The National Institutes of Health, after months of pressure, announced last week that it would consider imposing tougher regulations aimed at reducing financial conflicts of interest in scientific research. But it might actually not do anything.
An NIH official, outlining the agency’s plans, told The Chronicle on Tuesday that a newly announced review of NIH policies might end in a few months with a decision to leave regulations just as they are now.
And any changes that the NIH does make will not seek to overturn the fundamental understanding that universities, not the NIH, have primary responsibility for monitoring their employees, said the official, Sally J. Rockey, the NIH’s acting deputy director for extramural research.
“We feel it is appropriate that the institutions manage their financial interests,” Ms. Rockey said.
The NIH’s position underscores the dilemma with which both universities and their Congressional critics have long contended: The current system does not provide an easy solution for cases in which researchers fail to disclose personal financial benefits from their scientific output.
That’s because the NIH is a research and grant-awarding agency, not an enforcement agency, said Patrick White, vice president for federal relations at the Association of American Universities, which represents the country’s top research universities.
“The NIH has historically feared that moving into any kind of policing or investigative capacity would actually hinder its ability to work with scientists” on matters of science, he said.
Reports of Ethical Breaches
That approach has spawned a variety of problems, according to Congressional critics led by Sen. Charles E. Grassley, a Republican of Iowa, who issues frequent reports of cases in which researchers have accepted corporate money or benefits that could pose ethical conflicts.
In the past week alone, those reports have included the case of a University of Texas psychiatrist who is believed to have failed to report more than $160,000 in drug-company payments she received while conducting government-financed research on adolescents with depression, and a determination that a former surgeon at the Walter Reed Army Medical Center had taken money from a medical company and then published a study making false claims about the company’s success in healing the bones of soldiers injured in Iraq.
Such problems may not be rare exceptions, and disclosure alone may not be sufficient to prevent abuses. A study published this week in the journal Cancer found that nearly one-third of the cancer-research papers published in highly rated scientific journals had disclosed conflicts of interest.
The frequency of such conflicts suggests a need for greater efforts to “disentangle cancer research from industry ties,” said the study’s author, Reshma Jagsi, an assistant professor of radiation oncology at the University of Michigan at Ann Arbor.
The NIH could start by requiring universities and their researchers to observe the same level of restrictions that the agency imposes on its own staff researchers, said Susan C. Chimonas, an associate research scholar at Columbia University’s Center on Medicine as a Profession.
Those internal NIH standards include a ban on a researcher’s running a clinical trial if he or she holds any financial stake in the outcome, Ms. Chimonas said. Some medical centers have similar rules, she said, but there is no mandatory nationwide standard.
In general the NIH doesn’t even ask universities to explain their standards. A report last year by the inspector general of the Department of Health and Human Services, the NIH’s parent agency, said the NIH had received hundreds of reports of financial conflicts from universities without bothering to check the details.
A Demand for Accountability
The NIH may not need to become a police force, but given the amount of federal money it controls, it is “ideally situated” to demand more accountability, Ms. Chimonas said.
The acting director of the NIH, Raynard S. Kington, seems to agree. He told an NIH advisory committee about the planned rule-making process last December, pledging that the agency would “have action on this” within six to 12 months.
But the NIH’s Ms. Rockey said, “We can’t say definitely we would change the regulations.” She said the 60-day comment period announced last week is a means for the NIH “to have this conversation” with universities and other interested parties. The agency may opt to extend the comment period by a month or so and then decide within a few more months whether and what new regulations it may introduce, she said.
She added that the NIH would consider recommendations by groups such as the Association of American Universities and the Association of American Medical Colleges, which have proposed specific procedures for financial disclosures by scientists and public reporting by their institutions.
Congress, meanwhile, may force some action. Mr. Grassley and a Democratic colleague, Sen. Herb Kohl of Wisconsin, have proposed a measure that would require the NIH to “actively enforce its conflict-of-interest policies and respond in a timely manner when those policies have been violated by grantees.”
NIH officials should seize the opportunity, Ms. Chimonas said. “It would be a shame if they did nothing,” she said.
