New proposed rules by NIH boost public disclosure, aid Sunshine law
New proposed rules from the NIH yesterday on preventing conflicts of interest in biomedical research improve public disclosure but leave the decision about what constitutes a financial conflict with an investigator’s institution. The rule lines up with much of Community Catalyst and Pew Prescription Project’s recommendation to the agency in July 2009. The Institutes are again seeking public comment for 60 days.
The proposed rules require investigators – that is, anyone involved with the design, conduct or reporting of publicly-funded research – to disclose to their institution all payments greater than $5000. Those payments include consulting, honoraria, speaking or travel funds, or paid authorship. The institution – commonly an academic medical center or university—must then determine what is a potential conflict and report those payments and a management plan to the NIH.
This is a shift from the current rules, which require an investigator to disclose payments to her institution only if she believes it conflicts with her research – a system, it seems, that left too much room for interpretation. News reports have documented millions of drug company dollars that went to investigators running trials on drugs made by those companies. (GoozNews has about a complete a list of news clips as one could want.)
The proposed rule also requires each institution seeking NIH funding to establish a publicly accessible website on which it would post its conflict of interest policy and all financial conflicts of interest held by investigators, updated at least annually. This is a great step toward better transparency that is meaningful to patients and consumers, as it will provide an important crosscheck to the Sunshine database and other disclosure websites for assessing conflicts and compliance.
We’d still like to see payments below $5000 be disclosed to institutions – the number is arbitrary, and studies suggest gifts and payments much lower than that can create bias. Though the NIH cited concern over administrative burden, many institutions and companies have already begun requiring disclosure at a much lower threshold, suggesting it’s important, and doable.
And the big increments that NIH set for public disclosure on the websites (less than $20,000, less than $50,000, less than $100,000 or more than $250,000) leave too much guesswork. There is a difference between a $250K relationship and one in the millions, but the public won’t be able to see that if the proposed rule stands as is.
The nature of academic-industry relations has changed dramatically in recent years, and it’s encouraging to see that the NIH rules get that—and account for it. For instance, the NIH addressed the shift in industry-backed CME by making explicit that payments for lectures, seminars, and speaking gigs sponsored by non-profits are not exempt from disclosure, acknowledging that for-profit companies often create non-profit arms to fund talks and execute programming. And they added “paid authorship” and “travel reimbursement” to the list of examples of payments to acknowledge industry’s heavy reliance on speakers’ bureaus, backing researchers to attend or present at conferences, and ghostwriting – or soliciting an academic to sign an article that was not written by her/him in full:
With regard to “paid authorship”, in particular, although there should be little question that receipt of payment from an entity in exchange for the drafting of a publication constitutes payment for services, we believe it is important to reference this form of payment specifically in the regulations.Read more about our original comments to the NIH here, or read the proposed rule at the Federal Register.
–Kate Petersen, PostScript blogger