NIH Conflict-Of-Interest Regs Impending

New agency rules will require universities to ensure that grantees have no monetary stake in corporate enterprises The Department of Health and Human Services is moving ahead with final work on long-awaited regulations to deal with financial conflict-of-interest questions involving researchers funded by the National Institutes of Health and other Public Health Service (PHS) agencies, NIH officials confirm. A draft of the regulations obtained by The Scientist puts nearly all responsibility for enforcing avoidance of conflicts of interest--such as equity ownership in biotechnology start-up firms benefiting from on-campus research--on the shoulders of universities receiving government funds. "We don't want to see full disclosure statements," says George J. Galasso, NIH associate director for the Office of Extramural Affairs. "We try to avoid the role of a policeman.... We're not going to ask that [universities] submit their policy to us, but we reserve the right to ask for it. And if there are any problems, we want to know about it." Although that policy is consistent with NIH's approach to other problem areas, such as protection of human subjects in medical and scientific experiments, it has prompted some critics within and outside the academic community to charge that universities cannot be trusted with such responsibility because in some cases they stand to reap substantial profits from involvement with biotech and other ventures. Others object to the proposed regulations as a restriction on academic freedom. As NIH attempts to resolve the conflict questions, the National Science Foundation has proposed and is receiving comment on its own regulations to deal with financial conflicts. In addition, the issue of conflicts of interest in university research has been attracting renewed attention of congressional investigators. A previous attempt by NIH in 1989 to establish voluntary guidelines on dealing with conflicts of interest was abandoned after it drew hundreds of negative comments from researchers and institutions when it was published for comment in the Federal Register. Galasso at NIH says the draft conflict-of-interest regulations have been approved by NIH director Bernadine Healy and sent to the office of Assistant Secretary for Health James O. Mason for further consideration. They are then likely to be returned to NIH for revisions, he says, and passed to HHS chief Louis W. Sullivan for final approval. Following are excerpts from a draft version of conflict-of- interest regulations being developed by the National Institutes of Health and the Department of Health and Human Services for institutions receiving Public Health Service (PHS) funds. Each institution must establish policy and procedures for: ---(2) Informing each investigator to whom the institutional policy applies of the contents of the institutional policy on financial interest. (3) Establishing an Institutional Committee or SBIR [Small Business Innovation Research] Committee...to solicit, review, and annually update financial disclosure statements from each investigator who is participating or is planning to participate in PHS-funded research. ---(5) Establishing procedures for resolving any allegation of undisclosed or misrepresented financial interest and establishing a range of appropriate sanctions for any individual who does not comply with the financial conflict of interest policy. ---(7) Notifying the PHS agency, prior to drawing funds from an award, of any financial conflict of interest that has not been resolved. Restricted activities. The Institutional Committee shall ensure that, unless a waiver has been granted...none of the following types of financial interest are held by any investigator participating in research funded by the PHS: (1) ownership of stock, stock options, and/or any equity, debt, security, or capital holding in any business enterprise that owns the patent, manufacturing, or marketing right with regard to... [any] product or byproduct of PHS-funded research whenever the primary purpose of the research is to evaluate the commercial marketability of the product or byproduct including, but not limited to, research such as clinical trials... (2) salary and/or other remuneration, or financial consideration, or thing of value for services as an employee, consultant, officer, or board member of any business enterprise that owns the patent, manufacturing, or marketing right with regard to ... [any] product or byproduct of PHS-funded research... As to how soon the regulations will be officially published, Galasso says: "I gave up making those predictions a long time ago. I thought it'd be out a long time ago." Discussing the overall rationale of the regulations, the NIH official says: "Basically, the bottom line is we don't think it's appropriate for investigators to make money on the basis of the research they are conducting using taxpayer money.... If somebody is doing a clinical study for us to test drug X, they shouldn't have stock in drug X, and they shouldn't be a consultant for companies that own drug X." Galasso says he believes the climate in the research community, including institutions that would be required to enforce the proposed conflict regulations, has changed considerably since NIH made its first attempt at guidelines in 1989: "When we put out the guidelines originally, the community was up in arms. The community thought [the guidelines] were going to change the face of biomedical research, and that all kinds of awful things were going to happen." Since then, Galasso says, "a number of institutions have already initiated their own rules for conflict of interest. And some of them are more restrictive than anything we would do." The draft version of the NIH conflict-of-interest regulations says the proposed rules are intended "to require intra- institutional disclosure of the biomedically related financial interest of each individual conducting PHS-funded research and to prohibit the types of financial interest that could predictably be enhanced in value by the results of the research." The draft says, "Because any type of research, including fundamental investigations and clinical trials, may lead directly to a product or byproduct of commercial value, the proposed rule would apply to all PHS-funded research." It says that "each institution would be required to develop viable methods for enforcing the policies and procedures." According to the draft, "The value of the results of PHS-funded research to the health and the economy of the nation must not be compromised by a real or perceived conflict arising from a financial interest or professional activity of an investigator that is related to that research." Robert Rosenzweig, president of the Washington, D.C.-based Association of American Universities (AAU), representing most major research universities in the United States, says of the draft: "It needs work. It's not too bad--it's certainly better than the last one [the 1989 guidelines] was." With regard to AAU member universities, Rosenzweig says, "Most have some sort of disclosure now, but I wouldn't say that most have a disclosure system that would be satisfactory under either the NSF or the NIH proposals." Rosenzweig says he believes the NIH approach of relying on information-gathering and enforcement by the universities would be "much preferable" to NSF's proposed requirement that financial data be submitted to the agency in a sealed envelope along with grant requests. AAU vice president Howard Gobstein notes that "there will be those who might suspect that the universities aren't sufficiently credible to ensure that these processes are done the way the public would expect them to be done and, indeed, need them to be done." However, Gobstein says that in view of the need to preserve their reputations, "I would maintain that universities also have a vested interest ... in making sure that there aren't egregious examples of faculty who are collecting money on the side through research." Among critics of NIH's approach to controlling conflicts of interest is Leonard Minsky, executive director of the National Coalition of Universities in the Public Interest, a Washington- based organization of about 2,000 scientists and other academics interested in public-policy issues. Minsky criticizes the "innocent and sweetly childish way they [NIH] trust the universities to implement the policy." He says the evidence is that "the universities are not taking this [conflict-of-interest issues] seriously. In fact, the universities are involved usually with the accused in profit- making ventures." As to conflicts and other types of misconduct in research, Minsky says: "It's a considerably larger problem than the NIH wants to believe. The real problem seems to us to be the institutional matrix within which the misconduct takes place, and the institution's response to accusations of misconduct. And large- ly, the institutions are into denial. "If the problem is undeniable, they deny the significance of the problem. If they have got to deal with the problem, they try to obliterate the problem by multiple kinds of manipulations-- through internal inquiries and investigations. They typically try to drive a whistleblower out of business," he says. Howard Schachman, an emeritus professor in the department of molecular and cell biology at the University of California, Berkeley, and former president of the Federation of American Societies for Experimental Biology (FASEB), says that financial conflicts amount to "a very important issue." "It's a much bigger issue than the so-called fraud in science, in terms of volume and potential abuse," Schachman says. "It's also much more complicated. Whereas it's pretty easy to define what is called fraud in science ... it's not so easy to define conflict of interest." Physicist Peter Stein at Cornell University, the author of a recent report offering recommendations to the Cornell faculty about dealing with potential financial conflicts, says, "I think it's fair to say that universities have been lax in policing conflicts of interest--and they shouldn't be. "I'm probably an extremist on this, but I don't think a person should have a financial stake of any sort in the outcome of research." Norman Scott, Cornell's vice president for research, says the university has had a disclosure policy since 1986, and is now proposing to create a standing committee to deal with such matters. Scott notes that the growth of biotechnology and other research- intensive industries has been "in creasingly resulting in faculty having dual roles and interactions with executives from companies." About financial conflicts, he says, "I have the feeling that there's probably going to be a few cases which are going to be potentially difficult, but that, by and large, it's not going to be a huge problem." At Duke University, the faculty's governing body, the Academic Council, this past spring adopted a general conflicts policy, leaving its implementation to the university's individual colleges. Gordon Hammes, vice chancellor for academic affairs at the Duke University Medical Center, says the medical faculty's financial disclosure requirements will meet the NIH regulations. "It is a thorny question," he says. "You don't want to stifle the enterprise of faculty members, and you don't want to stifle start-up companies. All those things are good. You just have to make sure that things are set up so that there's no conflict of interest. "I personally don't see that that's a hard thing to do. I think it's pretty straightforward. My guess is that when it all shakes down we'll probably end up... with [only] three or four cases that we'll have to really sit and think about." Marcel C. LaFollette, a science policy analyst at George Washington University, says she finds the draft version of the NIH regulations somewhat disturbing because "it implies that biologists can't control their own behavior." "I'm clearly on the record as objecting to the kind of double- dealing and financial conflict of interest of the unethical kind that I know the intention is to prevent," she says. "On the other hand, I found this [the draft regulations] somehow a kind of troubling interference with the freedoms of the researcher." NSF's proposed regulations are similar to those of NIH in that they place a degree of responsibility for enforcement on the universities. The NSF policy would require that researchers disclose to review panels at their institutions "any significant financial ties they [or family or business associates] have with parties whose financial interests could be directly and significantly affected by the work to be funded." Under the proposed regulations, when a research proposal is submitted to NSF, details of any such financial ties would be included in a sealed envelope, to be opened only after the proposal has been approved on its scientific merits. The regulations--published July 16 in the Federal Register and open to public comment until October 14--note that "though NSF believes that significant conflicts of interest are rare in the work that NSF funds, we have no data by which to demonstrate the point. The proposed policy would create a bank of data to serve as a reality check." Meanwhile, the House Energy and Commerce Committee's investigations and oversight subcommittee, chaired by Rep. John D. Dingell (D-Mich.), is reported to have begun a major investigation into financial conflicts and other problems with the management of academic research grants. Prospects for further congressional scrutiny of the conflicts issue were dealt a setback by the death on September 14 of Rep. Ted Weiss (D-N.Y.), whose House Government Operations Committee subcommittee previously had held extensive hearings on this and other issues related to scientific misconduct. Barton Reppert is a freelance writer based in Gaithersburg, Md.

NIH Conflict-Of-Interest Regs Impending

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