The Belmont Report
The Belmont Report
Following the public outrage over the Syphilis Study at Tuskegee, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. The National Commission was charged with: • Identifying the ethical principles to guide all research involving human subjects • Developing guidelines for the conduct of ethical research involving human subjects
The Belmont Report identified three principles essential to the ethical conduct of research with humans: • Respect for persons • Beneficence • Justice
The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to additional protections
The challenges in applying the Belmont principle of respect for persons are in: • Making sure that potential participants comprehend the risks and potential benefits of participating in research • Avoiding influencing potential participants’ decisions either through explicit or implied threats (coercion) or through excessive compensation (undue influence)
Two general rules have been articulated as complementary expressions of beneficent actions: • Do no harm • Maximize possible benefits and minimize possible harms
The challenge inherent in applying the Belmont principle of beneficence is how to determine when potential benefits outweigh considerations of risks and vice versa.
Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.
The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the
Following the public outrage over the Syphilis Study at Tuskegee, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. The National Commission was charged with: • Identifying the ethical principles to guide all research involving human subjects • Developing guidelines for the conduct of ethical research involving human subjects
The Belmont Report identified three principles essential to the ethical conduct of research with humans: • Respect for persons • Beneficence • Justice
The principle of respect for persons can be broken down into two basic ideas:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to additional protections
The challenges in applying the Belmont principle of respect for persons are in: • Making sure that potential participants comprehend the risks and potential benefits of participating in research • Avoiding influencing potential participants’ decisions either through explicit or implied threats (coercion) or through excessive compensation (undue influence)
Two general rules have been articulated as complementary expressions of beneficent actions: • Do no harm • Maximize possible benefits and minimize possible harms
The challenge inherent in applying the Belmont principle of beneficence is how to determine when potential benefits outweigh considerations of risks and vice versa.
Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research.
The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the