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Which of the following is an example of how the principle of beneficence can be applied to a
study employing human subjects? ------- ✔ CORRECT ANSWER ✓✓Determining that the study
has a maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? ------- ✔
CORRECT ANSWER ✓✓Respect for Persons, Beneficence, 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: ---
---- ✔ CORRECT ANSWER ✓✓Persons with diminished autonomy are entitled to protection.
According to the authors, there are four common abuses that historically are described as
giving rise to vulnerability. Which response below contains the correct four? ------- ✔ CORRECT
ANSWER ✓✓Physical control, coercion, undue influence, and manipulation
When an IRB is reviewing a research study and they are considering if a potential subject
population is vulnerable, they should consider: ------- ✔ CORRECT ANSWER ✓✓Is there a power
differential between researchers and subjects?
Subjects with a serious illness may be at risk for exploitation because they may be desperate for
a possible cure. This is an example of: ------- ✔ CORRECT ANSWER ✓✓Medical vulnerability
, The NBAC looks at characteristics individuals might have that would prevent them from being
able to provide voluntary informed consent. The traits may be thought of as falling into six
broad areas: cognitive or communicative, institutional, deferential, medical, economic, and
social. Prospective research subjects who are not able to comprehend information, deliberate,
and make decisions about participation in a proposed research study have a: ------- ✔ CORRECT
ANSWER ✓✓Cognitive or communicative vulnerability
Which is an example of a situation where deferential vulnerability might be a factor? ------- ✔
CORRECT ANSWER ✓✓A physician recruiting patients to be subjects
An example of an individual financial COI is: ------- ✔ CORRECT ANSWER ✓✓A researcher's
spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the
researcher's study.
A researcher's membership on an advisory board with an organization sponsoring research can
create a COI because: ------- ✔ CORRECT ANSWER ✓✓It may be difficult for the researcher to
appear neutral, as the researcher may have an interest in the research's success
The COI management plan aims to: ------- ✔ CORRECT ANSWER ✓✓Provide procedures or
extras steps to be taken to minimize the risk of bias when a COI is disclosed
The peer review process can create conflicts of interest because the choice of who reviews a
potentially publishable project may show: ------- ✔ CORRECT ANSWER ✓✓There may be bias by
the peer reviewer as to the area of research
A researcher calls you stating that he plans to submit a proposal to the NIH for a human
subjects research study. He wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. ------- ✔ CORRECT ANSWER ✓✓No later than the
time of proposal submission