Volume 19, Number 2
Inside UPDATE...
Speaking at the California Institute of Technology on January 21, President Clinton previewed his coming Fiscal Year (FY) 2001 budget for science and technology. He announced that the budget, due for release on February 7, will greatly accelerate the "march of human knowledge" by enhancing the federal investment in these areas.
The President recognized the current strength of the U.S. economy has been built on improvements created by advances in science, particularly information technology. He also acknowledged TIME Magazine's selection of Albert Einstein as the "Person of the Century," and noted that the 20thCentury will be remembered in TIME's words "for its earthshaking advances in science and technology." Yet, Clinton reminded his audience that "there are so many more great scientific questions just waiting to be answered." One of them, what the President called "the biggest question of them all," is "How is it possible that you can add $3 billion in market capitalization just by adding ‘dot com' at the end of a name?"
In pursuit of this new knowledge, the President will propose, in his forthcoming FY 2001 budget, an increase of $2.8 billion for the 21st Century Research Fund. The fund is the device the administration has used to put science and technology together in one budgetary pot. The proposed increase includes a $1 billion boost for the National Institutes of Health, as well as major funding increases for information technology, space exploration, and the development of cleaner sources of energy. Clinton did make clear that his budget "makes research at our nation's colleges and universities a top priority" and that the increases for science and technology are "in all scientific and engineering disciplines."
The National Science Foundation is scheduled for a $675 million increase in the proposed FY 2001 budget. This 17 percent increase, if enacted by the Congress, will provide the largest dollar amount boost for NSF in its history and put NSF's budget at $4.6 billion. The increase includes $320 million to strengthen core disciplinary research "that extend the frontiers of science and engineering across the board." The rest of the increase will allow for enhanced support for last year's initiatives in Information Technology, Biocomplexity in the Environment, and Building a 21st Century Workforce. Within the latter, there will be a competition for Centers for Teaching and Learning. NSF will also participate in the new National Nanotechnology Initiative.
The administration proposes a $227 million increase over current spending in nanotechnology research, bringing total federal spending to around $500 million. Nanotechnology is the ability to move and manipulate matter. It can produce increased memory storage on smaller devices, create stronger, yet lighter, materials, and boost energy efficiency. The initiative will be spread over 5 federal agencies, with the National Science Foundation, the Department of Defense, and the Department of Energy the major recipients. Included in the initiative, as was done in last year's Information Technology initiative and in the Human Genome research program, are funds for studies on the legal, ethical, social, economic, and workforce preparation implications of the new technology.
At Cal Tech, the President also noted: "For far too many of our citizens, science is something done by men and women in white lab coats, behind closed doors — something that leads, somehow, to things like Dolly the sheep and satellite TV." He called on scientists "to help open the world of science to our citizens — to help them understand the great questions that science is seeking to answer, to help them see how those answers will directly affect their lives." Clinton also reminded his audience that scientists must "ensure that science always serves humanity, never the other way around."
With Congress returning to open the second session of the 106th Congress on January 24th, the President's State of the Union on January 27th, the election season well under way, and the budget release on February 7th, the policymaking lull of the past few months is now over. President Clinton's strong embrace of enhanced investment in the science and technology promise indicates a recognition of the important impacts previous investments have had on our current lives and the need to invest now to improve our lives in the future. With an increased budget surplus to allocate, will Congress buy into this vision? Stay tuned!
On January 7, 2000, the Panel on Scientific Boundaries for Review (PSBR), submitted to the Center for Scientific Review (CSR) Advisory Committee its Phase I final report that offers many recommendations for revising the CSR's peer review system. The report, according to Panel Chair and National Academy of Sciences (NAS) President Bruce Alberts, is to "position the CSR peer review system so that it best fosters the expanded research opportunities created by the stunning successes of the health-related research enterprise, as well as permitting this review system to keep pace with the accelerating rate of change in the way that health-related research is performed." At the urging of COSSA and its allies, "health-related research" replaced "biomedical research" from the Panel's earlier version (See UPDATE, September 13, 1999, No. 16).
The Panel received more than 800 comments on the first iteration of the report, including ones from COSSA, the American Anthropological Association, the American Psychological Association, the American Sociological Association, and members of the Health and Behavior Alliance. In her reply to those who commented on the draft report, CSR Director Ellie Ehrenfeld noted that "this has been a very challenging task."
The Panel recommends that the CSR's peer review panels be organized into 24 Integrated Review Groups (IRGs), as compared to the current structure of 20 IRGs. As advocated by COSSA, the Panel will leave intact for several years the seven IRGs and component study sections that were recently created for the behavioral and social sciences, AIDS, and neuroscience until an evaluation of their effectiveness can be conducted.
The implementation of the Panel's recommendations will occur during the next three years. (It can be followed at: http://www.csr.nih.gov.) Expert groups of extramural scientists and the NIH will create the 24 IRGs based on the principles outlined in the Panel's report. The Panel also suggests that adjustments to its proposed organization, including new study sections, may be made during the implementation effort.
The report lays out three guiding principles that the expert groups should follow when determining the structure of the IRGs:
There should be at least one appropriate venue for the review of all science that is relevant to contemporary health-related research.
The research topics encompassed by each IRG should be sufficiently cohesive to allow an external advisory group of scientists for that IRG to judge the content of its entire portfolio.
The organization should be flexible enough to adjust to the rapid changes in scientific opportunities expected in the years ahead.
In considering the design of the IRGs, the Panel underscores that it "attempted to cluster, whenever possible, all types of research whose major emphasis is focused on a given organ system or disease in an IRG devoted to that system or disease." IRGs were also created for the review of basic scientific discovery and the development of methods that do not apply to any specific system or disease. "To ensure a vigorous foundation for future progress, NIH must continue to support a sizable proportion of research that has no immediate or specific application to human health."
The final report also outlines some cultural norms the Panel believes should govern the CSR review process. The Panel notes that "an appropriate peer reviewer is an active researcher, who can understand and judge both the research goals and the research means being proposed by the applicants." They should be experienced researchers who have achieved recognition for their own research, and are reasonably diverse in seniority, outlook, geographical location, gender, and ethnicity. The role of a peer reviewer is to judge the research proposed and provide the Institutes with honest and informed advice about the merits of the proposals under review. These cultural norms also address the following questions:
What are the roles and responsibilities of the Scientific Review Administrators (SRAs), Chairs, and Members of study sections?
What is the appropriate relationship between study sections and disciplines?
What types of research have the potential to impact the ability of the NIH to achieve its mission?
What should a grant application propose?
What perspective should be used in review, and how should the results of the review be communicated?
What is the role of preliminary data?
What procedures can be introduced to improve the operation of study sections?
The National Science Foundation's Education and Human Resource Directorate (EHR) seeks grant proposals for Research on Learning and Education (ROLE). It will award 20-30 grants, spending $8 million for research that capitalizes on important developments in a variety of fields related to human learning and education. This new solicitation is not to be confused with two others: the Interagency Education Research Initiative, an NSF, Department of Education, and NIH's National Institute on Child Health and Human Development collaboration, or the Social, Behavioral and Economic Sciences Directorate's program on Child Learning and Development.
The ROLE program will support research along a four-quadrant continuum that includes: 1) brain research as a foundation for research on human learning; 2) fundamental research on behavioral, cognitive, affective, and social aspects of human learning; 3) research on science, mathematics, engineering, and technological (SMET) learning in formal and informal educational settings; and 4) research on SMET learning in complex educational systems. ROLE seeks gains at the intersections of these areas, where issues arising from research and educational practice can be reconciled and hypotheses generated in one area can be tested and refined in others.
The goals for the ROLE program, according to EHR, are to: 1) discover and describe neural, cognitive, affective, and conceptual learning processes required for life-long SMET learning; 2) understand how pre-K through secondary teacher and post-secondary faculty content knowledge and pedagogy relate to the implementation that innovative and effective curricula, materials, and assessments require; 3) develop research-based learning tools, pedagogical approaches, and materials that enhance SMET education at all levels; 4) reevaluate the overall curriculum structure to enhance SMET education at all levels; 5) develop and refine new educational research and evaluation methods; 6) increase the research capacity of the field, especially the development of new researchers and research-oriented education practitioners; 7) collect and analyze data and to use data to inform researchers, decision-makers, and the general public; 8) understand the factors that enhance the full participation of all Americans in the SMET enterprise and the approaches that can increase this participation; and 9) increase the knowledge of learning, teaching, and organizational models that lead to substantial and large-scale improvement in the efficiency, efficacy, and cost-effectiveness of the U.S. educational system.
Preliminary proposals are due on March 1 and September 1. Final proposal deadline dates are June 1 and December 1. A full description of the program may be found at http://www.nsf.gov/cgi- bin/getpub?nsf0017.
For further information contact: Nora Sabelli, 703/306-1650, nsabelli@nsf.gov; Elizabeth VanderPutten 703/306-1650, evanderp@nsf.gov; or Anthony Kelly, 703-306-1650, aekelly@nsf.gov.
Both political parties agree that the future of the reauthorization of the Office of Educational Research and Improvement (OERI) for this legislative session is up in the air. At a policy luncheon of the American Educational Research Association (AERA) and the Institute for Educational Leadership, three congressional staffers spoke about possible legislative outcomes during the second session of the 106thCongress. The OERI is the Department of Education's research, development, and dissemination agency.
Susan Hattan, from the Senate Health, Education, Labor, and Pensions Committee chaired by Senate James Jeffords (R-VT), noted that the Senate would first consider the reauthorization of the Elementary and Secondary Education Act (ESEA) and then work on the OERI reauthorization. The Committee, she said, would hold a mark-up (or vote) of an ESEA "as soon as possible," but noted that it may not occur soon.
Sally Lovejoy, from the House Education and Workforce Committee chaired by Representative William Goodling (R-PA), noted that House would consider ESEA reauthorization in a piecemeal approach and that OERI would not be considered until the separate ESEA pieces (including Fund for the Improvement of Education (FIE) and Safe and Drug Free Schools Act) were completed.
She said this would be a difficult and perhaps lengthy process. She reminded the crowd that this is an election year and that there are only 60 legislative work days scheduled. She noted, therefore, that House action on the OERI bill would depend on the time remaining in the session and "the focus of Congress." Assuming that OERI reauthorization is considered, though, Lovejoy questioned whether an OERI reauthorization should "tinker around the edges" or make "wholesale changes," including the possibility of making OERI an independent agency outside the auspices of the Department of Education.
June Harris, Education Policy Coordinator of Democrats on the House Education and Workforce Committee, noted that her bosses would be focused on four issues this upcoming session: 1) school construction, 2) class size reduction, 3) ESEA reauthorization, and 4) OERI reauthoriztaion. Regarding OERI, Harris noted that Democrats want it reauthorized this session, but questioned whether it would happen before adjournment.
Secretary of Agriculture Dan Glickman has decided to fund the Initiative for Future Agriculture and Food Systems. The department will spend $120 million to fund competitive research, education, and extension grants under a program authorized by Congress in 1998. In the FY 1999 appropriations bill, Congress prohibited the department from funding the new initiative. Apparently the lack of such a prohibition in the FY 2000 appropriation allowed Glickman to go forward and fund the program. The grants will focus on production agriculture, natural resource management, and consumer issues. The priorities for the fund include: agricultural genomics and risk assessment; food safety and the role of nutrition in health; new uses for agricultural products, including biomass fuel sources; natural resources management, pest management, and precision agriculture; and farm efficiency and profitability, with an emphasis on small- and mid-sized family farms.
The actual solicitation notice will be available within the next two months. The legislation gives priority to multi-state, multi-institutional, or multi-disciplinary efforts; and work that integrates agricultural research, extension, and education.
In addition, the Secretary announced $20 million in research grants under the Fund for Rural America program enacted several years ago, but which has also been denied funding by Congress in recent appropriations bills. The new grants were awarded for a: National Resource Center for Rural People in Forest Communities; Consortium for Site-Specific Resource Management; Northeast Center for Food Entrepreneurship; Center for Minority Land and Community Security; and a National Center for Manure and Animal Waste Management. The remaining $40 million from the Fund for Rural America will be allocated for rural development activities including Rural Business Opportunity Grants, farm labor housing projects, and water and water disposal projects.
Tired of waiting for Congress to act, the Clinton Administration has issued proposed regulations on medical privacy. The 600 page proposal appeared in the Federal Register (November 3, 1999, pp. 59917-60065). Comments are due to the Department of Health and Human Services on February 17, 2000. (This is an extension of the original deadline of January 3, 2000). They may be submitted to: http://www.aspe.hhs.gov/adminimp.
A section on "Uses and Disclosures for Research" notes that covered entities are permitted to use and disclose protected health information for research without individual authorization, provided that the covered entity receives documentation that the research protocol has been reviewed by an Institutional Review Board or equivalent privacy board. The board must find that the research protocol meets specified criteria designed to protect the subject. Absent such documentation, the subject's protected health information could be disclosed for research only with the individual's authorization.
These criteria, according to the proposed rules, are: 1) the use or disclosure of protected health information involves no more than minimal risk to the subjects; 2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; 3) the research could not be practicably carried out without the waiver or alteration; 4) whenever appropriate, the subjects will be provided with additional pertinent information after participation; 5) the research would be impracticable to conduct without the protected health information; 6) the research project is of sufficient importance to outweigh the intrusion into the privacy of the individual whose information would be disclosed; 7) there is an adequate plan to protect the identifiers from improper use and disclosure; and 8) there is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers.
The proposal recognizes that "much important and sometimes lifesaving knowledge has come from studies that used individually identifiable health information." It notes research associating the reduction in the risk of heart disease with dietary and exercise habits. The proposal also indicates that research on behavioral, social, and economic factors that affect health may require individually identifiable health information. This research, it declares, has yielded important information about treatment outcomes, patterns of care, disease surveillance and trends, health care costs, risk factors for disease, functional ability, and service utilization. For example, it acknowledges research demonstrating that screening and treatment patterns vary with the race of a person, leading to focused outreach programs to improve health.
The proposal also extends the Common Rule governing research on human subjects agreed to by 17 federal agencies to all research, including that supported by private funds. The full proposal can be viewed at: http://www.access.gpo.gov/su-docs/fedreg/a991103c.html.
The Office of Juvenile Justice and Delinquency Prevention (OJJDP), an arm of the Office of Justice Programs (OJP), recently released its Fiscal Year 2000 Program Plan. The Plan describes the programs that OJJDP plans to fund and undertake during the coming year.
The Plan notes that the youth violence problem facing the nation in the late 1980s and early 1990s seems to have subsided. But, it suggests that not all the news is good. Specifically, the Plan points to the problems of gangs and juvenile drug use. The latter, according to the report, which declined during the 1980s has steadily increased since 1992 . . ." This mix of reassuring and troubling statistics "serves as a reminder that while great progress has been made in reducing juvenile delinquency, violence, and victimization, much more needs to be done." It further notes that beneficial effects of research and evaluation on the ability of local officials to know "what works in the areas of prevention and intervention."
A few examples of the programs OJJDP plans to undertake, or continue to fund throughout the year, include:
OJJDP will continue to provide funds for the Program of Research on the Causes and Correlates of Delinquency, a longitudinal study involving three sites: Institute of Behavioral Science, University of Colorado at Boulder; Western Psychiatric Institute and Clinic, University of Pittsburgh; and Hindelang Criminal Justice Research Center, University at Albany, State University of New York. Since 1986, this study has produced a large amount of information on delinquent behavior. Topics for upcoming reports include: defining characteristics and predictors of very young offending, delinquency and victimization at school, and the causes of violence in disadvantaged neighborhoods.
The OJJDP will continue to work in a multiagency effort to fund research projects on child neglect to address the lack of research focusing specifically on this issue. Along with the National Institute of Justice (NIJ), the Department of Education, the National Institutes of Health (NIH), and the Administration of Children, Youth, and Families, the OJJDP will work to consider the "etiology, extent, services, treatment, management, and prevention of child neglect."
In FY 2000, the OJJDP will continue to provide support to the National Academies of Science (NAS) "for a review and synthesis of existing evidence regarding the effectiveness of community-level intervention and service programs designed to promote positive youth development."
For the sixth year, the National Institute on Drug Abuse (NIDA) of the National Institutes of Health brought together representatives from a variety of disciplines and affiliations, including COSSA, for its annual constituent conference. The meeting is important, said NIDA Director Alan Leshner, because it "provides a forum for discussion" and an opportunity for the Institute to get advice from its constituency in establishing its research agenda. He stressed that a major purpose for the meeting is "to find out what NIDA needs to be doing."
Leshner noted that drug use and related adverse behavioral and social consequences are increasingly becoming a focus of drug abuse and addiction research. He used a slide of a puzzle — with behavior [and social science] as the center piece — as a metaphor for all the types of research required to find a solution to the problems of drug abuse and addiction. He talked of his recent appearance at the COSSA Annual Meeting in November and of his desire to find a way to most effectively describe drug addiction as a brain disease (See UPDATE, December 6, 1999, No. 21). He said he received an email from Social Science Research Council (SSRC) President Craig Calhoun suggesting drug abuse and addiction be described as a "brain disease shaped by behavioral and social context." Leshner liked this explanation, but said he is still looking for an even clearer way of communicating the complicated phenomenon of drug abuse and addiction.
Leshner noted that NIDA is in the process of releasing a request for application, "Drug Use and Related Adverse Behavioral and Social Consequences." This RFA, he said, is significant because the risk factors for drug abuse and addiction are also the risk factors for most everything bad that can happen to an individual. It is not just about risk, he said. The majority of the people who have the majority of the risk factors do not use drugs, he continued. What is it that protects them? Why don't they use drugs? He stressed that this nuance is a very important factor in the development of new and improved prevention strategies.
According to Leshner, NIDA's next set of initiatives will focus on several areas including: vulnerability to addiction, transition to addiction, neuroscience, next generation of prevention research, AIDS, and other medical consequences.
As in previous years, NIDA prepared a "Report Card" that describes how the Institute has responded to the recommendations made the preceding year. Several core issues continue to be concerns for both NIDA and the field including: collaborative efforts, children and adolescents, HIV/AIDS, special populations, treatment, prevention, education, and information dissemination. Additional issues that have been identified by NIDA constituents as priorities for this year include: research on the prevention of drug abuse and HIV; prenatal drug exposure; prevention interventions for children, adolescents, and families; Hepatitis C; treatment for special populations; criminal justice and drug courts in relation to health issues and approaches; the translation of interventions into clinical practice; and the impact of organizational structure and management on treatment, access, quality, cost, and patient outcomes.
Recently Released Requests for Applications (RFAs)
Fulfilling Leshner's promise of increased research, NIDA has released several requests for applications (RFAs).
Noting that the treatment and management of HIV/AIDS in drug users are complicated by social, behavioral, clinical, and pharmacological factors which may alter the long-term effectiveness of HIV therapies, NIDA invites applications for research on access, adherence, and effectiveness relevant to the treatment of drug users with HIV. The mechanism of support for this RFA will be the investigator- initiated research project grant (R01). A letter of intent is due by February 28, 2000; the application is due March 29, 2000. For more information see the announcement at http://grants.nih.gov/grants/ guide/rfa-files/RFA-DA-00-007.html.
A second RFA, the "Next Generation of Drug Abuse Prevention Research," encourages a new generation of drug abuse prevention research. Applications are being solicited to examine components of empirically validated drug abuse prevention interventions that may account for program effectiveness. Prospective applicants are asked to submit a letter of intent by February 28, 2000; the application is due March 28, 2000. For more information see the announcement at http://grants.nih.gov/grants/guide/rfa- files/RFA-DA-00-004.html.
NIDA is also seeking applications for research projects in basic behavioral, cognitive, and neuroscience research that can address the complex relationship between drug abuse and addiction and HIV/AIDS transmission and progression. Prospective applicants are asked to submit a letter of intent by February 29, 2000; the application is due March 29, 2000. For more information see the announcement at http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-00-005.html.
Finally, NIDA has launched a new initiative in response to the increasing popularity of substances known as "club drugs" — substances commonly used by young adults at dance clubs and bars — and has issued a notice to inform the research community that it is interested in expanding its research portfolio on all aspects related to the use, abuse, and the short- and long-term effects of "club drugs." Applications can be in response to several NIDA Program Announcements (PAs):
Drug Abuse Prevention Intervention Research (http://grants.nih.gov/grants/guide/pa-files/PA-00- 002.html); and
Drug Use and Related Adverse Behavioral and Social Consequences (http://grants.nih.gov/grants/guide/pa-files/PA-99-113.html).