NIH, industry discuss collaboration pitfalls - C&EN Global Enterprise

Oct 16, 1989 - That development has been encouraged both by profit-seeking firms and by Congress, which has been trying to encourage the transfer of t...
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Funding hike urged for agricultural research The Department of Agriculture has declined to endorse a report just issued by the National Research Council calling for a $500 million boost in annual federal funding for agricultural research supported by competitive grants. The increase would expand by 11 times USDA's competitive research grants program and further open up the agricultural research system to scientists excluded from that establishment. "I would like to be able to endorse the funding program proposed in the initiative/' says Charles E. Hess, assistant secretary for science and education at USDA, "but to be perfectly candid, we operate within the constraints of the federal budget." Hess adds, however, that the report "accurately portrays the challenges we now face." The report was produced from internal funds of NRC's Board on Agriculture whose chairman is Theodore L. Hullar of the University of California, Davis. It says that four "challenges" facing U.S. agriculture—competition from other countries, improvement of food quality, preservation of the agricultural environment, and the conservation of its water and soil resources—make new research thrusts in agriculture that much more imperative. The new program would consist of six areas—plant systems; animal systems; nutrition, food quality, and health; natural resources and the environment; engineering, products, and processes; and markets, trade, and policy. Half the new funding would support multidisciplinary studies, average individual grants would rise from $50,000 to $100,000, and special emphasis would be put on strengthening institutions. The board took the unusual step of initiating the study on its own because "it is now the time to take advantage of recent scientific and technological advances" that apply to the four challenges and because the existing competitive grants program has, because of its small size, largely failed. "The USDA's competitive grants program has not fulfilled even a 20

October 16, 1989 C&EN

small portion of broadening the nation's overall science and engineering infrastructure," the report charges. "Nor has it brought about an adequate network of active linkages and partnerships involving food and agricultural scientists and the broader scientific community." Can the government afford another half-billion dollars in research? Yes it can, the board answers, because USDA has already been cutting back on the billions that have gone into farm subsidies. "Commodity price supports have decreased from $26 billion to $11 billion during the past three years, as U.S. agricultural export prices have improved," it says. The d e p a r t m e n t ' s competitive grants program is currently housed in the Cooperative State Research Service (CSRS) and is funded at about $50 million. The main function of CSRS, whose total fiscal 1990 budget is $349 million, is to administer the 1863 Hatch Act that established the state land grant colleges. It funds, with matching money from states, agricultural research in those institutions. Hatch Act money is not without its intense politics, because researchers in those institutions must scramble for their share of the state-federal Hatch Act money. Any $500 million infusion into CSRS would scramble the agency as well and require the type of bureaucracy that, say, the National Science Foundation needs to carry out the administration of grants. So the NRC report recommends that CSRS be left to carry out its Hatch Act duties and that its Competitive Grants Research Office (CGRO) be elevated in status to form a quadrumvirate with CSRS, the Agricultural Research Service, and the Agricultural Extension Service under Hess. A CGRO with clout would give nonland grant scientists influence they never had at USDA but always thought they needed. The NRC report says its aim is not to propel USDA into the popular era of "big science." "The proposed expanded program involves a substantial increase in funding . . . but it does not fit into this category of science and technology because it is neither unusual nor distinct." Wil Lepkowski

NIH, industry discuss collaboration pitfalls To many scientists, the National Institutes of Health is virtually synonymous with basic research. The giant agency is the premier source of funding for biomedical research in the U.S.: About 80% of its roughly $7 billion a year R&D budget goes to universities and other research institutions and another 10% supports NIH's own intramural scientists. But in the past decade, biomedical research—NIH-funded or otherwise—has moved into the commercial arena. That development has been encouraged both by profitseeking firms and by Congress, which has been trying to encourage the transfer of technology from the laboratory to the business world. NIH is having to come to grips with the worry that undue emphasis on commercial benefits that derive from a science may change the course of that science. NIH has now proposed conflictof-interest g u i d e l i n e s for cases where researchers are funded both by government agencies and by private companies. And the agency is addressing similar issues that its own intramural scientists face when they collaborate with companies. "We're at the point in biomedicine where we are dealing with a

Bick: problem stems from success

Chen: cooperative agreements

problem because of the success of our research efforts," said Katherine L. Bick, NIH's deputy director for extramural research, at a forum on conflict of interest that NIH sponsored last summer. "We've been able to move to products, research mate-

rials, and research technology that have commercial value." At that forum about 300 scientists and research administrators discussed some of the pitfalls to be avoided and debated what standards researchers should meet to avoid financial conflicts of interests. Among the key issues identified were the need to ensure that results of federally funded research are promptly disseminated rather than kept secret for commercial reasons and the danger of diverting federally funded research from basic science toward short-term quick exploitation. The product of that meeting is a set of proposed conflict-of-interest guidelines for NIH and the Alcohol, Drug Abuse & Mental Health Administration (ADAMHA) that were published in the Sept. 15 issue of the NIH Guide for Grants and Contracts (C&EN, Oct. 2, page 14). Their stated intention is "to ensure that NIH- and ADAMHA-

supported research is carried out in a completely objective manner, and that research results are not influenced by the possibility of financial gain." NIH is asking for comments on the proposal by Dec. 15. The guidelines list three situations as real or apparent conflicts: • No investigators or their spouses or dependents may own stock or options in any company that would be affected by the outcome of the research. • Until information or research products derived from federally funded research is publicly distributed, they may not be shared with any company with which a conflict exists. • Investigators may not receive fees or honoraria from companies whose products they are evaluating in a government-funded study. Universities and other research institutions are charged with enforcing these policies under the proposed guidelines. For example,

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Government researchers applying for grants must disclose all sources of funding—including support for laboratory activities, consulting arrangements, honoraria, and other benefits—to their research institution before the applications are sent on. The institutions are supposed to catch any potential conflicts and may grant waivers in certain situations. NIH also has had to prepare policies for its own intramural scientists who are collaborating with commercial firms. Under the Technology Transfer Act of 1986, government scientists are encouraged to work with private firms to speed commercialization of their discoveries. NIH has set up a mechanism called a Cooperative Research & Development Agreement (CRADA) to set the terms of such collaboration for NIH and ADAMHA scientists. Under CRADAs, companies supply funds, staff, and materials for a project while NIH scientists bring their specialized expertise. In return,

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the industry gets the rights to an exclusive license to any patented inventions that come out of the CRADA. Government scientists, in turn, are guaranteed a share of any royalties. Already more than 100 such cooperative arrangements are under way at NIH and ADAMHA, with perhaps as many more under negotiation. "A CRADA should be used whenever there is interaction between government and industry scientists," says Philip S. Chen Jr., NIH's associate director of intramural affairs. Chen, who heads the NIH/ ADAMHA patent policy board, last month chaired a panel on developing CRADAs at a forum held at NIH on industry collaboration. More than 200 people attended the full-day session, designed to explain how CRADAs work to industry representatives and to help them identify which government scientists are doing work of interest. In the afternoon, NIH and ADAMHA

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researchers presented their work in poster sessions. To deal with possible conflict-ofinterest situations, Chen says, NIH and ADAMHA developed a policy statement on CRADAs. The policy statement, which will be updated every six months, says, for example, that no CRADA can interfere with government scientists' freedom to choose the subject matter of their research. The policy also states that "NIH/ ADAMHA research results generally are disseminated freely through publication in the scientific literature and presentations at public fora." However, it then goes on to say that delays in publicizing research may be permitted under a CRADA until a patent has been filed—a point that raises a red flag to those concerned that such industry/government collaboration may impede the free passage of scientific data. Pamela Zurer

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October 16, 1989 C&EN