Observations Yankee Doodling

NIH updates its conflict of interest guidelines

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d5493 (Published 31 August 2011) Cite this as: BMJ 2011;343:d5493
  1. Douglas Kamerow, chief scientist, RTI International, and associate editor, BMJ
  1. dkamerow{at}rti.org

How much does the public need to know about reports of conflicts?

Last week the US National Institutes of Health (NIH) published its long awaited final rule on conflicts of interest.1 2 In doing so it tried to balance the benefits of increased disclosure of financial connections between NIH funded investigators and the industry with the drawbacks of a greater burden of reporting and loss of privacy.

This issue came to broad public attention about three years ago, when a series of investigations by Senator Charles Grassley uncovered several highly publicised scandals. A few NIH funded scientists were found to have huge undisclosed investments in drugs they were testing or to have received large “consulting” fees that had not been reported to their universities.3 They were disciplined.

Financial relationships between academia and industry have grown dramatically in recent years. A widely publicised 2009 report on conflicts of interest from the Institute of Medicine documented that growth.4 More than two thirds of academic departments and most department chairs have financial relationships with the industry, such as consulting, board memberships, and intellectual property licensing. Companies now commonly fund research centres or programmes and, in some cases, entire departments. Industry funding of biomedical research has almost tripled in the 10 years since the current conflict of interest rules were introduced in 1995, to $94.3bn (£58bn; €65bn).5

As I noted when it was released,6 the 2009 Institute of Medicine report included a broad set of recommendations about all facets of conflicts of interest—not just financial—in biomedical research, medical education, creation of clinical practice guidelines, medical practice, and medical institutions. The recommended actions targeted everyone from medical students to deans and included drug and device companies, the NIH, practising doctors, medical societies, and the US Congress as well. The final NIH conflict of interest rule is much narrower, focusing on scientists’ financial conflicts and their reporting.

Under a headline titled “HHS [Department of Health and Human Services] tightens financial conflict of interest rules for researchers,” NIH’s press release accompanying the new rule7 focused on the following changes:

  • Decreased thresholds for reporting, to $5000 from $10 000

  • Required disclosures of financial interests by investigators and leaders of institutions, relating to their research and to their institutional responsibilities

  • Required management of conflicts by institutions, with required reporting to the funding agency, and

  • Required training for investigators in conflict of interest policies and regulations.

In an accompanying statement NIH’s director, Francis Collins, said, “Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds.”

But a government watchdog group, headed by a former investigator for Senator Grassley, wasted no time in lambasting the new rule.8 Asking how and what exactly will be disclosed about the conflicts, the Project on Government Oversight pointed to what had been deleted from the draft version of the report released for public comment last year. Apparently the draft report required posting on the internet of conflicts of interest by institutions, a requirement that was dropped from the final version. The final rule requires that investigators and others report their financial interests and that the institutions “manage” them and report all this to the funder. The public is never informed unless there is a request for the information, presumably through some sort of freedom of information query.

Also, it seems that the new rule does not go beyond requiring the institutions to “manage” the potential conflicts, without defining exactly what that means. One of the strengths of the 2009 Institute of Medicine report was its insistence that mere disclosure was not enough of a remedy for competing interests. It recommended eliminating conflicts wherever possible, by removing or sharply limiting participation by investigators in conflicted research projects. That was a very radical suggestion, one that NIH was certainly not prepared to take on.

One explanation for the scaled back requirements in the final rule was that President Barack Obama asked government agencies to try to decrease the burden of all the regulations they issue. The final rule includes a detailed estimate of the fiscal burden on institutions of complying with the new policies. Some institutions objected that maintaining a website of all the reported conflicts would have been an expensive undertaking.

That seems hard to believe. Websites are not expensive to mount today. Even a brief look at university and hospital websites makes it hard to argue that devoting a few pages to lists of reported conflicts would be a huge burden, especially as the conflicts need to be reported anyway.

As NIH’s Dr Collins said, transparency is a good goal; but it would have been better if the NIH had required public reporting and had created guidance for what is permitted and what is not. The fact that senior leaders in an institution know who is getting paid large consulting fees and who has stock in what company does not necessarily mean that the public can have faith that undue influence has been prevented.

Notes

Cite this as: BMJ 2011;343:d5493

References