Volume 20, Number 1 January 15, 2001
Volume 20, Number 1
January 15, 2001
When we last left you, the country was waiting for the Supreme Court to decide the presidential election and the appropriations process for Fiscal Year 2001 remained incomplete. In the intervening month, George W. Bush began putting his adminis-tration together, and all 13 FY 2001 spending bills finally became law, 21 Continuing Resolutions later and nearly three months into the fiscal year.
In subsequent parts of this edition of Update, we fill you in on the final results of the appropriations process. (For a more detailed picture of FY 2001 spending, see the chart on page 7.) The Labor-Health and Human Services-Education and the Commerce-Justice-State spending bills were finally signed on December 26. Along with the final decisions on programs in these bills, the Administration and Congress agreed to a 0.22 percent decrease for all programs not in the Labor-HHS-Education legislation. Thus, the National Science Foundation lost about $9.7 million from its final appropriation of $4.4 billion.
The 107th Congress opened for business on January 3. Two major situations needed working out. With a net gain of four seats by the Democrats in the election, the Senate ended up divided 50-50. As Vice-President Gore remains in office until January 20, the Democrats are the majority for 17 days. Congressional leaders agreed that Democratic Senators would chair the committees during that period, including a number of hearings on Bush cabinet nominees. Following the inauguration of President-elect Bush and Vice-President-elect Cheney on January 20, the Republicans will have the tie-breaking vote. Republicans will take over as committee leaders, but Democrats fought for and received equal committee representation and staff allotments. Majority Leader Trent Lott (R-MS) will be allowed to break ties in committee votes, allowing, for example, cabinet nominations to move to the Senate floor.
In the House, where the Republicans maintained their majority for the fourth election in a row, albeit by a rather slim margin, the major activity was a game of musical chairs among Committee heads. The rule instituted by the GOP after they took control of the House in 1994 (limiting panel leaders to three terms) created significant shifts among senior Republicans (described in the story on page 3). Among the new House members, the only one with a social/behavioral science doctorate is Tom Osborne (R-NE), who has a Ph.D. in educational psychology. Osborne is better known as the highly successful former football coach at the University of Nebraska.
After taking care of procedural activities and counting the electoral vote, Congress adjourned until the new administration officially takes over. In the meantime, there are confirmation hearings scheduled by the relevant Senate committees. The most anticipated is the Judiciary Committee's consideration of John Ashcroft for Attorney General on January 16.
Looking forward into 2001, the major legislative battles will occur over President Bush?s initiatives for a major tax-cut, education reforms, defense build-up, and his spending priorities. The new President is expected to present a budget outline in early February, but a full-blown FY 2002 budget proposal may not show up until March or April. The education reforms should take place as part of the reauthorization of the Elementary and Secondary Education Act (ESEA). Whether reauthorization of the Office of Education Research and Improvement is included in ESEA or comes up later remains to be seen. Can NIH and NSF continue on track for doubling funding? With a tax cut and defense build-up, there are some who express concern over whether funding will be available for major increases in science. However, with a large surplus and general bipartisan agreement on the importance of basic research, significant boosts in the spending for these two agencies should continue.
Two and a half months into the fiscal year, appropriations for FY 2001 finally came to an end in Congress with the passage of the Consolidated Appropriations Bill for Labor-HHS-Education, Legislative Branch, and Treasury-Postal. While overdue, the December agreement was preferable to the situation desired by some Congressional leaders in which funding would have been postponed until President-elect Bush takes office.
Disagreements over the appropriate funding level for Labor-HHS-Education contributed to the delay in the bill's passage. The final agreement provides $108.9 billion in discretionary funding for Labor-HHS-Education.
Education research received a healthy boost over last year. The education research institutes will receive $120.6 million, an increase of about 16 percent. This includes $20 million for continuation of the Interagency Education Research Initiative and $7 million to support a research initiative to improve schooling for language-minority students.
The regional education laboratories were level-funded at $65 million, and the National Center for Education Statistics will receive $80 million, about 18 percent more than in FY 2000.
FIPSE, the Fund for the Improvement of Postsecondary Education, will receive $146.7 million, compared to $75 million last year. This large increase, however, includes over $115 million in earmarks for specific schools and centers.
The agreement also includes: $10 million (for the 2002-2003 school year) for the Javits Fellowship program, which supports graduate students in the arts, humanities, and social sciences; $78 million for International Education and Foreign Language programs; $100.4 million for the National Institute for Disability and Rehabilitation Research (NIDRR); $31 million for Graduate Assistance in Areas of National Need; and a recommendation for the Secretary to fund a study by the National Research Council to evaluate the consequences of high stakes testing.
The National Institutes of Health (NIH) received a budget of $20.5 billion, a 14.2 percent increase over the FY 2000 funding level, slightly less than the 15 percent increase championed by NIH advocates. The agreement includes a provision to allow the current Acting Director of NIH, Ruth Kirchstein, to remain in that position; this may be an indication of the expected difficulty of finding a "suitable" individual for the post.
The conference agreement carves out of the Office of the NIH Director (OD) $130 million for the newly created National Center on Minority Health and Health Disparities (see Update, November 6, 2000). The conferees "recognized that NIH has made research into health disparities a high priority, and has already taken steps to expand the role of research into why some minority groups have disproportionately high rates of disease."
Legislation establishing the Center (the Minority Health and Health Disparities Research and Education Act of 2000) was signed into law by the President in November of 2000. The newly-created Center is expected to build on the work of the Office of Research on Minority Health and the success of the Minority Health Initiative.
For AIDS research, the agency is expected to provide $2.26 billion from the funds allocated to the NIH. Within the funds for the Office of the Director, the agreement includes resources to address the growing HIV/AIDS epidemic in communities of color. The OD is encouraged to expand and strengthen science-based HIV prevention research for minorities. Additionally, the OD is encouraged to expand existing "culturally competent behavioral research conducted by minority principal investigators that seeks to decrease the rate of mortality in targeted minority populations."
The conferees highlighted their support for the National Institute for Child Health and Human Development's (NICHD) plans to conduct a national longitudinal study of environmental influences (broadly defined) on children's health. NICHD Director Duane Alexander is urged to establish a consortium of representatives from appropriate Federal agencies, including the Centers for Disease Control and Prevention, the Environmental Protection Agency, and other NIH Institutes to plan and initiate pilot studies that will provide the information necessary to develop and implement the full national longitudinal study. Accordingly, the conferees provided funds to support the initiative.
The conference agreement provides $3.86 billion in funding to the Centers for Disease Control and Prevention (CDC), a 27 percent increase over FY 2000. The agreement includes $97.4 million for the CDC's National Center for Health Statistics (NCHS), an increase of $10.6 million (12.2 percent) over FY 2000. For the prevention centers, the conference agreement provides $23 million in funding.
The conferees recommend that the CDC increase funding to evaluate HIV prevention service delivery programs to improve funding decision-making and to implement more rapid effective transfer of technology to community-based service delivery organizations and health departments. The agreement states that "approximately half of this amount should support evaluation activities to track service delivery by community-based organizations and utilize cost-effectiveness analysis in HIV prevention."
For Chronic Disease Prevention and Health Promotion, the agreement provides $417 million in funding, an increase of $120 million (40.4 percent).
The Agency for Healthcare Research and Quality (AHRQ) received a 36 percent increase over last year for total funding of $270 million. AHRQ's total is made up of $105 million in direct funding and $165 million in transfers from other public health service agencies. The agreement provides an additional $50 million to AHRQ to determine ways to reduce medical errors. Likewise, an additional $10 million is provided for research that investigates the relationship between the health care workplace and its impact on medical errors and the quality of care provided to patients. Finally, AHRQ is urged to enhance its investigator-initiated research funding through all available mechanisms as appropriate.
The budget agreement provides $16.7 million for policy research. Included is $7.1 million to continue the study of the outcomes of welfare reform and to assess the impacts of policy changes on the low-income population.
Finally, the agreement changes the name of the National Neuroscience Research Center at NIH to the John Edward Porter Neuroscience Research Center in recognition of his efforts on behalf of NIH.
Labor
The Bureau of Labor Statistics will receive $451.6 million, an increase of four percent. This includes increases for improvements to existing economic measures, improvements in labor market information mandated by the Workforce Investment Act (WIA), and a new time use survey.
When the GOP took over the House in 1995, they imposed three-term limits on members' leadership of committees and subcommittees. This necessitated the widespread shifting of chairs that characterized the opening of 107th Congress. House Speaker Dennis Hastert (R-IL), with help from a steering committee, recommended choices for the new panel heads to the Republican House Caucus, often ignoring seniority in selecting among competing members.
Exemplifying the cascade effect of the new situation was the appointment of Rep. Sherwood Boehlert (R-NY) to replace Rep. F. James Sensenbrenner (R-WI) as head of the Science Committee. Sensenbrenner will now lead the Judiciary Committee, taking the gavel from Rep. Henry Hyde (R-IL), who now gets to chair the International Relations Committee.
Boehlert is a strong supporter of the National Science Foundation, particularly its science education programs. He is concerned about protecting the environment and has expressed interest in a crime and technology initiative developed by the Office of Science and Technology Policy in the waning days of the Clinton Administration (see Update, September 11, 2000).
Although subcommittee chairs for the Science Committee have not yet been chosen, it appears that Rep. Nick Smith (R-MI) will continue as head of the Basic Research panel, with another attempt at reauthorization of the National Science Foundation on the agenda.
Bypassing seniority, the Caucus chose Rep. John Boehner (R-OH) to chair the Education and Workforce Committee. Rep. Thomas Petri (R-WI), who has senior status, was expected to replace retired Chairman Bill Goodling (R-PA). However, Reps. Boehner and Peter Hoekstra (R-MI), who are considered more conservative than Petri, decided to mount challenges. Mr. Boehner prevailed and announced that he would push Mr. Bush's education proposals.
Rep. James Nussle (R-IA) takes the reins of the Budget Committee. Nussle was a member of the gang-of-seven, former Speaker Newt Gingrich's shock troops, and once wore a paper bag over his head on the House floor to protest the House bank scandal. He has been a deficit hawk in the past and will be expected to push the new president's spending priorities.
The Speaker chose Rep. Bill Thomas (R-CA) to replace the retired Rep. George Archer (R-TX) as head of the Ways and Means Committee. Thomas will be a key player on tax and trade matters. Rep. Nancy Johnson (R-CT) will head the Health Subcommittee, with Rep. Wally Herger (R-CA) taking over for Johnson as chair of the Human Resources Subcommittee, which oversees welfare reform.
Rep. Larry Combest (R-TX) remains as chair of the Agriculture Committee. Rep. Frank Lucas (R-OK) will be the new head of the Conservation, Credit, Rural Development, and Research Subcommittee, in a year when the farm bill will be up for renewal.
At the Government Reform Committee, Rep. Dan Burton (R-IN) will continue to chair the full panel. However, Rep. Stephen Horn (R-CA) will relinquish chairmanship of the Government Management, Information, and Technology Subcommittee.
The impact of term limits also strongly affected the heads, or "cardinals," of the 13 appropriations subcommittees. Nine of these panels have new chairs (though seven simply shifted from leading one subcommittee to another). These include: former Interior Appropriations Subcommittee Chair Ralph Regula (R-OH) leading the Labor-HHS-Education Subcommittee; Rep. Frank Wolf (R-VA) moving from Transportation to Commerce-Justice-State; and Rep. Joe Skeen (R-NM) moving from Agriculture to Interior. Rep. Henry Bonilla (R-TX) is a new cardinal taking over the leadership of Agriculture and Rural Development. Rep. James Walsh (R-NY) remains as head of the VA-HUD-IA Appropriations Subcommittee, which has jurisdiction over funding for the National Science Foundation.
In the Senate, committee assignments were completed on January 11. The major change will be the ascension of Sen. Charles Grassley (R-IA) to head the powerful Senate Finance Committee, replacing the defeated Sen. William Roth (R-DE). Sen. Max Baucus (D-MT) will become Finance's Ranking Member, taking over from retired Sen. Daniel Patrick Moynihan (D-NY).
More on Senate assignments in the next issue of Update!
With heightened awareness after the death of a research participant at the University of Pennsylvania and reports of abuses that led to temporary suspensions of research activity in other places, the protection of human research subjects has drawn the major attention of government and non-governmental bodies. A flurry of activity is underway to assess and strengthen the system of assuring that people who volunteer to participate in research are not subject to harm.
In all of these activities, the need to balance the protection of human subjects without the undue burdening of research and researcher becomes a difficult act. In addition, how to accommodate the social and behavioral sciences in a system that is based on a model to deal with biomedical and clinical research is another difficult problem.
On December 21, the Department of Health and Human Services' (HHS) National Human Research Protection Advisory Committee met for the first time. Chaired by Mary Faith Marshall, Professor of Medicine in the School of Medicine, and Bioethics Officer at Kansas State University Medical Center, the panel is closely connected to the Office of Human Research Protection headed by Greg Koski (the Committee's executive secretary). The Committee includes one social/behavioral scientist among its 12 members: Jennie R. Joe, Professor of Family and Community Medicine at the University of Arizona. Joe is a cultural anthropologist with a nursing degree who has conducted research and demonstration projects among Native Americans. COSSA has written HHS Secretary Donna Shalala to ask for more social/behavioral scientist representation on the panel.
After hearing Secretary Shalala describe the Committee's task as "very important," and listening to Senator Edward Kennedy (D-MA) review the history of the federal government's involvement in this area, the panel turned its attention to the social and behavioral sciences. Felice Levine, Executive Officer of the American Sociological Association and then-Chair of the COSSA Executive Committee, addressed the panel on how the social and behavioral sciences viewed the situation. Levine based her remarks on the paper prepared by Jonathan Knight of the American Association of University Professors (see Update, December 11, 2000) and her involvement with the working group that helped produce the paper.
Levine noted that the many assessments presently occurring provide an opportunity to rethink the system so that it protects research participants and promotes ethical and excellent research. She wants the committee to take a hard look at the "gaps" in the system between principle and practice, particularly with respect to the review and approval process of social science research. She suggested there has been a very troubling, growing "fault line" between the mandated purposes of the system of regulating research and its operations.
The key to reforming the system, Levine argued, involves altering the very structure of the Institutional Review Board (IRB) process itself. "At a minimum, this would mean a different thinking about the compositions and expertise on IRBs, on staffs, on advisory commissions, and on any accreditation groups to be established," she declared.
She noted the six categories of research that are explicitly exempt under the Common Rule that governs the protection of human subjects. What those types of research have in common is that they pose little or no risk of physically or mentally harming human subjects. Whether a risk is more than minimal is for an IRB to decide. Levine expressed concern that the bases of these decisions now vary even within IRBs of the same institution, as well as across institutions. The quality of IRB decisions ultimately depends on the experience of the IRB members. Levine worried that those members not familiar with social science research can have a difficult time discerning the putative benefits of research. At the same time, problems also arise if IRB members indiscriminately apply standards of research drawn from a clinical or biomedical perspective to the social sciences.
She also discussed informed consent and expedited review problems. With regard to the former, she suggested that IRBs "may be prone to implement the Common Rule too literally and mechanistically and with little consideration of the diverse nature and ethical requirements of research." She is concerned with how expedited review will work as the responsibilities of IRBs expand in response to the concern that they must be more vigilant in protecting human subjects. She advocated for opportunities to provide blanket exemptions for certain types of research (e.g., survey or oral history).
After the presentation, the Committee concluded that it needed to reach out further to the social science community, and it agreed to issue a formal request for guidance on how to proceed with the question of how to approach issues particular to non-biomedical research. They also sought answers to a series of questions concerning the social sciences, including: How many social/behavioral scientists are members of IRBs? How many social/behavioral science protocols are considered by IRBs? How many social science protocols are rejected because of potential psychological or emotional risk to the subjects? How should risk be defined for these sciences?
Meanwhile, at the
Institute of Medicine . . .
An Institute of Medicine (IOM) Committee, Assessing the System for Protecting Human Research Subjects, held its inaugural meeting on December 18 for a two-year study to address three interrelated topics surrounding the issue.
The IOM study is in response to a request from the Department of Health and Human Services? (HHS) Office of Human Research Protection (see Update, September 25 and November 6, 2000). Daniel Federman, M.D., Dean for Alumni Relations and Clinical Teachings at Harvard University, chairs the Committee.
The topics the Committee is addressing include:
1. Accreditation standards for Institutional Review Boards (IRB)
2. The overall structure and functioning of human subject protection activities, including, but not restricted to, IRBs
3. Criteria for evaluating the performance of human subject protection activities
Phase I (which is on a fast track) of the two-phase study is a six-month study on accreditation standards for IRBs. A report on accreditation is scheduled for release on April 1, 2001. To meet its deadline, a public meeting has been scheduled (January 22, 2001, 1:00 to 5:30 p.m.) to receive input for the report. According to the Committee, a major objective of the meeting is to provide the opportunity for public comment, in particular on the draft standards for an independent voluntary accreditation system proposed by the Public Responsibility in Medicine and Research group (PRIM&R). PRIM&R's proposed standards are available at www.iom.edu/hrrp.
At the December meeting, Sanford Chodosh, President of PRIM&R, discussed the standards and process. The underlying goal of the standards, said Chodosh, is to improve the protection of human research subjects. He also emphasized that the goals of PRIM&R include creating performance standards and fostering the organization of a second body to carry out the accreditation process.
Chodosh noted that the standards address three areas: institutions, human subject research protection programs, and investigators. PRIM&R, Chodosh said, has struggled to make the standards applicable across the human research spectrum. Areas not adequately covered by regulations, he continued, were given special consideration. He informed the Committee that the draft standards include input from the IOM.
The plan, Chodosh explained, is to test the standards in pilots and to license the copyright standards to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), currently in the process of incorporation. Once AAHRPP is established, the intent is to assess the accreditation process and make the appropriate changes where necessary.
Chodosh concluded by noting that while PRIM&R had an obligation to give IOM a document, they can continue to amend the revised document. The intent is to publicize the standards, he said.
Phase II will be a 24 month study of the structure, function, and performance of human subject protection activities. The report from Phase II of the study is expected to be released in September, 2002.
Any questions regarding the project should be addressed to Laura Lyman Rodriguez, Study Director, Board on Health Sciences Policy at 202/334-3193; email: lrodrigu@nas.edu.
The National Bioethics Advisory Commision's (NBAC) draft report on the oversight of human subjects protection is still available for comment (see Update, December 11, 2000).
The National Science Foundation?s (NSF) Division of Behavioral and Cognitive Sciences in the Social, Behavioral, and Economic Science Directorate has announced a new emphasis for proposals in the area of cognitive neuroscience. The Foundation is providing enhanced support for this research area through the division?s programs in Human Cognition and Perception, Linguistics, Social Psychology, Child Learning and Development, and Physical Anthropology.
The goals of introducing new funding for neuroscientific approaches are to: 1) enhance support of research on the basic mechanisms of cognition and perception; 2) provide substantially larger and longer grants for such work; 3) foster collaborations among investigators from different fields; 4) foster the extension of this neuroscientific approach to studies of language, social, and affective processes, development studies of cognition, memory, perception, higher cognitive processes, and sensory and attentional processes; and 5) support basic developmental cognitive neuroscience studies of the brain mechanisms that help explain when and how children learn new knowledge and skills.
Funding will be available through the regular programs by the existing programs noted above. Deadlines are January 15 and June 15 each year. For the January 2001 target date only, extensions may be granted by the appropriate program director. In addition, the division is providing additional funding mechanisms to build research capacity in cognitive neuroscience. These include small grants for pilot projects and planning activities, workshops, and doctoral dissertation research. Proposals for these activities are due no later than April 16, 2001.
For more information, contact: Joseph Young, Human Cognition and Perception, jyoung@nsf.gov, 703/292-8732; Catherine Ball, Linguistics, cball@nsf.gov, 703/292-8731; Steve Breckler, Social Psychology, sbreckle@nsf.gov, 703/292-8728; Rodney Cocking, Child Learning and Development, rcocking@nsf.gov, 703/292-8732; and Mark Weiss, Physical Anthropology, mweiss@nsf.gov, 703/292-7321.
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