Stuvia - Exam (Elaborations) ACRP-CP 2023 Correctly
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Terms in this set (69)
What are the three fundamental ethical Beneficence, Justice, Respect for Persons 3 multiple choice options
principles outlined in the Belmont Report
(1979) for the protection of human subjects
in research?
To establish ethical principles and guidelines for the protection of human subjects in
What is the purpose of the Belmont Report
research.
(1979)?
3 multiple choice options
A person capable of deliberation about personal goals and of acting under the
What defines an autonomous person? direction of such deliberation
3 multiple choice options
Do not harm, and strive to maximize possible benefits while minimizing possible
What does the principle of beneficence
harms.
entail?
3 multiple choice options
To each person an equal share, according to individual need, effort, societal
Which of the following concepts best
contributions, or merit.
represents the principle of justice?
3 multiple choice options
Which of the following principles is Justice 3 multiple choice options
concerned with ensuring that research
subjects are selected based on the
relevance to the research problem rather
than their vulnerability or availability?
Which ethical principle requires that Justice 3 multiple choice options
therapeutic devices and procedures
developed through publicly funded
research are accessible to all, and that
research does not disproportionately
involve groups unlikely to benefit from the
research outcomes?
Which of the following are the three Information, Comprehension, Voluntariness 3 multiple choice options
essential elements of the informed consent
process in research?
Which of the following is an example of Ensuring that the study maximizes potential benefits and minimizes possible risks to
applying the principle of beneficence in a participants.
study involving human subjects? 3 multiple choice options
Which of the following are the three ethical Respect for Persons, Beneficence, Justice 3 multiple choice options
principles outlined in the Belmont Report?
1/5
, Which of the following best describes the Persons with diminished autonomy are entitled to additional protection.
second ethical conviction incorporated in
the Belmont Report's principle of respect 3 multiple choice options
for persons?
Which of the following best represents the Individuals should be treated as autonomous agents, and those with diminished
two ethical convictions incorporated in the autonomy are entitled to additional protection.
Belmont Report's principle of respect for
3 multiple choice options
persons?
Which of the following is NOT one of the Researchers must ensure subjects receive financial compensation for their
key principles outlined in the Nuremberg participation.
Code (1947)? 3 multiple choice options
Authorized the creation of the National Commission for the Protection of Human
Which of the following was a key outcome Subjects of Biomedical and Behavioral Research, which was charged with
of the National Research Act (1974)? developing an ethical code and guidelines for researchers
3 multiple choice options
Required the establishment of IRBs at organizations receiving PHS support for
Which of the following was a key outcome
human subject's research
of the National Research Act (1974)?
3 multiple choice options
Which of the following was a significant Issued reports on vulnerable populations (such as fetuses, children, prisoners, and
contribution of the National Commission the "mentally infirm"), psychosurgery, and IRBs, influencing federal regulations.
(1975-1978) to the development of federal
regulations governing human subjects' 3 multiple choice options
research?
Which of the following best describes the Established the role of institutional review boards (IRBs) to review and oversee
purpose of 45 CFR 46, also known as the research involving human subjects.
Common Rule? 3 multiple choice options
Which of the following groups are Pregnant women, human fetuses, neonates, children, and prisoners.
provided with additional protections under
the federal regulations for research 3 multiple choice options
involving human subjects?
Providing guidelines for the proper documentation of informed consent in research
Which of the following is the primary focus
involving human subjects.
of 21 CFR 50?
3 multiple choice options
Sets forth the requirements for the composition, function, and operations of
Which of the following best describes the
Institutional Review Boards (IRBs).
purpose of 21 CFR 56?
3 multiple choice options
Governing the conduct of clinical investigations involving investigational medical
Which of the following is the primary focus
devices.
of 21 CFR 812?
3 multiple choice options
Governs the requirements for conducting clinical investigations of investigational
Which of the following best describes the
new drugs and biologics.
purpose of 21 CFR 312?
3 multiple choice options
Which of the following best describes the Recommendations guiding medical doctors in biomedical research involving human
primary purpose of the Declaration of subjects
Helsinki (1964)? 3 multiple choice options
2/5
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