ACRP – CP Exam (Latest 2023 – 2024)
With Complete Solution
Belmont Report (1979) - ethical principles and guidelines for the protection of human
subjects of research.
respect for persons - individuals should be treated as autonomous agents and persons with
diminished autonomy are entitled to protection
An autonomous person - A person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - Do not harm and maximize possible benefits and minimize possible harms
Justice - 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 - · 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 - · 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 - information, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - Determining the study has a maximization of benefits and a minimization
of risks
What are the three principles discussed in the Belmont Report? - 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: - Persons with diminished autonomy are entitled to protection
,Nuremberg Code (1947) - 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) - 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 - 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 - 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 - 1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - Informed Consent
21 CFR 56 - IRB
21 CFR 812 - Investigational Medical Devices
21 CFR 312 - Investigational Drugs and Biologics
Declaration of Helsinki (1964) - 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" - Documents designed to serve as international
guidelines for the review and conduct of research involving human subjects
ICH E6 - Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - Prisoners may not be used to conduct research that only benefits the larger
society
What was the result of the Beecher article? - Realization that ethical abuses are not limited
to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - US Public Health Service Policy
,What is included in the Nuremberg Code? - Informed consent
Informed consent is considered an application of which Belmont principle? - Respect for
persons
IRB (Institutional Review Board) - A review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - 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: - Approve research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred
since previous review, observe, suspend/terminate approval
Conveyed committee review - 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 - 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: - 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 - 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
4) Reports of unanticipated problems
US Department of Health and Human Services - Responsible for 45 CFR 46
National Institutes of Health (NIH) - Includes funding agencies that provide federal funding
for biomedical research
U.S. Food and Drug Administration (FDA) - Oversees the use of all drugs, devices, biologics,
etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - offers 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? - Report 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? - A 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? - The 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: - The 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: - occur at least annually
Informed consent - The 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: - 1) protect human subjects 2) Ensure
that potential study subjects clearly understand the benefits and risks associated with their
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 - Prospective consent for unspecified future research
Legally Authorized Representative(LAR) - Individual 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: - on 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: - 1) 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
With Complete Solution
Belmont Report (1979) - ethical principles and guidelines for the protection of human
subjects of research.
respect for persons - individuals should be treated as autonomous agents and persons with
diminished autonomy are entitled to protection
An autonomous person - A person capable of deliberation about personal goals and of
acting under the direction of such deliberation
Beneficence - Do not harm and maximize possible benefits and minimize possible harms
Justice - 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 - · 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 - · 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 - information, comprehension, voluntariness
What is an example of how the principle of beneficence can be applied to a study employing
human subjects - Determining the study has a maximization of benefits and a minimization
of risks
What are the three principles discussed in the Belmont Report? - 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: - Persons with diminished autonomy are entitled to protection
,Nuremberg Code (1947) - 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) - 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 - 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 - 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 - 1) pregnant women, human
fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - Informed Consent
21 CFR 56 - IRB
21 CFR 812 - Investigational Medical Devices
21 CFR 312 - Investigational Drugs and Biologics
Declaration of Helsinki (1964) - 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" - Documents designed to serve as international
guidelines for the review and conduct of research involving human subjects
ICH E6 - Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - Prisoners may not be used to conduct research that only benefits the larger
society
What was the result of the Beecher article? - Realization that ethical abuses are not limited
to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - US Public Health Service Policy
,What is included in the Nuremberg Code? - Informed consent
Informed consent is considered an application of which Belmont principle? - Respect for
persons
IRB (Institutional Review Board) - A review committee established to help protect the
rights and welfare of human research subjects
Regulations require: - 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: - Approve research, require modifications,
disapprove research, conduct continuing reviews, verify no material changes occurred
since previous review, observe, suspend/terminate approval
Conveyed committee review - 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 - 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: - 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 - 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
4) Reports of unanticipated problems
US Department of Health and Human Services - Responsible for 45 CFR 46
National Institutes of Health (NIH) - Includes funding agencies that provide federal funding
for biomedical research
U.S. Food and Drug Administration (FDA) - Oversees the use of all drugs, devices, biologics,
etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - offers 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? - Report 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? - A 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? - The 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: - The 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: - occur at least annually
Informed consent - The 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: - 1) protect human subjects 2) Ensure
that potential study subjects clearly understand the benefits and risks associated with their
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 - Prospective consent for unspecified future research
Legally Authorized Representative(LAR) - Individual 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: - on 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: - 1) 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
