HS-IRBs News - November/December 2009

Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 11, November, December 2009

Printer Friendly Newsletter November, December 2009

ARROW Update

The HS-IRBs office has held several sneak peek demos of ARROW for research personnel and we would like to thank everyone who took the time to attend. We received a lot of good questions and feedback about ARROW was quite positive. IRB staff are currently conducting unit testing of ARROW (e.g., reviewing the various applications, checking system functionality for agenda and minutes creation) and will begin alpha testing in early January.

IRB Fee Increase

Marc K Drezner, MD, Senior Associate Dean for Clinical & Translational Research sent out a memorandum earlier this fall alerting research investigators to changes in the Health Sciences Institutional Review Boards (HS-IRBs) Fee Schedule for those protocols reviewed by the Western Institutional Review Board (WIRB). On June 1, 2009 WIRB modified its Fee Schedule instituting a separate charge ($300) for each consent form submitted as part of an initial review beyond the first consent form.  The fee applies to the first site for a protocol reviewed by WIRB or any subsequent site that uses consent forms that are in addition to those already approved by WIRB.  The Information Sheet required by the Clinical & Translational Research Core is not considered a consent form.  As a result of the changes in WIRB fees, the following changes to the HS-IRBs Fee Schedule have been made: 

Use of the Initial Review Application for Non-Exempt Medical Records Research

An application specifically designed for researchers doing non-exempt medical records research is available. This application is available to researchers who are planning a study that does not qualify for exemption (e.g., the medical record data is not currently in existence or the researcher wishes to maintain a link to identifiable information).  This application can be used for research studies that solely involve the collection of medical information from medical records (including radiological imaging records) and databases or follow-up medical information from the research subject.  If the research study involves any other activities, such as a medical procedure, analysis of tissue, the creation of a research database, or if the researcher is serving as a reading center, statistical analysis center, or core lab this application cannot be used.  In these cases, a full Application for Initial Review of Research Projects Involving Human Subjects should be submitted to the IRB. 

Tips on Filling Out the Personnel Change Form

The Personnel Change form can be used to add or remove key personnel and to change the point of contact for a research study.  Please keep the following in mind when completing this form:

HS-IRBs Office Holiday Schedule

During the holidays, the HS-IRBs will be closed on certain days. As such, the continuing review deadline for the 1/12/10 HS-IRB meeting is unusual. In addition, WIRB coverage will be affected.

  • 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.