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ACRP-CP/543 QUESTIONS WITH COMPLETE SOLUTIONS 2023
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ACRP-CP/543 QUESTIONS WITH COMPLETE SOLUTIONS 2023
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ACRP-CP/543 QUESTIONS WITHCOMPLETE SOLUTIONS 2023
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
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