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
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.
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:
- The HS-IRBs Fee Schedule will now
differentiate fees based on which IRB is being utilized (HS-IRBs or WIRB). At
this time, the HSIRBs will not impose the new consent form fees mandated by
- Effective January 1, 2010, a fee of $325 will
be charged for each consent form beyond the first submitted at the time a
protocol is sent to WIRB for initial review when the UW is the first site to
have submitted this protocol to WIRB.
This fee also will be applied if the UW is not the original site
reviewed by WIRB for the study, but the UW research team submits additional
consent forms not approved by WIRB previously for prior sites. For example, the fee would be assessed for
any substudy consent forms that are in addition to the consent document for the
the Initial Review Application for Non-Exempt Medical Records Research
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
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:
form should not be used to add individuals to a study that fall under the
purview of another IRB (e.g., collaborators at another institution).
Personnel from another institution can only be added using the Personnel
Change form if the UW has agreed to serve as the IRB of record for that site.
Change forms generally should not be submitted for research that has been
determined to be exempt from further IRB review.
ensure that personnel being added have completed required human subjects
protection and HIPAA Privacy Rule training. The following are reminders
about what training is required.
UW personnel must complete human subjects protection training via the CITI
personnel can take the VA human subjects protection training instead of the
CITI modules the UW requires.
who interact with veterans or view health information about veterans are
generally required to take the VA human subjects training.
training does not include HIPAA Privacy Rule training. Anyone who is within the Health Care
Component of the UW is required to take the UW HIPAA Researcher Training
someone views protected health information from both UW and VA subjects for a
research study, both UW and VA HIPAA Privacy Rule training must be
make sure the questions on page 3 of the form are completed if new staff are
being added. These questions are often
not recognized as being part of Section C.
Office Holiday Schedule
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.
note that the HS-IRBs office will be closed on the following days:
24-25 (UW-Madison holidays)
30 (UW-Madison required furlough day)
31-January 1 (UW-Madison holidays)
December 21, 2009 through January 1, 2010 there will be very limited coverage
for WIRB related institutional review and assistance from the UW-HS-IRBs
office. If you require immediate
assistance please contact the WIRB Institutions Help Desks with all questions
of substance (which are non-UW requirement or process questions) at
1-866-956-2467 or 1-800-562-4789 for all very general WIRB questions. If you need immediate assistance with any WIRB
UW requirements or processes please contact our main phone line 263-2362 and
ask to be directed to the WIRB Point of Contact.
Western IRB will be closed on December 25, 2009 and January 1, 2010.
Protocol Progress submissions to be reviewed at the 1/12/2010 IRB meeting,
please note the submission deadline is Wednesday 12/23/2009 due to the
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.