HS-IRBs News February 2018

Health Sciences and Minimal Risk IRBs, IRB News/Volume 10, Number 1, February 2018

Special Newsletter Issue on the Revised Common Rule Delay

This issue of the newsletter is complemented by a second, special issue on the delay in revisions to the Common Rule. Check here for important information on how the HS IRBs' will be implementing some of the changes including in the revised Common Rule to help meet the needs our our researchers, and the special edition will be forthcoming. 

Exemption Training Sessions

Although the changes to the Common Rule have been delayed, UW-Madison is going ahead with implementing new exemption categories for research that is not federally funded, VA supported, or FDA-regulated. The Health Sciences IRBs Office are offering training sessions to help research teams understand these new categories and when they apply. The sessions will explain the new campus exemption categories, provide a refresher regarding the exemption categories for federally funded research, and describe updates made to ARROW to accommodate the different exemption categories available based on the regulations that do or do not apply to the human subjects research. To learn more about these changes, please sign up for one of our upcoming training sessions:

Ceded IRB Review Workshop

Please join members of the HS IRBs Reliance Team for a workshop on the basics of ceding IRB oversight to an external IRB. In addition to an overview of single IRB review, this workshop will cover the process preparing and submitting a request to ceding IRB oversight and the review process for such requests. Space is limited and registration is required. Please contact the Reliance Team (irbreliance@wisc.edu) with any questions.

Staff Updates

New Ceded Review Application and Resources

Changes to ARROW and the HS IRBs' website are being made to further support researchers as single IRB review mandates begin to become effective. Highlights of the changes include:

Please contact the Reliance Team (irbreliance@wisc.edu) with any questions about these important changes.

Upcoming Consent Form Changes

The Informed Consent Working Group (ICWG) is working to update the consent templates and additional model language to reflect recent campus policy changes. The updated documents are expected to be available on the IRB website in early spring, so stay tuned. ICWG is also planning educational sessions and materials to help study teams.

If you have any questions about consent templates or additional model language, contact Jennifer Fenne