HS-IRBs News December 2014

Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 12, December 2014

HS-IRBs Office Closures

The HS IRBs office will be closed or have limited coverage the following days in December and early January:

HS-IRBs Staff Updates

We are excited to welcome several new staff members to the HS-IRBs office:

New: Greater Plains Collaborative (GPC) IRB Reliance Agreement

UW-Madison is a founding member of the Greater Plains Collaborative, a PCORI-funded partnership of 10 medical centers across 7 states. The HS-IRBs staff have been very involved in the creation of a GPC IRB reliance agreement and review process that will allow GPC studies to have a single IRB of record. We are proud to announce that the reliance agreement was finalized in November and the first studies are making their way through the reliance process. If you have questions about the GPC reliance agreement, please contact Carol Pech (cap@medicine.wisc.edu).

Updated: IRB Requirements for Studies Involving Collaborators and Sites Outside UW-Madison

The flowchart describing IRB oversight requirements for studies involving collaborators and sites outside UW-Madison and UW Health has been updated for clarity and to better indicate which requirements apply if a study is federally funded. Study teams are encouraged to review this chart when planning studies involving personnel or sites external to UW-Madison and UW Health.

NIH Draft Policy Regarding Single IRB Review

The NIH recently issued a draft policy regarding requiring single IRB review for multisite studies funded by NIH. Some NIH funding announcements have already included this requirement. NIH is inviting comments on the draft policy, which are due January 29, 2015.

FAQ on Changes to Exempt and Not Human Subjects Research Projects

The HS-IRBs has developed a FAQ on changes to exempt and not human subjects research projects. The change of protocol process for these types of projects differs from that for studies which have undergone full or expedited initial review.

For more information on changes to exempt or not human subjects research projects, see Can changes of protocol be submitted for exemptions? .

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.