Do the HIPAA Privacy Rule’s requirements for authorization and the Common Rule’s requirements for informed consent differ?
Yes. Under the Privacy Rule, a patient’s authorization is for the use and disclosure of protected health information for research purposes. In contrast, an individual’s informed consent, as required by the Common Rule and the Food and Drug Administration’s (FDA) human subjects regulations, is a consent to participate in the research study as a whole, not simply a consent for the research use or disclosure of protected health information.
Related Questions
- By establishing new waiver criteria and authorization requirements, hasn t the HIPAA Privacy Rule, in effect, modified the Common Rule?
- By establishing new waiver criteria and authorization requirements, hasn ’t the HIPAA Privacy Rule, in effect, modified the Common Rule?
- Do the HIPAA Privacy Rules requirements for authorization and the Common Rules requirements for informed consent differ?
