Clinical trial disclosure
Defense and government contractors face a distinct compliance pressure on clinical trial disclosure: obligations that originate in health and research regulation but attach to contract performance requirements enforced by the U.S. Department of Defense and the U.S. Department of Health and Human Services, with the National Institutes of Health's 2017 Final Rule on ClinicalTrials.gov registration and results reporting setting the baseline that contracting vehicles increasingly reference. When a defense contractor operates a research division, runs occupational health programs under federal grants, or holds dual-use contracts with a health-research component, NIH and DoD oversight can overlap in ways that catch compliance teams off guard. Cresthaven is actively monitoring agency guidance, contract vehicle updates, and enforcement signals across this intersection.
Watch
- NIH Final Rule 42 CFR Part 11 results-submission deadlines for federally funded trials
- DoD DFARS clauses referencing research misconduct and disclosure obligations
- ClinicalTrials.gov registration requirements triggered by Small Business Innovation Research awards
- HHS Office of Research Integrity enforcement actions against contractor-affiliated institutions
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