HS-IRBs News November 2012

Health Sciences IRBs Closed November 22nd and 23rd

The HS-IRBs office will be closed November 22nd and 23rd in observance of the Thanksgiving holiday. The ARROW helpline also will not be staffed on these days.

Reminders About IRB Review of Federal Grants

• If a federal grant has been awarded to support human subjects research, submit the grant with the initial review application or, if the IRB already has approved the study, with a change of protocol to add the grant.
• If the HS-IRBs have determined a project to be exempt human subjects research, the research team should contact the HS-IRBs office to request confirmation that the grant is consistent with the existing exemption application. Please contact the staff reviewer who originally handled your exemption to request this review and provide a copy of the grant for the reviewer to compare to the exemption. If the staff reviewer is no longer with the IRB Office, please send your request to irbreview@medicine.wisc.edu.
• If the grant has not been awarded but the research team has been informed that it is likely to receive the award (e.g., Just-in-Time (JIT) notification), the research team can handle this one of two ways.
• If the research has not been approved by the IRB, submit an Protocol Development Activities (PDA) application. The PDA is a simplified application that allows the IRB to quickly review and approve the grant in concept for those activities described in the grant that do not involve human subjects. Additionally, approval of a PDA allows Research and Sponsored Programs (RSP) to release funds.
• If the grant will be used to support research that is already approved by IRB, do not use the PDA mechanism and instead submit a change of protocol when the grant has been awarded. If you need additional documentation for the funding agency or RSP, contact Nichelle Cobb (nlc@medicine.wisc.edu or 608-262-1980) for assistance.
• If a grant does not directly support human subjects research (e.g., a training grant), IRB approval is not needed unless required by the funding agency.

For more information, please see [Link for document 21528 is unavailable at this time.] .

2013 IRB Meeting Dates

The 2013 IRB Meeting Dates for the HS IRB and MR IRB are now available on the HS-IRBs website.

New: Instructions for Getting Credit for Human Subjects Research/CITI Training Completed at Another Institution

Personnel who have completed human subjects research training through CITI at another institution may receive at least partial credit towards the completion of UW-Madison human subjects research/CITI training. The Graduate School has provided instructions for obtaining credit for training completed at another institution, available here: http://www.grad.wisc.edu/research/hrpp/documents/GettingcreditforCITItrainingcompletedatyourpreviousinstitution.pdf

Reminder: IRB for Beginners Workshop

As announced via the HS IRBs listserv, a new workshop is being offered that will cover basic information about the HS IRBs website, the IRB review process, and using ARROW. This workshop is designed for people who are new to the IRB review process. Registrations is now full for currently scheduled workshops, but additional sessions will be scheduled soon. If you are interested in attending a future workshop, please email Brooke Mechelke (bmechelke@medicine.wisc.edu).

Update: Deferrals of IRB Oversight to Non-UW-Madison IRBs

Study teams who are considering requesting deferral of IRB oversight for a study to an IRB outside UW-Madison (except for a WIC institution or Meriter) should be aware that these agreements can take longer to complete than having the study reviewed and approved by the HS or MR IRB. Please contact Carol Pech (cap@medicine.wisc.edu) for guidance if you are considering requesting deferral of IRB oversight for a study that is especially time sensitive.

New: Instructions for Linking UW-Madison NetIDs with Human Subjects ResearchTraining/CITI Information

If someone takes human subjects research/CITI training without using a UW-Madison netID, this training information will not automatically show up in ARROW. The Graduate School has issued instructions for linking human subjects research training/CITI information with a UW-Madison netID, available here: http://www.grad.wisc.edu/research/hrpp/documents/ConnectingyourUWnetIDwCITIaccount.pdf

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.