The Belmont Report

Question 1

Which act was signed in to law in 1974

Answer 1

The National Research Act

Question 2

The National Research Act created _____

Answer 2

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

Question 3

What is the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research charged with?

Answer 3

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.

Question 4

What is the purpose of the Belmont Report?

Answer 4

to provide ethical principles, boundaries between practice and research

Question 5

What are the three basic ethical principles?

Answer 5

1) Respect for persons,
2) Beneficience, and
3) Justice

Question 6

What are the three applications of the Belmont Report?

Answer 6

1) Informed Consent, 2) Assessment of Risk and Benefits, and 3) Selection of Subjects.

Question 7

What is the purpose of medical or behavioral practice?

Answer 7

To provide diagnosis, preventive treatment or therapy to particular individuals.

Question 8

What does research designate?

Answer 8

It designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.

Question 9

What two ethical convictions does Respect for Persons incorporate?

Answer 9

1) Individuals should be treated as autonomous agents and

2) persons with dimished autonomy are entitled to protection.

Question 10

What does it mean to provide beneficience?

Answer 10

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.

Question 11

What two general rules have been formulated as complementary expressions of beneficient actions?

Answer 11

1) do not harm and 2) maximize possible benefits and minizmie possible harm.

Question 12

When does an injustice occur?

Answer 12

When some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.

Question 13

Applications of the general principles from the belmont report to the conduct of research leads to consideration of the following requirements:

Answer 13

1) Informed consent,
2) risk/benefit assessment, and
3) selection of subjects of research

Question 14

Informed Consent

Answer 14

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.

Question 15

Respect for person during informed consent is provided when adequate standards for informed consent are satisfied. What are the three standars of informed consent?

Answer 15

1) Information, 2) Comprehension, and 3) Voluntariness.

Question 16

Since 1945, various codes for the proper and responsible conduct of human experimentation in medical
research have been adopted by different organizations. The best known of these codes are:

Answer 16

1) The Nuremberg Code of 1947,
2) The Helsinki Declaration of 1964,
3) the 1971 Guidelines issued by the US Department of Health, Education, and
4) Welfare Codes for the conduct of social and behavioral research, such as, American Psychological Assocation published in 1973.

Question 17

What does Justice Mean?

Answer 17

selection of subjects should be applicable to the population being studied. Cannot seek out come classes because of their ease of availability , compromised position, or manipulability