This post originally appeared on Under The Poliscope, the NIH Office of Science Policy blog. To learn more about the All of Us Research Program, visit their website.

As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. All of Us aims to recruit one million people living across the United States, and as a central tenet of the program will also make data available to those participants, as well as the findings of research that use their samples and data. Recent revisions to the Common Rule have anticipated this movement, and the changes that will take effect in 2018 include new provisions that are specific to the return of research results.

As the research enterprise works to determine how and when to provide participants access to their individual-level research results and data, questions have emerged regarding whether the current regulatory environment is conducive to such access. One such example includes the Clinical Laboratory Improvement Amendments (CLIA) which is enforced by the Centers for Medicare and Medicaid Services (CMS). The Secretary’s Advisory Committee for Human Research Protections (SACHRP) has suggested that the requirements under CLIA may, in effect, create a conflict in some situations with the right of access provided by the Health Insurance Portability and Accountability Act (HIPAA) to laboratory test results. The Food and Drug Administration (FDA) device regulations may also require certain additional measures before returning individual-level research results.

In recognition of these important considerations, NIH, FDA, and CMS are collaborating to support a study by the National Academies of Sciences, Engineering, and Medicine who will convene a committee representing a range of diverse perspectives (e.g., clinicians, laboratory directors, researchers, research participants and advocates). This committee will consider whether the current regulatory environment for the return of individual-level results from analyses of biospecimens in research laboratories adequately minimizes risks and maximizes benefits both for individuals and society. This will require the committee to, among other activities, review the current regulatory environment and the evidence of harms and benefits from returning individual-level results from research laboratories, and to consider whether alternative approaches could achieve a more appropriate balance of risks and benefits.

The proceedings of this committee are sure to raise important questions and robust dialogue. I encourage all interested stakeholders to stay tuned to the National Academies for more news on this study.