ACRP CP FINAL EXAM v2 QUESTIONS WITH COMPLETE
SOLUTIONS GUARANTEED PASS BRAND NEW 2025
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
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
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 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
SOLUTIONS GUARANTEED PASS BRAND NEW 2025
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
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
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 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
