The Belmont Report Flashcards
Which act was signed in to law in 1974
The National Research Act
The National Research Act created _____
the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The national commission then created the Belmont report
What is the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research charged with?
To identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
What is the purpose of the Belmont Report?
to provide ethical principles, boundaries between practice and research
What are the three basic ethical principles?
1) Respect for persons
2) Beneficence
3) Justice
What are the three applications of the Belmont Report?
1) Informed Consent
2) Assessment of Risk and Benefits
3) Selection of Subjects
What is the purpose of medical or behavioral practice?
To provide diagnosis, preventive treatment or therapy to particular individuals.
What does research designate?
It designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.
What two ethical convictions does Respect for Persons incorporate?
1) Individuals should be treated as autonomous agents and
2) persons with diminished autonomy are entitled to protection.
What does it mean to provide beneficence?
It means that we must treat persons in an ethical manner not only be respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
What two general rules have been formulated as complementary expressions of beneficent actions?
1) do not harm and 2) maximize possible benefits and minimize possible harm.
When does an injustice occur?
When some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.
Applications of the general principles from the Belmont report to the conduct of research leads to consideration of the following requirements:
1) Informed consent,
2) risk/benefit assessment, and
3) selection of subjects of research
Informed Consent
Respect for persons requires that subjects, to the degree that they are eligible, be given the opportunity to choose what shall or shall not happen to them.
Respect for person during informed consent is provided when adequate standards for informed consent are satisfied. What are the three standards of informed consent?
1) Information, 2) Comprehension, and 3) Voluntariness.
