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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 and does not otherwise need to be reported. 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 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 Form to use
Medical Problem Report within 24 hours

REPORT: Problems

Submit by e-mail as instructed on the form

Problem reports are reviewed according to SOP Management of Research Related Problems

Breach (or possible breach of confidentiality or privacy)
Inappropriate access of protected health information (PHI)
Unanticipated Problem Report within 10 business days
Unanticipated medical device effect
Serious non-compliance
Continuing non-compliance

Emergency deviation from IRB-approved procedures

(See also SOP Modifications)

Continuation of research after IRB approval has lapsed

(See also SOP Continuing Review)

Complaint of a subject that cannot be resolved by the study team

(See also SOP Research Inquiries)

Audit, inspection, or safety-related inquiry by a federal agency

New information that has implications for the risks of the research

(e.g. A publication in the literature indicates an increase in the frequency or magnitude of a previously known risks, or uncovers a new risk)

APPLICATION: Modification, Approved Project

Submit paper copies as instructed on the form

Modifications are reviewed according to the SOP Modifications

Change in credentialing, licensing, resources, or facilities that affect the research
Premature suspension or termination of the research

Safety monitor or DSMB reports

Note: reports including new information about increased risk should be submitted as an Unanticipated Problem using the REPORT: Problems form

Change Notes

  • Noted 05/31/2012 @ 01:15pm
    Keyword newly added.
    - sherrye