GCRC Scientific Advisory Committee (SAC)
Mission Statement
The SAC consists of 8-12 members including a Chair, all of whom are appointed by the Dean of the College of Medicine who is also the PI of the NIH grant that funds the University of Vermont GCRC. Members are appointed, on a rotating basis, for a period of two years. The SAC is therefore responsible to the PI and is composed of a cross-section of facultymembers who are familiar with the broad range of the GCRC research activities. The SACmay not be chaired by the GCRC Program Director or bythe GCRC Associate Program Directors. Individuals receiving salary supportfrom the GCRC grant shall not be voting members of the SAC. The SAC supervises andreviews all operations of the GCRC, its Core Laboratories, Informatics Core, and othercomponents; sets general policies; delineates common needs of the GCRC investigators;establishes admission policies; and evaluates projects for GCRC use. All studies on the GCRC must have SAC approval. This approval must be obtained prior to initiation, except whentemporary approval has been given by the Program Director or his/her designee and the IRB for urgentstudies created by an unexpected opportunity to study unusual research patients; these studieswill be reviewed by the SAC at its earliest meeting.
The SAC prospectively prioritizes projects for GCRC use to assist the Program Director in allocatingresources. In all cases, NIH-funded clinical research is given preference. The SAC isresponsible for ensuring implementation of existing NIH policy on the inclusion of women,minorities, and children as study subjects and for approval of DSM plans for all GCRC protocols. With input from the GCRC Research Subject Advocacy Office, the SAC determines if a protocol involves significant risk, and if so,evaluates and approves the required Data and Safety Monitoring Board (DSMB). The SAC designates for each protocol, the category of inpatient research days and outpatientvisits as Category A, B, or D. For appropriate classification of industry-related projects, theSAC may request any additional materials deemed necessary in making this determination.
The SAC periodically reviews all GCRC operations to ensure that GCRC resources are
used for the most scientifically justified and relevant projects. Each year, a copy of the GCRC’s Annual Progress Report is posted on the secure member-only area of the GCRC website ( for viewing by SAC members and is reviewed at asubsequent SAC meeting. The SAC encourages junior faculty members to performclinical research and assist them in applying appropriate concepts and methods. Meetings of the full SAC are held at least quarterly, and usually monthly, and detailed meeting minutes are kept. The minutes of the SAC meetings are examined at the site visit when the GCRC grant application is reviewed. The SAC may form subcommittees to carry out some of its functions, which may include thereview of biostatistical design of projects, ethical concerns, or the assignment of priority scoresbased on scientific merit as well as their need for GCRC resources.
The SAC includes a biostatistician as a voting member who provides an independent review of project design and ensures that appropriate data analyses are planned. This individual is not the GCRC Biostatistician who is paid from the grant and who is available to assist investigators with the design and statistical aspects of their studies.
The SAC works closely with the Program Director to proactively address investigator resource needs,encourage GCRC use by investigators at the institution who are not currently using theresource, and provide outreach to investigators from institutions without a GCRC or
comparable resources.
The SAC oversees the GCRC budget. All requests to NCRR for funds (competitive
renewal, noncompetitive renewal, supplements) are endorsed by the GAC prior to
submission of the request to NCRR. Once funds are awarded, all significant rebudgeting is
endorsed by the SAC. During the grant year, the Program Director and Administrative Directorwork closely with the SAC and provide systematic updates on financial mattersincluding: comparison of projected expenditures with actual expenditures to date; and actual use to date of GCRC resources (inpatient days, outpatient visits, ancillaries) by specificprotocols. In addition, the Program Director and Administrative Director report to the SAC onapparent unmet needs of investigators, career development and other related activities, andother topics of relevance to the GCRC.
The GCRC Staff Assistant, records minutes of the SAC meetings which document all reports to the SAC and allrecommendations and actions made by the SAC.