Ensure compliance with new PHS rules on COIs
COI transparency is new model
As often happens in research, new rules, policies, and guidelines often follow media reports of research integrity and ethical breaches.
The federal government’s revised financial conflict of interest (COI) policy is one example of this, says Linda Darga, PhD, grant development specialist in the office of research administration at Oakland University in Rochester, MI.
The Public Health Service (PHS) finalized its revised policy on research conflict of interest in August 2012. One change was the requirement that investigators disclose to their institution any significant financial interests, including those of their spouses and dependent children, and that institutions have a disclosure form for this purpose.1
"Before, it was up to the researcher to disclose any kind of financial conflict of interest," Darga says. "Under the new rules it is up to the institution to have a disclosure form."
Also, the financial trigger is lower. Instead of $10,000 as a threshold, it’s now $5,000, including stock, ownership shares, payments for consulting, etc., Darga says.
"This includes any payment that would conflict with their position at their institution, which usually would be a university," she adds. "Anything a researcher does for a university, whether it’s teaching, meeting, sitting on an IRB, or conducting research, if there is a significant financial interest over $5,000 with an entity that might conflict with their position at the university, then they must report those interests to the university."
It’s up to the research institution to write guidance consistent with the federal regulations and to create and send a disclosure form to all researchers. These forms must be completed annually, and researchers receiving PHS grants must complete COI training, Darga says.
"Now that this is taken care of separately, the IRB will know whether a person is applying to an agency that requires a disclosure form," she says. "If there is a financial conflict of interest, the institution has to manage the COI so it would not bias the research."
Oakland University has had very few significant financial COIs so far, she adds.
While the new policy might be inconvenient for some institutions, it provides uniformity across the field. Before the changes, reporting conflicts of interest was handled on a trust basis: Either investigators made the report or they didn’t, and institutions might not know whether the omission of a report meant there were no conflicts of interest or whether the investigator simply did not file a report, Darga notes.
"Over a couple of decades looking at submitted IRB forms, I don’t ever remember having to answer a question about financial conflicts of interest," Darga says. "It was not on people’s radars at that point."
Now every institution that applies for these grants has to comply with the regulations on conflicts of interest, no matter how large or small the organization is, she adds.
The Oakland University significant financial interest (SFI) disclosure form is four pages and includes four questions for which the available answers are as follows:
- I personally have no SFI to disclose in this category.
- My immediate family members have no SFI to disclose in this category.
- I personally have SFI to disclose in this category.
- My immediate family members have SFI to disclose in this category.
The chief questions on the form include:
- With regard to publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
- Remuneration that includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- With regard to non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator’s spouse and/or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income that exceeds $5,000 related to such rights and interests.
The form also lists exclusions, reports of sponsored travel, and has a page with a chart for reporting the range of SFI in categories of $5,000-$9,000; $10,000-$19,999; $20,000-$100,000, and greater than $100,000.
When researchers complete these forms, the information becomes public and can be obtained by research participants and others, Darga says.
"Research participants can call the IRB number or principal investigator number on the consent form and they have to answer their questions about the conflicts of interest," she adds.
Some organizations might even put the information online.
"A lot of this is becoming more transparent, and I think that’s a good thing," Darga says. "Research is based on truth and honesty."
1. Implementing the final rule on financial conflicts of interest in Public Health Service funded research. Association of American Medical Colleges. Published March 2012. https://www.aamc.org/download/277644/data/coi-rule.pdf.