Scientific Review Process
Scientific Review Process for Research with Humans in the School of Medicine
The University Office of Research Integrity has as the requirement for Deans to name a Responsible Official to assure adherence to University policy for human research protection.
Below is a summary of the University policy which requires that the Responsible Official in each school or department conduct the following assessments with respect to research oversight:
- the design for the proposed research is sound and scientifically valid,
- the principal investigator has the knowledge, experience, and qualifications necessary to conduct the research and manage research personnel,
- the principal investigator has the resources necessary to conduct and complete the research as approved by the IRB,
- the conduct of the research and oversight of research personnel are within the scope of the principal investigator’s employment, and
- the principal investigator has the resources necessary to protect human subjects during and after the conduct of the research.
Pursuant to University requirements, the Responsible Office for the UNR SoM and the Office of Medical Research have established a scientific review process for research with humans in advance of submission to the UNR IRB. This review is separate and distinct from the role and purpose of IRB review. The goal of scientific review is to assure that research that is being done is sound in design, investigators have the necessary qualifications, and that adequate resources are in place to successfully conduct the proposed research. In addition, this process is meant to enhance the mentorship, scholarship, and educational experience of our faculty and medical trainees with the overall goal of strengthening clinical research within the School. Several designated reviewers with in depth clinical research experience in and outside the School of Medicine volunteer time to serve on the scientific review committee.
- Submit a narrative proposal using the most relevant template available at the following links for the research along with any data instruments, and the PI’s CV, to OMR@med.unr.edu .
- UNRMed general template(request document by emailing email@example.com) for biomedical or social behavioral research
- Protocol templatesfor descriptive, observational, registry, and clinical trials
- NICD observational protocol template
- OMR staff will assign for review and with a deadline of 5 business days for completion.
- Researchers will be notified of review status, either approved or revisions requested.
- If revision is requested, researchers will return a cover letter or the scientific review checklist responding to revisions point by point, and a track-changed revised protocol to OMR@med.unr.edu.
- OMR staff will notify researchers of final review outcome via email and provide final signed scientific review checklist for inclusion in IRB submission.
- Share Dr. Mark Riddle as the Responsible Official for sign off on all IRBNet submissions.
To understand what the scientific review is looking for please review the scientific review criteria to ensure your protocol contains sufficient detail for scientific review.
The review process takes approximately 2-3 weeks. Researchers are encouraged to work simultaneously on the IRB application, but may not submit the application to the IRB until the scientific review is concluded and Dr. Riddle has been shared and signs off on the IRBNet project. For questions or consultation about this process, contact OMR@med.unr.edu.