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

• Published in: BMJ Vol. 386; p. e079701
• Main Authors: Dal-Ré, Rafael, Bekker, Linda-Gail, Jha, Vivekanand, Le Louarn, Anne, Naudet, Florian
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 06.09.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Analysis; Clinical trials; Clinical Trials as Topic; Consent; COVID-19; FDA approval; Funding; General Data Protection Regulation; Government agencies; Humans; Information Dissemination - methods; Information sharing; International Cooperation; Life Sciences; Personal information; R&D; Regulatory agencies; Research & development; Research ethics; United States; United States; South Africa; United Kingdom > UK; United States > US; Germany; India

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