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New HHS and NIH Proposed Rule Falls Short in Mandating Lay Language

The regulatory landscape continues to move towards a more patient-centric approach to medical research. In November, the Department of Health and Human Services (DHHS) proposed a new rule that would expand public sharing of summary data from clinical trials for applicable products regulated by the FDA. The draft policy expands reporting requirements established in 2007 under Title VIII of the Food and Drug Administration Amendments Act to include publicly-funded drug and device studies. However, the new rule lacks a more meaningful consideration by US regulators to share clinical trial results with study volunteers in non-technical, lay language.

During the past several years, CISCRP has strongly advocated for lay-language clinical trial results summaries based on feedback from patients who have long held that narratives listed on are very hard to find and extremely difficult to understand. CISCRP has developed a special program to develop and deliver non-technical clinical trial summaries to study volunteers. At this time, more than three dozen pharmaceutical and biotechnology companies are participating in the program.

“We applaud the proposed rule but it is disappointing, and I anticipate patients, the public and professionals will submit comments in the coming months in response,” said Ken Getz, CISCRP’s founder and board chair. “HHS and NIH did not address the central issue: dissemination of lay-language clinical trial results summaries for patients and the public. The proposed rule does not go far enough in recognizing that research professionals have entered a binding social contract with study volunteers that is met only when central trial results are accessible and communicated appropriately to these volunteers and the public.”

“European regulatory agencies widely support a provision to require that clinical trial results be provided in lay language and non-technical summaries within a year after the trial ends, regardless of marketing authorization,” said Getz. “The American public and patients will demand the same provision and the same respect.”

CISCRP urges our community to share their views with US regulators about the value of engaging and appreciating patients as partners in research by disseminating summary results at the end of each clinical trial that are in easy-to-understand non technical, lay language.


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Comments should be submitted to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at

Via mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892

Or by fax at 301-496-9839.

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