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."
cIRB Application Update
June 24, 20221. 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
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.
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.
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.
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
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.
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.
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:
- Masks should be worn everywhere indoors, unless by yourself behind a closed door.
- Cloth masks should not be used anywhere, as per recent Nebraska Medicine and UNMC guidance, unless on top of a surgical/procedural mask
- Conduct any and all research activities remotely, if they can be done remotely, including one on one meetings and seminars
- Visitors should be limited, masked, and escorted with rigorous questions about recent exposures beforehand
- Take turns eating in designated spaces, by yourself or behind a closed door, or socially distanced if in a larger space
- Minimize time unmasked while eating, whether eating alone or in a room where others are sitting
For all lab building and lab-based programs:
- Return to scheduling time on shared equipment and other measures to enhance social distancing in the lab
- Starting Monday Jan 17, research volunteers will no longer be allowed to work in laboratories (such as high school, undergraduate, visiting students) except the following:
- International Scholars who have been already approved through the Office of Global Engagement
- UNMC health professions students or students enrolled in a University of Nebraska course,
- High school alliance students in their currently assigned laboratories.
- All volunteers must be vaccinated, no exceptions or exemptions, and show evidence of vaccination, per our policy. They should be strongly encouraged to obtain a booster, as soon as they are eligible.
For all face to face clinical research programs:
- Study monitors can come to campus if they are required to, if masked and escorted, and vetted for recent exposures
- Continue to ask research subjects before face to face contact as to recent exposures or symptoms,
- Continue to follow your approved biosafety protocol, and all policies of the institution where the research is to be conducted regarding masking, which may now require providing surgical/procedural masks for subjects or accompanying persons.
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.
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.
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.
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?
- RSS e-signature is now available for use for Federally funded research. RSS e-signature cannot be used for research which is FDA regulated. In addition, RSS e-signature does not at present support consent forms that require a second signature for optional studies.
- DocuSign, GMO GlobalSign and Solutions Notarius platforms may also be used for Federally funded research, since those 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.
- 21 CFR Part 11 (“FDA Part 11”) compliant systems, such as Part 11 compliant DocuSign may be used for FDA regulated research (research involving a drug or device). Note that the standard version of DocuSign, which is not part 11 compliant, is not acceptable.
- 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.
- 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.
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 (email@example.com)
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