Navigating US participant data sharing requirements: implications for international clinical trials

22 October, 2024

Navigating US participant data sharing requirements: implications for international clinical trials | The BMJ

<https://www.bmj.com/content/386/bmj-2024-079701>

May be of interest.

*Rafael Dal-Ré and colleagues* consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries

'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. 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. 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...'

[read in full here https://www.bmj.com/content/386/bmj-2024-079701 ]

HIFA profile: Richard Fitton is a retired family doctor - GP. Professional interests: Health literacy, patient partnership of trust and implementation of healthcare with professionals, family and public involvement in the prevention of modern lifestyle diseases, patients using access to professional records to overcome confidentiality barriers to care, patients as part of the policing of the use of their patient data. Email address: richardpeterfitton7 AT gmail.com