The document is a formal letter submitted by a broad coalition of scientific and academic organizations in response to an NIH Request for Information concerning registration and reporting standards for prospective basic science studies involving human participants. The signatories express strong concerns about NIH's recent policy shifts, which effectively broaden the definition of a "clinical trial" to encompass certain basic science research, and argue that this conflation creates confusion, administrative burden, and is factually incorrect. The organizations highlight that while they support increased transparency and appropriate reporting for basic science studies, these studies are fundamentally distinct from clinical trials in terms of design, objectives, methodologies, and implications for regulation and data management. They oppose any NIH funding policies that ignore this important distinction and suggest that such changes were implemented without sufficient consultation or engagement with the research community.
The letter provides a series of detailed recommendations urging NIH to avoid labeling basic science studies as clinical trials and instead develop separate, efficient frameworks for their reporting, formulated in collaboration with stakeholders. It raises concerns that imposing clinical trial registration requirements (such as those on ClinicalTrials.gov) on basic research is not only administratively inefficient and overly burdensome—especially for smaller institutions and individual researchers—but also risks misrepresenting the nature of basic research to the public and complicating NIH oversight. The signatories propose leveraging existing data sources (such as grant reports), utilizing alternate reporting platforms, and potentially creating clear distinctions or separate areas within federal databases for basic science research. They stress that any new processes should be reviewed by a dedicated NIH working group with broad input from the research community to ensure they are fit for purpose, reduce unnecessary workload, and genuinely enhance scientific transparency and rigor without undermining the NIH-stakeholder partnership or the conduct of basic science itself.
