HS-IRBs News September 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 9, September 2016
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!
- Tuesday, September 20th - 9 AM to 11 AM, HSLC 2121 - This session is full, but request to be added to the waitlist here. If there is enough interest, another training may be scheduled.
HS IRBs Office Staff Updates
The HS IRBs Office currently has two open staff positions and is welcoming applications:
- IRB Facilitator (PVL #86922): This position will serve as a member of the HS IRBs Reliance Team (which coordinates IRB agreements between institutions) and will facilitate the submission of IRB applications to commercial IRBs in addition to other duties.
- HS/MR Staff Reviewer (PVL #87898): This is a staff reviewer position, primarily supporting the HS IRB. The person in this position will independently conduct in-depth reviews of IRB applications and protocols to ensure compliance with federal regulations, state law, and campus policies.
Questions and applications (i.e., cover letter and resume) for either position can be sent to firstname.lastname@example.org.
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:
- Submission Process Update: Two changes are being made to ARROW to help study teams more easily navigate the submission process:
- Within the application forms, the Finish button on the last page will be relabeled Ready to Submit. When clicking the Ready to Submit button, a pop-up message will appear to remind study teams that the submit button in the application workspace must be clicked in order to return the application back to the IRB.
- Within the application workspace, the Submit activity on the left-hand side of the screen will now be at the top of the list of available activities. Moving the Submit link to the top of the activity list should make it easier to locate.
- PDF Formatting for Application Snapshots: Later this month, ARROW will be updated to use PDF formatting to create application snapshots. The snapshots will have a more polished appearance, including a header with protocol number and PI name. This format will be easier for study teams to read and navigate.
- Revised Message When Deleting Documents: When revisions to study documents are submitted with a change of protocol, they should be uploaded using only the Upload Revision button and not the Add or Delete buttons. Using the Upload Revision button prevents multiple versions of the same document from being listed. Revised instructions are being added to the first page of the change form and the consent document upload question.
If you have any questions about these changes or have suggestions for future updates to ARROW, please email the HS IRBs ARROW support team.
Updated Guidance Documents
The Guidance and SOPs Working Group (GSWG) has uploaded one updated document to the HS IRBs website:
- [Link for document 18872 is unavailable at this time]: This document has been updated to provide more information about the use of emails and compliance with HIPAA privacy and security requirements. This revised guidance also includes how to address email recruitment in IRB applications. Further updates to this document will be announced in future newsletters.
- Coming soon: GSWG is developing several new guidance documents for researchers regarding data repositories and databases. These new documents will classify various research models for storing data, specimens, and images for future use. They will also explain what research teams should consider when completing IRB applications for registry or repository studies in ARROW. More information will follow in future newsletters as these documents near completion.
If you have any questions for GSWG regarding the new guidance documents or suggestions for future guidance documents, please contact Tesha Zimmerman at email@example.com
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 differences between the "Ask" email addresses used by our office: asktheirb and askarrowirb. Both addresses are monitored throughout each business day by HS IRBs staff. However, each inbox serves a different purpose.
General IRB Questions:
For general IRB questions (e.g., how do I submit a personnel change, does a certain situation require a reportable event report, is a change of protocol needed, etc.), study teams should contact firstname.lastname@example.org
. This inbox is checked throughout the day by experienced staff reviewers who are very familiar with the intricacies of IRB policy and guidance. In addition to answering questions and providing guidance, the Ask Team will forward questions on to other IRB staff with knowledge of specific areas (e.g., the IRB reliance team, fee/funding point person) or recommend a consultation if the question is complex.
ARROW Technical Questions:
For ARROW technical issues or questions (e.g., how do I change my name in ARROW, how I can find study documents, etc.), study teams should contact email@example.com
. This inbox is monitored by the HS IRBs ARROW support team. These team members have limited technical capabilities in ARROW and they will determine if a problem can be fixed HS IRBs ARROW support team or if it needs to by addressed by the campus ARROW IT team.
Update on AAHRPP Site Visit
The UW-Madison Human Research Protection Program (HRPP), which includes the HS IRBs Office, had its 3rd re-accreditation visit from the American Association of Human Research Protection Programs (AAHRPP) in August. The site visit was an opportunity for the HRPP to demonstrate how it uses policies and procedures to ensure the protection of human research subjects, and the UW-Madison passed with flying colors. The site visitors were impressed with our HRPP and provided some minor suggestions for improvement. Thank you to all who were interviewed during the site visit and participated in this important process!