§289b–1 Protection Against Financial Conflicts of Interest in Certain Projects of Research

Summary

Create rules that say when a person or organization has a money tie that could bias a research project. The rules must apply the same to everyone doing clinical research paid for by the Secretary that tests the safety or effectiveness of a drug, device, or treatment. The Secretary must also set standards for how to handle those money ties — manage them, reduce them, or remove them — and groups can use their own procedures to follow those standards. Any group that asks for that funding must promise it has a system to find money ties, will tell the Secretary about any found ties and how they will be handled, and will follow the rules. The Secretary will check that these systems are in place and working. If a group fails to follow the rules, the Secretary will require the group to disclose the money tie in every public report of the research and may take other actions. Definitions: financial interest — includes consulting fees or honoraria and ownership of stock or equity. Assistance — means a grant, contract, or cooperative agreement.