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All research studies opened through the Methodist Healthcare IRB (MHIRB) remain under the MHIRB jurisdiction throughout the life span of the study. The MHIRB will continue to conduct ongoing reviews, audits and other activities appropriate to the oversight of the open studies.
The Investigator is responsible for submitting all re-approval applications, revisions, advertisements, local adverse events, safety reports, protocol violations/deviations and correspondence concerning the study to the MHIRB for review and consideration.
The MHIRB meets the second Thursday of each month at 7 a.m., University Hospital Cafeteria Meeting Room to consider all of the above items.
The following forms, with the investigator's original signature, are to be used for ongoing studies:
- Re-approval application
- Closure form
- Revision/amendment form
- Adverse event (local) form
A written report for non-serious adverse events occurring in a MH subject must be filed with the MHIRB within five (5) working days of discovery using the MHIRB Adverse Event Report Form.
All serious adverse events (life-threatening events that may be due to the test article), and all fatal events, regardless of the relationship to the test article occurring in a MH research subject, must be reported to the MHIRB (written/e-mail/fax is acceptable) within 72 hours of their occurrence.
- Safety report (outside adverse event) form
The following can be submitted on letterhead from the investigator:
- Advertisements (must include actual ad)
- Protocol violations/deviations
- Correspondence with associated attachments
Other information:
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