HS-IRBs News June 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 6, June 2013

HS-IRB Office Closures

The HS-IRBs office will be closed Thursday, July 4th and will close early at 12:30PM Friday, July 5th. The ARROW helpline also will not be staffed on the 4th or the afternoon of the 5th. Normal business hours resume on Monday, July 8th.

New Guidance on Investigational Software

The HS IRBs posted new guidance regarding software used, evaluated, or tested in a research study. This Investigational Software Guidance describes when software can be considered a medical device and thus FDA-regulated. In addition, the guidance indicates when such software is considered investigational and how to describe this to the IRB in the initial review application.

HS-IRBs Staff Updates

Human Subjects Research Training Tips

All study team members listed on a UW-Madison IRB application must complete human subjects research training through CITI. Please keep the following tips in mind regarding the human subjects research training requirement:

Reminder: IRB Approval Required Before Enrolling Vulnerable Populations 

A special consent process is often needed in order to enroll subjects who may be considered to be part of vulnerable population (e.g., individuals who are illiterate or who have physical limitations such as blindness or deafness). As a result, IRB approval must be obtained before enrolling such subjects in a study even if such populations are not targeted for enrollment. Please contact the HS-IRBs office for additional information if you considering enrolling members from such populations.

Tips for Preparing Personnel Changes

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.