HS-IRBs News - October 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 10, October 2010
Printer Friendly Newsletter October 2010
REMINDER: All study teams will begin
using ARROW (the new electronic submission and review system for the HS and MR
IRBs) on November 17, 2010.
ARROW Mini Quick-Start Training and Open
The HS-IRBs will be offering brief introductions
to ARROW for those who did not attend training earlier this fall. These
sessions will be held in the HSLC computer lab, with open lab time to follow
for those who want assistance with using ARROW or just want to try out the
Mini quick-start sessions will be offered
in HSLC 2121 on:
- December 13th from 10-11:30AM
- January 12th from 2-3:30PM
- January 17th from 10-11:30AM
Space is limited, so registration for
these sessions is required. To register,
please email your request to firstname.lastname@example.org.
Be sure to include the date for the session you wish to attend.
Small-Group Demonstrations Will Resume in 2011
Research groups wanting a more detailed introduction to ARROW may request a small-group
demonstration. NOTE: No small-group demonstrations will be offered for the
remainder of 2010. Slots for small-group
demos will again be available in January 2011. Requests for demonstrations should
be emailed to email@example.com.
about Going Live with ARROW?
more information on what going live with ARROW means, please see the [Link for document 17172 is unavailable at this time.] . For
more information about ARROW – including brief training videos as well as FAQs
– check out Health Sciences IRBs ARROW Help of the HS-IRBs website.
for Current ARROW Users
- Submit Legacy
Applications 2 months prior to expiration of IRB approval: Study teams should
allow additional time to prepare legacy applications and for the IRB to review
these applications. The HS-IRBs Office will work to ensure that legacy
applications are approved before IRB approval for a study expires. Legacy
application submitted less than 1 month prior to expiration of IRB
approval, however, will NOT be prioritized over legacy applications already
- Do NOT Add New Key
Personnel to Legacy Applications: When creating legacy applications in ARROW,
do NOT add personnel who are not already on the list of key personnel in the
currently approved version of the IRB application. A personnel change can be
submitted after the continuing review and legacy applications have been
approved. For the list of currently approved key personnel, please review the
last continuing review or initial review application, whichever is most recent.
- Cut and Paste
Information from Currently IRB Approved Documents: When completing the
legacy application, copy and paste
information directly from the most recently IRB approved versions of
the paper IRB application, consent documents, and study protocol. NOTE: If you
completed a non-exempt medical records application or an initial review
application form with the version date of 5/27/2008, please see the [Link for document 17435 is unavailable at this time.] document for a detailed list of where to find answers in
the paper applications to match the questions in the legacy application in
from the WIRB On Campus Symposium Now Available
for the panel presentations on accessing PHI and HIPAA from the WIRB On Campus
Symposium are now available:
- How to Gain Access to Protected Health Information (PHI)/Medical Records for Research and How to Protect Research PHIHIPAA Research Authorizations
from researchers attending these sessions was very positive, so please take a
look if you were unable to attend.
Human Subjects Protection Training Requirements
requires all personnel engaged in human subjects research to complete human
subjects protection training before they can be added to a protocol or a
protocol can be approved. The following
trainings are generally required:
all UW-Madison faculty, staff, and students engaged in human subjects research,
human subjects training must be completed every three years and generally must
satisfy this requirement through the completion of certain modules within the
CITI training course. For
UW Hospital and Clinics personnel engaged in human subjects research, the UW-Madison’s
CITI training courses must be completed. All
personnel within the Health Care Component at the UW-Madison or with UW Health
appointments also must complete HIPAA Privacy Rule training designed for
Individuals engaged in research that falls under the purview of the Madison VA
Hospital, VA Good Clinical Practice and Human Subjects Protection Training must
individuals who are not UW-Madison faculty, staff, or students, VA personnel,
or UW Health personnel, human subjects protection training must still be
completed if a UW-Madison IRB will serve as their IRB of record. These individuals can complete the UW-Madison
CITI training or other human subjects protection training programs, such the
National Institutes of Health Human Subjects Protection Training.
certain circumstances, a research team can propose alternative training for
personnel engaged in human subjects research who are unaffiliated with
UW-Madison, the Madison VA, or UW Health.
The reviewing IRB must approve this alternative training.
more information on human subjects training requirements, please see the Education and Training of HRPP Personnel Policy. To access CITI
training and for further practical details about training, please see the Graduate School’s training opportunities page.
July 2008, a new IRB fee schedule was implemented. Below are two clarifications regarding the
assessment of IRB fees. Please note that
only researchers within the School of Medicine and Public Health (SMPH) are
currently subject to IRB fees.
Protocols Funded by
a private sponsor provides indirects (aka F&A) to support a research study,
in most cases IRB fees will not be assessed.
Additionally, if a private sponsor has as a standing, publicly posted
policy that it will not provide indirects for any research its supports, no IRB
fee would be assessed. There are two cases when a privately sponsored study,
however, could be assessed a fee:
the indirect rate the sponsor provides is significantly under the current 28%
rate the UW receives for most research (e.g., under 10%) and the study does not
otherwise qualify for recusal from an IRB fee (e.g., the study is exempt human
subjects research or is a medical records study) the protocol will be placed on
a list of studies that have incurred fees that the IRB maintains, which is
provided to the principal investigator’s department at the end of the fiscal
year. The department would be
responsible for paying the IRB fee for the study.If
the sponsor has a policy to provide indirects as part of its support for
research studies but declined to provide them for a specific study and the
study does not otherwise qualify for recusal from an IRB fee (e.g., the study
is exempt human subjects research or is a medical records study), the protocol
will be placed on a list of studies that have incurred fees that the IRB
maintains, which is provided to the principal investigator’s department at the
end of the fiscal year. The department
would be responsible for paying the IRB fee for the study.
Protocols for which
Funding is Pending
a federal or private grant is not in place when the IRB receives a study for
review and the study does not otherwise qualify for recusal from an IRB fee
(e.g., the study is exempt human subjects research or is a medical records
study), IRB fees will be assessed for any reviews that occur before the federal
grant or other funding is awarded. IRB
fees that were incurred before any funds are awarded that qualify the study for
recusal from IRB fees will not be refunded.
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.