IRBMED - UMMS

Other Reportable Information or Occurrence (ORIO)

Unanticipated Problems Involving Risks to Subjects or Others--Assessment Criteria

1. The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.

2. There is a reasonable possibility that the procedures involved in the research caused or are linked in a significant way to the problem.

3. The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).

Click here for more information about making an ‘unanticipated problem' assessment.

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 IRB.

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 IRB approval.

ORIO Timetable

Type of Event or Information	Timing of Report to IRBMED
Any unanticipated problem involving risks to subjects or others or a problem significant to the rights and welfare of human subjects in the study. (If the problem entailed actual harm report as an adverse event)	Within 7 days of the event (or notification of the event) if serious and related Within 14 days of the event (or notification of the event) if non-serious and related
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	See Guidance
Protocol Deviations/Exceptions Deliberate Accidental Appointments Dosage/Intervention Confidentiality/ Privacy Consent/Assent Accidents/Incidents Subjects Data Specimen Facility Complaints Miscellaneous Information Audits and Inspections General Summary or Annual Reports to Oversight Bodies Reports/letters from oversight bodies Voluntary Hold of some or all study activities	Within 7 DAYS if one of the following criteria applies: urgent subject safety issue(s) regulatory concerns serious and suggests research may place subjects or others at greater risk of harm than was previously known or recognized requires a change (amendment) to the resesarch 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 DAYS when 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 IRB timeframe parameters at the left

Procedures for ORIO Reporting

When uncertain about whether or not to report an ORIO, report or contact the IRBMED Office or IRB BehSci/Health Office advice.

For studies in Legacy (IRBMED paper-based application system)

For studies in eResearch (IRB web-based application system):

1. Report to the IRBMED on a Previously-Approved Project Application.

• Submit sections 1, 2, 3 and 10.
• When reporting subject incarceration, page an IRBMED co-chair and email IRBMED immediately.
• Carefully review the information on the ORIO Guidance: Miscellaneous Information page.
• For background and additional information see Federal regulations (45 CFR 46 Subpart C) and guidance.
• Include section 8 if the ORIO necessitates an amendment to the protocol.
• If the ORIO obliges the investigator to inform previously enrolled subjects, include in section 8 the mechanism by which this will be done. For example, if a letter will be sent to all previously enrolled subjects, submit the letter and section 8.
• Include section 11 if the ORIO necessitates a change in the informed consent document.
• Include section 5 if the ORIO is being reported with the Scheduled Continuation Review.

2. Note that the "acknowledgement fax number(s)" are the only numbers to which the IRBMED Office will send an official acknowledgement of any ORIOs you report

1. Click on AE/ORIO function tab in the left column of a particular study' s home space .

2. Indicate, as directed, the type of ORIO you are submitting (e.g. complaint, protocol deviation)

3. If the ORIO necessitates an amendment to the protocol or informed consent document, submit a separate amendment application. For example, if the ORIO obliges the investigator to inform previously enrolled subjects, include in the amendment the mechanism by which this will be done (e.g. a letter that will be sent to all previously enrolled subjects,)

Updated 10/1/2007