Protocol Submission Procedures
School of Nursing Research Review Committee (SONRRC)
All University of Maryland School of Nursing (UMSON) faculty, staff, and students conducting human subject research must submit their research proposals to the UMSON Research Review Committee (SONRRC) prior to submission to the University of Maryland Institutional Review Board (IRB). The SONRRC consists of faculty members from UMSON and doctoral-prepared University of Maryland Medical Center nursing personnel. The SONRRC must review all UMSON research proposals (including exemptions/surveys) prior to IRB submission. The primary purpose of this review is to verify the scientific basis for the proposal and protect the rights and welfare of human subjects.
- The SONRRC conducts electronic reviews the second and fourth Wednesday of every month. Proposals and supporting materials are due in the Office of Research on the preceding Friday. Since the reviewers need adequate time to evaluate the proposals, exceptions cannot be made to this time line.
- The Principal Investigator (PI) must enter protocols in the electronic protocol submission program, CICERO (Collaborative Institutional Comprehensive Evaluation of Research Online). The PI should then copy and paste the completed protocol (CICERO application) into a Microsoft Word or PDF document and email it to the SONRRC manager, Lynnee Roane, BSN, RN, at firstname.lastname@example.org. Only materials submitted in electronic format, i.e., email with attached Word/PDF documents, will be accepted since the SONRRC members review protocols electronically and the protocol must be submitted to CICERO electronically. In addition, all data collection instruments and consent form(s) must be submitted.
- SONRRC faculty member(s) will review the proposal and comment on the following areas: study design and whether it is likely to answer the proposed question, potential risks and mechanisms for reducing those risks, ethical principles, conflict of interest, and the consent form.
- PIs are required to address SONRRC reviewers’ comments. Prompt response is required to prevent delays in the review process. PIs who have questions pertaining to the SONRRC review can meet with the SONRRC manager, faculty reviewer, and/or associate dean for research. Once the comments have been addressed, the faculty reviewer will be notified to give final approval for IRB submission. If a proposal does not express the requirements of scientific validity and protection of human subject rights and safety, the SONRRC comments will be given to the PI with instructions to revise the proposal and resubmit it for additional SONRRC review.
- After approval by the SONRRC, the PI submits the completed proposal to the IRB through CICERO. The CICERO system sends an email to the associate dean of research for review and signature. Once the associate dean for research reviews and electronically signs the proposal, the proposal is forwarded to the IRB in CICERO.
- Due to the increasing complexity of the regulatory environment, each new investigator will be encouraged to meet with the SONRRC manager to review and discuss PI responsibilities. At least once each year a synopsis of investigator responsibilities will be distributed to all investigators and they will be required to sign the agreement to indicate that they have reviewed the synopsis.