Mar 30, 2021
Meeting of the Research, Development, and Regulatory Roundtable (R3)
1:00 PM to 3:00 PM EDT
Discussion Topic: Communicating with National Regulatory Authorities Regarding Research Misconduct
Research misconduct allegations may trigger reporting obligations to domestic and international funding agencies, health regulatory authorities, and others. R3 attendees, which included representatives from U.S. funding and regulatory agencies, academia, and biopharmaceutical companies, discussed the challenges of varying reporting requirements, including timing, content, and need for confidentiality. Attendees clarified the different responsibilities of the different entities during investigations into research misconduct and identified strategies and solutions to mitigate these challenges.