ACRP CP EXAM (2025) QUESTIONS AND (DETAILED
ANSWERS) WITH COMPLETE SOLUTIONS.
Belmont Report (1979) - ...(ANSWERS)....ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - ...(ANSWERS)....individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to
protection
An autonomous person - ...(ANSWERS)....A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - ...(ANSWERS)....Do not harm and maximize possible benefits and
minimize possible harms
Justice - ...(ANSWERS)....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 - ...(ANSWERS)....· 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 - ...(ANSWERS)....· 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 - ...(ANSWERS)....information,
comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - ...(ANSWERS)....Determining the study has a
maximization of benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? -
...(ANSWERS)....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: - ...(ANSWERS)....Persons with diminished autonomy
are entitled to protection
Nuremberg Code (1947) - ...(ANSWERS)....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) - ...(ANSWERS)....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 - ...(ANSWERS)....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 - ...(ANSWERS)....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 - ...(ANSWERS)....1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ...(ANSWERS)....Informed Consent
21 CFR 56 - ...(ANSWERS)....IRB
21 CFR 812 - ...(ANSWERS)....Investigational Medical Devices
, 21 CFR 312 - ...(ANSWERS)....Investigational Drugs and Biologics
Declaration of Helsinki (1964) - ...(ANSWERS)....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" - ...(ANSWERS)....Documents
designed to serve as international guidelines for the review and conduct of
research involving human subjects
ICH E6 - ...(ANSWERS)....Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for
Justice because: - ...(ANSWERS)....Prisoners may not be used to conduct research
that only benefits the larger society
What was the result of the Beecher article? - ...(ANSWERS)....Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - ...(ANSWERS)....US Public
Health Service Policy
What is included in the Nuremberg Code? - ...(ANSWERS)....Informed consent
ANSWERS) WITH COMPLETE SOLUTIONS.
Belmont Report (1979) - ...(ANSWERS)....ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - ...(ANSWERS)....individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to
protection
An autonomous person - ...(ANSWERS)....A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - ...(ANSWERS)....Do not harm and maximize possible benefits and
minimize possible harms
Justice - ...(ANSWERS)....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 - ...(ANSWERS)....· 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 - ...(ANSWERS)....· 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 - ...(ANSWERS)....information,
comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - ...(ANSWERS)....Determining the study has a
maximization of benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? -
...(ANSWERS)....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: - ...(ANSWERS)....Persons with diminished autonomy
are entitled to protection
Nuremberg Code (1947) - ...(ANSWERS)....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) - ...(ANSWERS)....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 - ...(ANSWERS)....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 - ...(ANSWERS)....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 - ...(ANSWERS)....1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ...(ANSWERS)....Informed Consent
21 CFR 56 - ...(ANSWERS)....IRB
21 CFR 812 - ...(ANSWERS)....Investigational Medical Devices
, 21 CFR 312 - ...(ANSWERS)....Investigational Drugs and Biologics
Declaration of Helsinki (1964) - ...(ANSWERS)....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" - ...(ANSWERS)....Documents
designed to serve as international guidelines for the review and conduct of
research involving human subjects
ICH E6 - ...(ANSWERS)....Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for
Justice because: - ...(ANSWERS)....Prisoners may not be used to conduct research
that only benefits the larger society
What was the result of the Beecher article? - ...(ANSWERS)....Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - ...(ANSWERS)....US Public
Health Service Policy
What is included in the Nuremberg Code? - ...(ANSWERS)....Informed consent
