Application Process

Full Proposals

• Invited applicants are to follow the RFP guidelines for submitting the full proposal, which includes:
  • Specific aims
  • Background and significance, including the clinical and translational research and/or translational science relevance and potential impact on the field
  • Brief overview of approach
  • Study timeline with specific milestones to be accomplished 
  • Role of the study in securing extramural funding for a larger, forward-going project
  • References
  • Budget and justification
  • NIH Biosketches
  • Appendix
• Invited applicants are also encouraged to participate in the CTSI BERD Core's Research on a Napkin opportunity, which will provide project-specific advice to enhance pilot study full proposal applications. 

For proposals involving human subjects, the PI must register their study with Central Study Registration (CSR) prior to submission of the full proposal. Pilot studies proposals that involve human subjects that are not registered in CSR will not be accepted. To begin the CSR process, a proposal document (at minimum) is required. For any questions regarding CSR, contact the CTSI Clinical Research Facilitators (716-829-4357).

• The HRP-503-Protocol template can be found in the Click portal, within the IRB Library section, under the “Templates” tab.
• Exceptions to CSR and scientific review of HRP-503 protocols:

(1) If you are submitting your protocol to the IRB for determination of "Not Human Subjects Research."

(2) If you are seeking "Exempt Status" from the IRB for your study. 

(3) Due to reporting requirements, studies involving the use of clinical data (e.g., EHR data) must be registered within the system. If bypassing CSR, please leave a comment in Click indicating you are seeking one of the above listed determinations. This will allow the IRB Intake Coordinator to know your study should not be returned for registration. 

• For proposals involving human subjects, following submission of the full proposal, the PI must submit all necessary documentation (e.g., IRB protocol and related materials, human subjects education as applicable, ClinicalTrials.gov registration status if applicable, and conflict of interest) no later than 10 days following notice of award.
• For proposals involving animal subjects, the PI must submit their protocol to IACUC no later than 10 days following notice of award.

*PIs from Roswell Park Comprehensive Cancer Center should follow a similar process while utilizing the RPCCC Click and IRB.