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HS-IRBs News February 2014
Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 2, February 2014
ARROW Improvements Update
Several improvements to ARROW were implemented earlier this month. Changes to the system include:
- New and improved printer-friendly version functionality for applications
- More detailed instructions on the final page of each application about how to submit it to the IRB office
- Clearer display of information study teams enter on the funding and interviews/surveys pages of the initial review application
Announcing a New IRB Partnership: Midwest Area Research Consortium for Health (MARCH)UW-Madison is a founding member of a new research consortium called MARCH (Midwest Area Research Consortium for Health). Other MARCH members include Indiana University, Mayo Clinic, Medical College of Wisconsin, University of Minnesota, and the Ohio State University. The IRBs from these institutions are currently developing a reciprocal IRB deferral agreement that will allow MARCH studies to be reviewed by a single IRB of record. More information about MARCH and the IRB review process will be provided in future newsletters. If you have questions about the IRB review process for MARCH, please contact Carol Pech (firstname.lastname@example.org).
Reminder: ARROW Outage March 1st
ARROW will be offline for scheduled maintenance Saturday, March 1st from 1PM to 5PM. We apologize for any inconvenience.
IRB Exemption and Quality Improvement (QI) ResourcesThe HS-IRBs office frequently receives questions about quality improvement and exempt projects. Our website has several resources on exemptions and QI projects that researchers may find useful:
- Guidance on Research vs. Quality Improvement and Program Evaluation (including a link to the research decision tool)
- How can I tell if my study is exempt, and what categories of exemption can I choose from?
- [Link for document 18839 is unavailable at this time.]
- Guidance on Exemption: Not Human Subjects Research
- Does research with existing datasets require IRB review?
New: Five Year Renewal Notifications in ARROW
As part of the ARROW improvements implemented earlier this month, five year renewal notifications were incorporated into ARROW. Currently, IRB staff email study teams with a copy of the continuing review approval letter to notify them that a study is subject to the five year renewal policy. IRB staff are now using a new activity in ARROW to send an email notification to study teams informing them that a study is subject to the five year policy. A note that a five year renewal notification has been sent also appears in the history tab for that continuing review. Five year renewal language is still being included in continuing review approval letters, but the letters are no longer being emailed directly to study teams outside of ARROW. Study teams who have questions about whether their study is subject to the five year renewal policy should review the Exception to Five Year Renewal Policy (HS IRBs) and email email@example.com with any questions.
Reminder: Version Dates for Study Documents
The HS-IRBs require that most study documents include a version date, including consent documents and study protocols. For more information on what study documents require version dates and how to include a version date, see [Link for document 19060 is unavailable at this time.] .
Coming Soon: Updated Wisconsin IRB Consortium (WIC) Website
The WIC website is in the process of being updated by its host institution, Marshfield Clinic. The updated website will include revised submission instructions for study teams, information about local requirements for each WIC institutions, and new WIC educational materials. More information about the updated website will be provided in the March newsletter. If you have questions about the upcoming changes or WIC in general, please contact Carol Pech (firstname.lastname@example.org).
- 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 email@example.com. 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 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.