Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 9, September 2012
The HS-IRBs office is developing a new workshop for people new to the HS-IRBs review process. The workshop will cover basic information about the HS-IRBs website, the review process, and using ARROW. The first beginners workshop will be offered later this fall and will be announced through the newsletter or listserv. If you have questions or suggestions regarding the workshop, please contact Brooke Mechelke (firstname.lastname@example.org).
A new guidance document has been posted regarding Completing the Privacy and Confidentiality Section. With this new document, guidance is now available for eight sections of the initial review application in ARROW.
The HS-IRBs office is again biding a fond farewell as well as a warm welcome to some staff members:
ARROW automatically withdraws new applications when study teams do not respond within 3 months to IRB pre-review comments. Study teams receive automated email reminders that pre-review issues are still outstanding at 1 and 2 months after the IRB comments have been sent. When the third month has been reached without a response from the study team, the application automatically transitions to the “IRB Withdrawn” state. Once in “IRB Withdrawn,” the study team must submit a request to reactivate the application through ARROW.
Recently, several study teams have requested reactivation, but then still did not respond to the outstanding comments within 3 months after the IRB office reactivated the application. This has resulted in applications again being withdrawn by ARROW and further delaying the review process.
As of October 1, 2012, the IRB will only approve one request
to reactivate an initial application. Only under exceptional circumstances will
a second request to reactivate an application be granted.
A new FAQ - Does a pilot or feasibility study require IRB review and approval? - has been posted and clarifies that pilot and feasibility studies do require IRB review.
In August 2012, campus conflict of interest policies were revised to reflect changes to the regulations for Public Health Service (PHS) funded research. Some changes were made to the conflict of interest questions in the ARROW application to assist the campus in ensuring compliance with the revised regulations. For complete information on the revised regulations, please see the campus Conflict of Interest Committee website.
Beginning October 1st, all study teams submitting to the SBS and ED IRBs will need to submit their applications through ARROW. No ARROW applications - other than from the pilot group - will be accepted by the SBS and ED IRBs prior to October 1st.
The SBS and ED IRBs also will have their own ARROW helpline and email address separate from the HS-IRBs helpline. For questions about SBS IRB or ED IRB submissions in ARROW, please contact their helpline at 608-890-4898 or email@example.com.
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.