Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
Belmont Report (1979) - Answer ethical principles and guidelines for the protection
of human subjects of research.
respect for persons - Answer individuals should be treated as autonomous agents
and persons with diminished autonomy are entitled to protection
An autonomous person - Answer A person capable of deliberation about personal
goals and of acting under the direction of such deliberation
Beneficence - Answer Do not harm and maximize possible benefits and minimize
possible harms
Justice - 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 - 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 - 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 - Answer information, comprehension,
voluntariness
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - Answer Determining the study has a maximization of
benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - 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: - Answer Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - 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) - Answer 1) Authorized the creation of the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
,Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
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 - 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 - 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 - Answer 1) pregnant women,
human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - Answer Informed Consent
21 CFR 56 - Answer IRB
21 CFR 812 - Answer Investigational Medical Devices
21 CFR 312 - Answer Investigational Drugs and Biologics
Declaration of Helsinki (1964) - 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" - Answer Documents designed to
serve as international guidelines for the review and conduct of research involving
human subjects
ICH E6 - Answer Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - Answer Prisoners may not be used to conduct research that only benefits
the larger society
What was the result of the Beecher article? - Answer Realization that ethical abuses
are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer US Public Health
Service Policy
What is included in the Nuremberg Code? - Answer Informed consent
,Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
Informed consent is considered an application of which Belmont principle? - Answer
Respect for persons
IRB (Institutional Review Board) - Answer A review committee established to help
protect the rights and welfare of human research subjects
Regulations require: - 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: - 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 - 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 - 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: - 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 - Answer 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 - Answer Responsible for 45 CFR 46
National Institutes of Health (NIH) - Answer Includes funding agencies that provide
federal funding for biomedical research
U.S. Food and Drug Administration (FDA) - Answer Oversees the use of all drugs,
devices, biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - Answer 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? - Answer 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
, Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? - Answer 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? - Answer 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: - Answer 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: - Answer occur at least annually
Informed consent - Answer 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: - Answer 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 - Answer Prospective consent for unspecified future research
Legally Authorized Representative(LAR) - Answer 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: - Answer 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: - Answer 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
Correctly Answered!!
Belmont Report (1979) - Answer ethical principles and guidelines for the protection
of human subjects of research.
respect for persons - Answer individuals should be treated as autonomous agents
and persons with diminished autonomy are entitled to protection
An autonomous person - Answer A person capable of deliberation about personal
goals and of acting under the direction of such deliberation
Beneficence - Answer Do not harm and maximize possible benefits and minimize
possible harms
Justice - 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 - 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 - 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 - Answer information, comprehension,
voluntariness
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - Answer Determining the study has a maximization of
benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - 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: - Answer Persons with diminished autonomy are entitled to protection
Nuremberg Code (1947) - 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) - Answer 1) Authorized the creation of the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
,Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
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 - 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 - 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 - Answer 1) pregnant women,
human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - Answer Informed Consent
21 CFR 56 - Answer IRB
21 CFR 812 - Answer Investigational Medical Devices
21 CFR 312 - Answer Investigational Drugs and Biologics
Declaration of Helsinki (1964) - 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" - Answer Documents designed to
serve as international guidelines for the review and conduct of research involving
human subjects
ICH E6 - Answer Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - Answer Prisoners may not be used to conduct research that only benefits
the larger society
What was the result of the Beecher article? - Answer Realization that ethical abuses
are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer US Public Health
Service Policy
What is included in the Nuremberg Code? - Answer Informed consent
,Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
Informed consent is considered an application of which Belmont principle? - Answer
Respect for persons
IRB (Institutional Review Board) - Answer A review committee established to help
protect the rights and welfare of human research subjects
Regulations require: - 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: - 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 - 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 - 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: - 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 - Answer 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 - Answer Responsible for 45 CFR 46
National Institutes of Health (NIH) - Answer Includes funding agencies that provide
federal funding for biomedical research
U.S. Food and Drug Administration (FDA) - Answer Oversees the use of all drugs,
devices, biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - Answer 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? - Answer 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
, Exam(Elaborations)ACRP-CP 2023
Correctly Answered!!
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? - Answer 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? - Answer 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: - Answer 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: - Answer occur at least annually
Informed consent - Answer 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: - Answer 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 - Answer Prospective consent for unspecified future research
Legally Authorized Representative(LAR) - Answer 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: - Answer 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: - Answer 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
