Guiding Principles

Question 1

the 1974 National Research Act created

Answer 1

the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Question 2

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was directed to consider these basic ethical principles

Answer 2

1) the boundaries between biomedical and behavioral research & the accepted & routine practice of medicine
2) role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
3) appropriate guidelines for the selection of human subjects for participation in such research
4) the nature & definition of informed consent in various research settings

Question 3

Belmont Report (1978)

Answer 3

summarizes ethical principles for human subject research

Question 4

3 Core Principles of Belmont Report

Answer 4

1) Respect for persons
2) Beneficence
3) Justice

Question 5

Nuremberg Code

Answer 5

a set of ethical principles for human experimentation

Question 6

10 point of Nuremberg Code

Answer 6

1) voluntary consent
2) experiment should yield fruitful results for the good of society
3) based on animal studies (anticipated results justify the experiment)
4) avoid unnecessary physical and mental suffering
5) no experiments where death or disability is anticipated
6) risk should be in line with humanitarian importance
7) proper preparations and adequate facilities
8) conducted by qualified people
9) subject can end the experiment
10) scientist should be prepared to end the experiment

Question 7

Declaration of Helsinki

Answer 7

a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA)

Question 8

US country-specific guidelines for informed consent

Answer 8

21 CFR 50.35 (FDA) 45 CF 46 (Common Rule HHS)