- Research investigators must take all steps to protect the rights and welfare of human research subjects and to comply with all provisions of the IRB. The principal investigator is responsible for the compliance by all co-investigators and research associates. All research investigators must comply with the IRB decisions and requirements.
- New investigators and study staff must complete training in the protection of human research subjects prior to receiving IRB approval of a protocol. The Bridgeport Hospital IRB accepts the Training Modules for Assurance offered on-line by the National Institutes of Health. The link to access this training site is: phrp.nihtraining.com/users/login.php.
- Changes in previously approved research will be promptly reported to the IRB by the principal investigator.
- Changes in the conduct of the research study must be submitted to the IRB by the principal investigator and approved by the Institutional Review Board. Changes will not be initiated prior to IRB approval. The only exception to this policy would be emergency actions required to eliminate immediate hazards to study subjects. A copy of the document in the tracked changes format must be provided along with the final copy.
- Principal investigators are responsible for submitting continuing reviews of their study as determined by the IRB, but not less than once per year. At that time, you will be asked to divulge the number of subjects enrolled in the past year, any adverse events (including death, disability, or study-related problems that resulted in unscheduled hospitalization or withdrawal of subjects from the protocol). Any unanticipated problems involving risks to subjects or others that are related or possibly related to participation in the research must be reported to the Institutional Review Board within 30 days. Deaths or other severe adverse events should be reported within 5 days.
- Principal investigators are responsible for notifying the IRB and providing a final report when the study is closed.
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