HS-IRBs News March 2017

HS IRBs Office Staff Updates

The HS-IRBs Office bid a fond farewell to staff reviewer and community-based research specialist, Staci Lowe, who is leaving our office to assume a new role as the director of research and sponsored programs at the School of Nursing. We will miss Staci's expertise and humor, but wish her all the best in her new position.

New Guidance: Use of Email for Research Purposes

The HS IRBs' Guidance and SOP Working Group (GSWG) has developed new guidance on the use of email for research purposes. Incorporating feedback from the HIPAA Compliance Program and the Office of Legal Affairs, the new guidance is intended to assist study teams who want to use email for recruitment, scheduling initial study visits, and study participation. This new guidance expands upon and replaces previous guidance on using email for recruitment purposes. If you have any questions or suggestions for GSWG, please contact Tesha Zimmerman at tmzimmer@medicine.wisc.edu.

Interested in Single IRB Review? Contact the Reliance Team!

Changes in federal policies and regulations will soon require the use of single IRB review for many multi-site studies. The HS IRBs Reliance Team is well-prepared to assist researchers who want to learn more about single IRB review and how it may help streamline the IRB review process for them. The Reliance Team can assist researchers with questions like:

• Is ceding IRB review to a non-UW IRB a good option for my project?
• Can the UW serve as IRB of record for other sites for a new study I am planning?
• How can I add new sites to my currently approved study?
• What is SMART IRB and how can I use it for my study?
  

The Reliance Team also is available to consult with study teams who wish to discuss how best to manage the multi-site aspects of their studies.

ARROW Updates

In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned improvements for the March 25, 2017 update include:

• Improvements to the Change of Protocol Workspace: When study teams wish to change something within their IRB application, they complete a change form and then modify the application. This currently requires study teams to navigate between two different workspaces: one for the change of protocol and another for the modified application. Navigating between these workspaces can be challenging, so to address this, the modified application workspace will be eliminated. Study teams will still need to complete the change form and revise the modified application, but will no longer need to navigate to another workspace to do this. This also means that reviewer notes for the change form and modified application will be displayed in one place rather than two. The HS IRBs office updated its instructions for completing changes of protocol to reflect this change, and the revised help documents can be found here and here.
• Changes to VA Pages: For studies that fall under VA purview, the number of pages in the application will be reduced. Study teams will no longer have to fill out "VA Study Information" or "Renumeration: VA Studies." In addition, studies that only use VA facilities will need to contact the VA to ensure the appropriate permissions are in place, but this process will occur outside of the ARROW application. Finally, a new question has been added that specifically asks for the VA information Security Officer/Privacy Officer (ISO/PO) checklist, which will be less cumbersome for researchers than the current work-around of uploading it in the Supplemental Section.
• User Interface Improvements: When study teams log into ARROW after 3/25, they may notice subtle changes to improve the user interface. The study information is now larger, the tabs now appear in the center of the page, and the approval period of a study is now visible.

If you have questions about these changes to ARROW, please e-mail askarrowirb@medicine.wisc.edu.

New: Assisting Researchers with the Five Year Replacement Policy

As part of our continuing series on how the HS IRBs Office is working to improve IRB processes for researchers, we want to highlight a new process for assisting researchers with the campus five year replacement/renewal policy. Starting in April, we will email study teams who have ongoing studies that may need a replacement application. Our goal with this project is to assist study teams with determining whether their study will qualify for an exception to the five year replacement policy and, if not, facilitate the submission of a replacement application with sufficient time to avoid a lapse in IRB approval. We hope this proactive approach will help study teams meet the requirements of the policy and ease the replacement application process.

If you have questions about this process, please contact Tesha Zimmerman at tmzimmer@medicine.wisc.edu.

Tip: Answer Question on ICH/GCP Language

In Fall 2016, a new question was added to the ARROW application asking whether a clinical trial agreement (CTA) requires adherence to the International Council for Harmonization of Good Clinical Practice (ICH-GCP) Guidelines. This question relates to industry-sponsored studies where the sponsor has required such language as part of the study contract. Study teams involved in industry-sponsored applications should review their contract to determine if such language is mandated. Questions on this requirement should be directed to Travis Doran, Human Research Protection Program, at travis.doran@wisc.edu. 

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.

• 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@medicine.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@medicine.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.
• WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
• 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.