The University of Iowa
Human Subjects Office

Corrective measures

Manuals

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If the research team has enrolled more than five (5) non-English speaking subjects using the Short Form, the PI must:
  1. Submit a Reportable Event Form (REF) for noncompliance with federal regulations and IRB policies, explain the situation and describe a corrective action plan to prevent enrolling additional non-English speaking subjects with the Short Form
  2. If the PI anticipates enrolling additional non-English speaking subjects, s/he will submit a modification to the HawkIRB application with a translated ICD and updated study procedures, following the steps outlined in the "Proactive Measures" section.
 
Short Form Policy November 2013