HS-IRBs News January 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 1, January 2016
HS-IRBs Office Closures
The HS-IRBs office will be closed January 18th in observance of Martin Luther King Jr. Day. WIRB offices will be open.
Office Staff Updates
- Returning MR IRB Staff Reviewer—Sherry Holcomb has rejoined the Health Sciences IRBs Office as a staff reviewer for the Minimal Risk IRB. We are very pleased to have Sherry back in the HS-IRB’s Office.
- New HS and MR IRB Staff Reviewer—Kory Trott is joining the Health Sciences IRBs Office in January as a staff reviewer. Kory recently completed his J.D. at UW-Madison and has a MPH from Drexel University School of Public Health. We are excited to welcome Kory to the HS-IRB’s Office.
Important Updates to the Five Year Renewal Policy
A revised version of the campus Document 29793 is unavailable at this time. Policy has been posted. The policy has been revised to expand the types of studies for which a replacement application is not needed as well as to provide study teams with an additional year to qualify for an exception to the renewal policy. These changes are expected to decrease the number of studies for which a replacement application is required, which will reduce administrative burden for study teams and IRBs alike. Specific changes include the following:
- A replacement application is now not needed when study activities are limited to data, sample, or image analysis and/or long-term follow-up. This exception previously only included data analysis and has been expanded to include both image and specimen analysis.
- A 12-month extension period is now available for studies to qualify for an exception to the renewal policy. A replacement application will not be required IF study activities will be limited to data, sample, image analysis and/or long-term follow-up of participants by the start of the sixth year the study is open. No such extension was previously available to study teams. This exception, however, may only be granted one time per study. If study activities are not limited to data, sample, image analysis and/or long-term follow-up by the end of the 12-month extension period, a replacement application must be submitted.
- Elimination of the 4-month extension option. Study teams are no longer able to submit a continuing review requesting a 4 month extension if they fail to submit a replacement application in a timely manner. Therefore, please pay attention to the deadline for submitting a replacement application, which is stated on the continuing review approval letter.
Upcoming IRB 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.
ARROW Tip: Saving Work When Using the Back Button
Applications in ARROW now include a back button to allow for easier navigation to previous pages. While clicking the continue button to move forward in the application will automatically save your work, the back button does not have the same functionality. As a result, please remember to save your work before using the back button.
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 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 irbreliance.wisc.edu.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- WIRB updates, please sign up for the WIRB listsserv by emailing email@example.com 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.