Do Institutional Review Boards Adequately Address the CLIA Regulations When Studies Return Individual Research Results? A Document Analysis of IRB Policies and Guidance

In 2014, the Centers for Medicare and Medicaid Services (CMS), which oversees the federal Clinical Laboratories Improvement Amendments (CLIA) program, issued guidance that the CLIA requirements apply when researchers seek to return individual-level research findings to study participants or their physician (Centers for Medicare & Medicaid Services, 2014). The present study explores the stance of U.S. Institutional Review Boards (IRBs) toward the applicability of and compliance with the CLIA regulations when studies plan to return individual research results (RIRR). I performed a document content analysis of 73 IRB policies and supporting documents from 30 United States (U.S.) institutions funded for biomedical research by the National Institutes of Health in 2017. Documents analyzed included policies, procedures, guidance, protocol and consent templates, and miscellaneous documents (such as IRB presentations) found to address the RIRR to study participants. I used qualitative content and document analysis to identify themes across institutions related to the CLIA regulations and the RIRR. Basic descriptive statistics were used to represent the data quantitatively. The study found that 96.67% (n=29) of institutions had documents that addressed the RIRR to participants. The majority of the institutions had at least one document that referenced the CLIA regulations when discussing the practice of disclosing participant-specific results [76.67% (n=23)]. The majority of institutions [56.67% (n=17)] indicated that they require compliance with the CLIA regulations for returning individual study findings to participants, while 13.33% (n=4) recommended compliance. The intent of two (6.67%) institutions was vague or unclear, while seven (26.67%) institutions were silent on the topic altogether. Of the 23 institutions that referenced “CLIA” in their documents, 52.17% only mentioned CLIA in a one or two-sentence blurb, providing very little guidance to investigators. The study results provide evidence that the majority of U.S. biomedical institutions require or recommend compliance with CLIA stipulations when investigators intend to return individual research results to study participants. However, the data indicates there is heterogeneity and variation in the quality of the guidance provided.