A new study set in motion by the National Institutes of Health (NIH), in collaboration with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), hopes to create a committee to review and evaluate the return of individual-specific research results from research laboratories. The study will be conducted by the National Academies of Sciences, Engineering, and Medicine.
The ensuing committee will be charged with:
- Reviewing and assessing the current evidence concerning the benefits and harm to individuals and society regarding the return of individual-specific research results generated in research laboratories;
- Reviewing the current regulatory environment, including the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and any other applicable laws, for conducting tests and returning individual-specific research results; and
- Making recommendations on the issue of returning individual-specific research results generated in research laboratories that are regulated by CLIA.
For more information on the study, visit the National Academies website.