Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 5, June 2019
Upcoming Training Sessions
The HS IRBs will be offering two educational sessions in the coming weeks:
- “Ceding IRB Review and Single IRB Review” The Health Sciences IRBs Reliance Team will be offering a webinar on ceding IRB review to an external IRB. In addition, we will be discussing the revised Common Rule’s single IRB review mandate, which goes into effect in January 2020. The presentation will be held on Wednesday, June 26 from 1-2 PM. Please register by emailing Mike Bingham at firstname.lastname@example.org and contact him with any questions. “Understanding the Common Rule and the HS IRBs Submission Process” covers the Common Rule and what the IRB is looking for in their review, the IRB's review process, how to navigate the ARROW application system, and resources available to assist researchers with their submissions. The next presentation will be Thursday, June 27th from 2-3 PM in room 1309 of the Health Sciences Learning Center. Please register through the OTM Catalog available here. If you have any questions or issues registering for this presentation please contact Jake Rome at email@example.com.
The Professional Research Education Program (PREP) also will be offering the following session:
- “Working with Minors in Research” will be held August 6th from 12-1 PM in 1335 HSLC Registration for all PREP sessions is available through the Office of Talent Management catalog.
New Single IRB (sIRB) Review Resources and Outreach
To help researchers in the transition to the revised Common Rule’s single IRB (sIRB) review mandate coming into effect January 2020, the Reliance Team has posted some new resources for study teams:
- UW-Madison Single IRB Review (sIRB) Matrix: These documents provide detailed information about which sIRB options can be used by UW-Madison researchers for their studies, based on factors such as funding source and UW-Madison’s role in the study (i.e., lead vs. participating site). NOTE: Although NIH policy allows it, UW-Madison will NOT charge fees when serving as the reviewing IRB.
- Implementing the New Common Rule's Single IRB (sIRB) Mandate: Starting July 1, the Reliance Team will be identifying initial review applications in progress that may be affected by the revised Common Rule’s sIRB mandate. If an application may fall under the mandate, the Reliance Team will reach out to the study team to discuss options for complying with the mandate in the most efficient way possible. The goal of this outreach effort is both to education the research community about the mandate and ensure researchers have sIRB plans in place well in advance of the mandate.
We’ve updated several HS IRBs guidance documents:
- Initial Recruitment Contact and Screening Guidance is now posted. This guidance combines two previous guidance documents outlining recruitment using mailed letters and telephone into one comprehensive guidance.
- The Clinically Relevant Information and Reporting Guidance has been updated to incorporate additional guidance on reporting clinical results to subjects and their primary care physicians.
Please contact the HS IRBs Office at 608-263-2362 or AsktheIRB@medicine.wisc.edu with any questions.
New HS IRBs Quality Improvement Project
Beginning June 17th, HS IRBs’ staff reviewers working on full initial review applications are emailing study teams when they send pre-review comments in ARROW. This email will include a brief summary of the main issues identified during pre-review as well as guidance for study teams on when the application may be scheduled for an IRB meeting, depending on when a response to pre-review issues is received. The purpose of this quality improvement project is to provide more transparency to the pre-review process and predictability about review timelines. A previous pilot of this project demonstrated a 13.5 day improvement in time to IRB approval and our office will be monitoring this effort to determine if we are achieving similar results.
If you have any questions about this project, please contact Lynn Haynes (firstname.lastname@example.org).