IRB Updates

Consent regarding Human Biological Materials

August 26, 2022

Investigators are reminded that obtaining blood samples or other biological specimens for research, whether from a patient or from an employee or other normal volunteer, for use now or in the future, requires IRB approval and written informed consent. This includes drawing blood as “controls” for in vitro assays, unless those assays are performed solely for clinical purposes (and usually in a CLIA certified laboratory).

 

The IRB is happy to work with you to develop protocols to encompass a number of different activities involving collection of samples from human subjects, and to discuss further.  Please contact us.

 

Conducting human subject research without IRB approval and informed consent, including obtaining blood or other biospecimens for any research purpose, is serious non-compliance and may be reported to HHS, FDA, NIH, or other Federal authorities."

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cIRB Application Update

June 24, 2022 

1. The CIRB application has been updated to include a contact information sheet which can be automatically generated in RSS.  This contact sheet includes the Rights of Research Subjects and Research Questions
a. Check the box next to personnel you would like to list on the Contact Information sheet.     6/24/22 IRB update 1
b. When all personnel have been selected, click “Save.” The page will refresh.
c. Select “Contact Information Sheet” from the left side menu to generate a pdf that includes a list of  authorized personnel and the last 2 pages appended to any consent form.
6/24/22 IRB update 2

2. Additional questions have been added to the CIRB application:
a. “Does this study involve an investigational drug or device?” If yes, prompted for IND/IDE#.
b. “Will subjects age 18 years of age or younger be included in this research?”  If yes, prompted to enter age range.
c. “Method of Subject Identification and Recruitment” section added for consistency with other IRB applications and to ensure UNMC investigators are following UNMC policies.
d. “Process of Informed Consent” section added for consistency with other IRB application and to ensure UNMC investigators are following UNMC policies.

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Financial Interest Disclosure

June 21, 2022

As of June 21, 2022, PIs and Faculty Advisors must personally complete the Financial Interest Disclosure questions at the time they are signing section I of the application.  Though other research personnel may collaborate on completing other sections of the IRB application, no one other than the individuals signing the application will have the ability to answer the financial disclosure questions.  This change applies not only to new applications but also to approved applications when a change request is initiated.

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Revised Paper Continuing Review Forms

June 17, 2022

The continuing review applications for existing paper applications have been revised.  These forms have been revised to remove personnel changes from the continuing review so that the continuing review and personnel changes on paper applications are handled like the electronic applications in RSS.  These forms can be found on the IRB website: https://www.unmc.edu/irb/procedures/forms/paper-protocols.html

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RSS New Application Update

June 8, 2022

All IRB applications begun after today will no longer require certification and signature by a Resource Reviewer.

Investigators are reminded that they are still responsible for assuring that there are adequate resources available to conduct the research, and to protect the rights and welfare of human subjects.

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COVID-19 Update

February 9, 2022

The request to voluntarily defer the start of new protocols and pause face-to-face research activities is now lifted. Investigators should continue to use remote visits, when and where feasible, and review all subjects for potential exposures or risk before any scheduled face-to-face visit. Location or timing of visits may still be impacted by changes in Nebraska Medicine or other clinical facility changes and/or staff shortages.

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Reinforcing COVID-19 Guidelines

January 11, 2022

With increasing cases of COVID and COVID breakthrough, we want to clarify/reinforce the new UNMC/Nebraska medicine policies as they are relevant to research spaces. We will make one change in our current policy regarding volunteers in research labs.

 For all research programs:

 For all lab building and lab-based programs:

 For all face to face clinical research programs:

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Demographic Data Requirement Update

January 10, 2022

The Vice Chancellor of Research and the IRB now require that all human research studies provide demographic data (gender, race, and ethnicity) of all enrolled subjects, at time of annual review. This information will be submitted as part of the Continuing Review form, for studies requiring continuing review. For studies not requiring Continuing Review, PIs and Lead Coordinators will receive an email directing him/her to a new Demographics form which has been generated in the FORMS section of your application in RSS.

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DocuSign Availability for Electronic Signature

December 6, 2021

DocuSign may now be available for use to document research informed consent in the limited cases where sponsors require its use. This is limited to research NOT subject to the FDA regulations. There may be a charge associated with use of DocuSign; contact Courtney Kennedy in IT for approval or for more information. In addition to DocuSign, investigators may continue to use the RSS e-signature system as previously noted.

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Electronic Signature through RSS Expanded Availability

November 11, 2021

Previously only available for studies that were not Federally funded, the RSS e-signature function may now be used for Federally funded research studies also. To request use of this function, please send a message to the IRB via the RSS message portal. Please note, the RSS e-signature function is NOT available for any study that is FDA regulated regardless of funding source.

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Remote Consent and Electronic Signatures FAQs

1.    What is remote consent?

2.    What is e-Signature?

3.    What is the difference between remote consent and e-signature?

4.    What platforms are allowed for e-signature?

5.    How do I access these systems?

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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?

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 (irbora@unmc.edu)

 

 

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.

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
Professor, Pediatrics
University of Nebraska Medical Center
987680 Nebraska Medical Center
Omaha, NE 68198-7680
bgordon@unmc.edu