Belmont report Flashcards
when was the national research act signed into law?
1974
what did the national research act create?
national commission for the protection of human subjects of biomedical and behavioral research
what is the national commission charged with?
1) identify basic ethical principles that should underlie conduct of biomedical and behavioral research involving human subjects
2) to develop guidelines that will assure research is conducted in accordance with those principles
purpose of belmont report
provide ethical principles and boundaries between practice and research
3 ethical principles
1) respect for persons
2) beneficence
3) justice
3 applications of belmont
1) informed consent
2) assessment of risks and benefits
3) selection of subjects
purpose of medical or behavioral practice
provide diagnosis, preventive treatment or therapy to particular individuals
what does research designate?
an activity designed to test an hypothesis, permit conclusions to be drawn, and develop or contribute to generalizable knowledge
2 ethical convictions incorporated into Respect for Persons
1) individuals should be treated as autonomous agents
2) persons with diminished autonomy are entitled to protection
what is providing beneficience?
we must treat persons in an ethical manner, not only respecting their decisions and protecting them from harm, but making efforts to secure their well-being
2 general rules formulated as complementary expressions of beneficient actions:
1) do not harm
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 Belmont to the conduct of research leads to consideration of the following requirements (3):
1) informed consent
2) risk/benefit assessment
3) selection of subjects
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
what are 3 standards of informed consent that show respect for person?
1) information
2) comprehension
3) voluntariness