An unanticipated problem or even occurred during my study-project what do I do
An unanticipated problem that requires reporting to the IRB must meet three criteria. A reportable unanticipated problem is any incident, experience, or outcome that is:
- Unexpected
- Related or possibly related to participation in the research
- Places participants or others at a greater risk of harm
If all three criteria are met, complete an IRB Events Reporting Form within 48 hours and submit to the IRB.
Other events that may require reporting to the IRB include deviations from an approved study plan and violations of the terms of approval. If any of these occur, complete an IRB Events Reporting Form within 48 hours and submit to the IRB.
If anything unanticipated happens during your study/project, contact your chair immediately. They will help you decide if reporting to the IRB is required. If in doubt, contact the IRB: IRB@Aspen.edu and be sure to cc your chair.