Who Oversees the Regulations to Protect Research Participants?

 

Who Oversees the Regulations to Protect Research Participants?

Office for Human Research Protections (OHRP)

OHRP is part of the U.S. Department of Health and Human Services (HHS). OHRP oversees and enforces the Common Rule and other HHS regulations for protecting people in research that is funded with HHS money.

HHS and OHRP
HHS agencies include, for example, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Human research funded by these agencies falls under OHRP’s oversight. Research funded by other Federal departments that follow the Common Rule is overseen by the respective departments.
NIH and CDC
 
OHRP works with institutions to ensure compliance with the regulations, and responds to complaints about potential violations.
OHRP provides clarification and guidance about the regulations.
OHRP educates researchers and institutional staff on ethical expectations for conducting research with humans, Common Rule requirements, and the additional requirements in subparts B, C and D of the HHS regulations.
OHRP provides the general public information about research participation.
 
Potential research participants can find useful questions to ask researchers and learn about research protections and general research concepts at www.hhs.gov/about-research-participation.
 
HHS and OHRP
Protecting Human Subjects in Research
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