Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 6, June 2010
Printer Friendly Newsletter June 2010
ARROW Updates
- Phase 2 of ARROW rollout will
be happening in July. Study teams who
will begin using ARROW in this round of the rollout have already been
identified and include the Cancer Center, Family Medicine, some GRECC groups,
HIP, and study teams from OB-GYN. HS-IRBs staff will begin ARROW training with
these groups starting in late June.
- The final phase of ARROW
rollout will happen this fall. Announcements about ARROW training and
additional information about the final rollout will be coming later this
summer, so please stay tuned to the newsletter and listserv for details.
- The HS-IRBs Office recently
conducted a brief survey of the pilot group of ARROW users and here are some
highlights:
- When asked to rate their
satisfaction with the system, 88% of respondents indicated they were either
very satisfied or satisfied with the system.
- When asked to give a reason
for this rating, most respondents noted that working with IRB applications in ARROW
seemed faster and easier than preparing paper submissions.
- When asked whether they
thought ARROW made the IRB review process easier, harder, or had no effect, 86%
of respondents indicated ARROW made the process easier.
Modified IRB Meeting Dates
Due to July 4th Holiday
The HS-IRBs Office will be closed on Monday, July 5th
for the 4th of July holiday.
- As a result, there is no HS-IRB meeting the week of
July 5th. After the June 28th HS-IRB meeting, the next
HS-IRB meeting is July 13th. The deadline for continuing reviews to
be reviewed at the July 13th HS-IRB meeting is Friday, June 25.
- There is no MR-IRB meeting the week of July 5th.
After the June 21st MR-IRB meeting, the next MR-IRB meeting is July
12th.
Separation of Continuing
Reviews and Changes of Protocol
Please remember that since
early 2009, the HS-IRBs have not concurrently reviewed continuing reviews with
changes of protocol. This includes both full changes of protocol and expedited
changes. If you wish to submit a change of protocol but your study is within
one month of expiring, please submit the continuing review progress report
first, separately from the change form. After you have received approval for
the continuing review, you can then submit the change of protocol.
Review of Reportable
Events and Changes of Protocol
The HS-IRBs office has moved
toward specialization in staff reviewer roles. As such, please note that if a
reportable event and related change of protocol are submitted to the HS-IRBs
simultaneously, they will not be reviewed concurrently. The reportable event will
be reviewed first, with the change of protocol reviewed after. This process has
been put into place to (a) increase consistency in how reportable events are
reviewed, (b), ensure any subject safety the reports suggest are addressed in a
timely manner and (c) prepare for ARROW, where simultaneous review of multiple
submission types is not possible.
Please note, too, that a
revised Serious Adverse Event Reporting form has been posted on the Health
Sciences IRBs website and should now be used instead of the previous version.
HS-IRBs User Survey coming
in June
The HS-IRBs will be
conducting another IRBs user survey in June 2010. We want to hear your thoughts
on how we can improve our services. All key personnel listed on a research
project reviewed by the HS-IRBs and all people on the HS-IRBs listserv will
receive an invitation to complete this survey. The survey will take
approximately 20 minutes to complete and be completely anonymous.
Human Subjects and HIPAA
Training Reminders
HS-IRBs staff has noticed
that some personnel change forms submitted to the office indicate that
personnel to be added have completed the required training modules, yet the
campus training database shows they have not.
This is a friendly reminder that all personnel to be listed on human
subjects protocols must complete the required human subjects research training
module before they can be added to the list of key personnel. Information about
the CITI training module is available on the Graduate School website.
Personnel who are considered
to be part of the health care component or affiliated covered entity also must
complete HIPAA privacy rule training. Information about HIPAA privacy rule
training can be found on the HIPAA privacy rule research guidance website.
If you are not sure whether
new personnel have completed the required training modules, please consult the campus training database to make sure the personnel have completed the training
before submitting a personnel change. The HS-IRBs Office does check this
database when reviewing personnel changes and these changes will be placed on
hold until all new personnel have completed their training per campus policy.
Protocol Development Activities
(PDA) Applications
The Health Sciences IRBs developed the Application for IRB
Review of Proposal for Protocol Development Activities Only submission form (also
known as a PDA) to facilitate the submission of grant applications to the IRB
for review when research activities involving human subjects are planned in
future but have not been finalized (e.g., the grant incorporates a planning
stage) or when an agency or organization requires IRB approval of the concept
as part of the application for funding. In order to obtain approval to perform
research activities involving human subjects, a separate Initial Review
Application or Application for Exemption from IRB Review will be required. Only planning activities that do not involve
human subjects can be covered by this administrative approval. In some cases, an Application for Exemption
may be a more appropriate form to submit.
When the activities covered by a PDA are complete, please
submit a Protocol Closure form to the IRB that reviewed the application.
WIRB Updates
ACRRF
The UW-HS-IRBs WIRB Annual
Continuing Review Report Form (ACRRF) submissions process has been modified
effective June 1, 2010. Please see the
Power Point presentation posted on the UW-HS-IRBs/WIRB web page for
guidance. If you have any questions,
please email them to submitwirb@medicine.wisc.edu.
Information Sheet
The subject information sheet
submitted to WIRB will arrive with your approved documents containing tracked
changes. Because WIRB views this document
as subject material, you will not receive a clean copy of this
document. It is the research team’s
responsibility to prepare the clean copy for the research subject.
WIRB On Campus
Mark your calendars for September 21 and 22, 2010 for the WIRB On
Campus educational seminars presented by Sherry Felchlin, WIRB Account
Executive, New Business Development. If
you would like to suggest an educational topic to be covered, please email
Colette Wagner at caw@medicine.wisc.edu.
Financial Information for
HS-IRBs Submission Cover Sheet
Submitwirb@medicine.wisc.edu
will no longer accept HS-IRBs Submission Cover Sheets without questions 2a, 2b,
2c(1), 2c(2) and 2c(3) filled out. Even
though the form indicates that questions 2c(1), 2c(2) and 2c(3) need to be
filled out for initial application only,
we are now requiring this information just in case a typo occurs for
question 2b. If your research has yet
to be approved by WIRB, your response for question 2b should read “Waiting for
approval.” Thank you in advance for
your assistance with this matter.
Modification to the
Requirement for Licenses
It has been brought to our
attention that WIRB has modified their requirements for submission of
licenses. Please note that research
teams need only to supply the license for the Principal Investigator of the
study with their initial application submission from now on. There is no need to send all other staff
licenses, but, they will be submitted if you still wish to attach them to your
initial submission. This change does not
modify the requirements previously used for CVs. Please submit CVs as you have done in the
past.
Business Associate
Agreement (BAA)
WIRB is now sending a BAA
with approved research. WIRB believes
they are engaged in this type of agreement with our research teams. UW Legal Services disagrees with WIRBs
assertion that we are engaged in a BAA and have asked the research team to
disregard this document if received.
Currently UW Legal Services are working on resolving the situation with
WIRB. UW Legal services have requested
that research teams alert submitwirb@medicine.wisc.edu
to identify what studies have received this document. Therefore, if you have in the past or you do
in the future receive this document for your study please send a quick email
documenting the receipt of the BAA.
Thank you in advance for your assistance with this matter.
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
of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call
or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general
questions.
- 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 askarrowirb@medicine.wisc.edu.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
- WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu 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.