ACRP CP EXAM NEWEST 2024 ACTUAL
QUESTIONS AND CORRECT VERIFIED
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Belmont Report (1979) - ANSWER-ethical principles and guidelines
for the protection of human subjects of research.
respect for persons - ANSWER-individuals should be treated as
autonomous agents and persons with diminished autonomy are
entitled to protection
An autonomous person - ANSWER-A person capable of deliberation
about personal goals and of acting under the direction of such
deliberation
Beneficence - ANSWER-Do not harm and maximize possible benefits
and minimize possible harms
Justice - ANSWER-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 - ANSWER-· 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.
Justice - ANSWER-· 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 - ANSWER-information,
comprehension, voluntariness
What is an example of how the principle of beneficence can be
applied to a study employing human subjects - ANSWER-Determining
the study has a maximization of benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? -
ANSWER-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: - ANSWER-Persons with
diminished autonomy are entitled to protection
Nuremberg Code (1947) - ANSWER-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) - ANSWER-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 - ANSWER-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 - ANSWER-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 - ANSWER-1)
pregnant women, human fetuses, and neonates 2) children 3)
prisoners
21 CFR 50 - ANSWER-Informed Consent
21 CFR 56 - ANSWER-IRB
21 CFR 812 - ANSWER-Investigational Medical Devices
21 CFR 312 - ANSWER-Investigational Drugs and Biologics
Declaration of Helsinki (1964) - ANSWER-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" -
ANSWER-Documents designed to serve as international guidelines for
the review and conduct of research involving human subjects
ICH E6 - ANSWER-Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont
principle for Justice because: - ANSWER-Prisoners may not be used to
conduct research that only benefits the larger society
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