Belmont Report

Question 1

What was the charge of the commission?

Answer 1

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 2

What does “practice” refer to?

Answer 2

Interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success

Question 3

What does “research” refer to?

Answer 3

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

Question 4

How is “experimental” and “research” different?

Answer 4

Experimental refers to new, untested or different

Question 5

What are the three basic ethical principles?

Answer 5

1. Respect for Persons
2. Beneficence
3. Justice

Question 6

What are the 2 basic convictions related to respect of persons?

Answer 6

1. That individuals should be treated as autonomous agents

2. That persons with diminished autonomy are entitled to protection

Question 7

What are 3 examples to show lack of respect (for autonomy)?

Answer 7

1. To repudiate that person’s considered judgments
2. To deny an individual the freedom to act on those considered judgments
3. To withhold information necessary to make a considered judgment, when there are no compelling reasons to do so

Question 8

what are the 2 general rules of beneficence?

Answer 8

1. Do not harm

2. Maximize possible benefits and minimize possible harms

Question 9

What is the principle of justice?

Answer 9

Who ought to receive the benefits of research and bear its burdens?

Question 10

What are 5 formulations of the principle of justice?

Answer 10

1. To each person an equal share
2. To each person according to individual need
3. To each person according to individual effort
4. To each person according to societal contribution
5. To each person according to merit

Question 11

Why does the selection of research subjects need to be scrutinized?

Answer 11

In order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied

Question 12

What are the information requirements for informed consent?

Answer 12

1. The research procedure
2. Their purpose
3. Risks and anticipated benefits
4. Alternative procedures (where therapy is involved)
5. A statement offering the subject the opportunity to ask questions and to withdraw at any time from the research

Question 13

What is the question that remains regarding informed consent?

Answer 13

What the standard should be for judging how much and what sort of information should be provided

Question 14

What are the 3 criteria to be met when incomplete disclosure is used?

Answer 14

1. Incomplete disclosure is truly necessary to accomplish the goals of the research
2. There are no undisclosed risks to subjects that are more than minimal
3. There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them

Question 15

How does comprehension impact informed consent?

Answer 15

The manner and context in which information is conveyed is as important as the information itself

Question 16

What are conditions in which it is necessary to adapt presentation for informed consent?

Answer 16

Intelligence, rationality, maturity and language

Question 17

What are the criteria used to select third parties for informed consent?

Answer 17

The third parties chosen should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest

Question 18

What is Voluntariness?

Answer 18

An agreement to participate in research constitutes a valid consent only if voluntarily given

Question 19

What are the two components of Voluntary consent?

Answer 19

1. Free of coercion

2. Free of undue influence

Question 20

What is meant by the nature and scope of risks and benefits?

Answer 20

The requirement that research be justified on the basis of a favorable risk/benefit assessment

Question 21

What is meant by “risk”?

Answer 21

A possibility that harm may occur

Question 22

What is meant by “benefit”?

Answer 22

Something of positive value related to health or welfare

Question 23

What types of harm should be considered?

Answer 23

1. Psychological
2. Physical
3. Legal
4. Social
5. Economic

Question 24

How does the principle of beneficence apply to risk of harm?

Answer 24

Beneficence requires that we protect against risk of harm to subjects and also tat we be concerned about the loss of the substantial benefits that might be gained from research

Question 25

What is meant by the systematic assessment of risks and benefits?

Answer 25

This ideal requires those making decisions about teh justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically.
Benefits and risks must be “balanced” and shown to be “in a favorable ratio”

Question 26

What are the five considerations for the justifiability of research?

Answer 26

1. Brutal or inhumane treatment of human subjects is never morally justified
2. Risks should be reduced to those necessary to achieve the research objective
3. When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk
4. When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated
5. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process

Question 27

How does the principle of justice impact the selection of subjects?

Answer 27

It gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects

Question 28

What sources of injustice are there?

Answer 28

1. Social
2. Racial
3. Sexual
4. Cultural

Question 29

What is the definition of vulnerable subjects?

Answer 29

Subjects that are dependent or have frequently compromised capacity for free consent
Such as racial minorities, economically disadvantaged, the very sick and the institutionalized