HS IRBs News November 2019

Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 10, November 2019

HS IRBs Office Closures

Our office will be closed or have limited coverage the following dates:

Updated Guidance: Identification of Suicidality or Major Depression

HS IRBs’ staff have significantly revised our Identification of Suicidality or Major Depression Guidance guidance on how study teams should handle findings of depression or suicidality. The revised guidance describes what study teams need to address in any follow up plans when they plan to use questionnaires or other instruments that will collect information about suicidality or depression. It also provides instructions on what study teams should include in the IRB application, protocol, and consent documents.

Reminder: Single IRB Review and Exemptions

The federal single IRB review mandates (NIH and the revised Common Rule) only apply to federally-funded research that does NOT qualify for exemption. If UW-Madison’s role in a multisite study likely qualifies for exemption, the study team should submit an application for exemption via ARROW rather than a request to cede IRB review. We encourage study teams to reach out to the Reliance and Navigation Team (irbreliance@wisc.edu) with any questions about which IRB should oversee their role in a multisite study.

Upcoming Educational Opportunities

  • The Professional Research Education Program (PREP) will be offering the following session (register through the online catalog under Professional Research Education Program category):

    • “Capacity to Consent: Consideration in Research” on December 5th from 1PM to 2PM in 1335 HSLC
  • The Reliance and Navigation Team (RELIANT) will soon be piloting some small group trainings on topics like how to add a site to an already approved study. If you are interested in attending, please email irbreliance@wisc.edu to be added to the invitation list.

December ARROW Updates

ARROW will be updated December 7th with some important study team personnel-related improvements, including:

  • Removal of the accounting point of contact question and update account POC activity: With a new invoicing process, the IRB no longer needs to collect this information, so it will be removed.
  • Removing list of personnel administering instruments in the cognitive assessments section: While newer versions of this initial review application no longer have this question, it still exists for older versions and will be replaced with a more general confirmatory question about study team qualifications. Please note that this is for the HS and MR IRBs only.
  • Additional help text for study team training and listing study team members:

    • The View Study Team training activity will have new help text about how to view specific training information for each study team member.
    • The study team member page of the application will include a link to a FAQ about finding study team members who are not showing up in the chooser menu.

Please email askarrowirb@medicine.wisc.edu if you have any questions.

Keywords:office hours, office closure, guidance, depression, suicidality, single IRB, ARROW, ARROW update   Doc ID:95976
Owner:Monica E.Group:Health Sciences IRBs
Created:2019-11-19 11:16 CSTUpdated:2019-12-19 08:45 CST
Sites:Health Sciences IRBs
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