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Washington State University

HRPP policies & procedures manual

105: Conflict of interest: members, consultants, and staff

1. Purpose

The purpose of this policy is to describe the management of financial relationships and possible conflicts of interest (COI) for IRB members, consultants and ORA staff.

2. Policy

In the environment of research, openness and honesty indicate integrity and responsibility, characteristics that promote quality research and strengthen the research process. Therefore, conflicts of interest should be eliminated when possible and effectively disclosed and managed when they cannot be eliminated.

3. Specific policies

3.1 Disclosure and documentation of conflict of interest

No regular or alternate IRB member with a conflict of interest may participate in the review of the following (except to provide information as requested):

  • Initial review (full board or expedited)
  • Continuing review
  • Unanticipated problems involving risks to subjects or others
  • Non-compliance with regulations or requirements of the IRB

Definition of financial conflict of interest

A situation in which the IRB member will experience a financial gain or loss that is reliant on the outcome of the Committee’s decisions regarding the research.

Definition of non-financial conflict of interest

A situation in which the IRB Committee’s decision may have a positive OR negative affect on the individual IRB member’s position professionally, personally, departmentally, or socially.

It is the responsibility of each voting member or alternate member to disclose any COI in a study submitted to the IRB and recuse themselves from deliberations and voting. The IRB member with a COI may stay long enough to give requested information but must leave during deliberations and voting.

When an IRB member leaves the room for a conflicting interest, the minutes will state the name of the IRB member, the time the member left the room and returned, and that the reason the member was absent from the discussion and voting was due to a conflict of interest. The IRB member will not be counted towards quorum.

3.2 Consultants

Consultants with a declared conflict of interest may provide information as requested after review and determination by the chair and ORA director. The IRB members will be notified of the conflict. The consultant cannot vote and will be asked to leave the meeting during deliberations and voting. The consultant will not be counted toward quorum.

3.3 Employees

WSU staff whose job status or compensation is affected by research that is reviewed by the IRB must recuse themselves from any meeting at which such a protocol is reviewed.  

3.4 Education and training in COI

Conflict of interest training opportunities are available to IRB members and staff. They include online and classroom trainings.

4. Applicable regulations and guidelines

45 CFR 46.103, 107

21 CFR 56.107, 21 CFR 54

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
ORA directorMeet in person or by phone with potential consultants to review the conflict of interest
agreement and assist them in completing the form.
Maintain documentation of IRB member conflict of interest via meeting minutes.
Chairperson, IRB
coordinator, IRB
members
Ensure that IRB members with a conflict of interest do not participate in the IRB
deliberations subject to their conflict of interest disclosures.
IRB membersRecuse themselves from IRB deliberations where a conflict of interest exists or may
appear to exist.
IRB coordinatorDocument in meeting minutes when IRB members have recused
themselves for conflict of interest issues.