HS-IRBs News May 2014

Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 5, May 2014

HS-IRBs Office Closed on Memorial Day

The HS-IRBs Office will be closed Monday, May 26th in observance of Memorial Day. The ARROW helpline also will not be staffed on May 26th.

Tips for Handling Study Team Transitions

With the end of the academic year upon us, some researchers may be leaving the UW. The following tips may be helpful in handling these study team transitions:

Consent Document Changes and Changes of Protocol

When submitting a change of protocol that includes revisions to the consent documents, please include the following information in the change of protocol form:

The following is an example of language that could be used by study teams in the Informed Consent section of the Change of Protocol form:

“Enrollment to the study will not be halted while this change in risk information is being reviewed because we do not think the new risk information substantially alters the risks for subjects. The new information will be conveyed to study subjects orally, while we wait for the revised consent forms to be approved.  Once the revised consent forms are approved by the IRB we will formally re-consent study subjects at their next in-person study visit.  Subjects who are no longer on study do not need to be re-consented as this new risk information will not affect these participants (i.e., this risks are not late effects of the drugs).”

Please see Re-Consenting Subjects Guidance for additional information. 

ARROW Outage May 31st

ARROW will be offline for scheduled maintenance on Saturday, May 31st from 1PM to 5PM. We apologize for any inconvenience.

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 asktheirb@medicine.wisc.edu. 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 askarrowirb@medicine.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • WIRB updates, 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.