"If we knew what it was we were doing, it would not be called research, would it?" - Albert Einstein
Develop a hypothesis
Complete a preliminary li review
Establish commitment from a mentor
Complete CITI training
Finalize literature review
Develop study design
IRB submission no later than the end of PGY2 year (earlier if large project)
Determine funding sources (do this early!)
Finish data collection on your project
Poster presentation or abstract submission (or both!)
Finalize your manuscript for publication
Submit your work for publication
Finish any ongoing study
You do not want to be finishing this while studying for boards
If you are lucky enough to be done early, help others!
Don't forget to update your CV with all of your hard work
CHOOSE AN ADVISOR
THINK OF A PROJECT
Develop a hypothesis. More generally, what question are you trying to answer, and how would you answer/test this hypothesis? Keeping this question simple will maximize your success through the Office of Research & Innovation and the IRB.
This is an important time to determine what do you want to do with your project when you’re done. Is the end goal a poster presentation or would you like to publish in a journal? I recommend you consider striving for both. Your faculty mentor can assist you with determining feasibility with these goals.
Another thing to consider is that you do not need to go this adventure alone. If you are considering a moderate to large scale project, it would be beneficial to partner with another resident. A shared google drive can be used to organize literature, templates and keep everyone involved on the same page.
An important aspect of developing an idea is to determine if this question has already been answered. Visit our “how to do a literature review” article for step-by-step instructions on how to do this. You may perform multiple lit reviews before you find a feasible project. This is normal.
START ORGANIZING A PROTOCOL
This is where you start organizing your thoughts on paper and begin designing a draft of your protocol and informed consent document. You need to consider WHO will be involved in the study (attendings, residents, pharmacist, patients, students, etc.). Further, you need to consider HOW your data will get collected and how your patient’s will be enrolled in your study. Will you need any funding for your project? How will you record and store the data safely and securely? See the "how to develop a research protocol" page for detailed assistance with this. Your protocol does not need to be completed before moving to the next step, but it will save you time on the back end if you start organizing it now.
OFFICE OF RESEARCH & INNOVATION CONSULT
Before submitting to the Mercy Health Regional Institutional Review Board (IRB), all researchers must first consult the Office of Research & Innovation for a feasibility review. To do so, submit a consultation request. The Executive Director will review the research proposal, provide any necessary guidance and grant approval to proceed. Written approval by the Office of Research & Innovation must be obtained prior to IRB submission. The IRB cannot process a project for review until written sign off has been received. Visit the "how to consult the office of Research and Innovation" page for a step-by-step guide on how to do this. Please allow 6 weeks for the pre-IRB submission process.
DETERMINE A MINIMUM SAMPLE SIZE
While you are working with the Office of Research and Innovation, go ahead and submit a Scholarly Activity Consultation Request with the MSU Statewide Campus System. The Office of Research and Innovation will ask you “How many patients must be enrolled in your study.” We are partnered with MSU-SCS and we have access to their Statisticians. They analyze your data and tell you how many patients you need for adequate power for statistical significance. Visit the "how to consult MSU" page for a step-by-step guide on how to do this.
COMPLETE ETHICS TRAINING
1. CITI Training
All study members must complete CITI training for certification in Human Subjects Protection. This certification is good for 3 years. Click the CITI Training link below for further instructions.
2. NIH Financial COI Module
For each individual study, the NIH Financial Conflict of Interest module must be completed. Every person on your study will need to complete this module and have a certificate for submission of your project to the IRB. Make sure you save a certificate before submission to the IRB. Make sure you save the certificate before exiting the module. I recommend you screen-shot the certificate with your name on it as well, as the site tends to save the certificate without the name listed.
Funding and financial support for a study requires approval by the Office of Research & Innovation. Fortunately, they can also help you find and apply for funding if needed. Not all studies will require funding. In fact, the minority will. Mercy health has institutional standard operating procedures for this. Consult the Office of Research & Innovation if you feel your project will need funding.
FINALIZE AND SUBMIT TO THE IRB
The Office of Research & Innovation will provide all necessary guidance on your research proposal and grant approval. They will need to give you a written sign off prior to IRB submission. All changes to your protocol or study design will need to be reviewed by the Office of Research & Innovation prior to IRB submission. Submission occurs through the IRBManager portal. All research staff will require access, and a username and password can be requested using the links below. Further, a checklist of items typically required for IRB can be found using the link below. It is important to understand that the Office of Research & Innovation will assist you with the specific items you may or may not need.