Financial Conflict In Trials Should Be Ignored In Complex Cases – AdvaMed
This article was originally published in The Gray Sheet
Executive Summary
Medical technology inventors should be permitted to participate as clinical trial investigators provided their interests are disclosed beforehand, AdvaMed claims in comments to an HHS proposal regulating financial conflict of interests in medical studies
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Industry/Academic Research CoI Guidelines Urged By Beckman Coulter CEO
Voluntary guidelines stipulating conflicts of interest between medical product manufacturers and academic facilities pursuing joint R&D should include a certification and inspection component, Beckman Coulter CEO John Wareham suggested Oct. 7
Regulatory News In Brief
HHS issues conflict of interest draft guidance: "1Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection" recommends taking measures such as separating responsibility for financial and research decisions and establishing CoI committees to verify the absence of financial interests. Aimed at individuals and organizations engaged in human subjects research, the March 31 guidance provides points to consider and aligns with December 2001 GAO recommendations calling on HHS to develop best practices for managing investigator and institutional financial CoI in biomedical research. Comments on the guidance are due by May 30...