HS-IRBs News - September 2009

Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 9, September 2009

Printer Friendly Newsletter September 2009

Federal Requirements for IRB Review of Grants

Federal regulations require that each grant application or proposal for Department of Health and Human Services supported human subjects research be reviewed and approved by an IRB.  As part of this review, IRBs are required to ensure that the activities described in the grant are consistent with the proposed or IRB-approved protocol.  Any discrepancies between the IRB protocol and grant must be resolved before the grant can be approved for addition to the research study.

Although this is not a new federal requirement, the University’s office of Research and Sponsored Programs recently identified several cases where researchers were unaware that specific IRB approval of federal grants is required.  Here are some helpful hints should you have federally funded research:

Submitting Federal Grants with New IRB Applications:

Adding Federal Funding to an IRB-Approved Study (Non-Exempt):

Adding Federal Funding to an IRB-Approved Study (Exemptions):

Federal Funding and New Personnel

Other Ways to Meet RSP and Federal IRB Requirements

ARROW Sneak Peek 10/28/2009

As part of an “Afternoon with ICTR” event, IRB office staff will be providing a brief overview of ARROW as well as a sneak peek of the system. The event will be held from 12:30-3:30 on 10/28 in the HSLC. The schedule is currently being finalized, so please consult the ICTR website for additional information as the date draws nearer.

ARROW: Beta Testers Needed

Internal testing of ARROW for bugs and additional development of the system continues at a quick pace. After internal testing is complete, the HS-IRBs office will move toward alpha and beta testing. We are still looking for volunteers to help us with beta testing, which we expect to begin late this year or early next year. Following an initial training session, volunteers will be asked to commit between 2-4 hours per week for about 3 weeks. Beta testing will involve going through different parts of the system and helping identify bugs and other issues. This is a great chance to get early exposure to ARROW and provide feedback about the system. If you are interested in being involved in beta testing ARROW, please contact Carol Pech at cap@medicine.wisc.edu.

WIRB Educational Sessions

Western IRB on Campus Educational Sessions have been rescheduled for October 7 and 8, 2009.  It is highly recommended that research staff attend these sessions.

IRB Submission Tips

A recent change in Submission Cover Sheet format and reminder: All submission cover sheets submitted electronically should be sent in MS Word format (the website instructions will be updated) with a submission for IRB review.  This change in requested document format is a result of internal fee processing in collaboration with OCT. 

  • 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@hsirb.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@hsirb.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.
  • 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.