April 8, 2025
For the Record- April 8, 2025: ITHS REDCap and Part 11 Compliance, more
In this Issue:
ITHS REDCap and Part 11 Compliance
Update
HSD has been advised that the Institute of Translational Health Sciences (ITHS) instance of the Research Electronic Data Capture (REDCap) system should not be considered compliant with FDA 21 CFR 11 when used for electronic consent. 21 CFR Part 11, or “Part 11,” is a set of FDA regulations that define the criteria for ensuring electronic records and signatures are trustworthy, reliable, and equivalent to paper records and handwritten signatures. UW Research IT recently reassessed the ITHS’ REDCap instance and concluded that further validation is necessary to consider the system fully compliant.
HSD has removed all references to the ITHS REDCap system being Part 11 compliant from our website and application materials. FDA-regulated studies that wish to use e-consent will need to identify alternative Part 11 compliant consent tools or obtain a waiver of documentation of informed consent from the IRB (if applicable). Use of REDCap e-consent for non-FDA regulated studies is fine and unaffected by this change.
If you have any questions or concerns, please contact hsdinfo@uw.edu.
Compensation for Injury Consent Language for Industry Clinical Trials
New
For research initiated by drug or device manufacturers, the study sponsor will typically agree to cover the medical costs associated with any injury a participant experiences directly resulting from participation in the trial. The circumstances under which these injuries are covered are included in the terms of any Clinical Trial Agreement (CTA), Master Clinical Trial Agreement (MCTA), Clinical Study Agreement (CSA), or other contract negotiated by the UW Office of Sponsored Programs (OSP).
Additionally, it is a requirement of the FDA that information about the availability of this kind of coverage be provided to study participants as part of the informed consent process.
During the past year, HSD, OSP, UW Clinical Trials Office (CTO) and UW Medicine have been collectively making changes to the requirements for compensation for injury in industry-initiated research with the intention to:
- Better protect study participants,
- Better protect the University of Washington,
- Improve clarity of policy and process for all, and
- Reduce potential for inaccurate consent materials.
What has already changed?
On July 8, 2024, UW Medicine’s Comp 202 policy was revised to prohibit the billing of study participants and/or their insurer’s first with the sponsor only to pay the remaining balance. This universal policy provides greater protection to study participants and the UW.
Beginning January 1, 2025, OSP is using stock contract terms that align with the updated Comp 202 policy when negotiating CTAs for single studies with industry sponsors. OSP is currently assessing whether already established MCTAs align with Comp 202 and developing a plan for renegotiating these agreements.
What is changing now?
HSD has developed example consent language that aligns with Comp 202 and the contract terms negotiated by OSP. This language is suitable for all consent forms for single study CTAs starting immediately. Use of this language is currently optional; however, research teams are strongly encouraged to begin using it because HSD intends to make it mandatory later this year. The language can be found in HSD’s GUIDANCE Consent Elements for Externally Reviewed Studies.
Because assessment of MCTA’s for alignment to Comp 202 is ongoing, this consent language may or may not match the terms of each MCTA. At this time, study teams operating under a MCTA should continue to work with sponsors and/or the CTO to ensure that consent language aligns with the terms of the applicable MCTA.
For questions about the new consent language, contact hsdrely@uw.edu.
Diversity in Clinical Trials Initiative
Update
In our January 7, 2025 newsletter, we announced the publication of the UW’s finalized Diversity in Clinical Trials (DCT) policy. This policy implements WA State’s new law aimed at improving participation in clinical trials from underrecognized and under-recruited communities so that their data inform and contributes towards better health outcomes in these populations.
The UW Medicine Office of Healthcare Equity and the DCT Initiative Strategic Leadership team have evaluated the potential impact recent federal executive orders and memoranda have on the UW’s efforts to comply with state law. We are closely monitoring the evolving situation. The efforts to implement the UW policy by the January 1, 2026 effective date will proceed.
The UW will continue to monitor the situation, consult with the Attorney General’s Office, and make updates or adjustments, as necessary. If you have any questions, please contact us at hsdinfo@uw.edu.
Single Patient Non-Emergency Expanded Access – New Chair Concurrence Pathway
New Policy
The Single Patient Expanded Access mechanisms allow for use of investigational drugs, biologics, or devices to treat or diagnose patients in limited situations (GUIDANCE Expanded Access). Unlike other Single Patient Expanded Access mechanisms, Single Patient Non- Emergency Expanded Access for drugs or biologics, has historically required full committee IRB review and approval prior to use.
The UW IRB is now allowing treating physicians, per FDA guidance, to employ an alternative pathway for use that does not require full committee IRB review. Physicians can request, via section 10.b. on Form FDA 3926, authorization to obtain concurrence by an IRB chairperson in lieu of full committee IRB review. If this has been requested through FDA, the treating physician can use HSD’s new APPLICATION Notification Single Patient Non-Emergency Expanded Access Use, Drug or Biologic to facilitate the review. The form walks through all the requirements before submission to the IRB via: hsdreprt@uw.edu. Review through this pathway is anticipated to reduce the median turnaround time for approval from 71 days (full board review) to 14 days.
Questions? Please email hsdinfo@uw.edu.