Navigating US participant data sharing requirements: implications for international clinical trials
BMJ 2024; 386 doi: https://doi.org/10.1136/bmj-2024-079701 (Published 06 September 2024) Cite this as: BMJ 2024;386:e079701
- Rafael Dal-Ré, emeritus investigator1,
- Linda-Gail Bekker, professor2,
- Vivekanand Jha, executive director3 4 5,
- Anne Le Louarn, co-director6,
- Florian Naudet, professor of therapeutics7 8
- 1Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain
- 2Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, South Africa
- 3George Institute for Global Health, UNSW, New Delhi, India
- 4Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, India
- 5School of Public Health, Imperial College, London, UK
- 6GCS Comité National de Coordination de la Recherche (CNCR), Paris, France
- 7University of Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) -UMR-S 1085, Centre d’investigation clinique de Rennes (CIC1414), Rennes, France
- 8University Institute of France, Paris, France
- Correspondence to R Dal-Ré rafael.dalre{at}quironsalud.es
Despite practices and guidelines to promote the transparency of clinical trials such as the sharing of de-identified individual participant data having been discussed for years, such sharing is still the exception rather than the norm.123 However, this may change with two regulations in the US aimed at increased sharing of individual participant data. Firstly, the National Institutes of Health’s (NIH) policy for data management and sharing (DMS), which requires sharing of scientific data generated from NIH funded research, was enforced in January 2023.4 Secondly, the White House Office of Science and Technology Policy issued a memorandum in 2022 requesting that supporting data of all US federally funded research should be freely accessible immediately on publication, starting no later than 31 December 2025.5 The requirements are likely to have repercussions outside the US, particularly in low and middle income countries.
US requirements for data sharing
The NIH policy on data sharing applies to all research submitted to the NIH on or after 15 January 2023 that is funded or conducted in whole or in part by the NIH. The policy stipulates that scientific data should be made available to third parties no later than the time of an associated publication or the end of the performance period, whichever comes first, but considering any potential restrictions or limitations. Investigators must also submit a data management and sharing plan with the trial protocol and other relevant documentation, which must be approved by the NIH.4 All data management and sharing practices should be consistent with the FAIR data principles—that is, they should be findable, accessible, interoperable, and reusable.6 Given that the NIH is the largest single clinical …
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