The Chairman of the GCRC Advisory Committee assigns two physicians to review each study submitted. Protocols are also reviewed by Unit Director Carolyn Borne, Clinical Nurse Specialist Patti Jakel, Research Subject Advocate Laurie Shaker-Irwin, Research Bionutritionist Patricia De Miranda, Core Laboratory Supervisor Najib Aziz and Biostatician Robert M. Elashoff. Each reviewer presents a written report on the qualifications of the principal investigator, proposed science, suitability of study design, strengths and weaknesses, subject safety and welfare, and need for center resources. At least one reviewer, who also details the report of the other reviewer, must be present at the meeting in order for the proposal to be considered.

     UCLA-GCRC staff are ex officio non-voting members of the GCRC Advisory Committee and attend the meetings in order to assist the committee in its evaluation of the appropriateness of the requests for center resources.

     After each meeting, the principal investigator of each study reviewed is sent a written notice indicating the action taken by the committee at the meeting.

     No studies requiring center support can take place without GCRC Advisory Committee approval, except when temporary approval is given by the GCRC Director for urgent studies created by an unexpected research opportunity.

     All research studies conducted on the UCLA-GCRC must also have been approved by the IRB. Subsequently, research projects which already have undergone peer review and have been funded by NIH, or other national or local agencies (American Heart Association, American Diabetes Association, etc.) will be reviewed by the GCRC Advisory Committee and evaluated for use based primarily on feasibility (i.e., whether the center can accommodate the needs of the research in the period required to complete the project). Projects funded by foundations, drug companies, or groups without mechanisms for peer review are rated by the committee for scientific merit, need for center resources, and feasibility.

     For industry-sponsored studies, the principal investigator must provide copies of the official, signed research agreement between the industrial company and the UCLA investigator/UCLA Office of Contract and Grant Administration (OCGA) (including the itemized budget). These data must be accompanied by other relevant correspondence to permit appropriate categorization of patients when submitting the application.