ACRP-CP EXAM 2025 QUESTIONS AND
ANSWERS
Belmont Report (1979) - ANS ethical principles and guidelines for the protection of human
subjects of research.
respect for persons - ANS individuals should be treated as autonomous agents and persons
with diminished autonomy are entitled to protection
An autonomous person - ANS A person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - ANS Do not harm and maximize possible benefits and minimize possible harms
Justice - ANS 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 - ANS · 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 - ANS · 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
1
from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Page
@COPYRIGHT FYNDLAY 2025/2026
, Three elements of the consent process - ANS information, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - ANS Determining the study has a maximization of benefits and a
minimization of risks
What are the three principles discussed in the Belmont Report? - ANS 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: -
ANS Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - ANS 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) - ANS 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 - ANS 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 - ANS Also known as the Common Rule, this legislation established the role of
2
institutional review boards (IRBs) for research on human rights.
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@COPYRIGHT FYNDLAY 2025/2026
, Additional protection for these individuals in research - ANS 1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ANS Informed Consent
21 CFR 56 - ANS IRB
21 CFR 812 - ANS Investigational Medical Devices
21 CFR 312 - ANS Investigational Drugs and Biologics
Declaration of Helsinki (1964) - ANS 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" - ANS Documents designed to serve as
international guidelines for the review and conduct of research involving human subjects
ICH E6 - ANS Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because: -
ANS Prisoners may not be used to conduct research that only benefits the larger society
What was the result of the Beecher article? - ANS Realization that ethical abuses are not
limited to the Nazi regime
3
Issued in 1974, 45 CFR 46 raised to regulatory status: - ANS US Public Health Service Policy
Page
@COPYRIGHT FYNDLAY 2025/2026
, What is included in the Nuremberg Code? - ANS Informed consent
Informed consent is considered an application of which Belmont principle? - ANS Respect for
persons
IRB (Institutional Review Board) - ANS A review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - ANS IRB review and approval for research involving human subjects if
it is conducted, supported, or regulated by US federal departments and agencies
Federal regulations stipulate that an IRB can: - ANS Approve research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred since
previous review, observe, suspend/terminate approval
Conveyed committee review - ANS Full committee review. Standard type of review described
in the federal regulations. Must be used for the initial review of all studies that are not eligible
for expedited review or exemption
Expedited review - ANS Can be used for established categories and minor changes in
previously approved research, and for limited IRB review of select exemption categories
Categories for expedited review: - ANS 1) The research does not involve more than minimal
risk
2) The entire research project must be consistent with one or more of the federally defined
categories (IND/IDE note required)
Types of IRB submissions - ANS 1) Application for initial review
4
Page
@COPYRIGHT FYNDLAY 2025/2026
ANSWERS
Belmont Report (1979) - ANS ethical principles and guidelines for the protection of human
subjects of research.
respect for persons - ANS individuals should be treated as autonomous agents and persons
with diminished autonomy are entitled to protection
An autonomous person - ANS A person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - ANS Do not harm and maximize possible benefits and minimize possible harms
Justice - ANS 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 - ANS · 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 - ANS · 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
1
from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Page
@COPYRIGHT FYNDLAY 2025/2026
, Three elements of the consent process - ANS information, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - ANS Determining the study has a maximization of benefits and a
minimization of risks
What are the three principles discussed in the Belmont Report? - ANS 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: -
ANS Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - ANS 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) - ANS 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 - ANS 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 - ANS Also known as the Common Rule, this legislation established the role of
2
institutional review boards (IRBs) for research on human rights.
Page
@COPYRIGHT FYNDLAY 2025/2026
, Additional protection for these individuals in research - ANS 1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ANS Informed Consent
21 CFR 56 - ANS IRB
21 CFR 812 - ANS Investigational Medical Devices
21 CFR 312 - ANS Investigational Drugs and Biologics
Declaration of Helsinki (1964) - ANS 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" - ANS Documents designed to serve as
international guidelines for the review and conduct of research involving human subjects
ICH E6 - ANS Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because: -
ANS Prisoners may not be used to conduct research that only benefits the larger society
What was the result of the Beecher article? - ANS Realization that ethical abuses are not
limited to the Nazi regime
3
Issued in 1974, 45 CFR 46 raised to regulatory status: - ANS US Public Health Service Policy
Page
@COPYRIGHT FYNDLAY 2025/2026
, What is included in the Nuremberg Code? - ANS Informed consent
Informed consent is considered an application of which Belmont principle? - ANS Respect for
persons
IRB (Institutional Review Board) - ANS A review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - ANS IRB review and approval for research involving human subjects if
it is conducted, supported, or regulated by US federal departments and agencies
Federal regulations stipulate that an IRB can: - ANS Approve research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred since
previous review, observe, suspend/terminate approval
Conveyed committee review - ANS Full committee review. Standard type of review described
in the federal regulations. Must be used for the initial review of all studies that are not eligible
for expedited review or exemption
Expedited review - ANS Can be used for established categories and minor changes in
previously approved research, and for limited IRB review of select exemption categories
Categories for expedited review: - ANS 1) The research does not involve more than minimal
risk
2) The entire research project must be consistent with one or more of the federally defined
categories (IND/IDE note required)
Types of IRB submissions - ANS 1) Application for initial review
4
Page
@COPYRIGHT FYNDLAY 2025/2026
