ACRP CP Exam Verified Exam Questions and Answers Latest update
2026/2027
Question:
Belmont Report (1979)
Answer:
ethical principles and guidelines for the protection of human subjects of research.
Question:
respect for persons
Answer:
individuals should be treated as autonomous agents and persons with diminished autonomy are
entitled to protection
Question:
An autonomous person
Answer:
A person capable of deliberation about personal goals and of acting under the direction of such
deliberation
Question:
Beneficence
Answer:
Do not harm and maximize possible benefits and minimize possible harms
Question:
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
Question:
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.
,Question:
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.
Question:
Three elements of the consent process
Answer:
information, comprehension, voluntariness
Question:
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
Question:
What are the three principles discussed in the Belmont Report?
Answer:
Respect for persons, beneficence, justice
Question:
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
Question:
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
,Question:
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
Question:
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.
Question:
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.
Question:
Additional protection for these individuals in research
Answer:
1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
Question:
21 CFR 50
Answer:
Informed Consent
Question:
21 CFR 56
Answer:
IRB
, Question:
21 CFR 812
Answer:
Investigational Medical Devices
Question:
21 CFR 312
Answer:
Investigational Drugs and Biologics
Question:
Declaration of Helsinki (1964)
Answer:
Recommendations guiding medical doctors in biomedical research involving human subjects
Question:
WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Healthrelated
Research with Human Participants"
Answer:
Documents designed to serve as international guidelines for the review and conduct of research
involving human subjects
Question:
ICH E6
Answer:
Guideline for Good Clinical Practice
Question:
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
Question:
What was the result of the Beecher article?
Answer:
Realization that ethical abuses are not limited to the Nazi regime
2026/2027
Question:
Belmont Report (1979)
Answer:
ethical principles and guidelines for the protection of human subjects of research.
Question:
respect for persons
Answer:
individuals should be treated as autonomous agents and persons with diminished autonomy are
entitled to protection
Question:
An autonomous person
Answer:
A person capable of deliberation about personal goals and of acting under the direction of such
deliberation
Question:
Beneficence
Answer:
Do not harm and maximize possible benefits and minimize possible harms
Question:
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
Question:
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.
,Question:
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.
Question:
Three elements of the consent process
Answer:
information, comprehension, voluntariness
Question:
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
Question:
What are the three principles discussed in the Belmont Report?
Answer:
Respect for persons, beneficence, justice
Question:
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
Question:
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
,Question:
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
Question:
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.
Question:
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.
Question:
Additional protection for these individuals in research
Answer:
1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
Question:
21 CFR 50
Answer:
Informed Consent
Question:
21 CFR 56
Answer:
IRB
, Question:
21 CFR 812
Answer:
Investigational Medical Devices
Question:
21 CFR 312
Answer:
Investigational Drugs and Biologics
Question:
Declaration of Helsinki (1964)
Answer:
Recommendations guiding medical doctors in biomedical research involving human subjects
Question:
WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of Healthrelated
Research with Human Participants"
Answer:
Documents designed to serve as international guidelines for the review and conduct of research
involving human subjects
Question:
ICH E6
Answer:
Guideline for Good Clinical Practice
Question:
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
Question:
What was the result of the Beecher article?
Answer:
Realization that ethical abuses are not limited to the Nazi regime
