Membership
The SAC shall have a diverse membership with broad capabilities, where each member brings important and relevant areas of expertise.
- The SAC shall include representatives of the kidney, liver, heart, heart-lung, intestine, pancreas transplant communities, and the organ procurement community as well as transplant candidates/recipients, and shall include individuals with qualifications in the areas of clinical, statistical, and/or epidemiologic research related to transplantation, multi-center data collection, quality control and utilization, and biostatistics. To the extent feasible, the following areas of expertise and related issues shall also be represented: pediatrics; ethics; minorities; consumer and living donor. The SAC shall include representatives from relevant OPTN committees, especially representatives from organ-specific committees.
- The size of the SAC should be of an appropriate size to facilitate meaningful input from all members.
- No more than 50 percent of the SAC shall be comprised of transplant surgeons and transplant physicians.
- The Project Officer and the Director of the Division of Transplantation, or their designees, shall serve as ex-officio, non-voting members of the SAC and all sub-committees and working groups that may be established. In addition, the Project Officer shall have the authority to have Federal experts present at SAC meetings and involved in the work of the SAC. A representative of the OPTN who is familiar with the data collected by the OPTN shall serve as an ex- officio member of the SAC upon approval of the Project Officer.
- For the initial term of the SAC, a Chairperson will be selected by the Contractor, with the approval of the Project Officer.
- The Chairperson shall serve in this role for a standard term of one year, with the option to extend service for a second year.
- Once selected, the Chairperson shall preside over the election of a Vice-Chairperson to assist in managing the SAC, to serve as Chairperson in the Chairperson's absence, and to succeed as Chairperson.
- Members of the SAC shall serve for a standard term of three years. Initial terms may be longer for some members to achieve a staggering of membership terms in order to achieve continuity of membership as determined by the Chairperson and Contractor, and approved by the Project Officer. One third of the initial constituted committee shall have a term of the standard three years, one third shall have an intial term of four years, and one third shall have an initial term of five years.
- Non-voting members shall have the same rights and privileges as other members, except that they shall not vote on any matter.
- A majority of the members eligible to vote represented in person, by teleconference or by video conference, shall constitute a quorum for the transaction of business at any meeting. A vote of a majority of those present and eligible to vote shall be sufficient to transact any business that might come before the meeting. Interval actions of the committee may be taken by vote conducted via fax and/or e-mail.
Guard Against Conflicts of Interest
Since the technical expertise required to make informed decisions may best be obtained from those involved in organ procurement and transplantation, it is reasonable to expect that conflicts of interest may arise within the SAC. The SAC shall ensure that its deliberations do not constitute a conflict of interest for its members, and where conflicts do arise, the SAC shall conform to the following procedures:
- Each year, each member of the SAC shall sign a statement of disclosure of conflicts of interest.
- SAC members shall declare any possible conflict of interest in discussions during each SAC meeting and on other occasions such as in working groups, in publications, etc.
- Should special topics arise which bear potential conflict of interest concerns for individual members of the SAC, the SAC shall follow procedures that allow the affected member participation during deliberations but not in the decision making: The affected member may remain present during discussion, but shall not be permitted to vote on the issue, and shall be absent from the room during voting by other members.
- When in doubt about conflicts of interest, the SAC shall err on the side of caution and transparency in order to assure the conflict of interest does not affect decisions of the SAC.
- Conflict of Interest Certification coordinated by the Contractor shall certify to the HRSA Contracting Officer each year, in the documented minutes of the SAC, that such conflicts do not exist in the deliberations and decisions of the SAC.
Convene Meetings
- The SAC shall meet at least four times a year or as modified by contract with HRSA. At least one meeting of the SAC shall be in the Washington, D.C. metropolitan area. The quarterly SAC meetings shall be held with the full SAC.
- Special meetings of the SAC may be called at any time by HRSA, the Contractor, the Chairperson, or a majority of the SAC members with approval of the Project Officer (based on available funds). Special meeting requests shall be submitted in writing to the Contractor and should state the requested time, place and purpose of the meeting.
- Expenses related to voting SAC members (excluding Federal members) attending SAC meetings shall be paid by the Contractor; however, SAC members shall receive no further financial compensation for their work.
- The Contractor shall provide the Project Officer and the SAC members with a meeting agenda and background materials at least two weeks in advance of each scheduled SAC meeting.
- Minutes of all SAC meetings shall be taken by Contractor staff. All minutes shall be completed within 2 weeks following SAC meetings.
SAC Directed Studies
- Studies requested by the SAC should be conducted by Contractor-assigned staff with appropriate training, experience, and credentials in medicine, biostatistics, epidemiology and computer programming.
Annual Goals
- The SAC shall develop an annual set of goals consistent with the scope of work and deliverables under this contract. The SAC shall consult with the relevant entities and organizations including the OPTN, the Project Officer and the Secretary's Advisory Committee before establishing the annual set of goals.
- Annual goals shall be submitted to the Project Officer by month 6, 15, and 27 of this contract or as modified by contract with HRSA.
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