HS IRBs News 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:

• May 14, 2018 - 12:00 - 1:30pm, 4201 HSLC (Harting Mullins Board Room) - register here

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:

• Guidelines for ceding IRB review to an independent (commercial IRB) - see [Link for document 22374 is unavailable at this time.]
• Guidelines for ceding IRB review to another external IRB - see Guidelines for Ceding IRB Review to an External IRB

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.

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.

• Brief Summary of Investigator Responsibilities Related to the Protection of Human Subjects for Exempt Research - This new document outlines some of the responsibilities that researchers assume when conducting exempt research involving human subjects.
• Can changes of protocol be submitted for exemptions? - This document has been updated to reflect the new ability to create changes for exemptions. The Exemption Change Guidance Table outlines types of changes and whether or not they need to be submitted to the IRB. In general, any updates to the study that could increase risks of participation, adversely affect the risk:benefit ratio, or affect research participants' willingness to participate in a study should be submitted to the IRB.
• Guidance on Exemption Categories under the Revised Common Rule - This new document links to a decision tool intended to assist study teams in determining whether, under campus policy, their human subjects research projects may qualify for exemption under one or more of the additional institutional categories and whether limited IRB review is required. If a project is FDA-regulated, federally funded, or with the VA, it may still qualify for exemption under the federal exemption categories but not under the institutional categories at this point.

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.

• Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
• General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@hsirb.wisc.edu. These are the quickest ways to get help with general questions.
• Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
• Help with single IRB review and reliance questions, email irbreliance@wisc.edu.

• Assistance with ARROW or technical questions, email askarrowirb@hsirb.wisc.edu.
• Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
• Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
• Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.