HS-IRBs News - August 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 8, August 2010
Printer Friendly Newsletter August 2010
ARROW Rollout Coming in November
ARROW (the HS-IRBs new electronic submission and
review system) has been rolled out to the research community in phases, with
the 3rd and final phase now scheduled for this November. This means
that all study teams will begin using ARROW on November 17, 2010.
- For information on quick-start training sessions being offered
this fall or scheduling an ARROW demonstration for your group, please see the
special ARROW edition of the newsletter on Health Sciences IRBs News of the HS IRBs website.
- For information on what going live with ARROW
means, please see the [Link for document 17172 is unavailable at this time.]
If you have any questions about
the final phase of ARROW rollout, please email email@example.com.
- Are you a future ARROW user and curious
about the system? A variety of ARROW resources can be found on Health Sciences IRBs ARROW Help
- of the HS-IRBs website, including
demonstration videos which provide a good idea of what the system looks
like and how it works.
- Smartform Tip: When completing
applications in ARROW, please read each question carefully. Many questions
are new or phrased differently than those in the current paper
applications. Since several questions in ARROW will branch the application
to different pages depending on the answer, so making accurate choices
will save time during the pre-review process. If you are not sure how to
answer a question, please ask for assistance.
- Getting Help: Current ARROW users can get
assistance with using ARROW by calling the Help Line (262-0041) from 9-3
Monday through Friday. Questions also can be emailed to firstname.lastname@example.org.
HS-IRBs User Survey Closing
The Health Sciences IRBs user survey is
closing on August 31st. Thank you to everyone who took the time to provide
their feedback. HS-IRBs Office will soon begin reviewing the responses and
survey results will be reported in future issues of this newsletter.
Due to the new ICTR DMC replacing the previous
Data and Safety Monitoring Committee at the hospital-based General Clinical
Research Center, now the Clinical and Translational Research Core (CTRC) a
modification was necessary to the UW/WIRB Consent Template Language and the
Required Optional Consent Language Check List text. The only modification made
was the removal of the CTRC optional language block. The removal of this
entire block is acceptable since our statement, “Research oversight and
research support offices at the University of Wisconsin-Madison…” located
under, “Who can see your study records?” covers the Research Subject
The Required Optional Consent Language Check
List version #3 will be accepted for initial application submission until
August 31, 2010 with the CTRC language optional block marked “No.” Starting
September 1, 2010 version #4 of the check list, see attached, will only be
accepted with all submissions.
If you have a WIRB study that utilizes the
CTRC please remove the language block from your consent(s) at your next Change
in Research (CIR) for the study. WIRB will not automatically remove this
language from your previously approved WIRB consent document; this is the
research team’s responsibility to remove the language.
If you have any questions regarding this
change please feel free to contact Colette Wagner at 262-7544 or email@example.com.
NEW: Guidance for Analysis Centers (Including Fundus Reading and
Statistical Data Analysis Centers)
The HS-IRBs Office has issued new
guidance for fundus reading centers and other statistical or
specimen or image analysis centers for multi-site studies that streamlines the
change of protocol and continuing review process. The following guidance is
- Only changes of protocol that affect
local procedures need to be submitted for review and approval to the
HS-IRBs. These include revisions to data transmission procedures, local
personnel changes, and changes to information associated with data,
images, or samples provided to the UW-Madison or the type of data, images,
or samples the UW-Madison will review.
- Copies of revised documents (e.g.,
study-wide protocol, IDBs) that do not affect the analysis center
activities do NOT need to be submitted with the continuing review
application. Changes to these documents should instead be described in the
continuing review application
The full text of the guidance is also posted
on the Policies
and Guidance page of the HS-IRBs website.
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.
- 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 firstname.lastname@example.org. 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 irbreliance.wisc.edu.
- 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.
- WIRB updates, please sign up for the WIRB listsserv by emailing email@example.com 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.