HS IRBs News June 2020

Research Reboot Reminders

As on-campus research activities slowly reboot, some FAQs from our website that human subjects researchers may find helpful:

• What role can the IRB play for department chairs, center directors, and deans who are determining whether specific research studies can reopen face-to-face visits?
• What are the first steps for study teams to get approval to restart face-to-face visits for an IRB-approved study?
• What is required from an IRB standpoint before restarting face-to-face research activities?

Questions?

• Study teams with questions about the research reboot process should contact their department chair, center director or dean.
• Chairs, center directors, or deans with questions for the IRB about restarting research should email the IRB director (irbdirector@hsirb.wisc.edu)

Resources for Planning Remote Study Activities

In response to many questions from study teams about moving study activities remote, we have created a new page on our website with all our remote study guidance in one place, including information on e-consent and remote consent options: Remote Study Activities Guidance. We are happy to assist study teams with questions about moving their study activities remote, although we encourage study teams to read through our guidance before reaching out.

E-Consent Update

Researchers interested in using an e-consent process for FDA-regulated studies must use a part 11 compliant platform. UW-Madison is in the process of purchasing DocuSign for this purpose. Researchers interested in using DocuSign for their studies should contact one of the following:

• For UWCCC, please contact Danae Wolff.
• For all other studies, please contact Tina Graber in OCT.

Recent ARROW Updates

The ARROW update at the end of May included various changes to improve the study team user experience, including;

• Addition of model language to the exemption application to enable study teams to complete the application quickly and effectively
• New questions in the submission form for initial review asking specifically about any needs for urgent approval
• Addition of a tool in the View Study Team Training activity allowing study teams to directly email anyone on their study team who has incomplete training certification