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IRB Authority

The IRBs operate under the direction of the Vice Dean for Clinical Investigation.

The JHM IRBs must determine that: (a) the rights and welfare of the research subjects are protected adequately, (2) the risks to subjects are outweighed by the potential benefits of the research, (3) the selection of subjects is equitable, and (4) informed consent will be obtained and, when appropriate, documented.

The IRBs have the authority to suspend or terminate approval of research associated with unexpected serious harm to participants or not conducted in compliance with the IRBs conditions of approval or the federal regulations. If the IRBs suspend or terminate a research project for cause, the action will be reported to appropriate institutional officials, the head of any supporting Federal department or agency, and the Office for Human Research Protections (OHRP) at DHHS. If the project that is suspended or terminated involves a drug, device, or diagnostic regulated by the FDA, the FDA will also be notified of the suspension/termination.

Research projects approved by a JHM IRB may be subject to further review by officials of the Institutions. Administrative Institutional officials may decide that an IRB approved study may not be done at the Institutions. Administrative officials, however, may not approve the research if the IRB has disapproved it.


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