The National Institutes of Health (NIH) needs to promulgate regulations that address the conflicts of interests of institutions, and not only individual researchers, according to a report released Monday by the Office of the Inspector General (OIG) in NIH’s parent agency, the Department of Health and Human Services.
The OIG report, and a brief summary of it available here, note that, in 2008, medical schools and universities, which are home to the vast majority of the scientists that the biomedical agency funds, usually discovered institutional conflicts when they went looking for them. Of 156 institutions responding to an OIG survey, just 21 had in 2008 sought out and identified institutional financial interests, like stock held by the institution. But of those, fully 18 found that those interests put the institution in conflict — meaning that their holdings could bias the NIH-funded work being performed by their investigators. Indeed, those 18 institutions identified at least 38 conflicts related to NIH research grants held by their scientists in 2008. The most common was that the institution held stock in a privately traded company. The institutions generally dealt with that by disclosing its holdings.
The biomedical agency’s conflict of interest regulations currently address only the financial interests of individual researchers, and not institutions. In the OIG report, the NIH declined to agree or disagree that it should develop regulations dealing with universities and medical schools. Instead, it noted that it is in the process of revamping regulations governing the reporting of individual researchers’ financial interests. The final version of those revamped rules is expected out in the coming months.
The OIG seemed a tad impatient with the agency for dodging the institutional question.
“OIG understands” that NIH is engaged in revamping the rules governing individual scientists, it wrote. “However [the proposed changes] focus only on researchers’ conflicts [and] do not address institutional conflicts.” In case the agency missed the point, the authors added: “OIG continues to recommend that NIH include institutional conflicts in regulations addressing financial conflicts of interest.”
In a comment today, NIH’s Office of Extramural Research responded that the agency “is carefully considering [public] comments (including comments on the topic of Institutional conflict of interest)” as it crafts the final version of its proposed rules changes.
In 2009, both the OIG and the Institute of Medicine advised the biomedical agency to put in place regulations governing institutional conflicts of interest.
It’s worth remembering that the amounts of money involved are not trivial. The OIG report notes that, in 2010, NIH’s budget totaled over $31.2 billion and that more than 80 percent of this funded almost 50,000 competitive grants. The report also reminds the reader that the institutional policies it is requesting are required by law: the Public Health Service Act (section 493A, to be precise) requires the government to institute regulations protecting NIH-funded research from bias resulting from conflicts of both researchers “and entities” (i.e. grantee institutions).
The NIH’s own detailed rendering of its proposed rules changes for individual investigators can be perused in this article in the Journal of the American Medical Association.