HS-IRBs News June 2014

Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 6, June 2014

HS IRBs Office Closed on Independence Day

The HS-IRBs Office will be closed Friday, July 4th in observance of Independence Day. The ARROW helpline also will not be staffed on July 4th.

HS IRBs Staff Updates

Farewell: Sherry Holcomb, MR IRB staff reviewer, is leaving the office at the end of July. She will continue to work part-time for the HS-IRBs for several months, focusing primarily on review of exemption applications. We want to thank Sherry for all of her hard work for the past seven years. Sherry has been an invaluable member of the HS IRBs Office. We wish her all the best and will miss having her in the office.

Filling In: With Sherry's departure, several people are assisting with the review of MR IRB applications. Chelsea Dahmen and Brandy Stoffel will be helping fill in on an initial applications typically covered by Sherry. Questions about any items that Sherry previously reviewed can be directed to Gretchen Anding (gla@medicine.wisc.edu or 263-4170)

New ARROW Guidance for Reactivating Submissions Withdrawn by the IRB

Throughout the IRB review process, a study may be closed, completed by the study team, withdrawn by the IRB or the study team, or archived. In some situations, ARROW will automatically close, withdraw, or archive a study if no action is taken by the study team. Applications will be listed as IRB Withdrawn in the submission workspace if ARROW has automatically withdrawn the application from the IRB review process. Applications will be withdrawn by ARROW if a study team does not respond to pre-review issues or IRB modification or deferral requests within 90 days.

Applications withdrawn by the IRB are archived 12 months after they have been withdrawn unless a request to reactivate is submitted by the study team. Guidance on Reactivating a Submission Withdrawn by the IRB has now been posted to the Health Sciences IRBs ARROW Help page. For additional information, study teams also are encourage to review Working with Closed, Completed, Withdrawn, and Archived Studies

ARROW Outage June 28th

ARROW will be unavailable on Saturday, June 28th from 1PM to 5PM for scheduled maintenance. We apologize for any inconvenience.

New August Dates for IRB for Beginners Workshops

Registration is now open for the next sessions of the IRB for Beginners workshop. The 90-minute workshop is held in the HSLC computer lab and gives participants a first-hand view of the resources available on the HS-IRBs' website as well as basic tools and tips for the ARROW submission system. The workshop will also introduce participants to the IRB’s review process and procedures. This workshop is designed to help people who are new to the HS-IRBs review process.

This workshop is scheduled for the following dates:

Tuesday, August 5th 1:00-2:30 PM (HSLC Room 2121)
Thursday, August 7th 9:30-11:00 AM (HSLC Room 2121)
Wednesday, August 13th 2:00-3:30 PM (HSLC Room 2121)

Registration is required. Please email Brooke Mechelke (bmechelke@medicine.wisc.edu) to reserve your spot. Space is limited.

SBIR Awards and IRB of Record Issues

Recently, SMPH leadership has reviewed the issue of the HS-IRBs serving as IRB of record for companies that receive SBIR (Small Business Innovation Research) awards involving UW-Madison personnel in the conduct of a human subjects research study. Although the HS-IRBs will still provide IRB review for research occurring at UW-Madison that is funded by a SBIR award, SMPH leadership has decided that the HS-IRBs will not be able to provide IRB of record services for those companies receiving SBIR awards. Companies in this situation will be advised to contract with an independent IRB. Study teams with questions about research involving SBIR awards should email asktheirb@medicine.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.

  • For 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.
  • For 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.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, 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.

Keywords:newsletter, listserv, workshops, withdrawn, closed, archived, SBIR   Doc ID:41061
Owner:Carol P.Group:Health Sciences IRBs
Created:2014-06-12 13:12 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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