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Investigator Resources
Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...
Submission Process
Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by ema...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...
Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
Which application do I use?
There are eight applications to choose from depending on the type of research that is planned. Pl...
Report a research problem or complaint
Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Res...
Introduction
Mailing Address: Institutional Review Board University of Nebraska Medical Center 98783...
IRB News & Updates
HRPP Update 6/12/2025 - Policy 1.4 revised HRPP Updates 5/15/2025 - HRPP 1.4 revised 5/5/2025 - H...
Training
SPAdmin offers a number of formal and informal educational opportunities for departmental adminis...
Purpose & Responsibilities
Purpose SPAdmin’s purpose is three-fold: To facilitate a principal investigators’ pursuit and...
Award Set-up
When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the a...
NIH Data Management & Sharing Policy
The National Institutes of Health (NIH) announced a new data management & sharing (DMS) policy to...
Forms, Templates, and Electronic Systems
Internal forms are a means for providing needed information to SPAdmin and SPAcctng and for docum...
NDAA Whistleblower Notice
Pilot Program for Enhancement of Employee Whistleblower Protections In order to encourage employ...
F&A Rates Policy
UNMC Facilities and Administration (F&A) Rates (formerly known as Indirect Cost Rates) The full...
Clinical Research Billing
Clinical Trial Master Matrix The Clinical Trial Master Matrix (CTTM) is a tool that is used to r...
UNeHealth
UNeHealth is the contracting and fiscal arm for industry-funded clinical trials on behalf of Univ...
Other Contract Types
In addition to negotiating industry-sponsored research agreements, SPAdmin negotiates many other ...
Confidential Disclosure Agreements (CDAs or NDAs)
Confidential Disclosure Agreements – also known as Non-disclosure Agreements, CDAs or NDAs – prot...
Industry-Sponsored Non-Clinical Research
Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates ...