1. Administrative Review

The PI should notify the CRHC administrator of plans to submit a research grant proposal as soon as the PI has determined to submit. In no instance may this be less than 30 calendar days before the submission is due. The PI should provide the following information via e-mail, letter, telephone, or in-person communication:

• The general topic.
• The due date of the proposal.
• The funding agency.
• Names of co-investigators and collaborators.
• Names of participating institutions.
• Names of two to five faculty members who are qualified to review the proposed research for scientific and technical merit and for overall research value.
• The URL for the RFA/RFP if applicable.
• An estimate of what kind of resources will be needed to get the proposal out:
  • Secretarial support and production assistance.
  • Writing/research design assistance.
  • Statistical consulting support (sampling plan, analysis design).
  • Graphics support (organizational/flow charts, conceptual framework depiction, etc.).
  • Budget development and budget justification.

To facilitate this process, we have developed a Grant Proposal Checklist for your use in providing this information. To download the checklist from the CRHC Web site, click here.

The administrator will develop a timetable with calendar dates for completion of specific tasks, and support staff will be assigned as needed.

Copies of the timetable will be distributed to the grants manager, the PI, and the responsible secretary.

The secretary will track the timetable and issue reminders to the PI if timely action has not been taken on specific tasks. However, the PI will have ultimate responsibility for ensuring completion of items on time.

If the PI is concerned that a deadline is going to be missed, he or she should discuss the problem and potential solutions with the administrator.

2. Data Management Review

For all proposals involving the collection or manipulation of data, the CRHC Data Center should be involved in planning the parts of the budget and technical proposal that relate to data management.

PIs are required to contact the Data Center director early in the proposal preparation process to begin to discuss this issue.

3. Budget Review

For all proposals to agencies that permit the inclusion of secretarial support, secretarial time should be estimated and associated costs must be included in the budget.

All proposals from the CRHC must undergo the Department of Medicine budget review process as well as the CRHC internal budget review process.

Based on experience and departmental requirements, a new schedule for final budget submission has been developed.

• A draft budget and budget justification must be submitted to the Department of Medicine for review 1 month before the proposal due date.
• All budgets that identify collaborators or key personnel from any institution or department outside the Department of Medicine must be submitted to the grants manager 45 working days before the proposal due date. This will allow the grants manager to verify salaries and contractual arrangements prior to submission of the draft budget.
• If no external departments or institutions are involved, the draft budget and budget justification must be submitted to the grants manager 35 days before the proposal is due.
• Once the budget has been drafted, it will be submitted to the Data Center director for review of data-related costs as applicable.
• The overall budget will be reviewed by the CRHC administrator to ensure that all costs are allowable and that sufficient effort has been allocated to complete the research.
• A final budget and budget justification must be submitted to the grants manager at least 10 days before the proposal is due.
• After the CRHC administrator signs off on the budget, it will be submitted to the Department of Medicine and the University's Office of Research for signatures.
  

4. Clearances from Additional Review Committees

Collaboration with other departments, schools, or institutions (e.g., Western Psychiatric Institute and Clinic) may require clearance of the research proposal by other review committees. The PI will be responsible for determining these requirements and meeting the deadlines.

5. Scientific Review

Investigators will have grant proposals reviewed by qualified peers who are at the University of Pittsburgh but are not formally part of the proposal. The administrator will contact two potential reviewers from the names submitted by the PI and inform them of the impending review. If they are unable to participate, other reviewers will be recruited.

Two copies of the research proposal will be submitted to the administrator within 3 calendar weeks of the submission deadline. If applicable, copies of the funding agency guidelines or specific requirements (e.g., full text of the RFA or RFP) should accompany the proposal so that responsiveness to specific application criteria can be assessed. If the proposal is a resubmission, the reviewer comments (i.e., "pink sheets") should be submitted to enable CRHC reviewers to ascertain whether the study section reviewer concerns have been sufficiently addressed. The submitted proposal is not expected to be in final form but should include the crucial elements—specific aims, background and significance, preliminary studies, research design and methods, project timeline, human subjects information, and literature cited—in sufficient detail to allow an adequate assessment of the proposal's merit. PIs who are unable to meet this deadline should inform the administrator and request an expedited review.

A copy of the proposal and a review (rating) form will be sent to two primary reviewers. To download the Internal Scientific Review Form, click here. PIs and reviewers are expected to notify the administrator of potential conflicts of interest. The primary reviewers will evaluate the submitted proposal in detail and complete the review form. Reviewers are expected to evaluate each of the following components of the proposal:

• Specific aims.
• Hypotheses.
• Background and significance.
• Preliminary studies.
• Research design.
• Data analysis plan.
• Feasibility.
• Clarity and organization.
• Qualifications of PI.
• Facilities and environment.
• Protection of human subjects. (Please note: The federal requirements regarding the section pertaining to human subjects have changed substantially, so it is important to read all of the PHS 398 instructions for this section.)
• Inclusion of minorities and women.
• Responsiveness to the RFA/RFP (if applicable).
• Personal statement (for K awards).
• Career plan (for K awards).
• Response to reviewers (for resubmissions).

Reviewers are asked to rate each of these components on a scale ranging from 1 (good) to 5 (poor). In addition, they are asked to offer specific comments and suggestions, especially on components judged to require substantial revision. They are also asked to assess whether the proposal is exempt from IRB submission or whether it should undergo an expedited or full IRB review process.

To give the PI ample time for revision, reviewers are expected to complete and return the scoring sheets and a detailed critique within 1 week of receipt of the draft proposal. They are expected to submit their reviews to the PI and to the CRHC administrator. Reviewers have the option of contacting the PI directly to discuss the proposal or of keeping their comments anonymous. Any reviewer who finds a proposal to be unacceptable should inform the CRHC administrator to allow for corrective action. Proposals rated as unacceptable must be re-reviewed after revisions have been made. Given the adverse consequences of deferred submission, every effort will be made to correct problems and to submit the proposal on time. However, some proposals may need such substantial revision that timely submission is unrealistic. Deferral to the next cycle may be recommended in these cases. If there is not unanimity among reviewers and the PI regarding the type of IRB review the protocol should undergo, the PI should meet with the CRHC administrator to make the appropriate determination. Once the review process has been completed and revisions made, the PI may proceed with submission to the external funding agency.

6. Consideration of Special Circumstances

• Collaborative Proposals—CRHC investigators who collaborate as co-investigator or co-PI on grant proposals submitted through another division, department, school, or institution are encouraged to submit a proposal for review. This will not be mandatory.
• Competing Continuations—Maintain the same schedule for administrative and scientific review as outlined above.
• Noncompeting Continuations—Conform to the schedule for administrative and budgetary issues. Scientific review is not mandatory.
• Proposals Responding to RFAs/RFPs—Research proposals responding to RFAs/RFPs should maintain the same schedule for administrative and scientific review as outlined above. However, RFAs/RFPs are occasionally released with only a short time interval (e.g., 60 days or less) to the submission deadline. Peer review of research proposals should still be undertaken under these circumstances, but submission for review may be as late as 10 working days prior to the funding agency deadline. In this case, a written critique should be returned to the PI within 2 working days.
• Training Grants—Maintain the same schedule for administrative and scientific review as outlined above.
• Career Development Awards—Maintain the same schedule for administrative and scientific review as outlined above.
• Other—Investigators sometimes become aware of a funding opportunity at a very late date (e.g., 1 month or less before the deadline). In this case, the PI should meet with the CRHC administrator to establish an appropriate timeline and determine an appropriate review procedure.

7. Review and Submission of IRB Protocols and UPMC Fiscal Review Forms

Current regulations allow for submission of an IRB protocol after the proposal has been funded.

The instructions for the IRB protocol outlined in the University of Pittsburgh IRB Reference Manual (see http://www.irb.pitt.edu/manual/default.htm) must be followed precisely. All protocols being submitted to the IRB must undergo the CRHC scientific review process and be accompanied by a Scientific Review Certification Form (click here to download a copy of the form). As indicated in Appendix C of the IRB Reference Manual, protocols that are submitted to the IRB without a signed document indicating technical approval will be returned to the PI. If the protocol is associated with a proposal that has successfully undergone CRHC scientific review, then the CRHC administrator will review the protocol and sign the review documentation. If the protocol has not been previously reviewed, then another reviewer, along with the CRHC administrator, will review the protocol.

All investigators performing research in UPMC facilities are also required to submit fiscal review forms. The forms and the associated instructions can be found at http://www.irb.pitt.edu/upmcforms/fiscal.htm. The forms must be submitted at the same time the IRB protocol is submitted for review.