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
|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
- 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
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