HS IRBs News March 2018

Health Sciences and Minimal Risk IRBs, IRB News/Volume 10, Number 2, March 2018

Exemption Training Session

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 is offering a training session to help research teams understand these new categories and when they apply. The session 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 below:

Please note that this session is the same as those previously offered in February and March.

Concurrent Changes and Continuing Reviews

Recently the HS IRBs have had several study teams hold off submitting a continuing review because they mistakenly thought they had to await approval of a pending change before they could submit the continuing review. This is a friendly reminder to researchers that a change and a continuing review can be submitted at the same time in ARROW. The IRB staff reviewers assigned to the continuing review and change of protocol will work with each other and the study's point of contact to coordinate these reviews, taking into account the study's expiration date and the urgency of the change.

Please do not wait to submit a continuing review until a change is approved as this may result in a lapse in IRB approval.

For more information on submission guidelines, please see Continuing Review Submission Guidance and How to Complete Changes of Protocol.

Reminder: New, Expanded Guidelines for Ceding IRB Review

The HS IRBs' guidelines for ceding IRB review have recently been expanded to allow many more types of studies to be reviewed by an external IRB, including industry-sponsored research:

We strongly encourage study teams to explore ceding IRB review for studies that qualify under these expanded guidelines. The HS IRBs' Reliance Team is happy to assist study teams with the ceded review process and with any questions researchers may have.

Reminder: Self-Service Removal of Study Team Members

For studies reviewed by the Health Sciences IRBs that are either approved or expired, Principal Investigators (PIs) and Points of Contact (POCs) can remove study team members using the "Remove Personnel" activity. This means study teams no longer need to submit a personnel change only to remove study team members.

To use the "Remove Personnel," study teams should select that activity on the left-hand side of the study workspace.

RemovePersonnelActivity.png

Please see our guidance for additional information.

New and Updated Guidance Documents

To reflect changes to institutional policy, the HS IRBs Office has created and updated several guidance documents.

Please see Upcoming Changes to Human Subjects Regulations and Policies for more details.

If you have any questions about or suggestions for this guidance, please contact Tesha Zimmerman.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.