The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created as a result of the National Research Act of 1974, published the Belmont Report in 1979.
Attention to and outrage at the harm done to people during a few particularly unethical research studies prompted the commission to be formed; especially, for example:
Prior ethical research standards, particularly those listed below, also informed the Belmont Report's formulation of ethical principles and guidelines:
The Comission:
"was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles."
The Belmont Report:
"identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects."
Source: HHS.gov
- Respect for persons:
"Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy."
- Beneficence:
"Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being... Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms."
- Justice:
"Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly... There are several widely accepted formulations of just ways to distribute burdens and benefits... These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit."
Source: The Belmont Report
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Informed consent
- Information, not deception
- Comprehension
- Voluntariness & right to withdraw
- See the Planned Parenthood Tumblr page for a great definition of consent
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Assessment of risks and benefits
- The nature and scope of risks and benefits-always minimize risk of harm!
- E.g. question of anonymity
- The systematic assessment of risks and benefits
- The nature and scope of risks and benefits-always minimize risk of harm!
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Selection of subjects
- Fair recruitment and selection
Source: The Belmont Report