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.
- Subject incarceration
- Ward of State Enrollment
- Involving Study Data/Specimens
- Involving Study Facility
- Involving Subject
- Notification of Audit / Inspection / Inquiry
- Protocol Deviations/Violations
- Deliberate Procedural Deviations (including "protocol exceptions")
- Accidental Procedural Deviations
- Appointment/Visit Deviations
- Dosage/Intervention Errors or Deviations
- Breach of Confidentiality or Privacy
- Investigator Responsibility on the Routine Reporting of Audits, Inspections, Reports and Correspondence to/from Oversight Bodies
|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.|
Within 7 DAYS if one of the following criteria applies:
Within 14 DAYS
when non-serious and suggests research may place subjects or others at greater risk of harm than was previously known or recognized
may jeopardize integrity of study results
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