The Health Insurance Portability and Accountability Act of 1996 (HIPAA) carries with it an associated Privacy Rule became effective April 14, 2003. HIPAA significantly affects the way researchers obtain, use, and disclose protected health information (PHI) in research involving human subjects, human derived data, and/or human derived samples.
From a clinical investigator’s perspective, these regulations affect how existing health information is accessed, and how individually identifiable information created as part of research is handled.
At least one HIPAA-related form must be filled out and approved by CPHS for EACH current and new research study (including those exempt from HIPAA, for which an investigator is required to complete the form entitled "Studies Exempt from HIPAA").