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103.3 Organization Statement of Commitment to the Principles Governing Human Subjects Research

August 2010

As stated in the Federal Wide Assurances on file with OHRP, the Organization is guided by the ethical principles stated in the Belmont Report and codified by the Department of Health and Human  Services (DHHS) regulations at 45 CFR 46, and the FDA regulations at 21 CFR 50 and 56.  The Organization adheres to the guidance provided by the Office of Human Research Protection (OHRP) and by the FDA as part of that commitment.  Additionally, the IRBs follow Organization policies that provide additional protections to studies involving students and employees.  This fundamental commitment to the protection of human subjects applies to all human subject research conducted by a Hopkins faculty member or senior staff, regardless of funding source or site of the research.  All projects which meet the definition of research and that involve human subjects will be reviewed by one of the JHM IRBs.  All policies and procedures applied to research conducted in the U.S. are applied to JHM research conducted in other countries.