HRPP Newsletter November 2021

Coming Soon– Non-Protocol Based Application (nPBA) 

As mentioned in previous newsletters, work on a new application, the nPBA, designed for studies likely to be minimal risk and without a standalone protocol, including exemptions, is well underway. It will be a more streamlined application for these kinds of studies and, where possible, remove decision points for study teams that can cause delays. It will retain tools, such as the template language, that already reduce delays and burden. The nPBA will replace the current “Standard Application” option.

Also, with the introduction of the nPBA, another change to be aware of is related to Expanded Access and Humanitarian Use Devices (HUD) applications. Currently, these application types reside in the Standard Application. Going forward, these will be standalone application options in the ARROW Application Wizard, the starting point for creating an IRB application. Given this update, along with the nPBA, changes to the ARROW Application Wizard are needed. Please see the screen shot below for what the wizard will look like.

The nPBA and the other updates referenced here will be available to researchers on December 19th, after an ARROW update on December 18th.

Lastly, the IRB office will hold a training session, which will be recorded, related to the nPBA in December, prior to the December 18th ARROW update. Stay tuned as more information on date, time, and registration will be forthcoming shortly.

Toolkit Updates: Short Form and other Special Consent Processes

The Investigator’s Manual section on enrolling subjects with limited English proficiency has been updated to describe consent guidelines for other special populations that may require alternative consent processes, such as visually or hearing-impaired subjects.

Additionally, the process for obtaining IRB approval for a special consent process when such a subject is encountered unexpectedly has been updated:

If the subject population is not already approved, submit a change of protocol application in ARROW for IRB review. This can be an expedited change, as long as there’s no increased risk and the change meets criteria in HRP-313 – Worksheet – Expedited Review for a minor modification to previously approved research. The change of protocol application and revised protocols/applications should describe safeguards and accommodations for the added population(s) as well as the consent process for the population.

If the change is time-sensitive, please indicate this in the change workspace when submitting and email AsktheIRB@hsirb.wisc.edu to inform the IRB of the forthcoming time-sensitive submission.

Finally, a new Vietnamese translated short form is now available on our website! Remember, if you use the translated short forms posted on the IRB website or short forms translated by UWHC, you do not need to submit these forms for IRB approval.

New Single IRB Review (sIRB) Guidelines

The UW has developed new guidelines outlining when the UW will and will not serve as the reviewing IRB or cede IRB review to an external IRB. These guidelines apply to all non-exempt studies. A new decision tree and revised sIRB matrix/rubric will soon be posted; the reliance manual also will be updated. In the interim, please note the following changes:

• • Starting January 1st, study teams will be required to consult with RELIANT when asking the UW to serve as the reviewing IRB (sIRB) for multisite studies BEFORE submitting a grant proposal or IRB application. Without a prior consultation, the UW cannot guarantee to serve as the sIRB. RELIANT will support study teams in identifying another external IRB if the UW is unable to serve.

• • Effective now:
    • • UW will only cede or serve for non-exempt studies with external funding
        • Single IRB review is only required for federally-funded studies and therefore, may still not be the best option even if your study has external funding.  RELIANT will assist you in identifying the best IRB review option for your study.
      • UW will neither cede nor serve for sites without AAHRPP accreditation or a robust HRPP

     

  • Studies that do not fall into the new sIRB guidelines will be reviewed by the UW IRB.

 

• These new guidelines do not affect the following:
  • Study teams using a commercial IRB or the NCI CIRB.
  • Addition of external individuals to a study. The UW will continue to serve as the reviewing IRB for individuals as appropriate; the guidelines only pertain to external sites.
  • Exempt studies- as is currently the case, the UW will neither serve as the reviewing IRB nor cede IRB review for exempt studies.

 

Questions? Please contact RELIANT (irbreliance@wisc.edu) – we are happy to help.

IRB Website Updates: VA Research

The VA Research page has been updated recently to remove Madison VA templates, including the VA Consent Form template, the VA HIPAA Authorization Form template, and the VA Application for Waiver or Alteration of Authorization template. These templates have also been removed from the HRPP Toolkit Library.

The Madison VA templates and other tools are now being housed by the Madison VA Research Service and are available on IRBNet. For more information on accessing the Madison VA templates and tools using IRBNet, please contact the VA Research Service at 608-280-7007 or VHAMADRDCOORDINATOR@va.gov.

Previous editions of the HRPP Newsletter can be found here.