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1.7 IRB Member, Consultant, Staff and Guest 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, IRBconsultant, consultant,staff and IRB staffguest potential conflicts of interest.

2.0 Policy

It is the policy of the Organization thatthat:

all
  • 2.1. potentialAll financial and non-financial conflictsinterests which may represent a conflict of interest thatfor an IRB members,member, IRB consultants, and IRBconsultant, staff or guest must be self-identified to the best of the individual’s knowledgeknowledge, and appropriately managed to prevent such conflicts from interfering with the objectivity and validity of the expeditedreview process.
  • 2.2. Any financial interest of any monetary value by an IRB member, consultant, staff or fullguest boardat reviewthe process.meeting Theis Organizationconsidered doesa notconflict requireof disclosureinterest for the purposes of this policy.
  • 2.3. Disclosure of the specifics of the conflict unlessto anthe exceptionIRB and ORA is requested.

    not required.

3.0 Definitions

  • 3.1. Covered Persons: Covered persons are IRB members, IRB consultants, IRB staffstaff, or guests at an IRB meeting, and the 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. TheConflicts of Interest: a situation in which financial or non-financial interest may compromise, or have the appearance of compromising, a covered personperson’s isprofessional an advisor,judgment or aobjectivity directin supervisor, of a trainee’s (medical, graduatereviewing or undergraduateevaluating student)research research.involving human subjects.

    • 3.2.3. TheFinancial coveredInterest: person has a financial interest (inincludes any amount)of definedthe as:following: 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.research Mutual(excluding fundsmutual arefunds); excluded.

      or

    • 3.2.4. The covered person holds3) 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.

      months;
      • or

    • 3.2.5. The covered person holds4) 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.

      Organization;
      • or

    • 3.2.6. The covered person has a5) 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.

    • 3.2.7.4. TheNon-financial coveredinterest: persona haspersonal or professional circumstances that includes (but is not limited to) 1) serving as an investigator, participating personnel, or coordinator for the protocol, or serving as a faculty advisor for a student as PI; or 2) having a personal relationship, or a conflict, with any research personnel listed on the IRB application which would potentiallycompromise, causeor have the IRBappearance member,of compromising, a covered person’s professional judgment or objectivity in his/herreviewing opinion,or toevaluating be less than objective in their review.research.

      Note: In the following instancesgeneral, the covered person doesis not considered to have a conflict of interest:

      interest

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

      review;

      or 2) Thethe 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)3.5. TheGuests: individualpersons is listed onattending the IRB applicationmeeting aswho aare participatingneither physicianmembers, non-voting alternates, or IRB staff. Guests may be organizational officials (for example, Chief Compliance officer, or Privacy Officer), legal counsel, representatives of other components of the HRPP (for example, the FPBCC Scientific Review Committee) or other studypersons personnelspecifically and the only involvement in the protocol is in the context of providing clinical careinvited to subjects. The individual will not obtain and document informed consent or be included as an author on any publications arising from the research.attend.

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

  • 4.1. AllIRB members (including IRB membersanalysts serving as IRB members) must notify the IRBORA Executiveif Chair/designeethey ofhave a potential conflict ofrelated interestto any protocol being reviewed by the board at a which they are attending. If the member is assigned to review any action related to a protocol for which they have a conflict, they must notify the ORA in advance of the IRB meeting orso uponthe assignmentprotocol ascan anbe expedited reviewer for any action under review (i.e., review of new research, changes, continuing review, adverse events, unanticipated problems involving riskre-assigned to subjects or others, and noncompliance). If the IRB member is uncertain if a potentialnon-conflicted conflict of interest exists, they are encouraged to consult with the IRB Executive Chair/designee.member.
  • 4.2. Whenever a prospective consultant is asked to review a protocol, he/sheConsultants 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. They will be excluded from serving as a consultant if a conflict exists.
  • 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, anAn IRB member with a conflict of interest (other than serving as participating personnel; see below) 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.interest. Upon request of the IRBIRB, 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. An IRB member whose only conflict is that he/she is participating personnel on a protocol may serve as protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting room during the vote, but will abstain from voting.
    • 4.4.2. 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.
  • 4.8.7. 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 anya of the conflicts listed in section 3.2 aboveconflict are excluded from serving as the keyprimary IRB administratoranalyst 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 keyprimary IRB administratoranalyst 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.
  • 5.3. IRB staff 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 which they have a conflict.

6.0. Procedures for identification and management of conflict of interest by guests at the IRB meeting

  • 6.1. Guests 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 which they have a conflict.

DOCUMENT HISTORY:

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

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

 Revised 10/10/2022 - Added identification and management of COI for a guest at IRB meeting; clarified that any financial interest by IRB members, consultants, staff and guests at the meeting is considered a significant financial interest within the context of this policy; clarified definitions of financial and non-financial COI; added definition of guest; clarified timing of disclosure of COI by IRB members; added IRB member whose only conflict is that he/she is participating personnel on a protocol may serve as protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting room during the vote, but will abstain from voting; added that IRB staff with COI must leave room during the discussion and voting phases of the review of the protocol in which they have a conflict; deleted option for member with COI to request exception from recusal; stylistic changes for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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