New Research Procedure

• The Research Committee will meet quarterly to review all protocols
• The agenda for each meeting will close approximately 1 month prior to the meeting date

Example schedule:

Agenda close date (Protocol submission deadline)	Meeting date
December 15, 2018	January 15, 2019
March 15, 2019	April 15, 2019
June 15, 2019	July 15, 2019
September 15, 2019	October 15, 2019

 

• Similar to an NIH process, each protocol will be assigned a primary reviewer (MED, BIN, ECN, or RHT) who will also serve to mentor the investigator, if necessary.
• Assignments will be made by MED or ECN
• All protocols MUST follow the NIH format and include the following elements of an NIH grant
  • Significance
  • Innovation
  • Approach
    • Define the primary outcome
    • Perform a power analysis (with the help of your mentor) based on the primary outcome
    • Proposed analysis
    • Expected Results
    • Pitfalls, Solutions, Limitations
    • Future Directions (include the journal that you plan to submit your manuscript to, as well as potential external sources of follow-on funding [e.g. societal grants, NIH R-21, etc.]
  • Budget including a cost estimate, which includes equipment, coordinator time, statistical support, etc. For reference, the approximate cost of commonly incurred expenditures (Appendix A) and guidance (Appendix B) is included below
• When a protocol is approved, the investigator will receive an internal grant for the cost estimate. We will find a clever name for these internal grants.
• Database/retrospective protocols that carry a significant cost (i.e. for coordinator time, statistical support, etc.) will be approved by the Database Committee before moving through this process. Database/retrospective protocols that do NOT carry a significant cost, can bypass this process.
• Education research protocols that carry a significant cost (i.e. for coordinator time, statistical support, etc.) will be approved by the Education Research Committee before moving through this process. Educational research protocols that do NOT carry a significant cost, can bypass this process.
• All protocols that do not follow this process will not be financially supported by the Department of Anesthesiology

Appendix A:
CRC hourly rate: $50
Statistical support hourly rate: $150

Appendix B: Useful Assumptions (modify as appropriate)
Estimate that 1/3 of subjects approached for your study will consent
Estimate a 20% drop-out rate
Estimate hours to consent a single patient
Data collection, analysis to be determined by the applicant