ACRP-CP CERTIFICATION COMPREHENSIVE
REVIEW GUIDE WITH SCENARIOS AND
ANSWERS
◉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
◉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
REVIEW GUIDE WITH SCENARIOS AND
ANSWERS
◉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
◉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
