Financial Terms Compared to HHS' Proposal
FDA’s draft guidance comes more than a year after the U.S. Department of Health and Human Services (HHS) proposed its own regulations on managing conflicts of interest for researchers receiving funding from the U.S. Public Health Service (PHS). NIH’s Office of Extramural Research told GEN the new PHS rules remain under consideration by the Office of Management and Budget.
In many cases HHS’ proposed regulations exceed FDA’s current draft guidance and 2001 guidance, and HHS is about to get even tighter. For example, 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.
FDA’s draft guidance, by contrast, requires disclosure of: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.
- A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright, or licensing agreement.
Also required to be disclosed, 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.
Significantly, FDA’s list of required disclosures under the draft guidance has not changed too much from the 2001 guidance. But the draft makes some changes, for example, the 2001 guidance required disclosure of “any equity interest in a publicly held company that exceeds $50,000 in value” compared with any public companies that sponsor a covered study.
As with current rules, exempt from disclosure are “income from seminars, lectures, or teaching.” HHS’ guidance changes what kind of entities can convene advisory committees or review panels where service is exempt from disclosure from “public or nonprofit entities” to “government agencies or institutions of higher learning.”
HHS’ proposal requires 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.