Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 9, October 2019
HS IRBs Staff Update
We are excited to welcome Rob Whitehead (firstname.lastname@example.org, 262-7544) as our new quality assurance and operations specialist. Rob will be serving as our submission manager as well as assisting with ARROW support and enhancements, among other duties. Welcome, Rob!
New Guidance: Making Editorial Changes to Recruitment Materials
To help alleviate the administrative burden for researchers, the HS IRBs have developed new guidance on when editorial changes can be made to recruitment materials without needing IRB approval. Changes to recruitment materials no longer need to be submitted for IRB approval if the changes are limited to:
- Contact person is changing and they are already listed as a study team member;
- Contact phone number is changing and the number is internal to UW-Madison/UW Health
- Contact email address if email is already approved for recruitment and the new email is university-approved email account;
- Correction of typographical or spacing errors; and/or
- Changes in graphics unrelated to subject remuneration.
Upcoming Educational Opportunities
- The HS IRBs will be offering the "Common Rule and IRB Submission Overview" workshop, covering the Common Rule and what the IRB is looking for in their review, how to navigate the ARROW application system, and resources available to assist researchers with their submissions. The next presentation will be Wednesday, November 20th, from 1PM to 2PM in room 1309 of the Health Sciences Learning Center. Please register through the online catalog and look for this session under the Health Sciences IRBs category.
- The Professional Research Education Program (PREP) also will be offering the following sessions (register through the online catalog under the Professional Research Education Program category):
- "Recruitment: Building Trust between Minorities and Researchers" will be held November 12th from Noon to 1PM in 1335 HSLC.
- Researcher Regulatory Fair will be Tuesday, October 29th from 11AM to 1:30PM in Varsity Hall, Union South, with representatives from the key compliance areas on hand to answer your questions, including Jackie and Lara from our office. Free snacks!
Study Personnel Resources
Our office gets many questions regarding study personnel and here are some helpful resources for the most frequently asked questions:
- For help finding someone in the ARROW application, see this FAQ: What if I can't find someone in ARROW?.
- Information about human subjects training, Good Clinical Practice (GCP), and HIPAA training requirements can be found here.
- The campus training database—which lists courses and completion dates for individuals—can be found here.
- If you need help with the CITI program itself (e.g. merging accounts, transferring training from another institution, etc.), please contact email@example.com.
- If you have questions about adding someone outside UW-Madison/UW Health, please contact the Reliance and Navigation Team (RELIANT) at firstname.lastname@example.org.
Coming Soon: Self-Service Personnel Updates in ARROW
In early 2020, ARROW will be updated to allow study teams to change personnel (except for PI) via a self-service model. This model will be implemented across all application types (e.g. exemptions, ceded, full initial) and means that personnel changes and exempt changes for personnel will no longer be required unless the PI is being changed. This improvement is being made to reduce administrative burden for researchers and IRB staff alike. Details will be forthcoming in future newsletters, but please contact email@example.com with any questions in the meantime.