Test 4 The Simon Belmont Report

Question 1

What was the charge of the commission?

Answer 1

One of the charges to the Commission was 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

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

The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research.

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

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

Question 7

What are 3 examples to show lack of respect?

Answer 7

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 8

What are the 2 general rules of beneficence?

Answer 8

(1) do not harm and (2) maximize possible benefits and minimize possible harms.

Question 9

What is the principle of justice?

Answer 9

equals ought to be treated equally

“fairness in distribution” or “what is deserved.”

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, and (5) to each person according to merit.x

Question 11

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

Answer 11

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, 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

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.x

Question 13

What is the question that remains regarding informed consent?

Answer 13

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

x(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, and (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 in formed consent?

Answer 15

limiting an participants ability to comprehend limits a subject’s ability to make an informed choice.

Question 16

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

Answer 16

Special provision may need to be made when comprehension is severely limited – for example, by conditions of immaturity or mental disability.

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

the degree to which an action is voluntary

Question 19

What are the two components of Voluntary consent?

Answer 19

freedom from coercion and undue influence.

Question 20

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

Answer 20

kind and size

Question 21

What is meant by “risk”?

Answer 21

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

psychological harm, physical harm, legal harm, social harm and economic harm

Question 24

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

Answer 24

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 25

What is meant by the systematic assessment of

risks and benefits?

Answer 25

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

(i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. (v) 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

Individual justice in the selection of subjects would require that researchers exhibit fairness. Social justice requires that distinction be drawn between classes of subjects that ought, and 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.

Question 28

What sources of injustice are there?

Answer 28

social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research.

Question 29

What is the definition of vulnerable subjects?

Answer 29

racial minorities, the economically disadvantaged, the very sick, and the institutionalized