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Human Subjects Division (HSD)

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Research Non-Compliance and the IRB

The Human Subjects Division (HSD) considers non-compliance to be a human subjects research activity that disregards or violates:

  • The ethical principles of human subjects research, as described in the Belmont Report, which the University of Washington has pledged to uphold, or
  • Federal, state, or local regulations applying to human subjects research under the jurisdiction of the UW IRB, or
  • UW IRB policies and procedures, or
  • The study activities as approved by the UW IRB, including any IRB requirements or determinations.

Researchers should report non-compliance that occurs during their research study to HSD within 10 business days of discovery using the Report of Other Problems form.

The IRB reviews non-compliance reports and determines if they meet the definitions of serious or continuing non-compliance. If so, and the study is supported by federal funds, it is HSD’s obligation to report these occurrences to the federal Office of Human Research Protections (OHRP).