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The investigator must notify the MHIRB of any adverse reactions that is:
A report must be in the MHIRB office within five days of discovery using MHIRB Adverse Event Report Form. Follow-up reports regarding the event should promptly be reported to the MHIRB. Life-threatening events that may be due to the test article, and all deaths, regardless of the relationship to the test article, must be reported to the MHIRB (telephone or e-mail is acceptable) within 72 hours of their discovery.
The MHIRB will investigate the event and may, in some cases, suspend some or all study-related procedures pending the outcome of the investigation. The MHIRB may deem it necessary to permanently terminate MHIRB project approval if the additional risks to the subject are found to be unacceptable.
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