HS-IRBs News April 2016

• New Quality Assurance and Operations Specialist—Tesha Zimmerman has joined our office as the new Quality Assurance and Operations Specialist. Tesha comes to us from the Environmental Department of the Sault Ste. Marie Tribe of Chippewa Indians, where she performed administrative, grant management, and project-based duties. She will be assuming quality assurance and submission manager responsibilities in the HS-IRBs Office. Welcome Tesha!

We've implemented a more user-friendly process to make it easier than ever to submit a consultation or group presentation request. Whether you’re looking for assistance on a specific project or application and would like to meet with someone from our office, or you have a group that would benefit from a presentation on an IRB-related topic, we’re here to help. Visit our updated page to learn more about these great free services.

In response to a recent NIH mandate, UW-Madison now requires Good Clinical Practices (GCP) training every 3 years for all members of the study team engaged in research with drugs, devices, biologics or radiation. The effective date for this training requirement is August 1, 2016. For more information about GCP training, please visit this page. If you have any questions about this requirement please contact the Office of Research Policy at hrpp@research.wisc.edu or 608-890-4399.

Health Sciences IRBs for Beginners Workshops

Are you new to the HS-IRBs review process? Consider registering for one of our upcoming IRB for Beginners workshops. This two-hour session provides an introduction to the HS-IRBs review process, resources, and the ARROW online application system.

• Tuesday, May 17th, 2-4 pm, HSLC 2121 - Registration available here
• Wednesday, May 25th, 9-11 am, HSLC 2121 - Registration available here

The UW's Human Research Protection Program (HRPP) has been an AAHRPP accredited program since 2008 (re-accredited in 2011). AAHRPP accreditation indicates that our institution follows the highest standards for ethics, quality, and human participants protections. It also allows for more opportunities of collaborative research with other institutions. We are currently undergoing AAHRPP re-accreditation, and our Step I application was recently accepted indicating that our institutional policies and procedures meet accreditation standards. The remaining piece of our successful re-accreditation is a site visit from AAHRPP here at UW this fall. Many individuals throughout UW's research enterprise will be involved in this site visit, and the HRPP will assist in preparing all those involved.

For cancer-related studies, an additional submission and review by the UWCCC Protocol Review & Monitoring Committee (PRMC) may be required in addition to your IRB application. The PRMC provides the necessary scientific and regulatory oversight of UW cancer-related clinical research. The determination for review by the PRMC is based on the following three questions, found in the ARROW application:

• Is the scientific question of the protocol cancer related? Does the hypothesis of the study aim to develop the understanding of cancer or its mechanisms?
• Are you specifically targeting cancer patients for enrollment in this study?
• Does this study involve the review and/or use of biological specimens/data/images/records from cancer patients?

To find more information on how to submit a protocol to the PRMC for review, or if you have questions about this process, please visit the Protocol Review and Monitoring homepage or contact the PRMC coordinator at protocolreviewmonitoring@uwcarbone.wisc.edu or (608) 263-0169.