Here are COI final rule changes for research
Documentation, education required
The U.S. Department of Health and Human Services (HHS) recently published its final rule on research conflicts of interest, titled, "Responsibility of Applicants for Protecting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors," in the Federal Register, Vol. 76, No. 165, Aug. 25, 2011.
Set to be implemented by Aug. 24, 2012, the regulations provide specific institutional responsibilities regarding financial COI. Here are some of those responsibilities:
• Written COI policy: Institutions have to maintain an up-to-date, written, enforced policy on financial COI, and this policy must be publicly accessible via a website.
• Inform investigators of the policy: Institutions are responsible for informing each investigator of the institutional financial COI policy and require each investigator to complete COI training before engaging in research related to any federally-funded grant. This education must be renewed every four years.
• Ensure subcontractors comply with the COI policy: Institutions have to take reasonable steps to ensure any subrecipient investigator or contractor complies with the regulations.
• Designate someone to review COIs: An institutional official is needed to solicit and review disclosures of significant financial interests from each investigator. Also, investigators have to submit updated disclosures of significant financial COI at least annually.
• Provide guidelines: Institutions should design guidelines that are consistent with the new regulation (45 CFR Part 50, Part 94) to help the designated official determine whether an investigator's financial interest is related to federally-funded research and whether the significant financial interest is a financial COI.
• Manage COIs: Institutions should be prepared to take actions as necessary to manage financial COIs, including the development of a management plan, retrospective review, and/or mitigation report.
• Report to HHS: Institutions should provide initial and ongoing financial COI reports to the federal government, as required.
• Maintain records related to COI disclosures: Institutions are required to maintain records related to investigator financial interests and to review all actions under the institution's policy for at least three years from the date of the final expenditures report submission.
• Establish enforcement mechanisms: Part of institutional responsibility is to provide for employee sanctions and other administrative actions to ensure researcher compliance.
• Certify the institution's actions: An up-to-date, written, and enforced administrative process should be in place to identify and manage financial conflicts of interest in research. All information should be made available upon request to HHS relating to any investigator disclosure of financial interests and the institution's review, response, disclosure, and determination.
The U.S. Department of Health and Human Services (HHS) recently published its final rule on research conflicts of interest, titled, "Responsibility of Applicants for Protecting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors," in the Federal Register, Vol. 76, No. 165, Aug. 25, 2011.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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