The Application Process
As noted elsewhere, GCRC resources are free to a study, but getting GCRC support involves a peer-review competitive application process. The body responsible for this process is the GCRC Advisory Committee (GAC). Utilization of GCRC resources by a study occurs as collaboration between the GCRC staff and the Principle Investigator’s team. The earlier in the process you talk with us, the better that collaboration will be. You are encouraged to contact Susan Eberly, GCRC Administrative Manager at 865-4302 to set up a meeting to discuss your protocol.
GCRC Application Submission
Your completed GCRC application form will provide reviewers with detailed information on your protocol. You are required to include investigator information, information on GCRC resources requested, IRB approval information, nursing and nutrition requirements, laboratory and ancillary requirements and funding information. The protocol will include a detailed scientific protocol and scientific abstract. An optional lay abstract may also be included. You are also required to include a copy of either your approved or submitted outside funding budget, if appropriate, and any questionnaires or similar tools used in your study. We suggest that you meet with the GCRC staff to plan how your study will be executed in the GCRC before you finalize your GCRC and IRB Applications in order to avoid multiple protocol modifications.
Data and Safety Monitoring Plan
NCRR requires that all GCRC protocols have a data and safety monitoring plan that has been approved by the GAC. This plan is to be submitted as part of your GCRC Application for review and approval by the GAC. The Research Subject Advocate is available to assist you with any questions you may have as to the appropriate level of risk associated with your study.
Meeting Dates and Submission Deadlines
The GAC meets monthly and the deadline for submitting a protocol to the GCRC is three weeks prior to each GAC meeting. During this time we will meet with you and your team to review what you propose and to discuss the details of your protocol. If your application requires extensive collaborative development, we reserve the right to delay submission. Therefore, we recommend that you involve us as early in the project as possible.
GCRC Modification Request Form
Any modification to an existing GCRC protocol must be approved by the GCRC Advisory Committee as well as the IRB. In order to simplify the process for investigators, a copy your correspondence to the IRB outlining the changes you propose should be sent to Susan Eberly in 112 Elmore Research Wing/Noll Lab, or via email to sxe1@psu.edu.
If the changes you propose do not affect a) subject risks/safety, b) the science of the study, or c) the GCRC resource utilization, then no further action will be required by the investigator and you will be notified when the changes have been administratively approved. If your request does result in changes to any of the above, we will then ask you to fill out the Request for Modification of an Existing GCRC Protocol Form.
IRB Application Submission
All research conducted involving human participants must have IRB approval before you begin. For more detailed information please visit the Office of Research Protections website at http://www.research.psu.edu/orp/.
While the primary role of the GCRC staff is to collaborate with investigators, the GCRC staff has some similar responsibilities to those of the IRB. The GCRC and IRB therefore have worked closely to develop a sequenced review to streamline the review process in order to provide better service to investigators. This process includes the sharing of decisions/recommendations by both bodies as well as the investigator responses to both.
GCRC Advisory Committee Review
Your protocol will be reviewed by the GAC and assigned priority scores for both resource utilization and scientific merit. There are four possible outcomes for a protocol: 1) approved as written; 2) approved pending required changes, (a response is required from the PI which will be forwarded back to the reviewers for acceptance), 3) approved with suggested changes, and 4) denied. You may not begin your study until all requirements have been satisfied and the IRB has approved any changes made.