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The e-signature function in RSS is a way to electronically sign consent forms. It can be used if the consent process is conducted in person (face to face) or remotely (telephone or video as approved by the IRB). RSS e-signature can only be used for certain st...

Guides to assist with RSS procedures: If there is a topic that does not appear below, please contact irbora@unmc.edu Adding Personnel Adding Documents to an Application Consent Forms 101 Creating and navigating a New Application Deleting Personnel Functions w...

This page serves as a hub for all of the Investigator Guidance Series documents. Each document is an abbreviated version of one of our HRPP Policies and Procedures intended for investigators, coordinators, and other study team members. This page is a good star...

All individuals that work on human subject research projects must complete human subject research training. Faculty, students, or employees of UNMC, NM, CHMC, UNO, BMC, or another academic partner institution are required to take CITI training. Community partn...

Single IRB is a model of IRB review that is intended to streamline and reduce administrative burden on IRBs reviewing multisite studies. In a single IRB model, one IRB serves as the reviewing IRB or “IRB of Record” and the participating site (pSite) IRBs serve...

The UNMC sIRB Process is captured in the diagram below. Contact sirb@unmc.edu with any UNMC sIRB process questions.

sIRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change Deadline for Continuing Review submission is the 1st day of the month prior to expiration. Full Board Deadlines (printable PDF) sIRB Full Board Submission Dea...

Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval of a study. The UNMC IRB uses the term “single IRB” or “sIRB” to indicate that UNMC is serving as the reviewing IRB (i.e., the IRB of record) of a multisite study...

The UNMC IRB uses the term “central IRB” or “cIRB” to indicate that the reviewing IRB (i.e., the IRB of record) of a multisite study is external to UNMC. The UNMC IRB has contracted with two commercial IRBs, Advarra and WCG. In addition, the UNMC IRB partners...

Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the funding agency or sponsor (as applicable), prior to initiating the research. UNMC cIRB Initial Review Process External cIRB Process Contact your external cIR...

When requesting to rely on an external IRB, the UNMC IRB will assess the external IRB’s qualifications in accordance with HRPP Policy 1.4 (UNMC Ceding Review to an External Central IRB). The UNMC IRB may request information related, but not limited, to: SMART...

Note: the UNMC IRB cannot answer questions related to external IRB processes or applications. Contact the external IRB's helpdesk or designated representative directly for assistance. For questions regarding UNMC cIRB processes or applications, please contact...

In line with most other academic medical centers and universities, the Office of Regulatory Affairs and the IRB charges an initial submission and an annual continuing review fee for commercial and industry sponsored protocols. Central IRB: effective 7/1/202...

For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu.

Iqbal Ahmad, PhD Chair, SROC 402-559-4091 Email IRB Analyst III, SROC 402-559-3779 Email

In 2008, the Human Embryonic Stem Cell Research Advisory Committee of the National Research Council and Institute of Medicine published Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research. Section 2.0 (page 11) describes th...

Scientific Research Oversight Committee (SROC) Submission Form for Stem Cell Research SROC Application for Continuing Review SROC Request for Change in Protocol

Below investigators will find a variety of resources that may assist with research goals: Allowable Costs Related to Participant Inclusion Activities Emergency Preparedness / Continuity of Operations Plan (EP/COOP)

Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR: 21 CFR Part 56-Institutional Review Boards National Institutes of Health: NIH Home Page Office of Recombinant DNA Activities (ORDA) Office of Grants and Contrac...

MENTAL HEALTH CONSIDERATIONS FOR RESEARCHERS DECEMBER 2023 EXPLANATION OF RISKS: Be clear in application and ICD about risks associated with mental health assessments (cognitive status assessments, IQ screens, mental health assessments, exploitation/abuse/v...