CITI -SOCIAL BEHAVIORAL

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CITI -SOCIAL BEHAVIORAL

RESEARCH QUESTIONS A ND

ANSWERS

Question :An example of an institutional COI is:

• A researcher's financial interest in the sponsor of the

research

• A research staff member's significant interest in the

company that manufactures a device used in a research study

• An industry sponsor pays for the construction of a new

research laboratory at the organization

• A principal investigator who is a member of the board

of directors of a startup biotechnology company that is developing the drug under study

Correct answer:An industry sponsor pays for the

construction of a new research laboratory at the organization

Question :The peer review process can create conflicts of

interest because the choice of who reviews a potentially

publishable project may show:

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• There may be bias by the peer reviewer as to the area

of research

• Peer reviewers have an interest in maintaining the

status quo in their field of research

• Peer reviewers may have an interest in delaying the

publication of the potentially publishable project

• All of the above

Correct answer:There may be bias by the peer reviewer as

to the area of research

Question :During an Institutional Review Board (IRB)

meeting, any IRB member who may have a potential COI

with a study under review should:

• Vote "no" to indicate concern about potential COI

issues

• Disclose their potential COI and may answer

questions, but recuse themselves from voting

• Not attend the meeting
• Vote "yes" to indicate their support for the study

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Correct answer:Disclose their potential COI and may

answer questions, but recuse themselves from voting

Question :A researcher's membership on an advisory

board with an organization sponsoring research can create

a COI because:

• It may be difficult for the researcher to appear neutral,

as the researcher may have an interest in the research's success

• The researcher may receive financial compensation

from the organization sponsoring the research

• The researcher may be asked to provide advice on the

research project

• All of the above

Correct answer:It may be difficult for the researcher to

appear neutral, as the researcher may have an interest in the research's success

Question :The FDA regulations governing disclosure of

individual COIs require:

• Institutions to report all individual COIs to the FDA

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• Institutions to manage individual COIs of researchers

who conduct clinical studies

• Applicants submitting marketing applications to

disclose financial COIs of researchers who conducted clinical studies

• Researchers to disclose all individual COIs to the FDA

Correct answer:Applicants submitting marketing

applications to disclose financial COIs of researchers who conducted clinical studies

Question :An example of an individual financial COI is:

• An industry sponsor pays for the construction of a new

research laboratory at the organization

• A researcher's spouse holds equity in a publicly traded

pharmaceutical company that is also the sponsor of the researcher's study.

• A principal investigator who is a member of the board

of directors of a startup biotechnology company that is developing the drug under study

• A researcher's membership on an advisory board with

an organization sponsoring research