Monday, November 7, 2011

AAHRPP is Considering the New DHHS Conflict of Interest Rule

On August 25, 2011, the Department of Health and Human Services released, in the Code of Federal Regulations, new rules for financial conflict of interest in research entitled “Responsibility of Applications for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.” The new policy takes effect on August 24, 2012 and requires that organizations follow the 1995 regulations until that date.

Related to disclosure from investigators and others involved in the design, conduct and reporting of results, when Public Health Service (PHS)-sponsored research is involved, the new rule:
  • Lowers the monetary threshold for disclosure from $10,000 to $5,000.
  • Requires investigators and others to disclose financial interests related to their institutional responsibilities, such as research consultation, teaching, professional practice, institutional committee memberships, and service on Institutional Review Boards and Data and Safety Monitoring Boards.
  • Requires disclosure of reimbursed or sponsored travel, including the identity of the sponsor or organizer, the destination, and the duration. This applies to sponsored travel and not to travel supported by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

The new regulations also stipulate institutional responsibilities including:
  • Written policies on financial conflict of interest that are available via a publicly accessible Web site.
  • Policies for disclosure, review, and management of financial conflicts of interests.
  • Enforcement mechanisms including employee sanctions or other administrative actions to ensure investigator compliance.
  • A mechanism for ongoing monitoring of management plans to ensure compliance.
  • Reporting mechanism to the PHS component sponsoring the research.
  • A publically accessible Web site that lists information concerning any significant financial conflict of interest disclosed or a process to provide the information upon request. 
The rule does not address harmonization with other government regulations pertaining to financial conflict of interest, such as those of the Food and Drug Administration or the National Science Foundation.

These changes will require significant modifications of institutional policies and procedures and will require additional resources for compliance. AAHRPP is considering how the new DHHS rule affects the AAHRPP Standard on individual financial conflict of interest (Element I.6.B.) and the accredited organizations. AAHRPP is open to hearing suggestions on this matter.

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