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In the 1960s, Sherry Arnstein helped transform health care in the United States by leading the development of a federal strategy to desegregate all of the country’s hospitals. She aimed to do the same for housing by designing guidelines to involve community residents in their local planning and policy-making activities.

Arnstein may be best known for her ladder of citizen participation, which outlines the types of contributions that citizens can make in shaping matters that directly affect them. At the very top of the ladder are the types of engagement that meaningfully share power with citizens — ones that are unfortunately rarely seen in practice.

To build a more vibrant biomedical research enterprise, we need to create opportunities for individuals who seek to serve in more active roles. Recasting Arnstein’s ladder of participation using the current vocabulary of biomedical research, the lowest rung is for human subjects: Research is done to you. A step up from that is for participants: Research is done for you. Another rung is for partners: Research is done with you. And the top rung is for researchers: Research is done by you.

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A key element that currently prevents individuals from making many types of contributions to scientific research is their inability to access their own data accumulated from their participating in studies and trials. There are many good reasons why research volunteers may want access to their research results. They may want to be more informed about the nature of the research they are involved in. They may want to ensure their privacy by inspecting the data being held about them by others — an exercise Congress has recognized elsewhere as a fundamental constitutional right, as embodied in the Privacy Act of 1974.

They may want to contribute their data to other causes or research organizations they care about that may differ markedly in the research aims or governance practices compared to the institution that initially generated the data. They may even use their own research results to lead their own research inquiries. Federal law allows researchers to give research participants access to their laboratory data, with limited exceptions. One big exception is if the participant is seeking it for clinical purposes.

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Privacy and agency of research volunteers are essential to a flourishing biomedical research enterprise, though it may be inconvenient to researchers. Informed consent and dutiful stewardship of data aim, in part, to confront and address these issues. However, these processes also fail to empower individuals who want more direct involvement in research beyond passively donating tissue specimens.

A surprising roadblock to sharing research results with participants is an unsigned PDF that appeared on the website of the Centers of Medicare and Medicaid Services in 2014. It states that “research testing where patient-specific results are reported from the laboratory, and those results will be or could be used ‘for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings’ are presumed to be subject to CLIA absent evidence to the contrary.”

CLIA refers to the Clinical Laboratory Improvement Amendments, which regulate laboratory testing and certification of clinical laboratories before they can accept human samples for diagnostic testing.

The PDF literally changes the text of CLIA and has had a chilling effect on researchers who are devoted to realizing progress through the simultaneous advancement of both scientific discovery and research governance. Many research institutions treat this PDF as carrying the weight of federal law and do not give individuals access to their research results when it is generated in a research laboratory.

A scientist affiliated with the Broad Institute implicitly referenced this PDF when asked about the number of genomes that had been made accessible to the tens of thousands of research subjects who contributed their DNA samples for research. “Approximately zero, per both consent and explicit CMS guidance forbidding return of non-CLIA data to participants.”

Two legal scholars, Barbara Evans and Susan Wolf, recently examined the legal standing of this PDF and found it to be questionable, at best. The Clinical Laboratory Improvement Amendments are narrowly written to pertain to clinical laboratories with clinical goals such as the diagnosis, prevention, and treatment of disease. Research laboratories and the research studies they support with nonclinical goals, such as scientific discovery, are excluded from regulation by CLIA.

Yet the wording of the PDF clumsily revises the scope of CLIA and expands the jurisdiction of CMS to regulate research labs that do not have clinical goals but instead aim to honor the civil rights of participants who seek access to their research results. Evans and Wolf note in their review that only Congress — not agencies like CMS — can amend federal statutes. This lowly PDF seems to have persuaded many venerable institutions otherwise.

 

Americans now enjoy a federally protected right to access copies of their medical records. Standards and technology-based services have grown to support access and portability of records. Decades before that federal mandate, a simple test for the “patient centeredness” of a hospital was whether the paper medical record hung inside the examination room or outside, where it was accessible only to the doctors and staff.

Without a more supportive policy environment, even small-scale experiments in more transparent and equitable research practices that involve sharing data from research laboratories are unlikely to happen.

Policies that impede efforts to engage, respect, and honor the civil rights of research volunteers, including the PDF on CMS’s website, need to go. It’s past time for researchers to make individual-level research results accessible to those who seek it for non-clinical purposes.

Jason Bobe is director of the Resilience Project and associate professor of genetics and genomic science at the Icahn School of Medicine at Mount Sinai in New York. George Church is professor of genetics at Harvard Medical School and founder of The Personal Genome Project. The views expressed here are those of the authors and not necessarily of their respective organizations.

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