Human Subject Research

The "Common Rule" Definition of Human Subject Research

The Department of Health and Human Services has issued the Code of Federal Regulations Title 45 Part 46, or "45 CFR 46", better known as the "Common Rule". This document offers the most authoritative working definition of human subject research and has become widely adopted by Federal and state agencies.

It defines "research" as any systematic investigation designed to develop and contribute to generalizable knowledge.

"Human subject" is defined as a living individual about whom an investigator obtains either 1) data through interaction or intervention (e.g. surgery), or 2) identifiable private information (e.g. medical records, tissue samples).

Find out more about the Common Rule: http://www.hhs.gov/ohrp/policy/#common

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