Human Research Protection Program

Reportable Events

Brief Overview

UT Southwestern (UTSW) reportable event requirements apply to all non-exempt human research conducted by or on behalf of UTSW and its affiliates, and by investigators, sites, and institutions relying on the UTSW Institutional Review Board (IRB). Investigators relying on an external (non-UTSW) IRB who are conducting research on behalf of UTSW or its affiliates are still responsible for submitting certain local events to the UTSW Human Research Protection Program Office (HRPPO). For more details on investigator responsibilities, refer to the 9.5 REPORTABLE EVENTS GUIDANCE.

Review Process 

This flow diagram illustrates the reportable event review process. 

Triage

All reportable event submissions are triaged by the Quality Assurance (QA) and Monitoring Program Division of the UTSW HRPPO. Each event is reviewed by HRPPO QA staff to ensure it meets prompt reporting criteria.

Investigation

Additional information and documentation may be necessary and will be requested by the QA team. Once all necessary information has been received, one of the following decisions will be made:

  • Withdraw (event is not promptly reportable)
  • Assign to the IRB reportable event (RE) subcommittee for review (event appears to meet the criteria of serious or continuing noncompliance and/or an unanticipated problem involving risks to subjects or others (UPIRSO))
  • Assign to the convened IRB (or UTSW Institutional Official (IO) for studies relying on non-UTSW IRBs) for review (event appears to meet the criteria of serious or continuing noncompliance and/or a UPIRSO and requires review by the convened IRB for a final determination)

Subcommittee Review

Events may be reviewed by the IRB RE subcommittee, which is made up of IRB members. The RE subcommittee evaluates whether:

  • An event meets noncompliance criteria
  • A noncompliance event appears to meet the criteria of serious or continuing noncompliance
  • An event appears to meet the criteria of a UPIRSO
  • Actions taken by the PI upon discovery of the event were appropriate
  • The proposed corrective and preventative action (CAPA) plan is appropriate
  • Additional actions need to be taken to protect human subjects

The RE subcommittee may make recommendations for the convened IRB, which will be provided to the IRB during their review.

IRB Review

At the convened IRB meeting, the IRB will determine whether:

  • An event is noncompliance, and if so, if it is serious or continuing 
  • An event is a UPIRSO
  • Actions taken by the PI upon discovery of the event were appropriate
  • The proposed CAPA plan is appropriate
  • Additional actions need to be taken to protect human subjects
  • The study should be suspended or terminated
  • The study continues to meet IRB approval criteria
  • The study approval period should be shortened

Reporting

The determination of the convened IRB will be sent to the Principal Investigator (PI) following IRB review. The determination letter may also be sent to the following offices/officials,* as appropriate:

  • Department Chair
  • UTSW IO
  • Institutional Officials (e.g., affiliates, compliance, privacy, sponsored programs, etc.)
  • Federal agencies (FDA, HHS, DOD, etc.) based on funding and FDA regulation of studies

Note: This list is not inclusive. Refer to the HRPP Reporting Policy for more information