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 email@example.com 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 [Link for document 16991 is unavailable at this time.].
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
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 firstname.lastname@example.org.
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.
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.