WASHINGTON -- The National Institutes of Health on Thursday proposed significant changes  in federal regulations governing financial conflicts of interest in biomedical research -- changes that would increase the expectations (and, they are likely to argue, the burden) on universities to examine and report potentially problematic entanglements.
The Notice of Proposed Rule Making, which was published today in the Federal Register, comes amid escalating agitation over corporate influences on higher education generally and over the sway of pharmaceutical companies on biomedical research in particular. "Partnerships between NIH-funded researchers and companies are essential -- they have been and they will be," given the funding situation for research and for the federal government, Francis S. Collins, director of the institutes, said on a conference call with reporters about the proposed rules.
But given that reality, it is incumbent on researchers, institutions and the federal government to make sure that scholarly work is conducted "without bias and with the highest standards," Collins said. And applying more stringent rules on financial conflicts of interest, to ensure that researchers' personal financial interests do not influence the nature or outcome of publicly funded studies, is one way of doing that, he said.
"Public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process," said Collins. So while the changes the NIH is proposing would "add some burden to investigators and to institutions, we believe that it is essential to tighten up the situation to make sure we are obtaining and maintaining the public's confidence." The NIH flagged its intention  to issue new rules, and laid out its possible areas of expansion and change, last summer.
Under the revision of rules proposed Thursday by NIH, on which the agency will be seeking comment  for the next 60 days, the fundamental structure and design of the existing system for regulating financial conflicts of interest would not change. Institutions, based on information disclosed to them by the researchers who work for them, would remain primarily responsible for ensuring compliance with the conflict of interest regulations, and the NIH and other Public Health Service agencies would remain responsible for overseeing the institutions' compliance.
But the proposed rules, which would update the regulations set in 1995, would significantly alter the nature and extent of the information that researchers must report to their employers and that institutions must report to the government, as well as the extent to which the public will be made aware of possible conflicts of interest.
Here's how it would work, in broad terms. As is now the case, individual researchers would be obligated to tell their institutions about "significant financial interests" they (and their spouses and family members) have that might reasonably be related to their work. But the definition of those interests would change in several ways that are both philosophical and practical -- and virtually all of which would result in the reporting of more information.
First, recipients of federal grant money are now expected to report to their universities not just about how their financial interests might affect a particular federal project or grant, but also all of their "institutional responsibilities," including research, consulting, teaching, and membership on university committees -- a change designed to "provide institutions with a better understanding of the totality of an investigator's interests."
Second, the proposed rules would drop to $5,000 -- from the current $10,000 -- the minimum level at which investigators would have to report money they had received in the previous year or equity they own in companies whose products are related to their work (the minimum would not apply to stock or ownership in privately held companies; for those, any equity at all would have to be reported). Payments from nonprofit organizations other than universities or government agencies for lectures or other forms of teaching would also have to be reported, a proposal that recognizes growth in the number of foundations and other entities sponsored by for-profit companies.
Increased Expectations for Institutions
Universities' obligations would also expand significantly under the proposed regulations, in ways big and small. Not only would they be required to have a policy on conflicts of interest, for instance, but they would have to publish their policies on the Internet and train all relevant researchers about them.
Institutions would then be required to review all reports of "significant financial interests" from their researchers to determine whether a given financial interest is "related" to the research for which the researcher is receiving federal funds, and whether it represents a conflict of interest. The first of those two obligations would represent a change from current practice, since under the existing rules, it is up to the researcher to decide whether a financial interest is "related" to his or her funded research. The institution would then be required, as it is now, to determine when a conflict of interest exists -- in other words, when the financial interest could "directly and significantly affect the design, conduct, or reporting of the PHS-funded research."
(The NIH proposal acknowledges that the combination of those changes is expected to "result in the disclosure by investigators to institutions of a wider array of interests on a more frequent basis," and that doing so will increase the burden on researchers and institutions alike. And while agency officials express concern about that and say they'll look for ways to minimize the extra work, the NIH's explanation essentially concludes that the benefits outweigh the burden.)
The expectations on institutions for responding to identified conflicts of interest would also grow. They are already expected to "manage, reduce or eliminate" conflicts they identify; under the new rules, they would be required to develop a formal "management plan," as some universities already do. The proposed rules would also require institutions to monitor a researcher's compliance with a management plan until the research project is completed.
Perhaps the biggest changes in the demands on universities would come in how they report potential conflicts, both to federal agencies and to the public.
Before an institution spent a dime of federal money for a particular project, it would have to submit a conflict of interest report "regarding any [significant financial interest] found by the institution to be conflicting and to ensure that the institution has implemented a management plan in accordance with the regulations." The volume and breadth of information universities would have to report would also increase, to be much more explicit about the dollar value of the financial interest in question (in $5,000 ranges up to $20,000, $20,000 ranges up to $100,000, and $50,000 increments above $100,000), the nature of the conflict, and the key elements of the management plan.
The NIH describes the last major piece of its plan -- a requirement that institutions list on a publicly accessible Web site information about any financial conflicts of interest they have found among their researchers -- as designed to "help the biomedical and behavioral research community monitor the integrity and credibility of PHS-funded research and underscore our commitment to fostering transparency, accountability, and public trust." The required information would include the investigator's name and relevant information, the nature of the financial interest, and the "approximate" dollar value, to a maximum of "greater than $250,000," in the agency's initial proposal.
The NIH proposal notes that the idea of requiring public disclosure was not included in its advance notice of possible rule making last summer, but said that the increased interest in and willingness to publicly disclose potential conflicts that colleges and drug companies had shown since then had changed the picture.
While some critics have argued that the NIH will be able to stifle conflicts of interest only by imposing penalties on researchers or institutions that engage in them, the new regimen would stop far short of that, essentially leaving enforcement in the hands of institutional leaders. But the additional information the new rules would produce would help the NIH keep tabs on the universities, by letting federal officials better compare the information investigators are reporting about their financial conflicts and the decisions institutions are making about what represents a conflict, Sally J. Rockey, acting deputy director for extramural research at NIH, said during Thursday's news conference.
"We have a system of compliance to assure that institutions are following their policies, and the additional information we're going to receive will allow the NIH to determine whether they're doing that," she said.
Many of those who might be affected by the new regulations said they had had too little time to pore over the 112-page notice to know for sure how the changes would play out. But the early reviews, from a range of perspectives, were pretty positive.
"Fundamentally we think the proposed rules are a significant milestone in preserving the public trust" in the scientific enterprise, said Ann Bonham, chief science officer at the Association of American Medical Colleges, which had joined the Association of American Universities last summer  in suggesting areas where the NIH ideally should (and shouldn't) go in regulating conflicts of interest. "This will provide more information to the institutions to help them make better decisions about potential conflicts of interest, and more information to the NIH to enable it to meet its obligation in preserving the public trust."
Even one of the toughest critics of potential conflicts in academic science, and the man arguably most responsible for keeping the heat on the NIH and universities to take the issue seriously, offered a generally upbeat assessment of the agency's proposed approach.
The office of Sen. Charles Grassley said in a news release  that the Iowa Republican considered the NIH proposal to be "a step in the right direction."
“I’m interested in meaningful transparency and more accountability,” it quoted Grassley as saying. “Letting the sun shine in and making information public is basic to building people’s confidence in medicine. And with the taxpayer funding that’s involved, people have a right to know. Public trust and public dollars are at stake.”