According to the U.S. Public Health Service, which of the following would be
considered a significant financial interest? correct answer -An equity
interest valued at $5,000 owned by the investigator's spouse in a company
that produces products related to the investigator's institutional
responsibilities.
According to the U.S. Public Health Service, a "significant financial interest"
includes royalty income paid to an investigator and its disclosure is required:
correct answer -Except if that income is from the institution that currently
employs the investigator.
According to the U.S. Public Health Service regulations, investigators are
required to disclose travel sponsored or reimbursed by: correct answer -A
publicly traded company.
An investigator received $4,000 of consulting income from a publicly traded
drug company over the past 12 months. The investigator also owns stock in
that company valued at $2,000. The investigator is submitting a grant to the
National Institutes of Health that involves evaluating the effectiveness of a
drug produced by the same drug company. Which of the following is true?
correct answer -The aggregate of the consulting income and the stock
exceeds $5,000 and therefore is a significant financial interest.
Which of the following is true regarding the U.S. Public Health Service and its
approach to the disclosure of significant financial interests? correct answer
-Any equity interest in a non-publicly traded company must be disclosed.
Which of the following statements is true regarding the reporting of outside
interests and the management of conflicts? correct answer -Investigators
must disclose their significant financial interests related to their institutional
responsibilities and not just those related to a particular project.
Institutions are required by the U.S. Public Health Service to do which of the
following: correct answer -Evaluate whether a significant financial interest
is related to an investigator's research and constitutes a financial conflict of
interest.
,Which of the following statements most accurately describes a mitigation
report? correct answer -A report to the U.S. Public Health Service of efforts
that will be taken by the institution to deal with any bias that was found in
research conducted while there was an unreported financial conflict of
interest.
The U.S. Public Health Service (PHS) requires institutions to: correct answer
-Disclose their investigators' new financial conflicts of interest to the PHS
awarding component within 60 days of discovering them.
Which of the following financial conflict of interest information must be made
available by institutions on a public website or within five business days upon
request? correct answer -The financial conflicts of interest of senior/key
personnel on projects funded by the U.S. Public Health Service.
Which of the following statements is true? correct answer -Many
institutions have conflict of commitment policies even though they are not
strictly required to by federal agencies.
Which of the following is most likely to be considered a conflict of
commitment? correct answer -A researcher cancels laboratory meetings in
order to perform consulting work.
Which of the following is the most appropriate way to handle a conflict of
conscience relating to a project? correct answer -Notify relevant parties
that a conflict may exist and seek advice about whether to accept or decline
the project.
Which statement most accurately describes a conflict of commitment?
correct answer -It occurs when outside activities interfere with one's
responsibilities to an employer.
Which statement most accurately describes a conflict of conscience? correct
answer -It occurs when an individual's personal beliefs could affect the
performance or outcome of research.
, A subject participates in a drug study because treatment is available at no or
reduced cost, and he could not otherwise afford it. This is an example of
correct answer -Economic vulnerability
NBAC proposed a concept of vulnerability in research based on features of
potential subjects or of their situation. Which of the following was NOT
included as possibly leading to vulnerability? correct answer -High
potential for individual benefit from participating in research
In considering NBAC's analytic approach, an otherwise competent person who
is acutely ill might be considered at especially high risk of harm for: correct
answer -Situational cognitive vulnerability
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?
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
The Belmont principle of beneficence requires that: correct answer -
Potential benefits justify the risks of harm.
Which of the following studies is linked most directly to the establishment of
the National Research Act in 1974 and ultimately to the Belmont Report and
Federal regulations for human subject protection? correct answer -The
Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following studies?
correct answer -Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)"
study
According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of:
correct answer -Justice.