HS-IRBs News September 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 9, September 2012
Coming Soon: IRB for Beginners Workshop
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).
New: ARROW Application Guidance for Privacy and Confidentiality Section
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.
HS-IRBs Staff Updates
The HS-IRBs office is again biding a fond farewell as well as a warm welcome to some staff members:
- Farewell: Gina Grumke, who handled many Minimal Risk IRB reviews, will
be leaving the IRB Office to return to her life as a cultural anthropologist.
We will miss Gina’s humor, willingness to tackle challenging applications, and
love of the absurd. Good luck, Gina!
- Welcome Back: Gretchen Anding, the HS-IRBs Office Assistant Director, returns to office on October 1st. Welcome back, Gretchen!
- Welcome: We are happy to welcome Lauren Stockman to the office as a new IRB staff reviewer. Lauren comes to us from the Centers for Disease Control (CDC) in Atlanta and will be primarily supporting the MR IRB. Welcome Lauren!
New: Limits on Study Team Requests to Reactivate Applications Under Review
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month has been reached without a response from the study team, the application automatically transitions to the “IRB Withdrawn” state. Once in “IRB Withdrawn,” the study team must submit a request to reactivate the application through ARROW.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 This has resulted in applications again being withdrawn by ARROW and further delaying the review process.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.
New FAQ on Pilot and Feasibility Studies
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.
Revised Conflict of Interest Regulations
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.
SBS/ED IRBs Going Live with ARROW on October 1st
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.
- 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 firstname.lastname@example.org. 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 email@example.com.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- 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.