Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 6, May 2009
Printer Friendly Newsletter May 2009
everyone who responded to the survey regarding preferences for training
materials and in-person training opportunities for the ARROW system. We had a
tremendous response to the survey and your feedback has been very valuable in
helping us develop a training plan for ARROW. As a result of your input, expect
to see training materials that include text accompanied by static screen shots
as well as online demos without narration. We hope to offer in-person training
in small group settings to allow ample time for questions and demonstrations.
As development of ARROW continues, we want to begin
introducing some features of the system as well as some administrative changes
that the new system will bring.
notifications and downloadable correspondence: ARROW will email study
teams to let them know immediately when IRB correspondence is ready. Study
teams will then be able to log into the system and view or download IRB
correspondence. Consent documents also will be available for download from
checking of human subjects training: When
study teams submit an application in ARROW, the system will automatically check
to ensure that human subjects training has been completed for all key personnel
listed on a study, as required by campus policy.
single application for all types of new studies and projects: ARROW will have just 1 application for all
new studies and projects. The new initial review application will include
questions for exemption, emergency uses, HUDs, protocol development activities
(PDA), and others. The new form uses branching logic to ensure that study teams
only see the questions that apply to their type of research or application.
regarding new fee structure
The HS-IRBs implemented a new fee structure in July
2008. All studies submitted prior to July 1, 2008 fall under our previous fee
structure, and all studies submitted after July 1, 2008 fall under the current
fee structure. Please note that the IRB office typically can’t determine
whether or not fees apply to specific studies over the phone given the number
of factors taken into account. If you have general questions about the fee
structure, please contact the IRB office. Otherwise, a good
starting place is our website, which includes information about the fee
structures. Visit for more UW-Madison Fee Schedule information.
brown bag update
are invited to two upcoming Western IRB (WIRB) brown bags:
join an educational session on: WIRB
Changes, How to Do Them, being held May 27, 2009 from 1pm to 3pm in
the HSLC room 1325. Presentation on the various processes used for WIRB
changes. Topics covered will be types of changes, what documents need to be
prepared, who do I send what to, and what will receive an invoice. Question and
answer section will be offered after presentation. The session has been
scheduled for two hours to cover all questions.
Western IRB Open Forum discussion will be held June 4, 2009 from 10 am to
12(noon) in the HSLC room 1306. Forum will be moderated by Colette
Wagner, Commercial IRB Specialist. Please bring your questions about WIRB
processes or documents to discuss amongst your peers. Opening topic will
be how to complete site section in the application. Western IRB Manager
of Institutions, Elaine Azarenko-Weakley will be available via conference
call to discuss how sites are fill out in the application with those who
Health Sciences IRBs have revised their guidelines for the submission of
revised Investigational Drug Brochures (IDBs) after initial approval of a
study. Revised IDBs should be submitted
at continuing review unless they result in a change to the protocol or consent
form or result in the provision of information to subjects.
If you have any questions about the new guidelines, please contact 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
- 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
- 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.