August 30, 2011

Researchers Face Tighter Conflict of Interest Rules

From Grants Resource Center (GRC):

On August 25, 2011, the U.S. Department of Health and Human Services (HHS) issued a final rule that amends the 1995 Public Health Service (PHS) regulations on applicant responsibilities for promoting research objectivity. The new ruling establishes standards to ensure that the design, conduct, and reporting of research funded under PHS grants and cooperative agreements will be free from bias resulting from investigator financial conflicts of interest (FCOI). Institutions have until August 24, 2012 to be in full compliance with the new requirements.

The reasons for the amendments are twofold. First, the growing complexity of biomedical and behavioral research and the increased interaction among the government, research institutions, and the private sector, especially drug companies, suggest that a more rigorous approach to investigator disclosure, institutional management of financial conflicts, and federal oversight is required. Second, the promises of translational research, the challenges of technology transfer, and intense expectations at all levels of government that universities function as engines of socio-economic development generate new pressures on institutions and their faculty members to expand their relationships and deepen their engagement with industry.

The amended regulations include a number of changes with which PHS applicants must comply:

  • Designating institutional officials to solicit and review disclosures of significant financial interests (SFI) from each investigator participating in the PHS-funded research. Each investigator planning to participate in the PHS-funded research must disclose to the institution's designated official the investigator's SFIs (and those of the investigator's spouse and dependent children) no later than the time of application for PHS-funded research;
  • Lowering the SFI threshold from $10,000 to $5,000 for payments, equity interests, and any equity interest in non-publicly traded entities;
  • Excluding income from seminars, lectures, teaching, or service on advisory or review panels;
  • Expanding investigator disclosure requirements to include SFIs that are related to an investigator's institutional responsibilities, with institutions responsible for determining whether a disclosed SFI relates to the research for which PHS funding is sought and constitutes a FCOI.
  • Requiring that institutions maintain an up-to-date, written, enforced policy on FCOIs that is available via a publicly accessible website;
  • Requiring FCOI training for each investigator on any PHS-funded grant or contract prior to engaging in research, and at least every four years thereafter;
  • Requiring PHS-funded awardee institutions to take reasonable steps to ensure that any subrecipient investigator complies with the institutional policy;
  • Expanding the scope of the regulations to include Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Phase I applications; and
  • Requiring each investigator who is participating in the PHS-funded research to submit an updated disclosure of SFIs at least annually.
GRC will continue to follow this issue and SPO will post updates as they appear. Additional details are available online.

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