Belmont Report

Question 0

What does “practice” refer to?

Answer 0

The term “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventative treatment, or therapy to a particular individual.

Question 1

What was the charge of the commission?

Answer 1

Identify the basic ethical principles that should underlie the conduct of biomedical and behavioral 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 “research” refer to?

Answer 2

The term “research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

Question 3

How is “experimental” and “research” different?

Answer 3

“Experimental” refers to when the clinician departs in a significant way from standard or accepted practice. An experimental procedure may be new, untested, or different, but it does not automatically place it in the category of research. Research requires an hypothesis, permits conclusions to be drawn, and develops or contributes to generalizable knowledge.

Question 4

What are the three basic ethical principles?

Answer 4

The principles of respect of persons, beneficence, and justice.

Question 5

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

Answer 5

First, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.

Question 6

What are three examples to show lack of respect?

Answer 6

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

Question 7

What are the 2 general rules of beneficence?

Answer 7

1: do not harm
2: maximize possible benefits and minimize possible harms

Question 8

What is the principle of justice?

Answer 8

Fairness and distribution; what is deserved; equals ought to be treated equally.

Question 9

What are the 5 formulations of the principle of justice?

Answer 9

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 10

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

Answer 10

In order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, there compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Question 11

What are the information requirements for informed consent?

Answer 11

The research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

Question 12

What is the question that remains regarding informed consent?

Answer 12

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

Question 13

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

Answer 13

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 14

How does comprehension impact informed consent?

Answer 14

Presenting information in a disorganized and rapid fashion, allowing too little time for consideration, or curtailing opportunities for questioning, all may adversely affect the subject’s ability to make an informed choice. Because the subject’s ability to understand is a function of intelligence, rationality, maturity, and language, it is necessary to adapt the presentation of information to the subject’s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information.

Question 15

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

Answer 15

When comprehension is severely limited by conditions of immaturity or mental disability, for example. Any time adaptation is required for comprehension, such adaptations must be made.

Question 16

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

Answer 16

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. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject’s best interest.

Question 17

What is Voluntariness?

Answer 17

An agreement to participate in research constitutes valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.

Question 18

What are the two components of Voluntary consent?

Answer 18

The element of informed consent requires conditions free of coercion and undue influence.

Question 19

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

Answer 19

The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons.

Question 20

What is meant by “risk?”

Answer 20

A possibility that harm may occur.

Question 21

What is meant by “benefit?”

Answer 21

Something of positive value related to health or welfare.

Question 22

What types of harm should be considered?

Answer 22

Psychological harm, physical harm, legal harm, social harm, and economic harm (and the corresponding benefits)

Question 23

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

Answer 23

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

Question 24

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

Answer 24

Those making decisions about the justifiability of research must be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. There should first be a determination of the validity of the presuppositions of the research; then the nature, probability, and magnitude of risk should be distinguished with as much clarity as possible.

Question 25

What are the five considerations for justifiability of research?

Answer 25

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. (It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures.)
3: when research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject– or, in some rare cases, to the manifest voluntariness of the participation)
4: when vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. (A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits.)
5: relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process

Question 26

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

Answer 26

• Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risky research.
• Social justice requires that distinction be drawn between classes of subjects that ought, and that ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects and that some classes of potential subjects may be involved in research subjects, if at all, only on certain conditions.

Question 27

What sources of injustice are there?

Answer 27

Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus, injustice arises from social, racial, sexual, and cultural biases institutionalized in society.

Question 28

What is the definition of vulnerable subjects?

Answer 28

Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.