Executive Committee

Chair:

Saul Suster, M.D.

Co-Chair:

David Harder, Ph.D.

Voting Members:

T. Clark Gamblin, M.D.; David Gutterman, M.D.; Ming You, M.D., PhD.; Susan Tsai, M.D.; Doug Rizzo, M.D., David Johnstone, M.D.; Elizabeth Jacobs, M.D, MBA; PhD.; Hallgeir Rui, MD, PhD; Ann Nattinger, MD, MPH, Jennifer McIntosh, DO

Non-Voting Members:

Mary Rau, Liz Steiner

Purpose:

To provide leadership for the most effective use of biospecimen resources under the governance of the MCW Tissue Bank Executive Committee.

Policy:

  1. 1) The MCW Tissue Bank Executive Committee has vested interest and authority over all biospecimens acquired by the MCW Tissue Bank that fall under the MCW Tissue Bank’s IRB approved protocol. All other specimens acquired under a separate IRB are under the jurisdiction and control of the PI of that IRB.
  2. 2) Requests for these MCW Tissue Bank biospecimens can be done only through MCW faculty members. This does not exclude outside investigators from utilizing the Bank, but it must be done in collaboration with an MCW faculty member.
  3. 3) Every request of the MCW Tissue Bank must first pass a feasibility check with the Utilization Committee. This represents a review of inventory and best use of specimens for the PI’s scientific intent by the members of the Tissue Bank’s Utilization Committee. Requests that pass the feasibility check will follow with communication to the PI, and will then have to go through the Executive Committee process.
  4. 4) The specimen request will be presented to the Executive Committee either as an Expedited Review or as a Full Committee Review request.
    • An Expedited Review will consist of a request presented to a select committee member via email for electronic approval or denial. An expedited review will be allowed one week for an approval or denial.
    • If a denial is rendered, a Full Committee Review will be initiated.
    • An Expedited Review request will only be accepted when the following criteria are met:
      • There are no existing competing requests for the same specimens.
      • The number of specimens requested is not flagged by the Utilization Committee during Utilization Committee review.
      • This flag could be raised by the Utilization Committee based on any concern that may require deliberation, such as the number of specimens collected compared to the total number of specimens banked, the total number of like specimens banked, and the total number of like-specimens collected thus far over the life of the bank.
    • A Full Committee Review will consist of a meeting of the Committee to determine if and/or how specimens will be distributed to investigator(s).
    • A Full Committee Review will be initiated when any of the following scenarios occur:
      • Competing requests for the same specimens occur
      • The Utilization Committee has flagged a request.
      • A denial has been submitted by any of the Committee members for an Expedited Review
      • Full Committee will meet adhoc whenever these circumstances occur.
  5. The criteria by which the Executive Committee conducts Full Committee Reviews will be based on a discussion of the following:
    • Funding Source
    • Scientific Merit of Proposal
  6. Once a decision has been made by the Executive Committee, either through an Expedited Review or a Full Committee Review, the PI of the request will be notified of the decision.
  7. The investigator may now go ahead and submit an IRB application and must submit the approved “MCW Tissue Bank Specimen Request Form” with the application.
    • If there are any changes made to the Specimen Request Form once the IRB application has been approved, the approved form must go through the Utilization Committee and Executive Committee processes again with the revised form.
  8. Specimens will only be released to an investigator once he/she has provided the MCW Tissue Bank with his/her IRB approval letter and smartform.