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ACRP-CP Exam Questions and Correct Answers the Latest Update and Recommended Version

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Belmont Report (1979) ethical principles and guidelines for the protection of human subjects of research. respect for persons individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person A person capable of deliber...

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  • October 23, 2024
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ACRP-CP Exam Questions and Correct
Answers the Latest Update and
Recommended Version
Belmont Report (1979)

✓ ethical principles and guidelines for the protection of human subjects of research.


respect for persons

✓ individuals should be treated as autonomous agents and persons with diminished
autonomy are entitled to protection


An autonomous person

✓ A person capable of deliberation about personal goals and of acting under the direction
of such deliberation


Beneficence

✓ Do not harm and maximize possible benefits and minimize possible harms


Justice

✓ 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
contributions 5) to each person according to merit


Justice

✓ · The selection of research subjects needs to be scrutinized 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.


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Justice

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


Three elements of the consent process

✓ information, comprehension, voluntariness


What is an example of how the principle of beneficence can be applied to a study employing

human subjects

✓ Determining the study has a maximization of benefits and a minimization of risks


What are the three principles discussed in the Belmont Report?

✓ Respect for persons, beneficence, justice


The Belmont Report's principle of respect for persons incorporates at least 2 ethical

convictions: first, that individuals should be treated as autonomous agents, and second, that:

✓ Persons with diminished autonomy are entitled to protection


Nuremberg Code (1947)

✓ 1) a requirements for voluntary consent 2) the research must have scientific merit 3) The
benefits of the research must outweigh the risks 4) Subjects have the ability to terminate
participation in the research at any time


National Research Act (1974)




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✓ 1) Authorized the creation of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, which was charged with developing an
ethical code and guidelines for researchers 2) Required the establishment of IRBs at
organizations receiving PHS support for human subject's research


The National Commission (1975-1978

✓ Issued a series of reports on vulnerable populations (such as fetuses, children, prisoners,
and the "mentally infirm") psychosurgery, IRBs, and other topics that included
recommendations for regulating human subjects' research. These recommendations had
significant influence on the development of the federal regulations governing human
subject research.


45 CFR 46

✓ Also known as the Common Rule, this legislation established the role of institutional review
boards (IRBs) for research on human rights.


Additional protection for these individuals in research

✓ 1) pregnant women, human fetuses, and neonates 2) children 3) prisoners


21 CFR 50

✓ Informed Consent


21 CFR 56

✓ IRB


21 CFR 812

✓ Investigational Medical Devices


21 CFR 312

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✓ Investigational Drugs and Biologics


Declaration of Helsinki (1964)

✓ Recommendations guiding medical doctors in biomedical research involving human
subjects


WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Health-

related Research with Human Participants"

✓ Documents designed to serve as international guidelines for the review and conduct of
research involving human subjects


ICH E6

✓ Guideline for Good Clinical Practice


The use of prisoners in research is a concern under the Belmont principle for Justice because:

✓ Prisoners may not be used to conduct research that only benefits the larger society


What was the result of the Beecher article?

✓ Realization that ethical abuses are not limited to the Nazi regime


Issued in 1974, 45 CFR 46 raised to regulatory status:

✓ US Public Health Service Policy


What is included in the Nuremberg Code?

✓ Informed consent



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