1PURPOSE
1.1This document describes the process for identifying and managing any conflict of interest that IRB members, HSD staff, or IRB consultants may have with respect to review and determinations about a research project.
2POLICY
2.1IRB members, Human Subjects Division (HSD) staff, and IRB consultants do not participate in the following activities related to a research project when they have a potential conflict of interest related to the project: pre-review, expedited review, voting in an IRB meeting, or making determinations. However, they may provide information to the IRB upon request.
3DEFINITIONS
3.1IRB member. In this document, the term is used for convenience to refer to: all IRB members, HSD staff, IRB consultants, and their immediate families, except where indicated.
3.2Immediate family includes:
3.2.1Spouse, domestic partner, or other similar type of partner
3.2.2Parents
3.2.3Children
3.2.4Siblings
3.2.5Household members
3.3Recusal.Conflicted IRB members leave the IRB meeting before the vote on the item with which they have a conflict. When this occurs, the member does not count towards the quorum for the vote. The member’s absence under these circumstances is called a recusal, not an abstention or an absence.
3.4Conflict of interest.Types of conflict of interest include:
3.4.1Significant involvement in the preparation of the materials submitted to the IRB for review or determination: IRB members occasionally are significantly involved in the preparation and writing of materials submitted to the IRB. It is considered a conflict of interest when this has occurred for:
3.4.1.1An initial application for IRB approval
3.4.1.2A continuing review application
3.4.1.3A modification that involves new risk information, decreased benefits, or a significant change in research procedures
3.4.1.4A request for a Not Human Subjects Research, Exempt Status determination, or Engagement determination
3.4.2Participation on the research team: The IRB member is listed as an investigator on the IRB application, or is otherwise a member of the research team.
3.4.2.1When the IRB member is not a co-investigator on the specific study under review but is a co-investigator on other studies with the investigator, the IRB member should bring the situation to the attention of the appropriate HSD staff person and/or the IRB Chair to determine whether there is a conflicting interest.
3.4.3Supervision of the investigator: This refers to any situation in which the investigator is currently under the professional supervision of the IRB member. Example: The faculty chair of a graduate student’s thesis or dissertation committee would have a conflict of interest as an IRB member regarding the review of the student’s IRB application.
3.4.4Supervision of the IRB member by a member of the research team: This means that the investigator on the IRB application has a supervisory or other official authority role with regard to the IRB member. Examples: the investigator is the chair of the IRB member’s department; the IRB member is a student, and the investigator is the student’s mentor or faculty advisor; the IRB member is a paid member of the investigator’s research team.
3.4.5Financial conflict of interest in the research: Financial conflict of interest is defined for IRB members in the same way as it is defined for investigators in the University of Washington’sUW Policy GIM 10.
3.4.6Other potentially conflicting relationship with the research sponsor: Examples include serving on a non-governmental sponsor’s board of directors, advisory board, scientific board, or safety board.
3.4.7Personal relationship with the investigator: This is defined as having an immediate family relationship or other close personal relationship with the investigator, or with co-investigators who have a significant role in the research.
3.4.8Competitive relationship with the investigator: This means the IRB member is in direct competition with the investigator for limited resources (e.g., funding, sponsorship, space, equipment, research subjects), or the IRB member is considered a personal or professional adversary of the investigator for reasons not related to the IRB or HSD. Whether this situation creates a conflict of interest for the IRB member should be determined by the IRB Chair or HSD Director.
3.4.9Investigational Drug Services (IDS) pharmacists are highly valued members of the IRB. However, they have a conflict of interest in any of the following situations:
3.4.9.1When the research will bring in substantial fees to the IDS.
3.4.9.2When the IDS pharmacist is listed on the FDA Form 1572 as a sub-investigator and the pharmacist’s role involves design, consenting of subjects, or data analysis.
3.4.9.3The following research-related activities by IDS pharmacists are not a conflict of interest:
3.4.9.3.1Preparation or labeling of drugs.
3.4.9.3.2Activities when performed as any pharmacist would: (a) telling subjects about the study medication; (b) teaching subjects about the study medication (e.g., about dosing schedules or injections); or (c) talking with subjects about compliance.
3.4.9.3.3Providing occasional dosing recommendations for drugs that are dosed kinetically.
3.4.10Other: The IRB member may have other interests that the IRB member believes conflicts with his or her ability to objectively review the research. For example, the IRB member may be a participant in a study; such participation may be a conflict of interest for participating in the review of a Status Report, modification, or study problem.
4RESPONSIBILITIES
4.1Responsibilities are defined in this document for HSD staff, HSD management, IRB members, IRB chairs, IRB consultants, and the Associate Vice Provost for Research Compliance.
5PROCEDURES
5.1Identification.A conflict is most likely to be identified when incoming materials are assigned to an IRB member for pre-review, determinations (e.g., exempt status), expedited review, reviewing materials for a convened IRB meeting, and serving as a consultant to the IRB.
5.2Disclosure.
5.2.1Voluntary disclosure. It is the responsibility of the IRB member to disclose all certain or potential conflicts of interest prior to engaging in any IRB review or HSD determination activities.
5.2.2Query at IRB meetings. At the beginning of each meeting, the IRB Chair asks the members to disclose any conflict of interest concerning any of the items on the agenda. During the meeting, any conflicted IRB member discloses the existence of the conflict just before the review of the relevant item begins.
5.2.3IRB consultants. Consultants are asked whether they have a conflicting interest with the research when they are asked to provide consultation. If they say “No”, they are sent the materials and a copy of this SOP. After receipt of the materials, the consultant is again asked whether there is any conflict of interest.
5.3Determination when not clear.When it is not clear whether a conflict of interest exists, the individuals listed below make a determination. The determination is based on gathering as much information as necessary from relevant sources.
5.3.1Conflicted IRB member: IRB Chair or HSD management
5.3.2Conflicted IRB Chair: HSD management
5.3.3HSD staff: HSD management
5.3.4HSD management: Associate Vice Provost for Research Administration and Integrity
5.4Management of conflict of interest.
5.4.1HSD staff: do not participate in review activities, pre-review, or regulatory determinations. These activities are assigned by an HSD managerto another HSD staff person with similar qualifications.
5.4.2IRB members:
5.4.2.1As reviewers. Do not serve as primary or expedited reviewers. If the conflict is disclosed after review assignment, the review is re-assigned to another IRB member.
5.4.2.2At IRB meetings. The conflict is disclosed at the beginning of an IRB meeting and just prior to the review of the relevant item. Though UW policy does not require the IRB member to leave the room during the IRB’s discussion, s/he does not participate in the discussion except to provide information at the IRB’s request.
5.4.2.2.1The IRB member is recused before the vote. That is, the member leaves the meeting and does not count towards the quorum.
5.4.2.2.2The meeting minutes and recorded vote tally note that the member (by name) was recused and did not count toward the quorum for the vote.
5.4.3Consultants. In most cases, a possible consultant who discloses a conflict of interest does not provide consultation to the IRB. However, a conflicted consultant may still be asked to provide consultation when: the IRB lacks specific expertise that is important to the review; the other IRBs also lack the required expertise; and an alternate consultant cannot be located. For example, this situation might arise if the research involves highly specialized technology, procedures, or subject matter. The conflict is managed as follows:
5.4.3.1The consultant is provided with specific questions to address that are as focused and objective as possible. Example: The consultant may be asked, “What are the risks associated with this research – specifically, their nature, magnitude, duration, and likelihood?” rather than an open-ended question such as “Do you think this research is too risky to perform?”
5.4.3.2HSD staff document the nature of the conflict in a Note to File, which is shared with the IRB members and placed in the IRB file. For Zipline, staff add a comment.
5.4.3.3When the IRB is provided with the consultant’s information, it is accompanied by a statement that the consultant has a conflict.
5.4.3.4If the consultant’s information has a negative effect on the IRB’s assessment of the research, the investigator is provided with an opportunity to respond.
6MATERIALS
6.1None
7REFERENCES
7.145 CFR 46.107(e) and 21 CFR 56.107(e)
7.2OHRP “Guidance on Written IRB Procedures”, section A.6; July 1, 2011
7.3FDA Information Sheet “Institutional Review Boards Frequently Asked Questions”, question 28; August 9, 2011
7.4UW Policy GIM 10 “Financial Conflict of Interest”
Version 1.6 / #503Implemented / 08/30/2017 / Page 1 of 5