A Researcher Conducts A Focus Group

Question: The FDA regulations governing disclosure of individual COIs require:

Answer: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

Question: The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Answer: Researcher

Question: What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Answer: Inherent controls

Question: 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

Question: 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

Question:

Answer: No, this does not need to be reported since it is unrelated to participation in the study.

Question: The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Answer: Determined by the institution in its written policies and procedures

Question: Researchers must report potential unanticipated problems that involve risks to others directly to:

Answer: Institutional Review Board (IRB)

Question:

Answer: Promptly

Question:

Answer: No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.