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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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