The Belmont Report

Question 1

Beneficence defined by the Belmont Report is the idea of:

a) do no harm
b) maximizing possible benefits while minimizing possible harms
c) distributing burdens and benefits
d) all of the above
e) a and b only

Answer 1

e) a and b only

Question 2

Justice, defined by the Belmont Report, attempts to answer the question:

a) who can provide consent to participate in research?
b) who should receive the benefits of research and bear its burden?
c) who can be approached to consent for research studies?
d) what agency(ies) govern research practices?
e) what type of research projects can prisoners participate in?

Answer 2

b) who should receive the benefits of research and bear its burden?

Question 3

_________ has a reasonable expectation of success. While ________ is a means to test a hypothesis, draw conclusions or contribute to generalizable knowledge.

Answer 3

1st blank: practice

2nd blank: research

Question 4

The 2 main elements of “Respect for Persons” are individuals should be treated as autonomous agents and individuals with diminished autonomy (vulnerable populations) are entitled to added protection.

true
false

Answer 4

true

Question 5

Voluntary consent of the human subject is absolutely voluntary.

true
false

Answer 5

true

Question 6

The experiment should be conducted as to:

a) avoid unnecessary physical injury
b) avoid unnecessary mental suffering
c) avoid animal experimentation
d) a and b

Answer 6

d) a and b

Question 7

It is the duty of the physician to promote and safeguard the health of patients, including those involved in medical research.

true
false

Answer 7

true

Question 8

The design and performance of each research study involving human subjects must be described in a research protocol that should include:

a) information regarding funding
b) information about the use of animals
c) information about potential conflicts of interest
d) a and c

Answer 8

d) a and c

Question 9

The basic ethical principles are:

a) respect for persons and informed consent
b) selection of subjects and informed consent
c) respect for persons, beneficence, justice
d) informed consent, assessment of risk and benefits, and selection of subjects

Answer 9

c) respect for persons, beneficence, justice

Question 10

The Basic Ethical Principles laid out in the Belmont Report are:

a) integrity, equity, respect for persons
b) justice, integrity, courtesy
c) equity, dignity, justice
d) respect for persons, beneficence, justice

Answer 10

d) respect for persons, beneficence, justice

Question 11

The Belmont Report was created in:

a) 1947
b) 1964
c) 1971
d) 1979
e) 1991

Answer 11

d) 1979

Question 12

A key concept of The Belmont Report is the special consideration for and protection of potentially vulnerable subject populations - children, prisoners, certain racial minorities, those with diminished autonomy, etc.

true
false

Answer 12

true

Question 13

The 3 elements of informed consent listed in The Belmont Report are:

a) treatment plan, contact information, participation costs
b) information, comprehension, voluntariness
c) beneficence, respect, justice

Answer 13

b) information, comprehension, voluntariness

Question 14

According to The Belmont Report, respect for persons typically demands that subjects:

a) share in the benefits of the research
b) gain maximum benefit from research
c) waive any rights or benefits from research
d) enter into research voluntarily with adequate information

Answer 14

d) enter into research voluntarily with adequate information

Question 15

The Belmont Report was created at/by:

a) Food and Drug Administration
b) International Conference on Harmonisation
c) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
d) Trials of War Criminals
e) World Medical Association

Answer 15

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

Question 16

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

true
false

Answer 16

true

Question 17

The Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare.

true
false

Answer 17

true

Question 18

The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

true
false

Answer 18

true

Question 19

Applications of the general principles to the conduct of research leads to consideration of the following requirements: (n=3)

Answer 19

1) informed consent
2) assessment of risks and benefits
3) selection of subjects

Part C: Applications (pg. 5)

Question 20

The Principle of Justice in the Belmont Report:

a) mandates that research participants be protected from harm
b) divides responsibility between research participants and researchers
c) states that research must be based on accepted laws
d) states that research participants must be treated as autonomous individuals

Answer 20

d) states that research participants must be treated as autonomous individuals

Question 21

Ethical rules flowing from the Beneficence Principle in the Belmont Report include:

a) to use research methods with the lowest risk possible
b) to maintain participant confidentiality
c) to avoid exploiting vulnerable populations
d) All of the above
e) Both a and b

Answer 21

d) All of the above

Question 22

Which of the following is true concerning the IRB?

a) A researcher is not required to submit a proposal to an IRB in most institutions
b) Obtaining IRB approval protects the researcher from legal liability
c) IRB approval represents only a suggestion on how to treat participants and is not binding on the researcher
d) Researchers can ignore the IRB because merely submitting a proposal protects the researcher from legal liability

Answer 22

c) IRB approval represents only a suggestion on how to treat participants and is not binding on the researcher

Question 23

In 1979, the National Commission published the Belmont Report, which is the cornerstone statement of ethical principles upon with the federal regulations for the protection of human subjects are based.

true
false

Answer 23

true

Protecting Study Volunteers in Research
p. 23

Question 24

The federal relations were directly derived from the ethical principles in the Belmont Report.

true
false

Answer 24

true

Protecting Study Volunteers in Research
p. 36