ACRP CP Practice Questions with Verified
Correct Answers
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
Correct Answers
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
