For studies that are greater than minimal risk, scientific review is required. This is required before you submit to the IRB.
The M Health Nursing Research Proposal Review Committee reviews and approves all research proposals being conducted at MHealth for which nurses are Principal Investigators or Co-Investigators. This review is done in partnership with Fairview Research Administration and the University of Minnesota Institutional Review Board. Approval must be obtained from all 3 bodies prior to initiation of the research at M Health. Please see the links below for more detailed information about the process. (The webpage below will provide the Application Submission Form and Evaluation Review Form.)
For questions, please contact email@example.com.
The RSRC reviews study protocols which have not already undergone appropriate scientific review by another peer-review committee (e.g. Nursing Research Council) for submission to the IRB by Fairview or community researchers.
If a study requires RSRC review, the researcher should submit an electronic copy of the protocol and drafted IRB application, along with an Investigator's Brochure or Device User Manual, if applicable. The submission should be emailed to Fairview Research Administration, and no signatures are necessary.
After the RSRC has reviewed the study, FRA will notify the researcher of any concerns (stipulations). Once the stipulations have been addressed, the committee will submit a formal approval letter to the researcher. This should be included in the IRB submission.
The Research Regulatory Affairs Officer may be reached at firstname.lastname@example.org.