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What if there is a problem with your study?

What to Report:

In general, only report those problems/events that you believe are related, probably related, or possibly related to your research activities or procedures. If the event is not related or unlikely to be related to the research, you do not have to report these to the IRB but you should record and track all events in your study records. Sponsors may require you to report unrelated events to the IRB. If so, please indicate that the report is being submitted because of sponsor requirements.

What Form to Use:

Use the Report of Other Problems (ROOP) form to report events such as protocol violations, deviations, other non-medical problems or events, and subject complaints.

Use the Human Subjects Adverse Event Report form to report a medical or physical (meaning something that has happened to a human body) or a psychological event that required treatment.

What is the Reporting Timeline:

Both the Report of Other Problems and the Human Subjects Adverse Event Report must be received by HSD no later than 10 business days after you become aware of the event. In addition, the Adverse Event Report must be accompanied by two copies of the subject's signed consent form.

What if the Event is Serious:

If you believe that an event of any nature is serious, you must notify HSD as soon as possible by calling the main office at 206-543-0098. A written report form (either a Report of Other Problems or Human Subjects Adverse Event Report) should follow as soon as possible.

If you need help determining what to report and what form to use, please call HSD at 206-543-0098 and ask for a member of the Compliance Team.