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Human Subjects Division (HSD)

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Report Problems and New Information

The table below includes a summary of problems and information that require reporting to HSD and the IRB, as well as the time frame for reporting and which form to use. Information, events and problems that are not research related do not need to be reported. Minor non-compliance only needs to be reported if it consists of an event or information listed in the table. When the components of the research are distributed across more than one institution or site, reporting requirements may differ depending upon the IRB review arrangements. For a more detailed description of HSDs reporting requirements, definitions, guidance and examples of what to report and what not to report, see SOP RNI Reporting by Researchers.

If you need help deciding what to report and what form to use, call HSD at 206-543-0098 and ask for a member of the Regulatory Affairs Team.

Information or Event When to report How to report
Qualifying Medical Problem covered by the UW HSAP Report within 24 hours

For studies in Zipline:

Follow the INSTRUCTIONS: Submit RNI (Researcher Version) in Zipline, making sure to include the:

  • ZIPLINE SUPPLEMENT: RNI form if the RNI involves non-compliance or a problem or event related to a subject
  • DSMB or other monitoring report (if applicable)
  • Audit or compliance report (if applicable)
  • Any other relevant supporting documentation

If the study also requires modification, follow the INSTRUCTIONS: Create Study Modification in Zipline. NOTE: revised Investigator Brochures (IB), package inserts, or device manuals only need to be submitted as a Modification. It is not necessary to also submit an RNI.

For paper studies:

Complete the PAPER REPORT: Problems form

If the new information also warrants a modification to the research, OR, only invovles a safety monitoring/DSMB report or revised IB, package insert, or device manual, complete the PAPER APPLICATION: Modification, Approved Project form.

Submit both by email to hsdreprt@uw.edu

Include as attachments any supplemental materials (e.g. revised IB, consent forms, DSMB or audit report).

Breach (or possible breach of confidentiality or privacy)
Inappropriate access of protected health information (PHI)
Incidental incarceration of a research subject in a study that the IRB has not approved for the inclusion of prisoners Report within 3 business days
For DOD funded EFICs studies only: All incidental incarceration of a research subject
Unanticipated problem Report within 10 business days
Unanticipated medical device effect
Serious non-compliance
Continuing non-compliance
Emergency deviation from IRB approved procedures
Continuation of research after IRB approval has lapsed
Complaint of a subject that cannot be resolved by the study team
Audit, inspection, or safety-related inquiry by a federal agency
New information that indicates a new or increased risk or safey issue (or a decrease in study benefits) (e.g. A publication in the literature indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk)
Premature suspension or termination of the research
All safety monitor or DSMB reports
Change in credentialing, licensing, resources, or facilities that affect the research

For studies in Zipline:

Follow the INSTRUCTIONS: Create Study Modification in Zipline.

For paper studies:

Complete the PAPER APPLICATION: Modification, Approved Project form and submit as instructed on the form.

Change Notes

  • Noted 11/23/2016 @ 08:49pm
    Updated to include both Zipline and Paper processes for RNI.
    - sherrye
  • Noted 05/31/2012 @ 01:15pm
    Keyword newly added.
    - sherrye