ACRP CP FINAL EXAM LATEST VERSION 2025 QUESTIONS
AND CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A
National Research Act (1974) - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - CORRECT ANSWER-Informed Consent
21 CFR 56 - CORRECT ANSWER-IRB
21 CFR 812 - CORRECT ANSWER-Investigational Medical Devices
21 CFR 312 - CORRECT ANSWER-Investigational Drugs and Biologics
Belmont Report (1979) - CORRECT ANSWER-ethical principles and guidelines for
the protection of human subjects of research.
respect for persons - CORRECT ANSWER-individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to
protection
An autonomous person - CORRECT ANSWER-A person capable of deliberation
about personal goals and of acting under the direction of such deliberation
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - CORRECT ANSWER-Determining the study has a
maximization of benefits and a minimization of risks
,What are the three principles discussed in the Belmont Report? - CORRECT
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: - CORRECT ANSWER-Persons with diminished
autonomy are entitled to protection
Nuremberg Code (1947) - CORRECT 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
Beneficence - CORRECT ANSWER-Do not harm and maximize possible benefits
and minimize possible harms
Justice - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-information,
comprehension, voluntariness
Declaration of Helsinki (1964) - CORRECT 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" - CORRECT ANSWER-
Documents designed to serve as international guidelines for the review and
conduct of research involving human subjects
ICH E6 - CORRECT ANSWER-Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for
Justice because: - CORRECT ANSWER-Prisoners may not be used to conduct
research that only benefits the larger society
AND CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A
National Research Act (1974) - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - CORRECT ANSWER-Informed Consent
21 CFR 56 - CORRECT ANSWER-IRB
21 CFR 812 - CORRECT ANSWER-Investigational Medical Devices
21 CFR 312 - CORRECT ANSWER-Investigational Drugs and Biologics
Belmont Report (1979) - CORRECT ANSWER-ethical principles and guidelines for
the protection of human subjects of research.
respect for persons - CORRECT ANSWER-individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to
protection
An autonomous person - CORRECT ANSWER-A person capable of deliberation
about personal goals and of acting under the direction of such deliberation
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - CORRECT ANSWER-Determining the study has a
maximization of benefits and a minimization of risks
,What are the three principles discussed in the Belmont Report? - CORRECT
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: - CORRECT ANSWER-Persons with diminished
autonomy are entitled to protection
Nuremberg Code (1947) - CORRECT 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
Beneficence - CORRECT ANSWER-Do not harm and maximize possible benefits
and minimize possible harms
Justice - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWER-information,
comprehension, voluntariness
Declaration of Helsinki (1964) - CORRECT 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" - CORRECT ANSWER-
Documents designed to serve as international guidelines for the review and
conduct of research involving human subjects
ICH E6 - CORRECT ANSWER-Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for
Justice because: - CORRECT ANSWER-Prisoners may not be used to conduct
research that only benefits the larger society
