Origins & Background
This century has seen great developments in the theoretical view of human subjects research. The evolution of our ethical understanding has evolved from problems faced in history as well as questions centering on new technologies and research applications.
The Nuremburg Code (1949):
http://www.nihtraining.com/ohsrsite/guidelines/nuremberg.html
The Nuremburg Code was written as a response to unethical research conducted by Nazi doctors during the Second World War. It enumerates several key ethical guidelines that should be addressed in human subjects research.
- Informed Consent of participants
- Research should be based on prior animal studies
- Risks for participants should be justified by anticipated results
- Research is to be conducted only by qualified scientists
- Physical and mental suffering must be avoided
- Research that may result cause death or disable participants should not be conducted
(Source: http://en.wikipedia.org/wiki/Nuremberg_Code)
The Declaration of Helsinki (1964):
http://www.cirp.org/library/ethics/helsinki/
The Declaration of Helsinki built on the principles developed in the Nuremburg Code, especially the requirement of informed consent. This document set the stage for institution of the IRB approval system.
The Belmont Report (1979):
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
Reactions to the Public Health Service Syphilis Study culminated in the Belmont Report, written by a panel of ethicists appointed by the US Congress. It catalyzed a number of legal protections governing human subject research in the United States and elsewhere. It introduced three key principles that are to govern all human subject research, namely respect for persons, beneficence, and justice.
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