The updated rules will take effect in August 2012 and will have implications for orthopedic and spine surgeons who conduct research as individuals or as part of institutional research projects supported by HHS agencies. The new rules cut the threshold of mandatory COI reporting in half, from $10,000 to $5,000 to improve transparency, according to the report.
According to the report, the regulations also state that:
• Surgeons and investigators disclose significant financial interests as they relate to institutional responsibilities
• Institutions report information on identified financial COIs, including how they are managed
• Surgeons and investigators complete training as it relates to regulations and the financial COI policies of their institute
Kristy L. Weber, MD, chair of the American Academy of Orthopaedic Surgeons’ Council on Research and Quality, said the new regulations will increase paperwork for individuals and institutions who would have been under the previous $10,000 threshold. Institutions will also have to spend more money on compliance, she said in the report, but complying institutions have the ability to positively shape the image of orthopedics.
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