ACRP CP Exam UPDATED ACTUAL
Questions and CORRECT Answers
Belmont Report (1979) - CORRECT ANSWERS ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - CORRECT ANSWERS individuals should be treated as autonomous
agents and persons with diminished autonomy are entitled to protection
An autonomous person - CORRECT ANSWERS A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - CORRECT ANSWERS Do not harm and maximize possible benefits and
minimize possible harms
Justice - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWERS information,
comprehension, voluntariness
,What is an example of how the principle of beneficence can be applied to a study employing
human subjects - CORRECT ANSWERS Determining the study has a maximization of
benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - CORRECT
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: - CORRECT
ANSWERS Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - CORRECT 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) - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWERS 1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
,21 CFR 50 - CORRECT ANSWERS Informed Consent
21 CFR 56 - CORRECT ANSWERS IRB
21 CFR 812 - CORRECT ANSWERS Investigational Medical Devices
21 CFR 312 - CORRECT ANSWERS Investigational Drugs and Biologics
Declaration of Helsinki (1964) - CORRECT 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" - CORRECT ANSWERS Documents designed
to serve as international guidelines for the review and conduct of research involving human
subjects
ICH E6 - CORRECT ANSWERS Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because: -
CORRECT ANSWERS Prisoners may not be used to conduct research that only benefits
the larger society
What was the result of the Beecher article? - CORRECT ANSWERS Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWERS US Public
Health Service Policy
What is included in the Nuremberg Code? - CORRECT ANSWERS Informed consent
, Informed consent is considered an application of which Belmont principle? - CORRECT
ANSWERS Respect for persons
IRB (Institutional Review Board) - CORRECT ANSWERS A review committee
established to help protect the rights and welfare of human research subjects
Regulations require: - CORRECT ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 1) Application for initial review
2) Application for continuing review: IRB must re-review greater than minimal risk not less than
once per year
3) Amendments or modifications
Questions and CORRECT Answers
Belmont Report (1979) - CORRECT ANSWERS ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - CORRECT ANSWERS individuals should be treated as autonomous
agents and persons with diminished autonomy are entitled to protection
An autonomous person - CORRECT ANSWERS A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - CORRECT ANSWERS Do not harm and maximize possible benefits and
minimize possible harms
Justice - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWERS information,
comprehension, voluntariness
,What is an example of how the principle of beneficence can be applied to a study employing
human subjects - CORRECT ANSWERS Determining the study has a maximization of
benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - CORRECT
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: - CORRECT
ANSWERS Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - CORRECT 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) - CORRECT 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 - CORRECT 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 - CORRECT 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 - CORRECT ANSWERS 1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
,21 CFR 50 - CORRECT ANSWERS Informed Consent
21 CFR 56 - CORRECT ANSWERS IRB
21 CFR 812 - CORRECT ANSWERS Investigational Medical Devices
21 CFR 312 - CORRECT ANSWERS Investigational Drugs and Biologics
Declaration of Helsinki (1964) - CORRECT 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" - CORRECT ANSWERS Documents designed
to serve as international guidelines for the review and conduct of research involving human
subjects
ICH E6 - CORRECT ANSWERS Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because: -
CORRECT ANSWERS Prisoners may not be used to conduct research that only benefits
the larger society
What was the result of the Beecher article? - CORRECT ANSWERS Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWERS US Public
Health Service Policy
What is included in the Nuremberg Code? - CORRECT ANSWERS Informed consent
, Informed consent is considered an application of which Belmont principle? - CORRECT
ANSWERS Respect for persons
IRB (Institutional Review Board) - CORRECT ANSWERS A review committee
established to help protect the rights and welfare of human research subjects
Regulations require: - CORRECT ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 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 ANSWERS 1) Application for initial review
2) Application for continuing review: IRB must re-review greater than minimal risk not less than
once per year
3) Amendments or modifications
