HS-IRBs News - September 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 9, September 2010
Printer Friendly Newsletter September 2010
Final ARROW Rollout Coming in November
final phase of ARROW rollout (the new electronic submission and review system
for the HS-IRBs) will happen this November. All study teams will begin using
ARROW on November 17, 2010. Please plan to attend a quick-start training
session in October or schedule a demonstration for your group so you are ready
to use ARROW on November 17th.
Quick-Start Training Sessions
large group training sessions have been scheduled to provide study teams with a
quick overview of ARROW and its key features. Attendees can try out ARROW in
the HSLC computer lab immediately following sessions held in the CSC. No
registration is required. Quick-start sessions will be offered on:
ARROW Small-Group Demonstrations
6th from 10-11AM at CSC G5/119
13th from 10-11AM at 260 Bascom
27th from 12-1PM at CSC G5/119
Research groups wanting a more detailed introduction to
ARROW may request a small-group demonstration. NOTE: Very few slots remain for
demonstrations in October and slots in November are limited, so please submit
your request soon. Requests for
demonstrations should be emailed to email@example.com.
Questions about Going Live with ARROW?
For 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.
Tips for Current ARROW Users
- Close Studies When Possible:
Before completing a continuing review and legacy application for a study
migrated in to ARROW, please review the study to determine whether it can be
closed. Creating and reviewing legacy applications takes a lot of effort on the
part of study teams and IRB staff alike, so closing studies when possible will
reduce everyone’s workload. For guidance on when a study can be closed, see the HS-IRBs Protocol Closure Guidance and call us if you have questions. NOTE:
For studies already migrated in to ARROW, closure reports will need to be
submitted in both paper and electronically.
- 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.
- Timing Continuing
Reviews and Changes: Please avoid submitting changes of protocol for
studies for which a continuing review and legacy applications are currently
under review in ARROW. If you must submit a change of protocol before the
continuing review and legacy applications are approved, please call the ARROW
helpline at 262-0041 or email firstname.lastname@example.org
before submitting the change in paper to discuss the prioritization of the
Use of Records or Databases to Identify Potential Subjects
and Waivers of Informed Consent
Current Office for Human Research Protections (OHRP) guidance indicates
that under the Common Rule, the use of records or databases to identify potential subjects
constitutes human subjects research.
Thus, researchers must disclose to the IRB any records or databases they
may use to identify potential subjects so that the IRB can determine whether a
waiver of documentation of informed consent can be granted for this
activity. Please note that in contrast
to the HIPAA Privacy Rule, the Common Rule does not include a preparatory to
- In May 2010, the Madison VA underwent an audit by the VA
Office for Research Oversight. This
audit included a review of IRB files and operations. The audit was generally favorable, but will
result in the IRB Office contacting some research teams about required changes
to VA consent and authorization forms. A
revised VA consent form template and other guidance will be issued in October.
- Under VA policy, research teams are prohibited from making
initial contact with potential research participants via the telephone. First contact can be made in-person or by
mail. (VHA Handbook 1200.12).
- The VA interprets the preparatory to research provision
under the HIPAA Privacy Rule differently than the University of
Wisconsin-Madison. For non-VA research University
of Wisconsin-Madison policy indicates that the review of records or databases
to identify potential subjects is considered a preparatory to research activity
under the HIPAA Privacy Rule. In
contrast, VA regulations require that the IRB grant a waiver of authorization
for such activities.
- 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.