HRPP Newsletter October 2021

Introducing new IRB Staff

We are excited to introduce the two newest additions to the IRB Office, Aly Vanderweide and Jennifer Wang!

Aly is our new IRB Office Administrator. Aly has a bachelor’s degree in political science and a paralegal associates degree. She has years of experience as an office manager for several Madison-based public/government relations and lobbying firms. In addition to serving as the liaison with HR, Aly manages the complex task of scheduling IRB members and meetings for 8 panels across both the HS and MRR IRBs!

Jennifer will be starting with the IRB office as a staff reviewer, primarily for the HS IRB, in mid-October. Jennifer has a bachelor’s degree in genetics from UW Madison, has worked as a study coordinator, and most recently as a regulatory manager in the Orthopedics/Rehabilitation and Urology Divisions. We are looking forward to her brining this expertise to the staff reviewer position!

Welcome Aly and Jennifer!

Education Needs Assessment

The Professional Research Education Program (PREP) would like your input on future course offerings. So far, PREP has offered over 35 courses based on your feedback and wants to continue to address topics that are important to you! Please take a few moments to fill out this brief needs assessment survey. The survey will be available through October 20th.

Announcing Secure Zoom

Secure Zoom is an environment that was requested by and created for the UW–‍Madison’s Health Care Component (HCC) population. It was configured in collaboration with the Office of Compliance and the Office of Cybersecurity to implement additional controls for increased security and reduce risk to meet HIPAA requirements.

Secure Zoom will help study teams in planning for and conducting study visits remotely, using a HIPAA compliant platform.

See this guidance for details.

New OVCRGE Training Lookup Tool

The tool used to track training completion for various research compliance purposes, including CITI and HIPAA training, has been revamped to improve the user interface. The improved tool will no longer show multiple listings for an individual and is much more streamlined. The Training Information Lookup Tool (TILT) can be accessed here.

Retiring IRB KnowledgeBase (KB) Sites

With the launch of the new and improved IRBs Office website which includes the Toolkit library and updated guidance, the HS IRBs and ED/SBS IRB KB sites will be phased out. While still accessible for now, study teams should visit irb.wisc.edu for current information. An announcement will be made prior to deactivating the KB sites.

Updated Consent Form Templates

Consent form templates and the Consent Form Wizard are in the process of being updated to remove the UW Health Patient Relations phone number as a contact for subjects who have research-related questions or concerns. This is being replaced with a confidential, toll-free research compliance phone number which will be monitored by Office of Research Compliance staff who will work with subjects to address concerns and triage issues to other offices as appropriate.

Already approved consent forms do not have to be updated. Study teams have the option of updating language with other changes, if they choose.

Once consent templates are updated, the language will be automatically incorporated into any versions using the new templates.

For studies ceded to an external IRB, the revised language about research-related questions will also need to be included for UW consent documents.

The Institutional Consent Language document (502c) will be updated to reflect the revised language. RELIANT is also working with the NCI CIRB and commercial IRBs to update template language.

For studies ceded to the NCI CIRB, the current boilerplate template should still be used until NCI has approved the revised template.
For studies ceded to a commercial IRB, or other external IRB, current template language may still be used until 502c is updated.

Please contact RELIANT (irbreliance@wisc.edu) with any questions about how the revised language will be implemented for ceded studies.

RELIANT (Reliance and Navigation Team) Reminders

Offboarding Study Team Members: The UW is not automatically the reviewing IRB for personnel no longer affiliated with the UW. If a study team member leaves the UW and will continue to be involved in study activities, a reliance agreement may be needed. Please contact irbreliance@wisc.edu in these situations so we can assist you with additional steps.

SMART IRB Reminders:

UW-Madison is a signatory to SMART IRB, which is a national reliance agreement that can help facilitate multisite research.
SMART IRB is not an IRB; it is a reliance agreement among institutions.

SMART IRB provides an online reliance system (ORS) that institutions can use to facilitate documentation of reliance decisions. Unless required by another site, the UW does not use the ORS due to the administrative burden it places on our researchers. Please contact us for assistance if you have questions about the ORS.
If an external study team or IRB provides you with SMART IRB documentation that needs to be completed, please contact us for assistance.