From the Hill – Fall 2002
S&T given big boost in homeland security department
Both the House and Senate would create an undersecretary for science and technology (S&T) in the proposed Department of Homeland Security (DHS). The House approved legislation creating the DHS on July 26. The Senate initially expected to approve its version in September, but an alternative bill introduced by Sens. Phil Gramm (R-Tex.) and Zell Miller (D-Ga.), as well as the inability of the Senate to pass a cloture vote to limit debate, has delayed action. Differences in the bills will have to be worked out by a conference committee, which is expected to happen by the end of the year, at the latest.
Under the House bill, the new undersecretary for S&T would coordinate the department’s S&T programs and oversee its research and development (R&D) funding. In addition, an advisory committee would be established and be charged with making recommendations with respect to the activities of the undersecretary, including identifying research areas of potential importance to the nation’s security.
The House bill would also create a Homeland Security Institute as a federally funded R&D center. Its work would include simulation and modeling to determine the vulnerabilities of the nation’s critical infrastructure; economic and policy analysis to assess enhancing security; and the identification of common standards and protocols to improve interoperability and the effective use of tools developed for first responders.
The Senate bill would create an undersecretary for S&T with broader responsibility for setting homeland security R&D goals and priorities, coordinating homeland security R&D throughout the federal government, facilitating the transfer and deployment of technologies for homeland security, and advising the DHS secretary on all scientific and technical matters. The Senate would create a Homeland Security Science and Technology Council of representatives from all federal agencies involved in counterterrorism R&D to advise the undersecretary and coordinate government-wide R&D activities. The Senate bill would also create a number of offices under the undersecretary, including an Office of National Laboratories, an Office of Risk Analysis and Assessment, an Office for Technology Evaluation and Transition, and an Office of Laboratory Research.
Rather than endorsing the House’s Homeland Security Institute, the Senate legislation would create a new research agency, the Security Advanced Research Projects Agency (SARPA), to fund high-risk high-payoff R&D. SARPA, modeled on the Department of Defense’s Defense Advanced Research Projects Agency, would manage a portfolio of extramural research. SARPA would also have responsibility for managing a $200 million Acceleration Fund for Research and Development of Homeland Security Technologies. The fund would be more development-oriented than the rest of SARPA and be aimed at facilitating the rapid transfer of research and technologies to working products.
President Bush’s original June 6 proposal for the DHS would create a $3.4 billion R&D portfolio (according to an estimate by the American Association for the Advancement of Science) out of a $37.5 billion budget, making it the sixth largest R&D funding agency. However, both the House and Senate versions of the legislation would include less than $500 million, because both would keep bioterrorism R&D programs within the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) instead of transferring them to the DHS.
The new department would be divided into four divisions, corresponding to its four main missions:
Information Analysis and Infrastructure Protection. Although R&D would not be a large part of this division, the administration, House, and Senate proposals would transfer the Department of Energy’s (DOE’s) National Infrastructure Simulation and Analysis Center (NISAC) to the DHS. NISAC is a partnership between DOE’s Los Alamos and Sandia National Laboratories. NISAC has a budget of $20 million in fiscal year (FY) 2002 and performs R&D to analyze critical infrastructures and their vulnerabilities and simulate infrastructure- or biological-attack scenarios. An unresolved issue is whether to transfer the National Institute of Standards and Technology’s (NIST’s) Computer Security Division to the DHS. The House would retain this division within NIST, whereas the latest Senate legislation would go along with the administration’s proposed transfer.
Chemical, Biological, Radiological, and Nuclear Countermeasures. This division would have primary responsibility for setting research priorities and conducting an integrated R&D program to enable the United States to respond to attacks made with weapons of mass destruction. The Senate legislation would name this division the Directorate of Science and Technology.
Both the House and Senate bills would follow the administration proposal for DOE programs, including the transfer of Lawrence Livermore’s Advanced Scientific Computing Research and Intelligence programs to the DHS. In addition, the Biological and Environmental Research program’s microbial pathogens activities and the national security and nuclear smuggling and other programs within Nonproliferation and Verification R&D would move to the DHS. Because these programs are embedded within larger programs, it is unclear how large these transfers would be, but combined they could total around $100 million.
The House and Senate have both rejected the administration proposal to transfer to the DHS the civilian biological defense research programs within NIH and CDC. The House-approved legislation and the latest Senate version of the legislation would keep bioterrorism R&D funding and priority setting in the Department of Health and Human Services, specifying only that the DHS would have a strong role in setting the research agenda.
Finally, the U.S. Department of Agriculture’s (USDA’s) Plum Island Animal Disease Center, with a budget of $25 million and 124 federal employees, would be transferred to the DHS under the administration and House proposals. The Senate, so far, is silent on the Plum Island transfer. The House version of the legislation would also transfer some activities of DOD’s Chemical and Biological Defense Program to the DHS.
Border and Transportation Security. This division would be by far the largest of the four in terms of budget and personnel and would integrate federal government operations aimed at securing U.S. borders and transportation systems. It would fold in the Immigration and Naturalization Service, the Customs Service, the Coast Guard, the Animal and Plant Health Inspection Service (APHIS) of USDA, and the recently created Transportation Security Administration (TSA). This division would inherit these agencies’ small R&D programs, including those of the Coast Guard ($24 million in FY 2003), the TSA’s aviation security R&D (a preliminary estimate of $47 million in FY 2003), and APHIS’s R&D portfolio ($29 million in FY 2003). The House and Senate would go along with these administration proposals.
Emergency Preparedness and Response. This division would coordinate all federal assistance in response to disasters, including natural disasters, and domestic attacks. It would not do R&D.
House votes to double NSF budget; is DOE next in line?
On June 5, the House of Representatives passed by a 397-to-25 vote the “Investing in America’s Future Act” (H.R. 4664), which would launch the National Science Foundation (NSF) on a path to double its budget. A similar bill (S. 2817) has been introduced in the Senate and was favorably reported out of two committees. Meanwhile, a bill has been introduced in the House that would put DOE on a doubling path. These moves come in the wake of budget increases that have doubled the budget of NIH during the past five years.
The House legislation would provide annual 15 percent increases for NSF over the next three years, boosting its budget from $4.8 billion in FY 2002 to $7.3 billion in FY 2005. If the budget continued on this trajectory, it would reach $9.6 billion in FY 2007, twice the total for FY 2002. The Senate bill would be slightly more generous, providing a budget of $9.8 billion by 2007.
The bill to increase DOE’s budget, the Energy and Science Research Investment Act (H.R. 5270), was introduced by Rep. Judy Biggert (R-Ill.), whose district includes the Argonne National Laboratory. Its cosponsors are Reps. Vernon Ehlers (R-Mich.), a physicist, and Ellen Tauscher (D-Calif.), whose district includes Lawrence Livermore National Laboratory. It would authorize $3.5 billion in FY 2003, $4 billion in FY 2004, $4.6 billion in FY 2005, and $5.3 billion in FY 2006 for general research activities, nanoscience research, advanced complex-simulation computing, and the Genomes-to-Life program, as well as for new construction. The bill would also create an undersecretary of energy research and science at DOE and would elevate the existing director of the Office of Science to an assistant secretary of science.
In a statement made when introducing the bill, Biggert noted that “science-driven technology has accounted for more than 50 percent of the economic growth in the United States” during the past half century. “Scientific research may not be as politically popular as health care and education,” she said, “but it is as important to progress in these two areas as it is to ensuring America’s economic, energy, and national security.”
A major concern driving the DOE doubling initiative is that federal spending on research in engineering and the physical sciences, including astronomy, chemistry, and physics, has stagnated at the expense of increases for medical research. The need for a balanced federal R&D portfolio has been a priority in the scientific community since the push to double the NIH budget was set in motion five years ago.
Such concerns were raised when the Senate Science, Technology, and Space Subcommittee conducted its first NSF reauthorization hearing on May 22. Sen. Ron Wyden (D-Ore.), the subcommittee chairman, supported doubling NSF’s budget, saying that “math and scientific achievement cannot stagnate at the expense of national security.” Sen. George Allen (R-Va.) concurred, noting that innovation in the technology sector has been lagging and that the capacity of universities to conduct R&D and educate a scientifically literate workforce is critical to turning the economic tide.
John Marburger, director of the Office of Science and Technology Policy, defended the administration’s budget request for NSF, noting that the September 11th terrorist attacks dramatically changed the FY 2003 budget outlook. He said the administration continues to place a priority on multidisciplinary research initiatives such as nanotechnology, information technology, and medical research, adding that the administration recognizes that there is an imbalance between medical research and other nondefense disciplines.
Alan Leshner, chief executive officer of the American Association for the Advancement of Science, said that the administration’s proposed increase of $8.9 billion for R&D in FY 2003 would be devoted entirely to the budgets of NIH and DOD. He stated that it was important “to maintain progress simultaneously across all of science and technology. In the 21st century, science and engineering fields are so interdependent that lags in one field inevitably will delay progress in others.”
Leshner argued that “NSF grossly underfunds every single grant that it makes, because it’s trying to maximize the number of grants . . . You could literally double every grant, double the budget instantly and consume all the money in an extremely productive way . . . When we’re funding, at most, 20 to 30 percent of the excellent proposals that come in, the array of opportunities lost is tremendous.”
Former House Speaker Newt Gingrich, another witness at the hearing, said the challenges facing the United States today require a major expansion in our investments in science and technology. He predicted that “the knowledge breakthroughs of the next 20 years will equal the entire 20th century. In other words the rate of change is accelerating and in the next two decades will be about 5 times as fast as the 20th century. The rate will continue to accelerate, and we will match the 20th century again between 2020 and 2035.” His solution: triple the NSF budget to an annual level of $15 billion.
Gingrich also said that Congress should not reestablish the defunct Office of Technology Assessment but continue to contract out assessment projects to the National Academies.
Legislation on human cloning stalls in Senate
The Senate in June put off any debate, most likely until 2003, on competing bills involving human cloning. A bill proposed by Sen. Sam Brownback (R-Kan.) would impose a comprehensive ban on human cloning, whereas a bill introduced by Sens. Dianne Feinstein (D-Calif.) and Arlen Specter (R-Penn.) would ban cloning for reproductive purposes but allow it for doing research. The Bush administration supports the Brownback bill, and the House has already passed a similar bill.
The cloning debate has closely divided the Senate, with each bill garnering about an equal number of supporters and about 10 senators undecided.
In 2001, Senate Majority Leader Tom Daschle (D-S.D.) promised Brownback a floor vote on his bill. In June 2002, Daschle said he would bring Brownback’s bill to the floor for a yea-nay vote, followed by an up or down vote on the Feinstein-Specter measure, an arrangement that Brownback believed would have put his legislation at a disadvantage. However, it also appeared that some of the crucial undecided senators were leaning toward the less restrictive Feinstein-Specter bill. Thus, Brownback rejected Daschle’s offer, releasing the Senate majority leader from his pledge.
Brownback has since vowed to introduce portions of his bill as amendments to other legislation. However, his attempt to attach an amendment prohibiting the patenting of a human embryo to a terrorism reinsurance bill backfired by angering some of his supporters, including Senate Minority Leader Trent Lott (R-Miss.).
House bill would bolster protection of humans in clinical trials
The highly publicized deaths in 1999 and 2001 of two volunteers participating in clinical research trials brought attention to what some consider weaknesses in the federal oversight of biomedical research using human subjects. After numerous hearings and congressional promises to correct this problem, legislation pertaining to human research subject protection has been introduced in the House and is expected in the Senate.
The boom in biomedical research means that an increasing number of human participants will be needed for clinical trials. Currently, however, there is no single federally mandated system for regulating, monitoring, and safeguarding human volunteers.
The federal guidelines now in use for the protection of human subjects in research are widely known as the Common Rule. They are followed by 17 federal agencies and apply only to research conducted or financially supported by a federal agency. The Common Rule outlines the formation and duties of institutional review boards (IRBs) in reviewing research proposals and studies. It stipulates that a potential human subject must give informed consent before participating in a study and describes the necessary elements to be included in such statements.
In June 2000, the Department of Health and Human Services (HHS) transferred its human research protection functions from the NIH Office for Protection from Research Risks (OPRR) to the Office for Human Research Protections (OHRP), located within the Office of the Secretary.
Several groups have pointed to inadequacies in current federal policy. In particular, they cite the lack of protection for people undergoing clinical trials at private institutions that do not receive federal funds. In addition, the current oversight system consists of sometimes redundant and confusing regulatory standards, and the degree and nature of human subject protection can vary from institution to institution. Even among federal agencies such as the Food and Drug Administration (FDA) and NIH, separate offices are responsible for managing the oversight of clinical trials.
In June 2000, the Association of American Universities published the results of its Task Force on Research Accountability, which essentially recommends that the university community strengthen existing systems of human subjects protection via enhanced voluntary accreditation programs. The task force also urged the OHRP to “develop a handbook of all federal rules and regulations, as well as specific departmental and agency contacts for questions that may arise during the IRB review of protocols.”
In August 2001, the National Bioethics Advisory Commission (NBAC), in a report entitled Ethical and Policy Issues in Research Involving Human Participants, recommended, among other things, that “a unified, comprehensive federal policy embodied in a single set of regulations and guidance should be created that would apply to all types of research involving human participants,” whether the research is publicly or privately funded. The commission also called for creating a new, independent federal agency outside of HHS to head the oversight process.
Currently, the Common Rule requires the same review standards regardless of the level of risk to the subject a particular study might generate. For example, a study testing an experimental drug is subject to the same rules as one that merely uses a patient’s medical history to gather data. The NBAC recommended creating a federal policy that would “distinguish between research studies that pose minimal risk and those that pose more than minimal risk.”
The NBAC proposal to create a new federal agency has been opposed by the Association of American Medical Colleges, which believes that the executive branch already “has sufficient authority to address problems of inconsistency in interpreting and applying the Common Rule, and that the Office of Science and Technology Policy and the Committee on Science of the NSTC should be directed to bring the representatives of the 17 federal agencies together to resolve these matters as expeditiously as possible.”
On May 9, Rep. Diana DeGette (D-Colo.) introduced the “Human Research Subjects Protections Act of 2002” (H.R. 4697), which is designed to address many of the criticisms of the NBAC and others by extending Common Rule compliance to all institutions, both private and public. In addition, it gives oversight authority to the OHRP.
The bill requires that patients be able to clearly understand the wording of an informed consent document. In addition, through modification of the informed consent form and IRB responsibility, the bill proposes steps that would minimize potential conflicts of interest between research sponsors and investigators that may adversely influence the outcome of clinical trials. The bill proposes specific rules for forming IRBs, which include increasing the number of members required and ensuring that an IRB is representative of proposed research subjects in terms of race and gender. In order to streamline the process of clinical trial approval in the case of collaborative research projects, the bill allows for IRB review at the institution heading the collaboration. Finally, the bill distinguishes between research with higher and lowers risks and stipulates stricter regulations for monitoring high-risk trials and reporting any unexpected adverse events.
Neither the NBAC recommendations nor H.R. 4697 address in great detail FDA’s role in overseeing clinical trials within the private sector. Questions remain regarding possible effects of the proposed changes on FDA’s monitoring of private research.
Senate energy bill would create new OTA-like service
A provision of the Senate’s 977-page energy bill would create a “Science and Technology Assessment Service” within Congress to “coordinate and develop information for Congress relating to the uses and application of technology.” The service would be similar to the defunct congressional Office of Technology Assessment (OTA), which lost its funding after Republicans took control of Congress in 1994. However, the proposal for the new service is not included in the House energy bill, and House Republicans continue to oppose the resurrection of OTA or the creation of a similar organization. The House and Senate are currently trying to merge their respective energy bills into a bill that can pass Congress.
The prime mover behind the new assessment service is Sen. Ernest F. Hollings (D-S.C.), chairman of the Senate Commerce, Science, and Transportation Committee. With science and technology playing a key role in many of the most important issues facing policymakers, Hollings and others have expressed concern that Congress does not have a good enough source of timely, reliable, nonpartisan advice on technical issues.
The importance of accurate scientific information to informed policymaking has been demonstrated emphatically in recent months. Debates over human cloning, nuclear power, climate change, and the fight against terrorism all rest on technical knowledge. Although many of these issues may ultimately be decided on political and moral grounds, Congress, in order to make good decisions, still must examine them within a framework of accurate and complete scientific information.
Congress currently receives much technical information and analysis from federal agencies and nongovernmental organizations such as the National Academies, as well as from its existing support agencies, the Congressional Research Service (CRS), and the General Accounting Office (GAO). However, many in Congress and the scientific community believe that an institution with substantial scientific expertise that answers only to Congress itself is needed. Federal agencies sometimes have a stake in the outcome of a policy debate, and the Academies, although chartered by Congress to advise the federal government, are nonetheless answerable to their members, who at times also have a stake in important decisions. The CRS and GAO are set up primarily for other purposes.
The assessment service would be governed by a board of 12 members of Congress, evenly split between the two parties and the two chambers. It would undertake assessments on its own initiative and when requested by a congressional committee. It would receive administrative support from the Library of Congress and would be required to report annually to Congress on its activities and on technological areas ripe for future analysis.
The Hollings proposal follows a small pilot program set up last year at the GAO to create such a service. The GAO pilot was included in a Senate-passed version of the fiscal 2002 legislative branch appropriations bill. The House opposed it, however, and as a compromise, the language specified that the program was to advise the Senate only. Also, it was placed in the conference report, rather than the bill itself. The report earmarked $500,000 for the project, which has been directed toward a study of border security issues.
Despite the proposed new assessment service, some in Congress support simply reactivating OTA. Because the legislation authorizing OTA was never repealed, Rep. Rush Holt (D-N.J.) and House Science Committee Chairman Sherwood L. Boehlert (R-N.Y.) have proposed a bill (H.R. 2148) that would simply reauthorize OTA at $20 million per year for five years. The bill has attracted 84 cosponsors.
Also supporting such an approach is Ellis R. Mottur of the Woodrow Wilson International Center for Scholars, whose report Technology Assessment in the War on Terrorism and Homeland Security: The Role of OTA, has been distributed by Hollings. It concludes that, “To fulfill its constitutional responsibilities in pursuing the War on Terrorism and ensuring homeland security, Congress urgently needs to reactivate OTA.”
“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science (www.aaas.org/spp) in Washington, D.C., and is based on articles from the center’s bulletin Science & Technology in Congress.