HS-IRBs News March 2017

Health Sciences and Minimal Risk IRBs, IRB News / Volume 9, Number 3, 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:

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:

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