Do the HIPAA Privacy Rules requirements for authorization and the Common Rules requirements for informed consent differ?
Yes. Under the Privacy Rule, a patients authorization is for the use and disclosure of protected health information for research purposes. In contrast, an individuals informed consent, as required by the Common Rule and the Food and Drug Administrations (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. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about the Common Rule. For this reason, there are important differences between the Privacy Rules requirements for individual authorization, and the Common Rules and FDAs requirements for informed consent. However, the Privacy Rules authorization elements are compatible with the Common Rules informed consent elements. Thus, both sets of requirements can be met by use of a single, combined form, which is permitted by the Privacy Rule. For e
Related Questions
- By establishing new waiver criteria and authorization requirements, hasn t the HIPAA Privacy Rule, in effect, modified the Common Rule?
- Do the HIPAA Privacy Rule’s requirements for authorization and the Common Rule’s requirements for informed consent differ?
- Do the HIPAA Privacy Rules requirements for authorization and the Common Rules requirements for informed consent differ?
