** All research activities must be suspended until the issues are resolved with IRB approval **

Student researchers: Your SEU faculty advisor is the responsible party who must complete and submit this form.

An unanticipated problem is any unexpected occurrence during IRB-approved research that increases risk to subjects. Federal regulations and the SEU IRB require the prompt reporting of research problems, incidents, or new risks to participants in an approved study. Reporting must occur via this form within five (5) business days of an event. Contact IRB@stedwards.edu with any questions.

Use this form when all of the following conditions are met:

• the issue was not anticipated or foreseen (e.g. not described in the Consent form).
• the issue involves risk or harm to research participant(s) or others.
• the issue is probably or definitely related to or caused by the research.