Belmont Report (1979) correct answer -summarizes the basic ethical
principles and guidelines for the protection of human subjects of research.
(Respect for persons, beneficence and justice)
released in 1979 by the National Commission for the Protection of Human
Subjects in Biomedical and Behavioral Research, provides the ethical
framework for the federal regulations designed to protect human research
subjects.
Which of the following is an example of how the principle of beneficence can
be applied to a study employing human subjects?
A.Ensuring that the selection of subjects includes people from all segments of
the population.
B. Providing detailed information about the study and obtaining the subject's
consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that persons with diminished autonomy are protected. correct
answer -C. Determining that the study has a maximization of benefits and a
minimization of risks.
(The principle of beneficence includes the obligation of researchers to strive
to do no harm and to maximize benefits and minimize harms. "Persons are
treated in an ethical manner not only by respecting their decisions and
protecting them from harm, but also by making efforts to secure their well-
being" (The National Commission 1979). The principle of beneficence can be
applied to a study employing human subjects by determining that the study
has a maximization of benefits and a minimization of risks. Providing detailed
information during consent and ensuring persons with diminished autonomy
,are protected would be examples of applying the principle of respect for
persons. Ensuring the selection of subjects is equitable is an example of
applying the principle of justice).
The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that:
A. Persons involved in research cannot financially benefit.
B.Persons with diminished autonomy are entitled to protection.
C. Persons with diminished autonomy should only participate in no more than
minimal risk research.
D.. Persons with diminished autonomy should be excluded from research.
correct answer -B.Persons with diminished autonomy are entitled to
protection.
The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that persons with diminished autonomy are
entitled to protection. Persons with diminished autonomy should not be
excluded from participating in research, because then they would be excluded
from receiving the benefits of research. The Belmont Report does not limit
persons with diminished autonomy with participating in greater than minimal
risk research. The Belmont Report also does not limit persons involved in
research from benefitting financially.
Which of the following are the three principles discussed in the Belmont
Report?
A. IRB Review, Federal Regulations, Declaration of Helsinki
B. Respect for Persons, Beneficence, Justice
C. Informed Consent, Institutional Assurance, Researcher Responsibility
C. Privacy, Confidentiality, Equitable Selection of Subjects correct answer -
B. Respect for Persons, Beneficence, Justice
The three principles discussed in the Belmont Report are Respect for Persons,
Beneficence, Justice.
Nuremberg Code correct answer -a set of ethical principles essential for a
medical experiment to be "permissible", these codes were subsequently
created after the Nuremberg trials at the end of the Second World War.
The National Research Act of 1974
, A.Identified guidelines to ensure the ethical conduct of research.
B. Established the National Commission.
C. Identified the basic ethical principles of human subjects research.
D. Required that all federal agencies have the same regulations governing
human subjects research. correct answer -Established the
NationalCommission.
The National Research Act of 1974 established the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research. The
identification of guidelines, ethical principles and regulations came as a result
of the deliberations of the National Commission.
Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C.Voluntary consent
D.Confidentiality of data correct answer -C. Voluntary Consent
The Nuremberg Code included the requirement of the voluntary consent of
subjects. While all of the choices are valid ethical concerns, none of the other
choices were included in the Nuremberg Code.
Issued in 1974, 45 CFR 46 raised to regulatory status: