Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 8, August 2016
HS-IRBs Office Closure
The HS IRBs office will be closed Monday, September 5th, in observance of Labor Day.
Upcoming Beginners Workshop
Are you new to the HS-IRBs review process? Consider registering for our upcoming HS IRBs for Beginners workshop. This two-hour session provides an introduction to the HS-IRBs review process, resources, and the ARROW online application system. Spaces are limited, so please register soon to reserve your spot!
- Wednesday, September 14th - 11 AM to 1 PM, HSLC 2121 - Registration available here
- Tuesday, September 20th - 9 AM to 11 AM, HSLC 2121 - Registration available here
HS IRBs Office Staff Updates
- Farewell: Staff reviewer Stella Krall had been working part-time for the HS-IRBs Office since her return in 2013; she bid farewell to the office at the end of July. We want to thank Stella for all of her hard work, especially with ARROW, over the years. We wish her all the best, and she will be missed.
- Filling In: With Stella's departure, Carol Pech and Tesha Zimmerman will be taking over ARROW support work. For questions regarding ARROW technical issues, please continue to e-mail email@example.com.
- Relocating: Brandy Stoffel, IRB Facilitator, is moving to Texas this month, but she will continue her work with the Health Sciences IRBs and Reliance Team remotely. Study teams can continue to contact her via e-mail at IRBReliance@medicine.wisc.edu.
- Farewell: Kory Trott, who joined the IRB Office in January as a HS and MR staff reviewer, will be taking a new position as a Presidential Management Fellow at the Centers for Disease Control and Prevention. His last day with the HS IRBs Office will be September 23rd. Although Kory was only with the HS IRBs Office for a short time, he will be greatly missed. Good luck, Kory!
New and Updated Guidance Documents
The Guidance and SOPs Working Group (GSWG) has two new documents to the HS IRBs website, both designed to help researchers with some commonly asked questions:
- Identifiability Guidance: This new guidance outlines what data is considered to be identifiable under the Common Rule and HIPAA and describes the differences between coded, anonymous, and de-identified data. Such information is useful when considering whether or not research requires IRB review. It can also be a resource when determining what type of IRB review is necessary (e.g., full review versus exemption) as certain exemption categories are contingent on data identifiability.
- Replacement Studies Guidance: This updated document now provides more detailed information on completing the subject population section in replacement applications. When submitting a replacement study, researchers should describe the total number of subjects intended to be enrolled overall (i.e., meaning the number of subjects to be enrolled under the current replacement application as well as the number of subjects that were enrolled under the previous iteration(s) of the study).
If you have any questions for GSWG regarding the new guidance documents or suggestions for future guidance documents, please contact Tesha Zimmerman at firstname.lastname@example.org
Improving IRB Processes for Researchers
As part of our continuing series on how the HS IRBs Office is working to improve IRB processes for researchers, we would like to highlight the Idle States Project. When an application is submitted to the HS IRBs Office, it progresses through different stages, called "states." These typically start with Pre-Submission, proceed to IRB Administrative Review, then to Issues Pending, IRB Pre-Review, etc. Study teams can see the current state of their applications in the upper left-hand corner of the main application workspace in ARROW. The Idle States Project aims to provide additional assistance to study teams whose applications appear to be lingering or stalled during the review process.
For example, the IRB Submission Manager may note during IRB administrative review that a study team member needs to complete his human subjects research training and the PI needs to upload the approval form from her department. The application is then sent back to the study team to address those two concerns. The study team answers the questions: the training is done and the approval uploaded. The study, however, remains with them in the Issues Pending state. Under the Idle States Project, the IRB Submission Manager receives weekly reports notifying her of applications, like this example, that appear to be stalled. The IRB Submission Manager then reaches out to the study team to see how the HS IRBs Office can assist the study team in moving the application forward (e.g., did the study team hit the submit button or do they need assistance with some part of the IRB application).
The fundamental goal of the Idle States Project is to help study teams more easily and quickly navigate ARROW and the IRB review process. The HS IRBs Office also wants to ensure study teams are aware of the many ways we can support study teams during the IRB review process. If you have any suggestions or questions about this project, please contact the IRB Submission Manager, Tesha Zimmerman, at email@example.com
In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned and recent improvements include:
- Formatting Consent Documents for ARROW: When consent forms are approved in ARROW, they receive an approval stamp from the IRB and are converted by ARROW to PDF documents. This process affects the final formatting of the stamped consent form, and as a result, study teams may encounter odd formatting errors. This updated KB document provides 9 guidelines to reduce the chance of formatting difficulties. For example, all ARROW users should ensure that consent forms are either created using the most up-to-date version of Word or converted to update the file type.
PDF Formatting for Application Snapshots: At the end of September, ARROW will be updated to use PDF formatting to create application snapshots. The snapshots will have a more polished appearance and will be easier to read and navigate.
- Improvements to the Submission Process: Study teams sometimes struggle with figuring out how to submit an application to the IRB office in ARROW. To address this problem, the submission instructions and finish button on the final page of the initial review application as well as the submit button in main study workspace will be updated and reformatted to be consistent across all ARROW modules on campus. Details about these changes will be included in the September newsletter.
If you have questions about these changes to ARROW or suggestions for future improvements, please e-mail firstname.lastname@example.org.
New Disposal of VA Research Documentation Schedule
Until recently, all research documents and related records, including investigator's research records, were required by VA Central Office (VACO) to be retained indefinitely. This has now changed, and the Madison VA is able to follow a documentation disposal schedule which parallels that used by the UW, simplifying tracking especially for study teams involved in both VA and UW research projects. The new schedule now specifies that VA research documentation must be maintained by a study team for at least seven years beyond the final closure or completion of the VA research. For questions or additional information regarding the disposal of VA research documents, please contact Lynn Tarpey, Madison VA Privacy Officer, at 608-256-1901 x11699.
- 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.