The CITI Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices

Question 1

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating…

Answer 1

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

Question 2

What was the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research supposed to do?

Answer 2

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 3

Four considerations for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research?

Answer 3

(i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
(ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
(iii) appropriate guidelines for the selection of human subjects for participation in such research and
(iv) the nature and definition of informed consent in various research settings.

Question 4

The Belmont Report attempts to…?

Answer 4

Summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the course of its deliberations.

Question 5

The Belmont Report is…

Answer 5

a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.

Question 6

The Nuremberg code developed as…

Answer 6

a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners.

Question 7

The Nuremberg code’s purpose was…

Answer 7

to assure that research involving human subjects would be carried out in an ethical manner.

Question 8

The term “practice” refers to?

Answer 8

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 9

The term “research’ refers to?

Answer 9

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).

Question 10

Research and practice may be carried on together when

Answer 10

research is designed to evaluate the safety and efficacy of a therapy

Question 11

the general rule is that if there is any element of research in an activity,

Answer 11

that activity should undergo review for the protection of human subjects.

Question 12

Three basic ethical principles?

Answer 12

1) Respect of persons
2) Beneficence
3) Justice

Question 13

The expression “basic ethical principles” refers to

Answer 13

general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions.

Question 14

Respect for persons incorporates at least two ethical convictions:

Answer 14

1) that individuals should be treated as autonomous agents

2) that persons with diminished autonomy are entitled to protection.

Question 15

The principle of respect for persons divides into two separate moral requirements:

Answer 15

1) the requirement to acknowledge autonomy

2) the requirement to protect those with diminished autonomy.

Question 16

An autonomous person is

Answer 16

an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.

Question 17

The extent of protection afforded should depend upon…

Answer 17

the risk of harm and the likelihood of benefit.

Question 18

The judgment that any individual lacks autonomy should be…

Answer 18

periodically reevaluated and will vary in different situations.

Question 19

In most cases of research involving human subjects, respect for persons demands that…

Answer 19

subjects enter into the research voluntarily and with adequate information.

Question 20

Why could prisoners be considered protected?

Answer 20

They may have diminished autonomy because under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer.

Question 21

Beneficence is

Answer 21

The obligation to do no harm, maximize possible benefits and minimize possible harms.

Question 22

Avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Therefore it is imperative to decided…

Answer 22

When it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

Question 23

An injustice occurs when…

Answer 23

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

Question 24

The 5 widely accepted formulations of just ways to distribute burdens and benefits.

Answer 24

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 25

Justice refers to

Answer 25

the sense of “fairness in distribution” or “what is deserved.”

Question 26

he selection of research subjects needs to be scrutinized in order to determine?

Answer 26

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 27

Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands…

Answer 27

that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

Question 28

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

Answer 28

1) Informed consent
2) Risk/benefit assessment
3) The selection of subjects of research

Question 29

the consent process can be analyzed as containing three elements:

Answer 29

1) information
2) comprehension
3) voluntariness

Question 30

Specific items for disclosure intended to assure that subjects are given sufficient information.

Answer 30

1) the research procedure
2) their purposes
3) risk 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 31

standard of “the reasonable volunteer”…

Answer 31

the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

Question 32

In all cases of research involving incomplete disclosure, such research is justified only if it is clear that

Answer 32

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 33

Undue influence occurs through…

Answer 33

an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.

Question 34

Coercion occurs when…

Answer 34

an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.

Question 35

undue influence would include actions such as:

Answer 35

1) manipulating a person’s choice through the controlling influence of a close relative
2) threatening to withdraw health services to which an individual would otherwise be entitled.

Question 36

Assessment of Risks and Benefits

Answer 36

For the investigator, it is a means to examine whether the proposed research is properly designed.
For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified.
For prospective subjects, the assessment will assist the determination whether or not to participate.

Question 37

risk/benefit assessments are concerned with

Answer 37

the probabilities and magnitudes of possible harm and anticipated benefits.

Question 38

most likely types of harms to research subjects are

Answer 38

psychological or physical pain or injury

Question 39

assessment of the justifiability of research should reflect at least the following considerations:

Answer 39

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 40

Justice is relevant to the selection of subjects of research at two levels:

Answer 40

the social and the individual

Question 41

Individual justice in the selection of subjects would require that researchers exhibit fairness: thus,…

Answer 41

they should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risky research.

Question 42

Social justice requires that…

Answer 42

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 43

An order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions is a matter of?

Answer 43

Social Justice

Question 44

When research is proposed that involves risks and does not include a therapeutic component,…

Answer 44

less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved