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A Single Subject Protocol deviation is a change in an IRB-approved protocol which is permitted for an individual subject when it is in the best interest of that subject and/or is necessary for research purposes (e.g., data completion). Protocol deviations are ...

Per HRPP policy 8.4 non-compliance (NC) involving the PI and/or study personnel must be promptly reported to the IRB. This non-compliance could involve failure to comply with the Federal Regulations related to the protection of human subjects of research, HRPP...

Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associat...

The contact list for Emergency Treatment authorization can be found here in RSS. Under certain circumstances, a physician may treat a patient with an investigational (non-FDA approved) drug, biologic or device, or treat a patient utilizing a non-IRB approved p...

What is CITI? Collaborative Institutional Training Initiative (CITI) certification is an institutional requirement for all personnel engaging in Human Subject Research (HSR). It includes three primary modules that are required by the institution to participat...

RSS Training for Consent Forms Consent Forms 101 Creating a Consent Form Functions within a Consent Form Signatures on a Consent Form Capacity to consent Assessment of capacity to consent to participate in research Consent Form Readability Recent...

Below are training topics related to the IRB, its history, and its function. Please let these videos serve as a training tool for those new to the IRB and research fields. If you need individual assistance with specific issues, or for general information, plea...

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 Completing a Completion Report Consent Forms 101 Creating a Consent Form Creating and navig...

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 intended for investigators, coordinators, and other study team members. This page is a good starting point for ...

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...

A helpful guide for starting an sIRB Request can be found here: Starting an sIRB Request The UNMC sIRB Process is captured in the diagram below. View diagram as text Step One: Request Determination Lead Site submits sIRB request through RSS sI...

Click here to be redirected to the page for sIRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change

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. For assistance on how to start a cIRB application, please find the guide here: How To...

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...