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Stop Work Orders, Suspension of Work, or Funding Terminations

Reporting to UNC-CH IRB

Directive Received: If a researcher receives a directive from a federal funding agency to stop, pause, suspend, modify, or terminate activities on an award, and the change in funding will result in a premature suspension or termination of some or all of the research, or a change in activities/funding, investigators should consider whether a promptly reportable information (PRI) submission and/or a modification is necessary.

  • Submit a PRI if you must take immediate action to eliminate an apparent immediate hazard to participants or if the directive places participants at increased risk.
  • Submit a PRI if the directive places participants at increased risk by terminating the study early.
  • Submit a PRI in cases where the research will not continue but an action plan is needed to transition participants off of the study or notify them of the study termination.
  • Submit a modification if the funding has changed but the study will continue, or if only certain aspects of the study will be changed.

External IRB Review

Create PRI Submission: If the study relies on an external IRB, create a Promptly Reportable Information (PRI) submission in IRBIS if:

  • The reviewing IRB identifies an unanticipated problem involving risk to subjects or others (UPIRSO), or serious or continuing noncompliance.
  • There is a suspension or termination of some or all research activities imposed by the reviewing IRB, sponsor, or federal agency.
  • There is a complaint or concern from UNC subjects or others about the study or a participant’s involvement.

Completing the PRI Submission

  • Indicate Unexpected Event: State that the event was unexpected (question A2) and related to the research (question A3).
  • Assess Risk: Describe if the event suggests greater risk of harm than previously known (question A4). Include:
    • Immediate actions to eliminate reduce risks to participants.
    • Study status (open/closed to enrollment, follow-up, data analysis).
    • Number of active participants.
    • Specify the remaining study activities.
    • Potential harm from ending study activities prematurely.
    • Explain why and how subjects will be informed of the study closure.

Describing the Event (Question B3)

  • Actions Requested: Detail the actions requested by the federal agency.
  • Appeal Intent: State if the PI plans to appeal the directive and the expected timeline.
  • Temporary Suspension: If suspension is temporary, state this and submit a follow-up report when activities restart. A modification may be required.

Corrective and Preventative Actions (Question E2)

  • Stopping Study Activities: Describe procedures to safely stop study activities (e.g., tapering meds, completing safety labs).
  • Alternative Treatment: Arrange for alternative treatment if applicable or transition to standard of care.

Appealing the Directive

  • Follow-Up Information: If appealing, the IRB will request follow-up information on whether the directive was removed or remained in place.

IRB Review Process

  • Review by IRB: The IRB will follow UNC-CH SOP 1402 for reviewing PRI submissions.

Additional Steps

  • Closure Request: If the study is to be closed, submit a closure request in IRBIS and select “Termination of funding”. The closure request and PRI submission can be reviewed simultaneously.

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