ACRP-CP Exam Questions with 100%
Correct Answers
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
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
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
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
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
What was the result of the Beecher article? Correct Answer: Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: Correct Answer: US Public
Health Service Policy
, What is included in the Nuremberg Code? Correct Answer: Informed consent
Informed consent is considered an application of which Belmont principle?
Correct Answer: Respect for persons
IRB (Institutional Review Board) Correct Answer: A review committee established
to help protect the rights and welfare of human research subjects
Regulations require: Correct Answer: 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: Correct Answer: Approve
research, require modifications, disapprove research, conduct continuing
reviews, verify no material changes occurred since previous review, observe,
suspend/terminate approval
Conveyed committee review Correct Answer: 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 Correct Answer: 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: Correct Answer: 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 Correct Answer: 1) Application for initial review
Correct Answers
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
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
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
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
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
What was the result of the Beecher article? Correct Answer: Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: Correct Answer: US Public
Health Service Policy
, What is included in the Nuremberg Code? Correct Answer: Informed consent
Informed consent is considered an application of which Belmont principle?
Correct Answer: Respect for persons
IRB (Institutional Review Board) Correct Answer: A review committee established
to help protect the rights and welfare of human research subjects
Regulations require: Correct Answer: 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: Correct Answer: Approve
research, require modifications, disapprove research, conduct continuing
reviews, verify no material changes occurred since previous review, observe,
suspend/terminate approval
Conveyed committee review Correct Answer: 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 Correct Answer: 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: Correct Answer: 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 Correct Answer: 1) Application for initial review
