Clinical, Research, or Clinical Research Laboratory—A Review of Laboratory Types and Regulating Bodies

Abstract

Oversight of individual clinical and research laboratories is variable and site dependent. There are several regulating bodies, each with their own requirements, leading to confusion in the certification process and returning information to study participants. A literary and web-based review of research, clinical research, and clinical laboratories compared regulatory differences among different laboratory types and regulatory bodies. A research laboratory generally performs scientific investigations, whereas a clinical laboratory investigates safety, devices, diagnostics, or potential treatments and specifically uses human biospecimens for diagnosis, treatment, or disease prevention. The Occupational Safety and Health Administration, the US Food and Drug Administration, and individual institutions have published guidelines on good laboratory practices and safety, but there are no regulating bodies that govern research laboratory practice. Clinical laboratories are expected to follow good clinical laboratory practices, and if they perform human testing, certification through Clinical Laboratory Improvements Amendments (CLIA) is required. Historically, genetic testing may be pursued through clinical or research avenues. CLIA prohibits releasing test results obtained from research; however, research results are freely released in many countries. The Health Insurance Portability and Accountability Act privacy rule contains an exception that could allow participants to obtain their results from a non-CLIA research lab. Determining laboratory regulatory requirements can often be difficult for research and clinical laboratories. It would be beneficial for CLIA and others to consider individual oversight for preanalytic processes. Insurance coverage for genetic testing is still variable and limited, so research testing could offer a cost-effective alternative for those affected by genetic conditions if return of results to participants is appropriately sanctioned. It is still unclear as to who would be responsible for disseminating, explaining, and determining if any follow-up care or monitoring is required from research results. Further guidelines are needed to direct release of research results and secondary findings.