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IRB reviews a wide variety of research involving human subjects.
FDA regulations require IRB review for all drug and device studies.
Changes in the IRB Application
June 10, 2021
Which applications are affected?
Biomedical/SBS, Human Biologic Material, Medical Records research, Tissue Bank, Data Registry and Humanitarian Use Device protocols.
What are the changes?
- You will be asked to provide an estimate of the time it will take to accrue the target number of subjects for this research.
- You will be asked to describe the timing of consent related to when screening tests are performed.
- The subject identification section has been simplified.
- The process of consent section has been revised.
When do these changes take place?
These changes went into effect June 9, 2021.
I just started a new application last week and have not yet submitted it, do I need to start another new application?
No. Much older applications which have not been submitted, however, may need to be updated. If so, an IRB administrator will contact you.
If you have any concerns please contact us by phone (402 559-6463) or email (firstname.lastname@example.org)
IRB Commercial/Industry Fee Changes
March 17, 2021
In line with most other academic medical centers and universities, effective July 1, 2021, the Office of Regulatory Affairs and the IRB will begin charging an annual fee for continuing review of commercial/industry sponsored protocols. This will apply only to protocols submitted after July 1, 2021. In addition, fees for expedited review, and for protocols where UNMC relies on a commercial IRB (like Advarra or WIRB) will increase.
- Full board review of commercial/industry sponsored protocols will remain unchanged at $3000 at time of initial submission. Annual continuing review will now be billed at $1250.
- Expedited review of commercial/industry sponsored protocols will increase from $1000 to $2000 at time of initial submission, and annual continuing review will be billed at $1000.
- Central IRB review (UNMC depending on a commercial IRB) will increase from $1000 to $1500. There is no charge for continuing review for studies using a commercial IRB.
A WBS number must be provided at the time of IRB submission, and billing will occur at the time of IRB review. The protocol will not be released until review fees are paid. Therefore, all investigators involved in commercially sponsored research projects should include the IRB review costs in their grant or contract budget.
If you have any questions regarding this policy, please contact Bruce Gordon, MD
Christopher J. Kratochvil, M.D.
Executive Director, Global Center for Health Security
Associate Vice Chancellor for Clinical Research, UNMC
Vice President for Research, Nebraska Medicine
Chief Medical Officer, UNeHealth
Bruce Gordon, MD
Assistant Vice-Chancellor for Regulatory Affairs
Executive Chairman, Institutional Review Boards
Institutional Official, Institutional Biosafety Committee
University of Nebraska Medical Center
987680 Nebraska Medical Center
Omaha, NE 68198-7680
Lifting Study Halt on New Approvals
January 14, 2021
As case numbers continue their downward trend, and hospital capacity is adequate, the IRB and the Research Office have, effective Friday 1/15, released the halt on approval of new human subject research projects that involve no prospect of direct subject benefit.
If research has been approved by the IRB AND all other institutional requirements have been met, PIs will shortly be receiving notification thru the RSS portal that they may proceed. YOU MUST WAIT FOR THIS NOTIFICATION BEFORE PROCEEDING
Investigators are reminded to continue to utilize appropriate mechanisms to reduce face to face contact with research subjects. In addition, research personnel and all research subjects undergoing face to face contact must be masked for all research encounters.
The Research Office and the IRB will continue to actively monitor COVID data, and investigators are advised that additional halts or other actions may be needed in the future.
Regarding COVID-19 and Continuing Review
During the COVID emergency the IRB has allowed investigators to implement procedures to minimize risk to subjects without modification to the IRB application or formal approval.
Changes made to the study that were minor (for example, institution of remote consent; changes in frequency, timing or location of research visits; flexibility in scheduling) do not need to be reported to the IRB until the time of continuing review. These changes should be reported within the Continuing Review form, in section I.3 (“If research activities have continued, describe any changes made to research procedures in response to the pandemic.”). These minor changes made due to the COVID pandemic should not be reported as a Single Patient Protocol Deviation or as Protocol non-compliance.
Further, as previous advised, the IRB expects all investigators that have made modifications to their research without specific IRB approval to either revert to the procedures described in the IRB-approved application OR to submit a formal Change Request to the IRB application and have IRB approval of the changes by January 1.
After January 1 any deviation from the IRB approved application will constitute non-compliance.
If possible, the Change Request should be submitted at the time of continuing review. If your study is not due for continuing review before January 1, or does not require continuing review, the Change Request should be submitted at your earliest convenience, but must be received and reviewed by January 1.
All other changes not intended to reduce risk require IRB approval before they can be implemented.
Bruce Gordon, MD
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In accordance with Health and Human Services Regulations for Protection of Human Subjects (45 CFR 46), an Institutional Review Board (IRB) composed of members from a variety of scientific disciplines and individuals from the community, assists investigators in the protection of the rights and welfare of human subjects.
The University of Nebraska Medical Center (UNMC) IRB was established to assure the protection of all human subjects in research projects conducted by anyone on the premises of UNMC, Nebraska Medicine, Nebraska Medicine - Bellevue, Children’s Hospital & Medical Center (CH&MC), and the University of Nebraska at Omaha (UNO). In addition, the IRB has oversight for all research that is conducted elsewhere by faculty, students, staff, or other representatives of these institutions.
The IRB also serves to facilitate valuable human subject research, as well as, protect the investigator and the institutions through a comprehensive review process. All human subject research projects must be reviewed and approved by the IRB prior to initiation and then conducted in full compliance with the federal regulations and institutional policies.