HS-IRBs News August 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 8, August 2013

New Dates for IRB for Beginners Workshops

Due to popular demand, the HS IRB office is offering additional sessions of the IRB for Beginners workshops. These 90-minute workshops will be held in the HSLC computer lab and give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system.  The workshop will also introduce participants to the IRB’s review process and procedures.  This workshop is designed to help people who are new to the HS-IRBs review process. 


This workshop is scheduled for the following dates:


Wednesday October 9th  9:00 - 10:30 AM (HSLC Room 2121)

Monday October 14th 11:00 - 12:30 PM (HSLC Room 2121)

Tuesday November 5th  3:00 - 4:30 PM (HSLC Room 2121)

Registration is required. Please email Brooke Mechelke at bmechelke@medicine.wisc.edu to reserve your spot in one of the future sessions.  Space is limited and the workshops fill up quickly.

ARROW FAQs: How to Find Personnel in ARROW

The ARROW helpline frequently receives questions from study teams about personnel whose names are not showing up in the ARROW application. This is just a reminder that information on locating personnel in the ARROW application and registering a netID is available in this FAQ on  How to Find Personnel in ARROW

Who to Contact with Questions about Funding and IRB Fees

Earlier this year, the Health Sciences IRBs Office hired a new office manager, Faye Levine. Two of Faye's primary responsibilities for the office relate to study funding and IRB fees including:
  • assisting study teams and others (e.g., RSP) with funding questions, such as what information to include in the funding section of the ARROW application and what to do if there are any changes to study funding or updates to accounts; and
  • answering questions about when IRB fees might apply and why IRB fees were applied to particular IRB submissions
Study teams already may have noticed questions in ARROW from Faye about study funding as part of the administrative review process for IRB submissions, especially at the time of initial review. This is part of increased efforts to ensure that the funding information is accurate because the IRB is responsible for ensuring funding information is current and congruent with the IRB-approved application.

If you need assistance with presenting study funding to the IRB, changing or updating funding, or about IRB fees, please contact Faye at 263-4922 or flevine@medicine.wisc.edu.

Listing Key Personnel in the Study Protocol and ARROW Application

The HS IRBs Office recently has received some studies that list personnel who fall under UW IRB purview in the formal study protocol document, but who are not listed on the Study Team page in ARROW. Please note that any UW, UWHC, UWMF, or Madison VA personnel listed inn the formal protocol also need to be listed on the Study Team page. Please ensure these documents are consistent as only personnel listed on the Study Team page  in the ARROW application are being approved by the IRB as study team members.

Please also note:

  • If the study team includes anyone (including students) who does not fall under UW IRB purview and a request is being submitted for the HS IRB or MR IRB to serve as their IRB of record, these individuals must be listed on the Study Team page.
  • If the study team includes anyone who does not fall under UW IRB purview and a UW IRB will not serve as their IRB of record, DO NOT list these individuals on the Study Team page. However, the study protocol must include all external collaborators and their roles in this study for investigator-initiated research studies.

Reminder: Protocol Exceptions and Deviations Guidance

The HS-IRBs Office has recently received a few questions from study teams about whether a protocol deviation requires reporting to the IRB. Study teams are encouraged to review the Health Sciences IRBs Protocol Exceptions and Deviations Guidance to ensure they understand when reporting of a deviation is required. Study teams who are unsure whether reporting is required should contact the HS-IRBs Office for assistance. 

Update on CITI/Human Subjects Research Training Outage

CITI is the program used by UW-Madison to offer human subjects research and other training courses. The University of Miami has updated the CITI Program interface and, after some assistance from the Graduate School's IT group, the UW's training courses are again available. Our thanks to the research community for their patience during this outage.

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.

  • For 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.
  • For 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.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, 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.

Keywords:newsletter, workshops, key personnel, funding, fees, deviations, personnel   Doc ID:32716
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-08-13 11:13 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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