In late August, the National Institutes of Health (NIH) passed new regulations that call for all institutions with investigators running research funded by Public Health Service (PHS) to adhere to new standards by August 24, 2012. While that may seem like a long way off, a breakdown of the requirements on the institution shows that significant changes may be necessary to meet the deadline.
Summary of the changes
The new regulation builds on the last version of the standards, which were published in 1995. The previous rules established a $10,000 threshold to denote a significant financial interest (SFI), and they allowed the investigator to determine which of his/her financial interests were applicable to the research being conducted, thus determining what should be ultimately reported to NIH. With the new changes, NIH has lowered the threshold to $5,000 and put the onus on the institution to evaluate potential financial conflicts of interest (FCOI) of the investigators. In this model, the investigator reports all SFIs to the institution, the institution must determine if an FCOI exists, and if so, it must then report those FCOIs to NIH. In addition, the new regulations embrace the trend toward greater transparency by requiring institutions to make both the conflict of interest policy and data on any FCOIs available to the public.
Another major change is the frequency of reporting. Most institutional compliance departments run an annual process to capture COI disclosures by staff members, or have a one-time disclosure requirement that occurs at the beginning of the research grant application process. Under the new guidelines, annual and one-time reporting will not be sufficient, as investigators are required to report “acquired” or “discovered” interests within 30 days to institutions throughout the course of the grant-funded research. The institution is then responsible for reporting any FCOIs to the NIH within a specified time period.
What does this mean?
Under the new guidelines, institutions have an increased responsibility to collect, evaluate and report any conflicts of interest to NIH. The traditional methods of running an annual or one-time process to capture financial interests from staff members will not be adequate with the new regulations. What’s more, with more public data on investigators’ relationships with industry, it is unclear who has the responsibility to determine whether an investigator failed to disclose a significant financial interest. In informal conversations I have had to date, many institutions are evaluating options for complying with the new regulations, but most agree that updates to a more automated, data-driven system will be necessary.
For those interested in reading more, I encourage you to look at the CMS website.
Oct. 25th update: I read a great article recently titled “The NIH gets tough on conflicts of interest” on Scope, the Stanford School of Medicine's blog.