What Regulations Protect Research Participants?
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What Regulations Protect Research Participants?
The Common Rule
The Federal rules that protect people who participate in research were initially published by the Department of Health and Human Services (HHS).
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The first section of the HHS rules (Subpart A) is called the Common Rule because it was simultaneously adopted by 15 Federal departments and agencies in 1991. The Common Rule was revised in 2017 to reflect how research has changed since 1991.
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Additional Protections
In addition to the Common Rule, there are 4 other subparts in the HHS rules. Three of these (Subparts B, C, & D) provide additional protections for certain groups of research participants that could be considered vulnerable.
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Content last reviewed on January 28, 2020