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1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the process and documentation of informed consent for non-English speaking persons, or persons with additional needs or vulnerabilities participating in human subject res...

1.0 Purpose The purpose of this policy is to describe the Emergency Preparedness and Continuity of Operations Plan (EP/COOP) for the HRPP. This policy and accompanying documents focus on the Office of Regulatory Affairs (ORA) and the IRB; the Organization ma...

1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. Purpose The UNMC Office of Regulatory Affairs (ORA) and the Human Research Protection Program (HRPP) is committed to the safety and protection of research participants, as well as ORA ...

Mailing Address: Institutional Review Board University of Nebraska Medical Center 987830 Nebraska Medical Center Omaha, NE 68198-7830 Phone: 402-559-6463 Email: irbora@unmc.edu The Institutional Review Board (IRB) is a committee formally const...

It is understood this project will be conducted in full accordance with all applicable HRPP Policies. It is also understood that the ORA will be immediately notified of any proposed changes for your research project that: Affect the risk-benefit relationship ...

Check back to this page for more updates regarding clinicaltrials.gov information. Please contact oract.gov@unmc.edu for more information. When requesting a new user account for ClinicalTrials.gov, please provide the following information: Preferred use...

Congruency, Consent, and Recruitment Materials Dec 13th, 2024 In order to assure that subject injury language in the consent forms matches that in contracts, UNeHealth or SPA will begin conducting congruency checks. The congruency check is an institutional re...

To help you determine if your project constitutes Human Subject Research and requires IRB review, you may complete the determination questionnaire by login into RSS. RSS The survey can be found in the IRB menu at the top of the page listed under the Applicat...

IRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change Submission deadlines are for Full Board (FB) protocols only. Review of submissions for Exempt (EX), Expedited (EP), and cIRB (CB) protocols will occur on a first...

There are eight applications to choose from depending on the type of research that is planned. Please make sure that you select the correct application type for your research. Once started, responses from one application cannot be transferred directly to a dif...

The purpose of this policy and procedure is to provide a basic description of UNMC’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all human subject research under the ov...

Full Board Review (initial submission) Investigators will be notified of the assigned IRB# by email. Applications for Full Board Review will be reviewed at the next possible IRB meeting. Submission Deadlines can be found here. These documents must also be at...

Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Research Comment Portal. Are you a research subject, staff or investigator who wants to report a complaint or problem to the IRB? By following the comment portal lin...

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 associ...

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 ...

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 particip...

Capacity to consent Assessment of capacity to consent to participate in research Consent Form Readability Recent changes to the Federal Regulations governing human subject research (the “Common Rule”) have included a focus on improving the readability of co...

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...