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 DelayThis 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 SessionsAlthough 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:
- February 26, 2018 - 10:30am - 12pm, HSLC 1225 - register here.
- March 2, 2018 - 12:30pm - 2:00pm, HSLC 1225 - register here.
Ceded IRB Review WorkshopPlease 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 (firstname.lastname@example.org) with any questions.
- March 1, 2018 - 8:30am - 10:00am, HSLC 1248 - register here.
- Farewells: Emily Jenner, Continuing Review Analyst and IRB Member Liaison, left our office at the end of January for a position in the UWCCC as their outreach and operations manager. Elizabeth Jach, IRB Facilitator, left our office in early February for a position in the School of Education as a policy and planning analyst. We thank Emily and Elizabeth for their work with us and wish them both the best in their new positions!
- Welcome: Becky Hoffman will be joining our office as a staff reviewer starting February 19th. Becky is a microbiologist and is coming to us from the Wisconsin State Lab of Hygiene. Welcome Becky!
- Stepping In: Jessie Johnson will be going on leave in the middle of February and returning later this spring. As result of her leave and Emily's and Elizabeth's departures, others in the office are filling in as follows:
New Ceded Review Application and ResourcesChanges 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:
- Starting February 17th, a new ceded review application and workflow will be available in ARROW. For details, please see How to Submit a Request to Cede IRB Review to an External IRB and Improved Ceded Review Process FAQ.
- The "Relying on an External IRB" section of our Collaborative Research and Single IRB Review Basics page has been updated with several new resources, including revised eligibility guidelines and instructions for preparing consent and authorization documents for studies for which IRB review has been ceded to an external IRB.
- The Central IRB Gateway has been revised to address the expanded use of independent (or commercial IRBs).
Upcoming Consent Form ChangesThe 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.
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