HRPP Newsletter – April 2025

New Guidance on HCC/Non-HCC Collaborative Research

The Office of Compliance has published new guidance for study teams with members both within and outside the healthcare component (HCC).  This document should be used prior to making any arrangements/plans to receive or use protected health information (e.g. submitting an IRB protocol, entering into a contract/agreement to receive protected health information).

Reminder: Guidance and Resources on Enrolling Non-English-Speaking Participants

The IRB has comprehensive guidance on enrolling non-English-speaking participants in research, both within and outside UW Health.  Study teams should be aware that UW Health Interpreter Services provides interpreters free of charge for faculty within SMPH and/or recruiting UW Health patients within UW Health facilities. Interpreters may be in-person or via phone or video conferencing. Researchers outside of UW Health/SMPH may access lists of approved interpreter/translation vendors here.

Finally, Spanish and Vietnamese translated short form consent documents are posted in the UW IRB’s Toolkit Library. Studies approved by the IRB to use a short form consent process may use these translated documents without additional IRB approval; these short forms do not need to be uploaded in ARROW.

Studies approved by the IRB to use a short form process may also use translated short forms from WCG IRB and the University of Utah, which are available in a wide range of languages.

Stop Work Orders, Suspension of Work, or Funding Terminations

New guidance is available on actions investigators may need to take if they receive stop work or funding termination notices from a federal funding agency.

Protocol Requirements for Upload with Summary Results to ClinicalTrials.gov

Investigators must upload a final study protocol with statistical analysis plan to their ClinicalTrials.gov record as part of summary results data.  Summary results are required within 1 year of the Primary Completion Date if the study is an:

• Applicable Clinical Trial (per FDAAA Law)
• NIH-funded clinical trial (per NIH Policy)

 

A study protocol document is defined on ClinicalTrials.gov as:

The written description of the clinical study, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations (if the protocol document includes the statistical analysis plan, use "Study Protocol with SAP and/or ICF" option). Note: All amendments approved by a human subjects protection review board (if applicable), before the time of submission and that apply to all clinical trial Facility Locations must be included.

Investigators may use the Interventional and Observational Protocol Templates provided by ICTR. These templates meet the above criteria.

A study team must add a revision history table to their protocol if:

• They used the IRB’s non-Protocol Based Application, or
• Have a study protocol document without a revision history table

 

Example: Protocol Version History

Protocol Version	Version Date	Summary of Revisions Made	Rationale
1.0	mm/dd/yyyy	Initial version

Each document for upload to the public on ClinicalTrials.gov must be saved as a PDF/A document and have a cover page with the following:

• Study title
• Most recent document date
• NCT number

 

If you have any questions about these requirements, please contact the UW ClinicalTrials.gov Service.