What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Answer- Inherent controls
An example of an individual financial COI is: - Answer- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also t...
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What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Answer- Inherent controls
An example of an individual financial COI is: - Answer- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's
study.
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - Answer- There may be bias by the
peer reviewer as to the area of research
The FDA regulations governing disclosure of individual COIs require: - Answer- Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
The COI management plan aims to: - Answer- Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
An example of an institutional COI is: - Answer- An industry sponsor pays for the construction of a new research laboratory at the organization
An example of an individual financial COI is: - Answer- A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's
study.
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. - Answer- No later than the time of proposal submission
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? - Answer- Researcher
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: - Answer- It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success - Answer- Humphreys collecting data for the Tearoom Trade study under the pretense that he was
a lookout is an example of a violation of the principle of: - Answer- Respect for persons. 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? - 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? - 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: - Answer- Justice
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? - Answer- Ensuring that risks are reasonable in relationship to anticipated benefits. - Answer- According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: - Answer- Identifiable private information.
A medical record is an example of: - Answer- Private information.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Answer- A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Answer- A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? - Answer- A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
According to federal regulations, the expedited review process may be used when the study procedures pose: - Answer- No more than minimal risk and the research activities
fall within regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if - Answer- The research falls into one of six categories of research activity described in the regulations.
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