Protection of Human Subjects
The organized oversight of research to ensure the rights and well-being of participants.
The protection of human subjects in clinical research evolved in response to conditions surrounding medical research that were deemed unacceptable in the early to mid-twentieth century. In December 1946, an American military tribunal opened criminal proceedings against 23 German physicians who conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently disabled as a result. The Nuremberg Code of 1948 resulted, stating that “voluntary consent of a human subject is absolutely essential” and that “the benefits of research must outweigh the risks” (NIH). In 1964, the World Medical Association published recommendations for research involving human subjects, and the Declaration of Helsinki governs international research ethics and defines...
References and Readings
- Association for the Accreditation of Human Research Protection Programs. Retrieved May 18, 2011 from http://www.aahrpp.org
- Center for Information and Study on Clinical Research Participation (CISCRP). Retrieved May 18, 2011 from http://www.ciscrp.org/
- Centers for Disease Control and Prevention (CDC). Retrieved May 18, 2011 from http://www.cdc.gov/tuskegee/timeline.htm
- NIH Office of Human Subjects Research. Retrieved May 18, 2011 from http://ohsr.od.nih.gov/guidelines/nuremberg.html
- The Belmont report. Retrieved May 18, 2011 from http://ohsr.od.nih.gov/guidelines/belmont.html
- The Hastings Center. Retrieved May 18, 2011 from http://www.thehastingscenter.org
- World Medical Association (WMA). Retrieved May 18, 2011 from http://www.wma.net/en/30publications/10policies/b3/