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

April 2016

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 Food and Drug Administration (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.  The JHM IRBs also follow Organization policies that provide additional safeguards for human subjects, including those in place for the protection of vulnerable populations.  This fundamental commitment to the protection of human subjects applies to all research overseen by the JHM IRBs, regardless of funding source or site of the research.  The JHM IRBs apply the same policies for the protection of human subjects in the United States to international research under their purview.