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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.

Remote Consent and Electronic Signatures FAQs

1.    What is remote consent?

  • Remote consent refers to the use of techniques like telephone, videoconferencing, or desktop, mobile, or web-based applications (for example, Zoom) as an alternative to face to face discussions in the process of obtaining informed consent.
  • HRPP policy 5.3 
  • To the extent that remote consent facilitates the process of consent, the IRB endorses and encourages its use.  However, the Board must approve the specifics of the process.

2.    What is e-Signature?

  • e-signature refers to the use of various platforms (like DocuSign, or Adobe Sign) to obtain signatures on a consent form electronically. 
  • The use of e-signature is independent of the use of a remote consent process.  A face-to-face consent process may include an electronic signature, and remote consent may include a “wet” (physical) signature.
  • The UNMC IRB must approve the platform used to obtain e-signatures. The specific electronic platforms allowable are dictated by FDA regulations and by Nebraska law.

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

  • Remote consent is the process of consent, when consent is not conducted face-to-face.
    • E-signature is signing the consent form electronically.

4.    What platforms are allowed for e-signature?

  • Federally funded studies: DocuSign, GMO GlobalSign and Solutions Notarius platforms are recognized by Nebraska law as equivalent to a “wet” signature. Other platforms may become available in the future, as allowed under Nebraska Law.
  • FDA regulated studies (Studies involving drugs or devices): 21 CFR Part 11 (“FDA Part 11”) compliant systems. 

·         Federally funded + FDA regulated studies: Part 11 compliant version of DocuSign. Note that the standard version of DocuSign, which is not part 11 compliant, is not acceptable.

  • RSS e-signature can only be used for research which is neither Federally funded nor FDA regulated.  In addition, RSS e-signature does not at present support consent forms that require a second signature for optional studies.
  • REDCap e-signature can only be used for research which is neither Federally funded nor FDA regulated

5.    How do I access these systems?

  • DocuSign, GMO GlobalSign and Solution Notarius: must be licensed by the investigator. DocuSign (not part 11 compliant) may be available thru Nebraska Medicine - contact the CRC. 
  • RSS: the IRB must turn on the e-signature function
    • Active Studies: no change request is required.  Send a message through the message portal requesting the use of e-signature. Note: If you are adding a remote consent process, a change request will be required.
    • For new studies, if you are planning to use a remote consent process, or an e-signature platform (like RSS or DocuSign), the plan must be described in the Consent section in the IRB application.

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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?

  • 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 (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.

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

 

 

 


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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.