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Resources for Terminated Awards

The safety and welfare of participants should always be the top priority when conducting human subject research. If a researcher receives a directive from a federal funding agency to stop, pause, suspend, 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, they are reminded to take the following actions:

  • If applicable, take any actions necessary to mitigate immediate risks to participants.
  • Develop an action plan addressing the following:
    • A description of any procedures necessary to safely stop study-related activities/interventions with participants (e.g. tapering meds, completing safety labs/imaging, follow-up assessments), considering the current status of the research (e.g., open to enrollment, closed to enrollment but with active participants, follow-up only, data analysis only)
    • Arranging for alternative treatment outside of the research study, if applicable (i.e., in the case of therapeutic research)
    • Communication plan for notifying:
      • Participants which must be approved by the IRB for non-exempt research before sending.
      • Stakeholders (e.g., study personnel, collaborators, subcontractors)
      • Service providers (e.g., labs, imaging centers) and facilities where study activities take place (e.g., schools, clinics)
    • Participant compensation obligations
    • A plan for study data and biospecimens (e.g., storage, disposition)
  • If FSU is the IRB of record, submit a Report of New Information (RNI) in RAMP IRB (see RAMP IRB Library/General to review HRP-214)
    • If the suspension is expected to be temporary, state this and submit a follow-up report when activities restart.
  • Studies reviewed by an external IRB should consult with that IRB of record and follow its reporting requirements.

NOTE: If a restart requires modifications to your research, a change of protocol must also be submitted in RAMP IRB.

If investigators plan to continue the research without funding or have identified new sources of funding, a change of protocol should be submitted to add/remove funding sources, as necessary, from the study workspace in RAMP IRB.

If investigators receive a directive to modify research, they should work with their program officer to make the necessary changes and then submit the changes as an amendment to the IRB of record.

The following is intended to serve as general guidance for closing out a terminated federal grant. Specific terms and conditions in notices of award or agency guidelines supersede this guidance.