Return of Individual-Specific Research Results Generated in Research Laboratories
The undertaking of research in human participants often includes development of clinical laboratory test results associated with an individual research participant. Depending in part on the specified arrangement for sharing individual research results laid out in the informed consent document, the results of laboratory tests conducted in the context of research may or may not be shared with the individual. The National Institutes of Health (NIH) requests that the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine convenes a committee to review and evaluate the return of individual-specific research results from research laboratories, which are required to be returned in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The committee will:
- Review the current evidence concerning the return of individual-specific research results to individuals, including the value to the individual participating in the research and society and the quality challenges particular to research results.
- Review the current regulatory environment, including CLIA and any other applicable laws, for conducting tests and returning individual-specific research results, including the potential regulatory considerations associated with returning such results.
- Review current practices in returning research results and identify what are considered to be best practices, if any, for doing so.
- Identify and assess available evidence of benefits and harm to individuals and society regarding the return of research results generated in research laboratories.
- Make recommendations on the issue of returning individual-specific research results generated in research laboratories that are regulated by CLIA, and also taking into consideration any other applicable laws or regulations.
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