Privacy and Agency are Critical to a Flourishing Biomedical Research Enterprise: Misconceptions About the Role of CLIA
9 Pages Posted: 15 Dec 2019
Date Written: December 6, 2019
The CLIA status of a lab that generates research data is regularly perceived to interfere with the ability of individuals to access data about themselves for a variety of reasons, including to advance research as an active participant who seeks to contribute to the research process in ways that go beyond serving solely as a source of tissue or data for others to use. 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." 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.
Keywords: CLIA, privacy, agency, ethics, policy, law, NASEM, return of results, equal access, ladder of participation
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