HS-IRBs News April 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 4, April 2016
Office Staff Updates
- 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!
New, User-Friendly Consultation & Group Presentation Request Process
Good Clinical Practice (GCP) Training
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 firstname.lastname@example.org 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.
AAHRPP Re-Accreditation Update
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.
UWCCC Protocol Review & Monitoring Committee (PRMC) Reminder for Researchers
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 email@example.com or (608) 263-0169.
- 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 firstname.lastname@example.org. 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 email@example.com.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- 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.