From the Hill – Summer 1999
Lab access restrictions sought in wake of Chinese espionage reports
In the wake of reports detailing the alleged theft by China of U.S. nuclear and military technology, bills have been introduced that would severely restrict or prohibit visits by foreign scientists to Los Alamos, Lawrence Livermore, and Sandia National Laboratories. Although intended to bolster national security, approval could inhibit the free exchange of scientific information, and the proposed legislation was severely criticized by Secretary of Energy Bill Richardson.
After the release of a report on alleged Chinese espionage by a congressional panel led by Rep. Christopher Cox (R-Calif.), the House Science Committee adopted an amendment to the Department of Energy (DOE) authorization bill (H.R. 1655) placing a moratorium on DOE’s Foreign Visitors Program. The amendment, introduced by Rep. George Nethercutt (R-Wash.), would restrict access to any classified DOE lab facility by citizens of countries that are included in DOE’s List of Sensitive Countries. Those countries currently include the People’s Republic of China, India, Israel, North Korea, Russia, and Taiwan. The Nethercutt amendment would allow the DOE secretary to waive the restriction if justification for doing so is submitted in writing to Congress. The moratorium would be lifted once certain safeguards, counterintelligence measures, and guidelines on export controls are implemented.
In early May 1999, the Senate Intelligence Committee also approved a moratorium on the Foreign Visitors Program, although it too allows the Secretary of Energy to waive the prohibition on a case-by-case basis. Committee Chairman Sen. Richard Shelby (R-Ala.) termed the moratorium an “emergency” measure that is needed while the Clinton administration’s new institutional counterintelligence measures are being implemented.
In another DOE-related bill, H.R. 1656, the House Science Committee approved an amendment introduced by Rep. Jerry Costello (D-Ill.) that would apply civil penalties of up to $100,000 for each security violation by a DOE employee or contractor. The House recently passed the bill.
DOE’s Foreign Visitors Program, initiated in the late 1970s, was designed to encourage foreign scientists to participate in unclassified research activities conducted at the national labs and to encourage the exchange of information. Most of the visitors are from allied nations. In cases in which the subject matter of a visit or the visitor is deemed sensitive, DOE must follow long-established guidelines for controlling the visits or research projects within the lab facilities.
Critics say that the program has long lacked sufficient security controls. In a September 1997 report, the General Accounting Office concluded that DOE’s “procedures for obtaining background checks and controlling dissemination of sensitive information are not fully effective.” It noted that two of the three laboratories conducted background checks on only 5 percent of foreign visitors from sensitive countries. The report said that in some cases visitors have access to sensitive information and that counterintelligence programs lacked effective mechanisms for assessing threats.
In response to the various congressional efforts to impose a moratorium, Secretary Richardson attacked the proposals recently in a speech at the National Academy of Sciences. He said that “instead of strengthening our nation’s security, this proposal would make it weaker.” He said that during his tenure DOE has established improved safeguards for protecting national secrets, including background checks on all foreign visitors from sensitive countries. He emphasized that “scientific genius is not a monopoly held by any one country” and that it is important to collaborate in research as well as to safeguard secrets. A moratorium would inhibit partnerships between the United States and other countries. He noted that the United States has access to labs in China, Russia, and India and participates in nuclear safety and nonproliferation exercises, and that curbing the Foreign Visitors Program could lead to denial of access to the laboratories of other countries. “If we isolate our scientists from the leaders in their fields, they will be unable to keep current with cutting-edge research in the disciplines essential to maintaining the nation’s nuclear deterrent,” he said.
Conservatives challenge science community on data access
Politically conservative organizations have made a big push in support of a proposed change to a federal regulation governing the release of scientific research data. The scientific community strongly opposes the change.
In last year’s omnibus appropriations bill, Sen. Richard Shelby (R-Ala.) inserted a provision requesting that the Office of Management and Budget (OMB) amend its Circular A-110 rule to require that all data produced through funding from a federal agency be made available through procedures established under the Freedom of Information Act (FOIA). Subsequently, OMB asked for public comment in the Federal Register but narrowed the scope of the provision to “research findings used by the federal government in developing policy or rules.” During the 60-day comment period, which ended on April 5, 1999, OMB received 9,200 responses, including a large number of letters from conservative groups.
Conservatives have been pushing for greater access to research data ever since they were rebuffed a couple of years ago in their attempts to examine data from a Harvard University study that was used in establishing stricter environmental standards under the Clean Air Act. Pro-gun groups have sought access to data from Centers for Disease Control and Prevention studies on firearms and their effects on society.
The research community fears that the Shelby provision would compromise sensitive research data and hinder research progress. Scientists are not necessarily opposed to the release of data but don’t want it to be done under what they consider to be FOIA’s ambiguous rules because of the fear that it would open a Pandora’s box. They are concerned that the privacy of research subjects could be jeopardized, and they think that operating under FOIA guidelines would impose large administrative and financial burdens.
A letter from the Association of American Universities, the National Association of State Universities and Land-Grant Colleges, and the American Council on Education questioned whether FOIA was the correct mechanism for the release of sensitive data: “Does interpretation of FOIA . . . concerning, ‘clearly unwarranted invasion of personal privacy,’ offer sufficient protection to honor assurances that have been given and will necessarily continue to be given to private persons, concerning the confidentiality and anonymity that are needed for certain types of studies?”
The American Mathematical Society (AMS) argued that the proposed changes will “lead to unintended and deleterious consequences to U.S. researchers and research accomplishments.” It cited the misinterpretation or delay of research, discouragement of research subjects, the imposition of significant administrative and financial burdens, and the hindrance of public-private cooperative research because of industry fears of losing valuable data to competitors. AMS proposed that the National Academy of Sciences be asked to study alternative mechanisms in order to determine a policy for sharing data instead of using FOIA.
Even with strong scientific opposition, the final tally of letters was 55 percent for the provision and 45 percent against or with serious concerns. The winning margin was undoubtedly related to a last-minute deluge of letters from groups that included the National Rifle Association, the Gun Owners of America, the United States Chamber of Commerce, and the Eagle Forum. These groups argued for a broad, wide-ranging provision that would allow for the greatest degree of access to all types of research data. The Chamber proclaimed that “there may never be a more important issue!” The Gun Owners of America argued that “we can expose all the phony science used to justify many restrictions on firearms ownership.”
Senators Shelby, Trent Lott (R-Miss.), and Ben Nighthorse Campbell (R-Colo.) cosigned a letter criticizing the narrow approach of OMB and supporting the Shelby amendment. “The underlying rationale for the provision rests on a fairly simple premise–that the public should be able to obtain and review research data funded by taxpayers,” they said. “Moreover, experience has shown that transparency in government is a principle that has improved decisionmaking and increased the public’s trust in government.”
Rita Colwell, director of the National Science Foundation, opposed the provision, arguing that its ambiguity could hamper the research process. “Unfortunately, I believe that it will be very difficult to craft limitations that can overcome the underlying flaw of using FOIA procedures,” Colwell said. “No matter how narrowly drawn, such a rule will likely harm the process of research in all fields by creating a complex web of expensive and bureaucratic requirements for individual grantees and their institutions.”
OMB seems to be sympathetic to both sides of the issue. An OMB official said that before any changes were made, OMB would consult with both parties on the Hill, since the original directive came from Congress. OMB will then produce a preliminary draft of a provision using FOIA, which will also be placed in the Federal Register and accompanied by another public comment period.
Bills to protect confidentiality of medical data introduced
With a congressional deadline looming for the adoption of federal standards ensuring the confidentiality of individual health information, bills have been introduced in Congress that would establish guidelines for patient-authorized release of medical records.
S. 578, introduced by Senators Jim M. Jeffords (R-Vt.) and Christopher J. Dodd (D-Conn.), would require one blanket authorization from a patient for the release of records. The bill would also cede most authority in setting confidentiality standards to the states. S. 573, introduced by Senators Patrick J. Leahy (D-Vt.) and Edward M. Kennedy (D-Mass.), would require patient authorization for each use of medical records and allow states to pass stricter privacy laws.
Many states already have patient privacy laws, but there is a growing demand for federal standards as well. The Health Insurance Portability and Accountability Act of 1996 requires Congress to adopt federal standards ensuring individual health information confidentiality by August 1999. The law was prompted by concern that the increasing use of electronic recordkeeping and the need for data sharing among health care providers and insurers has made it easier to misuse confidential medical information. If Congress fails to meet the deadline, the law authorizes HHS to assume responsibility for regulation. Proposed standards submitted in 1997 by HHS Secretary Donna Shalala stated that confidential health information should be used for health purposes only and emphasized the need for researchers to obtain the approval of institutional review boards (IRBs).
Earlier this year, the Senate Committee on Health, Education, Labor, and Pensions held a hearing on the subject, using a recent General Accounting Office (GAO) report as the basis of discussion. The report, Medical Records Privacy: Access Needed for Health Research, but Oversight of Privacy Protections Is Limited, focused on the use of medical information for research and the need for personally identifiable information; the types of research currently not subject to federal oversight; the role of IRBs; and safeguards used by health care organizations.
The 1991 Federal Policy for the Protection of Human Subjects stipulates that federally funded research or research regulated by federal agencies must be reviewed by an IRB to ensure that human subjects receive adequate privacy and protection from risk through informed consent. This approach works well for most federally funded research. However, privately funded research, which has increased dramatically in recent years, is not subject to these rules.
The GAO report found that a substantial amount of research involving human subjects relies on the use of personal identification numbers, which allow investigators to track treatment of individuals over time, link multiple sources of patient information, conduct epidemiological research, and identify the number of patients fitting certain criteria. Brent James, executive director of the Intermountain Health Care (IHC) Institute for Health Care Delivery Research in Utah, testified that his patients benefited when other physicians had access to electronic records. For example, he cited a computerized ordering system accessed by multiple users that can warn physicians of potentially harmful drug interactions. He emphasized, however, the need to balance the use of personal medical information with patient confidentiality.
IHC ensures privacy by requiring administrative employees who work with patient records to sign confidentiality agreements and by monitoring those with access to electronic records. Patient identification numbers are separated from the records, and particularly sensitive information, such as reproductive history or HIV status, is segregated. Some organizations are using encryption and other forms of coding, whereas others have agreed to Multiple Project Assurance (MPA) agreements that place them in compliance with HHS regulations. MPAs are designed to ensure that institutions comply with federal rules for the protection of human subjects in research.
James argued that increased IRB involvement would hamper the quality of care given by health care providers. The GAO study indicates that current IRB review may not necessarily ensure confidentiality and that in most cases IRBs rely on existing mechanisms within institutions conducting research. Familiar criticisms of IRBs, such as hasty reviews, little expertise on the matter, and little training for new IRB members, compound the problem.
An alternative is the establishment of stronger regulations within the private institutions conducting the research. Elizabeth Andrews of the Pharmaceutical Research and Manufacturers Association argued at the hearing for the establishment of uniform national confidentiality rules instead of the IRB process.
Controversial database protection bill reintroduced
A bill designed to prevent the unauthorized copying of online information that was strongly opposed by the scientific community last year has been reintroduced with changes aimed at assuaging its critics. However, the revisions still do not go far enough to satisfy the bill’s critics, who believe that the bill provides too much protection for database owners and thus would stifle information sharing and innovation.
H.R. 354, the Collections of Information Antipiracy Act, introduced by Rep. Howard Coble (R-N.C.), is the reincarnation of last year’s H.R. 2562, which passed the House twice but was subsequently dropped because of severe criticism from the science community. The bill’s intent is to ensure that database information cannot be used for financial gain by anyone other than its producer without compensation. Without adequate protection from online piracy, the bill’s supporters argue, database creators will be discouraged from making investments that would benefit a wide range of users.
Last year’s legislation encountered problems concerning the amount of time that information can be protected, ambiguities in the type of information to be protected, and the instances in which data can be accessed freely. This year’s bill has introduced a 15-year time limit on data protection and has also made clear the type of data to be protected. Further, it clarifies the line between legitimate uses and illegal misappropriation of databases, stating that “an individual act of use or extraction of information done for the purpose of illustration, explanation, example, comment, criticism, teaching, research, or analysis, in an amount appropriate and customary for that purpose, is not a violation of this chapter.”
“The provisions of H.R. 354 represent a significant improvement over the provisions of H.R. 2562,” stated Marybeth Peters of the U.S. Copyright Office of the Library of Congress during her testimony this spring before the House Judiciary Subcommittee on Courts and Intellectual Property. However, she tempered that statement, saying that “several issues still warrant further analysis, among them the question of possible perpetual protection of regularly updated databases and the appropriate mix of elements to be considered in establishing the new, fair use-type exemption.”
Although researchers still oppose the bill and are unwilling to accept it in its present form, they recognize that progress has been made since last year. “We were encouraged by the two changes that already have been made to this committee’s previous version of this legislation,” said Nobel laureate Joshua Lederberg in his testimony to the committee. “The first revision addresses one of the Constitutional defects that was pointed out by various critics . . . the second one responds to some of the concerns . . . regarding the potential negative impacts of the legislation on public interest uses.”
After a House hearing was held on H.R. 354, Rep. Coble introduced several changes to the bill, including language that more closely mirrors traditional fair use exceptions in existing copyright law. Although the administration and research community applauded the changes, they stopped short of endorsing the bill.
Genetic testing issues reviewed
Improved interagency cooperation and increased education for the public and professionals are needed to ensure the safe and effective use of genetic testing, according to witnesses at an April 21, 1999 hearing of the House Science Committee’s Subcommittee on Technology.
Currently, genetic tests sold as kits are subject to Food and Drug Administration (FDA) rules. Laboratories that test human specimens are subject only to quality-control standards set by the Department of Health and Human Services (HHS) under the Clinical Laboratory Improvement Amendments of 1998. However, in the fall of 1998, a national Task Force on Genetic Testing urged additional steps, including specific requirements for labs doing genetics testing, formal genetics training for laboratory personnel, and the introduction of some FDA oversight of testing services at commercial labs. At the hearing, Michael Watson, professor of pediatrics and genetics at the Washington University School of Medicine and cochair of the task force, argued that interagency cooperation is needed in establishing genetic testing regulations and that oversight should be provided by institutional review boards assisted by the National Institutes of Health’s Office of Protection of Human Subjects from Research Risks.
The subcommittee’s chairwoman, Rep. Connie Morella (R-Md.), stressed the need to educate the public about the benefits of genetic testing and to prepare health professionals so that they can provide reliable tests and offer appropriate advice. William Raub, HHS’s deputy assistant secretary of science policy, cited the establishment of the Human Genome Epidemiology Network by the Centers for Disease Control to disseminate information via the World Wide Web for that purpose. But he noted that health care providers often lack basic genetics knowledge and receive inadequate genetics training in medical schools. The Task Force on Genetic Testing recommended that the National Coalition for Health Professional Education in Genetics, which is made up of different medical organizations, take the lead in promoting awareness of genetic concepts and testing consequences and in developing genetics curricula for use in medical schools.
Budget resolution deals blow to R&D funding
R&D spending would be hit hard under a congressional budget resolution for fiscal year (FY) 2000 passed this spring. However, it is unlikely that the resolution’s constraints will be adhered to when final appropriations decisions are made.
Under the resolution, which sets congressional spending priorities for the next decade, federal R&D spending would decline from $79.3 billion in FY 1999 to $76.1 billion in FY 2004, or 13.4 percent after adjusting for expected inflation, according to projections made by the American Association for the Advancement of Science.
Despite growing budget surpluses, the Republican-controlled Congress decided to adhere strictly to tight caps on discretionary spending that were established when large budget deficits existed. Future budget surpluses would be set aside entirely for bolstering Social Security and for tax cuts. Only defense, education, and veterans’ budgets would receive increases above FY 1999 levels.
After adoption of the budget resolution, the House and Senate Appropriations Committees approved discretionary spending limits, called 302(b) allocations, for the 13 FY 2000 appropriations bills. Both committees authorized $538 billion in budget authority, or $20 billion below the FY 1999 funding level and President Clinton’s FY 2000 request.
As in the past, it is almost certain that ways will be found to raise discretionary spending to at least the level of the Clinton administration’s proposal, if not higher. Projections of increasing budget surpluses would make the decision to break with the caps easier.
“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science in Washington, D.C., and is based on articles from the center’s bulletin Science & Technology in Congress.