Changes include lowering of the minimum threshold for disclosure from $10,000 to $5,000.

The U.S. Department of Health and Human Services (HHS) issued final rules on conflict of interest. They hope it will provide a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest. Staff from the NIH worked with others in HHS to revise the 1995 regulations.

“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” says HHS Secretary Kathleen Sebelius. “Our financial conflict of interest rules must keep up with the times if we are to maintain our leadership role in the global scientific community.”

Major changes to the regulations include the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training.

HHS would lower the minimum threshold for disclosure from $10,000 to $5,000 and apply it to “payments and/or equity interests,” instead of “payments or equity interests.” Unlike current rules, any equity interest in a privately held entity would have to be disclosed. HHS is requiring institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.

Guidelines also now require investigators to disclose “significant” financial interests related to their “institutional responsibilities,” with their institutions to determine whether those interests relate to any PHS-funded research. Current rules limit disclosure to significant financial interests related to PHS-funded research only. The new plan would include travel reimbursements within the definition of significant financial interests, a change from current policy.

Separately, FDA is also working on guidelines for conflict of interest. The comment period for the 29-page “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators” ended in July. The document was developed to update current FDA regulations, which were issued back in 2001.

In terms of minimum threshold for disclosure, FDA’s draft guidance differs from HHS’ new rules, requiring disclosure of compensation made to the investigator by any sponsor of the covered clinical study in which the value of compensation could be affected by study outcome. It also requires disclosure of a proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright, or licensing agreement.

Also required to be disclosed under FDA’s guidance, both during the study period and up to one year after:

  • Any equity interest in any sponsor of the covered clinical study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.
  • Any equity interest in any sponsor of the study if the sponsor is a public company and the interest exceeds $50,000 in value.
  • “Significant payments of other sorts” with a cumulative monetary value of $25,000 or more made by any sponsor to the investigator or the investigator’s institution. These support activities of the investigator outside the costs of conducting the study or other clinical studies or provide additional reimbursement such as retainers for ongoing consultation or honoraria.
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