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Prospective Clinical Trials Involving the Consent Process: Protocol Deviations

Protocol Deviations

Researchers are responsible for conducting human subjects’ research in accordance with the principles for ethical research delineated in the Belmont Report, all applicable federal and state regulations, applicable policies and procedures, and the requirements of the IRB.

Federal regulations specifically require that changes in research activity must be reported to the IRB and “may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the subject”.  Research activity includes all aspects of the research study as disclosed in the application, protocol, and other materials reviewed and approved by the IRB (e.g., study procedures and timeline, accrual, members of the research team, recruitment methods, consent document and process, procedures used to protect privacy and confidentiality, etc.).

During the conduct of a research study, variances from the approved research activity, with or without intent, may occur.  Such variances must be reported to the IRB as Protocol Deviations.

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