Professors Barbara Evans and Susan Wolf have made a compelling case that, contrary to conventional wisdom, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) do not prohibit the return of research results from a non-CLIA lab when that return is done for any reason other than “for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” (clinical purposes). As a result of this analysis, two pearls of conventional wisdom that have impeded efforts to engage, respect, and honor the civil rights of research participants logically fall.
First, CLIA does not conflict with a research participant’s right under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to receive a copy of her research results that are contained in the designated record set (DRS). To the contrary, with very limited exceptions, HIPAA-covered entities are required by law to provide, upon request, access to individual research results held in the DRS, even when those results were produced in a non-CLIA lab. Second, in all other cases—i.e., all cases except when a research participant requests her individual results in the DRS held by a HIPAA-covered entity (a legal right under HIPAA) or when a lab or researcher returns non-CLIA results for clinical purposes (a legal prohibition under CLIA)—federal law permits, but does not require, the return of (or access to) individual research results (legal permissibility). Read More.