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

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Flashcards in The CITI Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices Deck (44)
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1

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

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

2

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

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

3

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

(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.

4

The Belmont Report attempts to...?

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.

5

The Belmont Report is...

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.

6

The Nuremberg code developed as...

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

7

The Nuremberg code's purpose was...

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

8

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.

9

The term "research' refers to?

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).

10

Research and practice may be carried on together when

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

11

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.

12

Three basic ethical principles?

1) Respect of persons
2) Beneficence
3) Justice

13

The expression "basic ethical principles" refers to

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

14

Respect for persons incorporates at least two ethical convictions:

1) that individuals should be treated as autonomous agents
2) that persons with diminished autonomy are entitled to protection.

15

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

1) the requirement to acknowledge autonomy
2) the requirement to protect those with diminished autonomy.

16

An autonomous person is

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

17

The extent of protection afforded should depend upon...

the risk of harm and the likelihood of benefit.

18

The judgment that any individual lacks autonomy should be...

periodically reevaluated and will vary in different situations.

19

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

subjects enter into the research voluntarily and with adequate information.

20

Why could prisoners be considered protected?

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.

21

Beneficence is

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

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...

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

23

An injustice occurs when...

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

24

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

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.

25

Justice refers to

the sense of "fairness in distribution" or "what is deserved."

26

he selection of research subjects needs to be scrutinized 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.

27

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

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.

28

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

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

29

the consent process can be analyzed as containing three elements:

1) information
2) comprehension
3) voluntariness

30

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

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