Other Reportable Information or Occurrence (ORIO)

Regulations require investigators to report unanticipated problems involving risks to subjects or other, as well as any other event or information that may increase risks, may alter the risk-benefit assessment, may affect subject willingness to participate in the research, or may represent a departure from applicable human subject protection regulations or policies.

Please note that ORIO guidance does not represent a new or additional reporting burden. Rather, the presentation and timeframe for reporting this information has been clarified in order for researchers to better understand the regulatory requirements for reporting to the IRBMED.

Investigators must also amend for any/all changes in research, including closure of accrual or completion of a study and submit an ORIO (protocol deviation) for any changes made prior to IRBMED approval.

The table below shows the types of ORIOs that are reportable to the IRBMED.

ORIO Timetable

Type of Event or Information
Timing of Report to IRBMED
Subject Incarceration Immediately if PI believes a prisoner should enroll or continue in study and study was not previously reviewed to enroll prisoners
Ward of State Enrollment
Audits and Inspections As soon as possible after notification of the audit and prior to a site visit by an external oversight entity (e.g., sponsor, FDA). For FDA audits, you should also call the IRBMED office.
Protocol Deviations/Exceptions      
  • Deliberate
  • Accidental
  • Appointments
  • Dosage/Intervention
  • Breach of Confidentiality/ Privacy
  • Consent/Assent
Within 7 DAYS if one of the following criteria applies:
  • urgent subject safety issue(s)
  • requires a change (amendment) to the research
  • the risk/ benefit ratio of the study is changed
  • subjects' willingness to participate is affected
  • federal oversight letter is received
  • PI response to oversight entity
Within 14 DAYSwhen non-serious and suggests research may place subjects or others at greater risk of harm than was previously known or recognized    

AND/OR

may jeopardize integrity of study results

AND/OR

may jeopardize potential benefits to subjects

Prior to next scheduled continuation review (study renewal)

when ORIO falls outside of other IRBMED timeframe parameters at the left

Accidents/Incidents     
  • Subjects
  • Data Specimen
  • Facility
Complaints
Miscellaneous Information     
  • General Summary or Annual Reports to Oversight Bodies
  • Reports/letters from oversight bodies
  • Voluntary Hold of some or all study activities

Updated 9/24/2012

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