HIPAA’s protections for health information used for research purposes…
A: Supplement those of the Common Rule and FDA.
B: May be used at the institution’s discretion instead of the Common Rule and FDA protections.
C: Only apply to the research conducted inside covered entities.
D: Replace those of the Common Rule and FDA for human subject’s protection.
The correct option is A.
HIPAA’s protections for health information used for research purposes supplement those of the Common Rule and FDA.
HIPAA Privacy Rule:
Most researches that involve human subjects operate under the Common Rule or the Food and Drug Administration’s (FDA). These social subject protection regulations help in keeping the privacy of subjects and the confidentiality of information.
FDA regulates both dietary ingredients and dietary supplement products. It regulates nutritional supplements based on a different set of regulations than those covering “conventional” foods products.
FDA also takes action against any misbranded or adulterated dietary supplement product when it reaches the market.