IRB                

 

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The Institutional Review Board

The IRB is the administrative body, and a standing committee established by the Board of Directors of the MedStar Research Institute to assure that all research activities conducted at the Washington Hospital Center, National Rehabilitation Hospital, the MedStar Research Institute and subsidiaries of MedStar Health adequately protect the rights of human subjects recruited to participate in research activities conducted under the auspices at the institution and are scientifically sound as required under Public Law 93-348. The IRB is an independent committee which reviews and approves clinical protocols, informed consent forms, study advertisements, and printed patient materials, to ensure that the rights and welfare of human subjects are protected. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. The IRB, decides whether to approve or disapprove the protocol based upon whether or not the rights and welfare of human subjects are adequately protected. Research that the IRB has reviewed and approved may be subject to review and disapproval by officials of each institution. However, those officials may not approve research if the IRB has disapproved it. The IRB functions independently of, but in coordination with other research committees.

The IRB is responsible for the initial and continuing review of all research activities carried out at all the MedStar Institutions, following federal requirements set forth in the FDA Code of Federal Regulations, HHS 45 CFR 46 and ICH Guidelines E6.

The IRB membership is composed primarily of physicians with varying backgrounds engaged in research. It also includes representation from the clergy, the community, legal counsel, and individuals with expertise in psychology, psychiatry, biomedical engineering and medical ethics. The members are professionally competent in terms of knowledge and appreciation of the institution?s commitments and regulations. The President of the Research Institute is an ex-officio member with the power to vote in case of a tie.

 

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