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

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 sharingThe NIH policy on data sharing applies to…
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