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1.7 IRB Member, Consultant, and Staff Conflict of Interest Identification and Management

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the identification and management of IRB member, IRB consultant, and IRB staff potential conflicts of interest.

2.0 Policy

It is the policy of the Organization that all potential financial and non-financial conflicts of interest that IRB members, IRB consultants, and IRB staff must be self-identified to the best of the individual’s knowledge and appropriately managed to prevent such conflicts from interfering with the objectivity and validity of the expedited or full board review process. The Organization does not require disclosure of the specifics of the conflict unless an exception is requested.

3.0 Definitions

  • 3.1. Covered Persons: Covered persons are IRB members, IRB consultants, IRB staff and immediate family members of a Covered Person (spouse, dependent children, parents or anyone that a Covered Person may claim as a dependent under the Internal Revenue Code).
  • 3.2. Potential Conflicts of Interest: Financial and non-financial conflicts of interest that may exclude IRB members, IRB staff, and IRB consultants from participating in the IRB review of protocols, amendments, adverse event reports, unanticipated problems involving risk to the subject or others, noncompliance, complaints, or other problems that are related to the conduct of human subject research.

    • 3.2.1. The covered person currently serves as an investigator, participating personnel, or coordinator for the protocol as listed on the IRB application or is serving as a scientific/medical advisor to the PI.

    • 3.2.2. The covered person is an advisor, or a direct supervisor, of a trainee’s (medical, graduate or undergraduate student) research.

    • 3.2.3. The covered person has a financial interest (in any amount) defined as: 1) salary, royalties (or a commitment for future royalties), consulting fees, honoraria, gift(s), or other payments that has been received in the last twelve months, will be received while the research is being conducted or will be received within twelve months after the research is completed; or 2) an equity interest in the sponsor of the research. Mutual funds are excluded.

    • 3.2.4. The covered person holds a position as director, officer, partner, trustee, or any other significant position in the company sponsoring the research or has held such a position in the past twelve months.

    • 3.2.5. The covered person holds patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving the Organization.

    • 3.2.6. The covered person has a financial interest (as defined above) in a company which has a marketed product, or is in the process of developing a new product which the covered person knows or would be reasonably expected to know, is, or will be, in direct market competition with the product in the protocol under IRB review.

    • 3.2.7. The covered person has a personal relationship, or a conflict, with any research personnel listed on the IRB application which would potentially cause the IRB member, in his/her opinion, to be less than objective in their review.

      Note: In the following instances the covered person does not have a conflict of interest:

      1) The individual serves on the sponsor’s scientific advisory board for an area unrelated to the research under review.

      2) The individual serves on an NIH study section or FDA advisory committee, where it has been determined by the NIH/FDA that a conflict does not exist.

      3) The individual is listed on the IRB application as a participating physician or other study personnel and the only involvement in the protocol is in the context of providing clinical care to subjects. The individual will not obtain and document informed consent or be included as an author on any publications arising from the research.

4.0 Procedures for identification and management of conflict of interest by members and consultants

  • 4.1. All IRB members must notify the IRB Executive Chair/designee of a potential conflict of interest in advance of the IRB meeting or upon assignment as an expedited reviewer for any action under review (i.e., review of new research, changes, continuing review, adverse events, unanticipated problems involving risk to subjects or others, and noncompliance). If the IRB member is uncertain if a potential conflict of interest exists, they are encouraged to consult with the IRB Executive Chair/designee.
  • 4.2. Whenever a prospective consultant is asked to review a protocol, he/she will be provided with a copy of this policy and will be excluded from serving as a consultant if a conflict exists. Consultants must certify in writing that they do not have a conflict of interest.
  • 4.3. Prior to the beginning of each meeting, IRB members will be asked to declare the existence of any undisclosed conflicts, but are not required to describe the nature of the conflict.
  • 4.4. Except as described below, an IRB member with a conflict of interest must be absent from the meeting room during the discussion and voting phases of the review of the protocol in question. The IRB member may not vote on any protocol where he/she has a conflict of interest as defined above. Upon request of the IRB the member may provide information or respond to questions. The absent member is not counted towards determination of quorum during the vote on the protocol in question.
    • 4.4.1. If the conflicted member is attending the meeting by conference call, videoconference, or web meeting, “absent from the meeting room” shall mean that the connection is terminated for the duration of the discussion and voting phases.
  • 4.5. When an IRB member is listed on the IRB application as a participating personnel or other study personnel and will be involved in both obtaining and documenting informed, that individual may serve as a primary or secondary IRB reviewer and participate in the discussion, but are required to abstain from voting.
  • 4.6. If an IRB member has a conflict of interest, but in his/her opinion, the conflict will not interfere with the objectivity and validity of the review, the member may request approval of an exception to allow them to serve as a reviewer and be granted voting privileges.
    • 4.6.1. After disclosure of the specifics of the conflict to the Executive Chair, he/she will have the authority to grant exception.
    • 4.6.2. The full IRB will be notified that an exception prior to the review of the protocol, and has the authority to overturn approval of an exception
    • 4.6.3. Minutes will reflect that an exception was granted, but not specifics of the conflict.
  • 4.7. The IRB meeting minutes will specifically record that COI is the reason any IRB member is out of the room and did not vote.
  • 4.8. An IRB member with a conflict of interest may not serve as an expedited reviewer for a protocol for which he/she has a conflict.

5.0 Procedures for identification and management of conflict of interest by IRB staff

  • 5.1. IRB staff must notify the IRB Executive Chair/designee if a conflict exists with any proposed or active research study under the jurisdiction of the IRB.
  • 5.2. IRB staff who have any of the conflicts listed in section 3.2 above are excluded from serving as the key IRB administrator assigned to process the study in question.
    • 5.2.1. IRB staff who have previously served as study personnel for an active protocol may serve as the key IRB administrator assigned to process the study; however, he/she may not be the sole expedited reviewer for any non-compliance, AEs or UPs in which he/she was directly involved during his/her tenure as study personnel.

DOCUMENT HISTORY:

Written: 12/29/2015 (Approved: 12/29/2015) - original author not recorded

 Revised: 2/1/2018 - revision not documented

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