National Academies Report: Provide Patients with Clinical Study Results

When a person provides clinical samples or participates in tests for various medical studies, they typically never find out what their individual results are. There are concerns about patients misinterpreting the results, or that the test results might not be validated, or that doing so places an additional burden on the study staff and resources.

But a report recently published by the National Academies of Sciences, Engineering, and Medicine concluded that institutions and researchers should regularly and carefully evaluate whether and how to provide study results to participants. It also recommends that a federal regulation related to the topic be revised.

One of the report’s authors, biomedical ethics professor Amy Lynn McGuire at Baylor College of Medicine, told STAT, “It’s really calling for a sea change in how we handle the issue of research results in studies with human specimens.”

This is a timely subject considering the recent launch of the All of Us initiative by the National Institutes of Health (NIH) to collect samples and health profiles of one million Americans, as well as the proliferation of at-home genetic testing kits such as those by 23andMe and others, and Google’s Calico Life Sciences teaming up with AncestryDNA. These data are often sold to pharmaceutical companies and researchers. The difference with the at-home genetic testing kits is the patient gets the information—that’s not always the case. The All of Us initiative does plan to share the data and some of the study results with participants.

Laws and regulations have tended to complicate the matter. STAT writes, “Patients who participate in research can request some study results under HIPAA. But the Centers for Medicare and Medicaid Services (which sponsored the report with the NIH and Food and Drug Administration) doesn’t allow research institutions to return results from labs that aren’t certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA.”

CLIA oversees clinical diagnostic laboratories in the U.S., although there is also a patchwork of organizations, such as the College of American Pathologists (CAP), the American Society of Clinical Pathology (ASCP), and state licensing boards, that also have a say and influence on how clinical laboratories operate.

The report recommends that CMS revise the policy so results can be provided from non-CLIA certified laboratories when a study participant requests it and the institutional review board gives its okay. It also suggests the NIH lead the effort to devise a new quality-control procedure as an alternative to CLIA to ensure the quality of study data.

But even then, it’s not without its challenges. Ellen Wright Clayton, a professor of health policy at Vanderbilt University Law School told STAT, “It is going to be a real challenge to return these results in a way that is helpful for people. That requires access to knowledgeable clinicians who can help people navigate the system, including payers who may be unwilling to provide coverage.”

One of the conclusions of the report is that more research should be done to determine best practices for sharing research data with participants. Researchers and what is dubbed the “research community,” has to come up with a balance between the participants, safety and quality, and the effect it has on research resources.