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Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates non-clinical and clinical research agreements with the exception of Phase I-IV Clinical Trial Agreements negotiated by UNeHealth. Non-clinical research Non-clini...

Clinical research is defined as research that involves human subjects as participants and/or requires the informed consent of a human subject. In addition to clinical trials, clinical research encompasses physiologic studies as well as any projects involving h...

Confidential Disclosure Agreements – also known as Non-disclosure Agreements, CDAs or NDAs – protect confidential information shared between a sponsor and investigator as they determine mutual interest in working together. The information may belong to the inv...

SPAdmin can assist you with many aspects of developing and submitting a proposal.  Once you identify a funding opportunity to which you intend to apply, please notify SPAdmin so that we can prepare to answer any questions you may have, discuss any special cons...

Just in Time refers to the period after application submission and peer review and before selection for funding.  During this period, the sponsor may request additional information that was not required to be submitted with the application.  Just in Time balan...

When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the award in UNMC’s sponsored program systems. The information below will guide you through the award set-up process, unique terminology, and issues that impact award ...

Reporting Requirements Technical The PI is responsible for preparing the technical report.  Either the PI or SPAdmin can be responsible for submitting the report, either via an electronic system and/or in paper.  SPAdmin’s review of a technical report is foc...

After the funded project is complete, UNMC must administratively close out the project with the sponsor and internally. Technical Reporting In general, a final technical report should include: Summary of progress made toward the achievement of the origina...

Introduction IRB News & Updates FAQ HRPP Policies Does my project require IRB review? Which application do I use? Submission Deadlines Report a research problem or complaint Procedures Adverse Event Reporting Clinicaltrials.gov Emergency Treatment Exem...

2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Proportionate IRB Oversight (Tonya Ferraro) Integrating IRB Review Into US Special Pathogens Research Efforts (Kristi DeHaai & Abby Lowe) Informed Consent: Why We ...

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. New Pricing Guidelines (effective...

TRANSFERS IN AND OUT Traditionally sponsors make awards to institutions/organizations and not to an individual therefore special processes are in place to allow for the transfer of a grant whether an investigator is joining UNMC or leaving UNMC. TRANSFERS TO...

Advertisement Policy Cheat Sheet Am I Doing Human Subject Research? Assembling your Research Team Demographic Recruiting Numbers Form SOP Direct Invitation Policy Cheat Sheet E-Signature Instructions Informed Consent Resources IRB Acronyms and Definitions IRB ...

Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a guide for study teams when deciding what constitutes noncompliance, when it needs to be reported, and how to report it. The following Noncompliance Guide will explain...