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 reportable event and/or change of protocol is necessary.

If investigators receive a directive to modify research to avoid termination, 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. Alternatively, 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.

If a directive to stop, pause, suspend or terminate research activities requires investigators to take immediate action to eliminate an apparent immediate hazard to participants, submit a reportable event in ARROW per guidance on eliminating apparent immediate hazards. This may be required in addition to a change of protocol if the research will continue with modifications as described above.

In cases where the research will not continue, investigators should develop an action plan addressing the following, which should be submitted as a reportable event and acknowledged by the IRB prior to implementation:

• 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) taking into account 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 and other stakeholders
• If the suspension is expected to be temporary (e.g. if you are appealing), state this and submit a follow-up report when activities restart. NOTE: If restart requires modifications to your research, a change of protocol will also be required.

Studies reviewed by an external IRB should consult with that IRB and follow their reporting requirements.