Conflict of Interest

Question 1

When does a conflict of interest exist?

Answer 1

when a person’s or institution’s secondary interests (e.g., financial gain, career advancement) could influence professional judgment about research responsibilities (e.g., protecting human subjects, ensuring objectivity).

Question 2

Do policies need to be in place at the IRB in regards to COI? If so, what do the policies need to do?

Answer 2

Yes. The policies need to be in place for identifying and managing COI

Document that members recused themselves from vote and were not counted toward quorum

Be aware of COIs involving investigators and ensure that management plans are in place

Question 3

What should happen if an IRB member has a conflict of interest with a study under review?

Answer 3

They must recuse themselves from discussion and voting and not count toward quorum.

Question 4

IRBs need to do what when Investigators have a COI?

Answer 4

Be aware of the COI and ensure that a management plan is in place.

Question 5

What are the Institution’s Responsibilities regarding COI?

Answer 5

Institutions are expected to:

Have written COI policies

Conduct financial COI disclosures and evaluations

Enforce management plans (e.g., independent data monitoring, disclosing COI in consent forms)

Question 6

For PHS-funded research, institutions must comply with 42 CFR Part 50, Subpart F, which includes what?

Answer 6

public reporting of certain COIs

Question 7

Who is responsible for ensuring investigator COIs are identified and managed?

Answer 7

The institution, but the IRB must confirm protections are adequate before approving research.

Question 8

What federal regulation governs financial conflicts of interest in PHS-funded research?

Answer 8

42 CFR Part 50, Subpart F