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Human subject regulations decision charts

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP)
September 2004

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These graphic aids are a guide to help decide if a research activity involving human subjects needs to be reviewed by an institutional review board (IRB) under the requirements of the US Department of Health and Human Services. The charts specify the following: whether an activity is research that must be reviewed by an IRB, whether the review may be performed by expedited procedures, and whether informed consent or its documentation may be waived. This document is useful for institutional review boards (IRBs), investigators, and others who are conducting research with human subjects

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