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Belmont Report (1979) - ansethical principles and guidelines for the protection of human
subjects of research.
respect for persons - ansindividuals should be treated as autonomous agents and persons with
diminished autonomy are entitled to protection
An autonomous person - ansA person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - ansDo not harm and maximize possible benefits and minimize possible harms
Justice - ans1) 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
from groups unlikely to be among the beneficiaries of subsequent applications of the
research.
Three elements of the consent process - ansinformation, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - ansDetermining the study has a maximization of benefits and a
minimization of risks
What are the three principles discussed in the Belmont Report? - ansRespect 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: -
ansPersons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - ans1) 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) - ans1) 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 - ansIssued a series of reports on vulnerable
populations (such as fetuses, children, prisoners, and the "mentally infirm") psychosurgery,
,Are You Ready to Unlock Your Research
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A Comprehensive ACRP-CP Exam Study
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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 - ansAlso 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 - ans1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ansInformed Consent
21 CFR 56 - ansIRB
21 CFR 812 - ansInvestigational Medical Devices
21 CFR 312 - ansInvestigational Drugs and Biologics
Declaration of Helsinki (1964) - ansRecommendations 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" - ansDocuments designed to serve as international
guidelines for the review and conduct of research involving human subjects
ICH E6 - ansGuideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because:
- ansPrisoners may not be used to conduct research that only benefits the larger society
What was the result of the Beecher article? - ansRealization that ethical abuses are not limited
to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - ansUS Public Health Service Policy
What is included in the Nuremberg Code? - ansInformed consent
Informed consent is considered an application of which Belmont principle? - ansRespect for
persons
IRB (Institutional Review Board) - ansA review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - ansIRB 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: - ansApprove research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred since
previous review, observe, suspend/terminate approval
Conveyed committee review - ansFull 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 - ansCan be used for established categories and minor changes in
previously approved research, and for limited IRB review of select exemption categories
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Categories for expedited review: - ans1) 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 - ans1) 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
4) Reports of unanticipated problems
US Department of Health and Human Services - ansResponsible for 45 CFR 46
National Institutes of Health (NIH) - ansIncludes funding agencies that provide federal
funding for biomedical research
U.S. Food and Drug Administration (FDA) - ansOversees the use of all drugs, devices,
biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - ansoffers GP guidelines
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery
of the adverse event occurrence? - ansReport the adverse drug experience in a timely manner,
in keeping with the IRB's policies and procedures, using the forms or the mechanism
provided by the IRB
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? - ansA minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - ansThe study involves no more
than minimal risk and meets one of the allowable categories of expedited review specified in
federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval
if: - ansThe changes must be immediately implemented for the health and well-being of the
subjects
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - ansoccur at least annually
Informed consent - ansThe process that begins with the recruitment and screening of a subject
and the signing of the consent document and continues throughout the subject's involvement
in the research and beyond study termination
Informed consent is mandated by the US Department of HHS at 45 CFR 46 and the US FDA
at 21 CFR 50. These regulations were developed to: - ans1) protect human subjects 2) Ensure
that potential study subjects clearly understand the benefits and risks associated with their
, Are You Ready to Unlock Your Research
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A Comprehensive ACRP-CP Exam Study
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participation in a study 3) Provide the potential study subjects with all information needed to
reach a decision on whether or not to participate in a research study
Broad consent - ansProspective consent for unspecified future research
Legally Authorized Representative(LAR) - ansIndividual or judicial or other body authorized
under applicable law to consent on behalf of a prospective subject to the subject's
participation in the procedure(s) involved in the research. If there is no applicable law
addressing this issue, LAR means an individual recognized by institutional policy as
acceptable for providing consent in the non-research context on behalf of the prospective
subjects to the subject's participation in the procedure(s) involved in the research
The emphasis of the discussion of informed consent is: - anson subject comprehension and
presenting information that a "reasonable person" would want to have in order to make an
informed decision to participate, and an opportunity to discuss the information
According to 46/116(b), legally appropriate informed consent will include the following
elements: - ans1) a statement that the study involves research, an explanation of the research's
purpose and the expected duration of the subject's participation, a description of the
procedures to be follow, and identification of an procedures that are experimental
2) A description of any reasonably foreseeable risks or discomforts to the subject
3) A description of any benefits to the subjects or to others that may reasonably be expected
from the research
4) A disclosure of appropriate alternative procedures or courses of treatment if any, that
might be advantageous to the subject
5) · A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained
6) For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if injury
occurs and, if so, what they consist of, or where further information may be obtained.
7) An explanation of whom to contact for answers to pertinent questions about the research
and research subject's rights, and whom to contact in the event of a research-related injury to
the subject.
8) A statement that participation is voluntary, that refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may
discontinue participation at any time without penalty or loss of benefits to which the subject
is otherwise entitled.
9) One of the following statements about any research that involves the collection of
identifiable private information or identifiable biospecimens:
Potential? Mastering the ACRP-CP
Exam: Strategies for Success.
A Comprehensive ACRP-CP Exam Study
Guide Current Updated Edition
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Belmont Report (1979) - ansethical principles and guidelines for the protection of human
subjects of research.
respect for persons - ansindividuals should be treated as autonomous agents and persons with
diminished autonomy are entitled to protection
An autonomous person - ansA person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - ansDo not harm and maximize possible benefits and minimize possible harms
Justice - ans1) 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
from groups unlikely to be among the beneficiaries of subsequent applications of the
research.
Three elements of the consent process - ansinformation, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - ansDetermining the study has a maximization of benefits and a
minimization of risks
What are the three principles discussed in the Belmont Report? - ansRespect 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: -
ansPersons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - ans1) 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) - ans1) 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 - ansIssued a series of reports on vulnerable
populations (such as fetuses, children, prisoners, and the "mentally infirm") psychosurgery,
,Are You Ready to Unlock Your Research
Potential? Mastering the ACRP-CP
Exam: Strategies for Success.
A Comprehensive ACRP-CP Exam Study
Guide Current Updated Edition
2025/2026
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 - ansAlso 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 - ans1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - ansInformed Consent
21 CFR 56 - ansIRB
21 CFR 812 - ansInvestigational Medical Devices
21 CFR 312 - ansInvestigational Drugs and Biologics
Declaration of Helsinki (1964) - ansRecommendations 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" - ansDocuments designed to serve as international
guidelines for the review and conduct of research involving human subjects
ICH E6 - ansGuideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice because:
- ansPrisoners may not be used to conduct research that only benefits the larger society
What was the result of the Beecher article? - ansRealization that ethical abuses are not limited
to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - ansUS Public Health Service Policy
What is included in the Nuremberg Code? - ansInformed consent
Informed consent is considered an application of which Belmont principle? - ansRespect for
persons
IRB (Institutional Review Board) - ansA review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - ansIRB 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: - ansApprove research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred since
previous review, observe, suspend/terminate approval
Conveyed committee review - ansFull 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 - ansCan be used for established categories and minor changes in
previously approved research, and for limited IRB review of select exemption categories
,Are You Ready to Unlock Your Research
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A Comprehensive ACRP-CP Exam Study
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Categories for expedited review: - ans1) 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 - ans1) 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
4) Reports of unanticipated problems
US Department of Health and Human Services - ansResponsible for 45 CFR 46
National Institutes of Health (NIH) - ansIncludes funding agencies that provide federal
funding for biomedical research
U.S. Food and Drug Administration (FDA) - ansOversees the use of all drugs, devices,
biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - ansoffers GP guidelines
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery
of the adverse event occurrence? - ansReport the adverse drug experience in a timely manner,
in keeping with the IRB's policies and procedures, using the forms or the mechanism
provided by the IRB
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? - ansA minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - ansThe study involves no more
than minimal risk and meets one of the allowable categories of expedited review specified in
federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval
if: - ansThe changes must be immediately implemented for the health and well-being of the
subjects
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - ansoccur at least annually
Informed consent - ansThe process that begins with the recruitment and screening of a subject
and the signing of the consent document and continues throughout the subject's involvement
in the research and beyond study termination
Informed consent is mandated by the US Department of HHS at 45 CFR 46 and the US FDA
at 21 CFR 50. These regulations were developed to: - ans1) protect human subjects 2) Ensure
that potential study subjects clearly understand the benefits and risks associated with their
, Are You Ready to Unlock Your Research
Potential? Mastering the ACRP-CP
Exam: Strategies for Success.
A Comprehensive ACRP-CP Exam Study
Guide Current Updated Edition
2025/2026
participation in a study 3) Provide the potential study subjects with all information needed to
reach a decision on whether or not to participate in a research study
Broad consent - ansProspective consent for unspecified future research
Legally Authorized Representative(LAR) - ansIndividual or judicial or other body authorized
under applicable law to consent on behalf of a prospective subject to the subject's
participation in the procedure(s) involved in the research. If there is no applicable law
addressing this issue, LAR means an individual recognized by institutional policy as
acceptable for providing consent in the non-research context on behalf of the prospective
subjects to the subject's participation in the procedure(s) involved in the research
The emphasis of the discussion of informed consent is: - anson subject comprehension and
presenting information that a "reasonable person" would want to have in order to make an
informed decision to participate, and an opportunity to discuss the information
According to 46/116(b), legally appropriate informed consent will include the following
elements: - ans1) a statement that the study involves research, an explanation of the research's
purpose and the expected duration of the subject's participation, a description of the
procedures to be follow, and identification of an procedures that are experimental
2) A description of any reasonably foreseeable risks or discomforts to the subject
3) A description of any benefits to the subjects or to others that may reasonably be expected
from the research
4) A disclosure of appropriate alternative procedures or courses of treatment if any, that
might be advantageous to the subject
5) · A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained
6) For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if injury
occurs and, if so, what they consist of, or where further information may be obtained.
7) An explanation of whom to contact for answers to pertinent questions about the research
and research subject's rights, and whom to contact in the event of a research-related injury to
the subject.
8) A statement that participation is voluntary, that refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may
discontinue participation at any time without penalty or loss of benefits to which the subject
is otherwise entitled.
9) One of the following statements about any research that involves the collection of
identifiable private information or identifiable biospecimens:
