ACRC: Proposal Steps
- Step One: Submit a Proposal
You must apply for a clinical research project by submitting a proposal with an approved faculty mentor (Mentor will schedule the ACRC presentation after the review). The proposal must include the following:
- A Title
- List of authors in order of proposed authorship for a manuscript
- A full study protocol including background and significance, methodology, statistics, and references. (Sample)
- A draft of an informed consent document. Templates can be found at http://www.med.umich.edu/irbmed/ict.htm. (Sample)
- A draft of data collection tools (this can be questionnaires, data collection sheet, patient diaries, etc) (Sample)
- If it is a retrospective query of a database (e.g. Centricity), the specific data fields should be listed. A brief description of time requirements. Include time for investigators are research staff for data collection.
- Step Two: Schedule a Presentation
A presentation can only be scheduled for an ACRC presentation by a mentor, so a PI must review a proposal with a mentor and have the mentor request that the proposal be placed on the ACRC agenda.
Contact the division representative (refer to the main clinical page), and submit the above stated documents for approval along with a completed proposal cover sheet. You may also contact the study coordinator as well for questions/guidance.
- Step Three: Present Your Proposal
You will present the proposal to the ACRC committee. Meetings are held bi-monthly.
- Step Four: Proposal Review
The ACRC will either:
- Accept the proposal,
- Ask for revisions of the study hypothesis, or
- Decline the research proposal.
Note: All study team members must be PEERRS and HIPPAA certified prior to IRB submission.
- Step Five: Write the Project Manuscript
It is the obligation of the primary researcher to write the manuscript for this research project.
The goal of the research project is to produce original research which is submitted for publication in a peer-reviewed journal.
Abstracts may also be developed for presentation at national meetings, but the manuscript and original research article is the primary goal of all clinical research.
To insure that completed research is published in a timely fashion, it is the expectation that once research has been presented as an abstract, a manuscript will be submitted with in 6 months. It is the responsibility (and opportunity) of the first author to write this manuscript. If this is not accomplished a co-author may request the opportunity to write the manuscript as the first author.
EndNote is a useful software tool for incorporating citations into your manuscript. Medical School employees can download a free copy to a laptop/home workstation from the Medical School application site. MCIT (936-8000) can download it free to any core workstation. It can also be purchased from the UM Computer Showcase.