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Project Title:

Return of Individual-Specific Research Results Generated in Research Laboratories
PIN: HMD-HSP-17-05        

Major Unit:

Health and Medicine Division

Sub Unit: Board on Health Sciences Policy

RSO: Mancher, Michelle

Subject/Focus Area: Health and Medicine; Policy for Science and Technology


Project Scope
The Health and Medicine Division of the National Academies will undertake a study that will 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). Currently, any research laboratory that returns individual-specific research results is regulated by CLIA.  Research laboratories that do not report patient specific results are excepted from the CLIA regulations. 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. In doing so, the committee will assess how the current regulations ensure or fail to ensure minimization of risks (e.g., erroneous or unreliable results) and maximization of the benefits that accrue to individuals and society. 
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. In making recommendations, the committee will take into account the desires of individuals regarding access to the information, the benefits and harms of returning research results to both the individuals themselves and to individual participation and trust in the research enterprise, the operational requirements and potential vulnerabilities associated with the return of results by research laboratories to the laboratory itself or the parent institution of the laboratory, as well as the need to protect both individuals and public health. In making the recommendations, the committee will consider and address, as appropriate:
The adequacy of the current CLIA regulations as applied to research laboratories (or subcategories of research testing by such laboratories) that currently return individual-specific results in accordance with CLIA. 
Barriers or perceived barriers that lead research laboratories to refrain from taking the steps necessary to become certified under CLIA.
Whether there are any operational or other requirements, including regulatory requirements, for research labs that may be developed or modified and implemented under CLIA or any other applicable laws to more adequately address the return of individual-specific research results. Additionally, whether there are or may be specific considerations for research laboratories (including any obligations or desires on the part of researchers to fulfill requests for access to research test results and whether they have the appropriate personnel or resources to explain the research results) or for individuals (including protections and ability to receive, store, and understand research results) regarding the return of such results. Also, whether, from a policy perspective, there are specific circumstances under which research results generated in research laboratories should be or should not be returned.
Whether there are any baseline test characteristics that should be met if individual-specific research results generated in research laboratories were to be returned in accordance with CLIA and any other applicable laws, such as the purpose or potential indication, analytic and clinical validity and potential clinical relevance of the test.
Whether the current regulatory requirements and policies are adequate to address returning research results in an appropriate manner and, if not, what new, revised, or alternative policies or regulatory requirements might better address the appropriate return of individual-specific research results generated in research laboratories. Also whether any such new or revised policies would have implications for the continuation of the current regulatory framework.

The committee will not undertake any examination of or deliberation on specific research results to be returned. The committee will also not make recommendations on the return of non-individual specific results (e.g., results in aggregate form). The committee will also not provide any legal interpretation or analysis regarding the scope or applicability of CLIA.

This study is sponsored by the National Institutes of Health, the Food and Drug Administration, and the Centers for Medicare and Medicaid Services. The final publication will be presented to sponsors approximately 14 months after study commencement.


 
Project Duration: 14 months    

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Committee Membership
Committee Membership

Meetings
 Meeting 1 - 07/19/2017
 Meeting 2 - 09/06/2017
 Meeting 3 - 10/24/2017
 Meeting 4 - 12/07/2017
 Meeting 5 - 12/11/2017

Reports

Reports having no URL can be seen
at the Public Access Records Office