department of anesthesia and Perioperative medicine
Preparing a Research Proposal
Considering a new project? Here is a preliminary checklist when planning a new project:
- Have you and all co-investigators to be included on the protocol completed the required “CITI” course through the IRB (links below)
- What problem are you trying to address? What is your hypothesis?
- Has this question been addressed before? If so, how is your study different and likely to lead to new and/or different knowledge?
- Do a thorough literature search; summarize and save results. You will need them for this application, the IRB process, and future publication.
- What new information will this project generate: for example, how will it help advance the field, improve (or change) existing paradigms, create new ones, improve patient care, etc.
- What is the most appropriate method to address this problem (study design)? Is it a chart review or pilot study (e.g. essentially no prior information about the problem or therapy), randomized controlled trial, etc.?
- What is your primary outcome or response variable? What are secondary outcome variables?
- If your goal is to examine an effect or outcome, compare 2 or more approaches or therapies, etc., what do you estimate the clinically significant result or difference to be? What is this estimate based on (e.g. clinical practice, published literature)?
- What types of data will be collected and how will it be analyzed?
- Are there sufficient numbers of patients and/or procedures of the type required? Should a power analysis be included?
- If informed consent is required, what is the likely consent rate given the kinds of patients and required study procedures?
- Are the patients’ other physicians (e.g. surgeons, intensivists) involved as co-investigators? If not, have they reviewed and agreed to cooperate?
- If a drug or device study, has the drug or device been FDA-approved for this (or any other) use? Is an IND or IDE from the FDA likely to be necessary (McGowan can help with this question)
- Discuss with a senior faculty member, advisor, and/or mentor to help address questions of novelty, study design, etc.
- What resources will you need to complete the project (Budget)? Include your time, that of other key personnel (e.g. data coordinators, significant statistical collaboration), any equipment and/or supplies that that need to be purchased, costs of services that need to be purchased (clinical laboratory tests, pharmacy charges (e.g. blinded dispensing), etc.
A& PM Research Proposal Forms