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  • IRB reviews a wide variety of research involving human subjects.

    IRB reviews a wide variety of research involving human subjects.

  • FDA regulations require IRB review for all drug and device studies.

    FDA regulations require IRB review for all drug and device studies.

IRB UPDATES

To view the latest updates from the IRB, visit our Updates Page 

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” and 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