Academic Medicine, April 1999
Volume 74, No. 4
Sustaining and Renewing the Federal Research Partnership With Universities
The research partnership between the Federal government and American universities has yielded benefits that are vital to each. It continues to prove exceptionally productive, successfully promoting the discovery of new knowledge, stimulating technological innovation, improving the quality of life, educating the next generation of scientists and engineers, and contributing to America's economic prosperity. As the Assistant to the President for Science and Technology, it is my job not only to look to the health of today's science and technology enterprise and the vital role of universities, but to look to the future. In any successful partnership, it is on occasion appropriate to review its basic principles and working assumptions and make corrections where necessary. While the government-university partnership has served the nation well over the past fifty years, we need to look to the next fifty years and make sure we are on the right track.
Stewardship of the government-university partnership must be an ongoing activity. This administration has taken an active role in a number of important areas. I outline three of these below:
First, in April the results of a multi-agency review of the government-university partnership will be announced. The review was conducted by order of a Presidential Review Directive under the auspices of the National Science and Technology Council (NSTC), a cabinet-level agency established to coordinate government science and technology research and development policy. The Task Force established to conduct the review was charged to assess and reaffirm the principles of the partnership, promote cost-effective university-based research, ensure fair allocation of research costs, and support the linkage between research and education, all while maintaining appropriate accountability for the expenditure of public funds. The Task Force solicited the views of universities and university associations regarding the issues of most concern to them. The responses provided the basis for the interagency discussions and for the report's findings and recommendations.
For the partnership to thrive, there must be a clear understanding on the part of both parties of the goals of the partnership and the responsibilities of the partners. Why does the Federal government invest in university research? What is the role of graduate students in the research enterprise? On what basis are the costs of research allocated among the parties? Federal laws, regulations, and circulars govern operational aspects of the government-university relationship in areas such as allowable costs, administrative procedures, compliance issues, and audit practices. Yet statements of the rationale, goals, and objectives of the public investment in university-based research remain implicit, or are dispersed in a variety of statutes and elsewhere. As long as this is so, the government-university partnership risks being defined primarily in an ad hoc manner, by detailed accounting, administrative, and financial management requirements, and not by broader national goals.
A clearly articulated statement of the principles of the partnership would help clarify the roles, responsibilities, and expectations of each of the partners and establish a framework for addressing future issues as they arise. Ultimately, an agreed upon statement of principles would also serve to shape future discussions, formulate policies, and help guide decision making. The process itself of engaging the government and university partners in a dialogue would increase mutual understanding and provide a good foundation for resolving complex issues in the future.
As a first step, the NSTC report will include a proposed set of principles that will be refined over the next year through discussion among stakeholders, including the Congress, the university community, and professional societies. Some of these discussions will be organized through the NSTC, but I urge all stakeholders to become involved. The principles can fundamentally shape our thinking and our actions with respect to the government-university partnership in such areas as the integration of research and education, cost sharing policies and practices, and the reasons why the Federal government invests in university research.
Second, I am pleased to report that an issue that has long been on the policy agenda will soon come to closure. Since April 1996, the NSTC, in collaboration with the Office of Science and Technology Policy (OSTP), has provided leadership in the development of a government-wide Federal policy for research misconduct. As a major funder, producer, and user of research, the Federal government has a vital interest in the integrity of the research record. Advances in science and engineering depend on the reliability of the record, as do the benefits associated with them in areas such as health and national security. Sustained public trust in the scientific enterprise also requires confidence in the record and in the processes involved in its ongoing development.
Although most agencies have policies and procedures in place for handling allegations of research misconduct, not all do, and policies are not uniform across agencies, creating complexities for universities. The 1993 National Academy of Sciences panel report on Responsible Science: Ensuring the Integrity of the Research Process and the 1995 Health and Human Services' report on Integrity and Misconduct in Research: Report of the Commission of Research Integrity recommended the development of uniform government-wide policies and procedures for research misconduct.[i] These reports differed in their specifics, but both urged that the Federal government and OSTP take a leadership role in bringing this issue to closure.
The draft NSTC policy will include a definition of research misconduct and guidelines for responding to allegations of research misconduct. The public will have an opportunity to comment on the draft policy before it is finalized, and I expect it to be available for public comment this spring. When the policy is finalized, all Federal agencies that perform or sponsor research will be required to adopt its definition and adhere to its guidelines. Agency adoption of the policy will have implications for universities, which will be expected to apply the same policies and procedures to Federally funded research activities. I am confident that the long gestation period for this policy which by some counts could be said to have lasted as much as twenty years will have been worthwhile. I believe the policy will be embraced by the scientific community and also will satisfy the Federal government's need for accountability.
A third important item on the current policy agenda is the question of ownership of and access to data that is generated through Federal grants. Public Law 105-277 passed by Congress last year directed the Office of Management and Budget (OMB) to develop regulations that would require researchers to make data produced under a Federal award available to the public under the Freedom of Information Act (FOIA). OMB issued the proposed modification to OMB Circular A-110 on February 4, 1999 marking the start of a 60-day public comment period. After reviewing the comments, OMB will issue a final rule or propose additional changes with further comment.
A number of concerns have already been expressed about this policy. Bruce Alberts, the President of the National Academy of Sciences, stated that such
an enormous change in federal policy . . . that . . . will have serious, unintended consequences for the nation's research enterprise.[ii] Congressman George Brown, (D-CA) has introduced legislation (H.R. 88) to repeal the provision. There are a number of questions that should concern the research community about how such a provision would be implemented. Perhaps the most serious of these is whether it would require or inadvertently result in the disclosure of confidential medical records or other sensitive personal information. FOIA and the Privacy Act contain provisions which exempt medical records from public disclosure. However, the new provision, as written, would require researchers to turn over those records to Federal agencies so that the Federal agencies can make the determination that the records are exempt. Researchers could not refuse to provide them to the Federal agencies. A possible consequence of such a policy would be reduced participation in clinical studies.
Other questions remain, such as what constitutes data? Does the rule cover all data? Would the rule apply retroactively? Who would bear the costs of providing the data? And would OMB's interpretation on these issues hold up in a court of law? These issues must be addressed, and I urge the scientific community to let its views on this issue be known.
I will continue to work to make sure that our science and engineering enterprise, and our academic health centers remain strong and healthy and serve national goals.
Neal Lane is Assistant to the President for Science and Technology and Director of the Office of Science and Technology Policy.
Information about the Office of Science and Technology Policy, including updates on the issues discussed here, can be obtained on the OSTP web site: /OSTP
[i] National Academy of Sciences (1992) Responsible Science: Ensuring Integrity of the Research Process, National Academy Press, Washington, D.C., vols. 1&2; Commission on Research Integrity (1995) Integrity and Misconduct in Research, U.S. Department of Health and Human Services, Public Health Service, Washington, D.C.
[ii] Letter from Bruce Alberts to Jacob J. Lew, January 26, 1999.
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