In addition to U.S. Department of Health and Human Services (HHS) regulations under 45 CFR 46 (including the Common Rule) and, when applicable, other regulations issued by federal agencies including the U.S. Food and Drug Administration (FDA) and the U.S. Department of Education, Johns Hopkins University (JHU) affiliates must also comply with relevant policies established by the university and by the Homewood Institutional Review Board (HIRB) when engaging in human subjects research.
Policies
The University and HIRB maintain policies that ensure human subjects research activities are compliant with applicable regulations, are responsive to emerging research methodologies, and reflect an ongoing commitment to participant protection.
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Guidance and Procedures
HIRB provides a variety of guidance documents and procedural instructions to assist researchers with institutional policy compliance and other requirements related to conducting human subjects research at JHU. Some guidance and procedures documents are HIRB-specific; others apply to all JHU IRBs.
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