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Research Insights

Human Subject Regulations Decision Charts

The Office for Human Research Protections (OHRP) has posted on its website a set of decision charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule).

The Office for Human Research Protections (OHRP) has posted on its website a set of decision charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule). The decision charts are necessarily generalizations and may not be specific enough for particular situations. The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments. These decision charts can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html.