Scientific Review Process for Research with Humans at UNR Med

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 Official for the UNRMed 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 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. Completion of this review is also a requirement of Research Integrity, which manages the IRB, in advance of that review. This review applies to biomedical and clinical translational investigator-initiated research with humans, their identifiable biospecimens, or identifiable data that has not undergone peer-reviewed grant application or industry application. This review does not apply to social behavioral and educational research.  Investigators covered by this review include UNRMed and Renown clinical or basic science faculty, affiliate faculty, students, medical trainees, and staff.

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.

Review process

1. Submit a narrative proposal for the research along with any data instruments, and the PI’s CV, to OMR@med.unr.edu . The “Protocol-biomedical” should be used and is available by registering in IRBNet, the online submission system for human research, and downloading it from the Forms and Templates library online.
2. OMR staff will assign for review and with a deadline of 5-7 business days for completion.
3. Researchers will receive notice of review status, either approved or revisions requested.
4. 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.
5. OMR staff will notify researchers of final review outcome via email and provide final signed scientific review checklist for inclusion in IRB submission.
6. Share Danielle Eaton as the Responsible Official for sign off on all IRBNet submissions.

To understand what the scientific review evaluates please review the scientific review criteria to ensure your protocol contains sufficient detail for scientific review.

The complete 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 Danielle Eaton has been shared and signs off on the IRBNet project. For questions or consultation about this process, contact OMR@med.unr.edu.