Research Involving Human Subject Regulations 45 CFR part 46 - Decision Charts

• Date: October 04, 2009

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The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on 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.