheet, 11/98.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." April 18, 1979
Office of Human Research Protections, Department of Health and Human Services. "IRB Guidebook."
Porter JP. "Basic Considerations in Informed Consent in Research." Clinical Research and Regulatory Affairs 1995; 12 (2): 95-109.
Warren Grant Magnuson Clinical Center, National Institutes of Health. "Partners in Research: Volunteer Patients and the NIH Clinical Center."
University of Minnesota Institutional Review Board. "Informed Consent Overview."
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