National Institutes of Health [Funding]: On January 19, 1999, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced S. Res. 19 to express the sense of the Senate that "federal investment in biomedical research should be increased by $2 billion in the fiscal year 2000." [Note: a "Sense of the Senate Resolution" is a non-binding statement of the Senate’s position on an issue.] At the time of writing, this resolution had gained twenty cosponsors. On March 2, 1999, Rep. George Gekas (R-PA) and five other members of Congress introduced H.Res.89, the Biomedical Revitalization Resolution of 1999, a similar resolution in the Houses of Representatives with 46 cosponsors.

On February 1, 1999, the President presented a very modest 2.1% increase in NIH funding as part of his FY 2000 budget proposal, bringing the total funding recommendation to $15.9 billion. In stark contrast to the FY 1999 increase of 15%, Donna Shalala, Secretary of the Department of Health and Human Services, stated that the President remains committed to increasing the NIH budget by 50% in 5 years.

The FY 2000 budget conference report, approved on April 15, 1999, includes a sense of the senate resolution on increased funding for the NIH. The language includes an assumption that: (1) there shall be a continuation of the pattern of budgetary increases for biomedical research; and (2) additional resources should be targeted towards autism research.

The Public Policy Council [PPC] will continue to work with the medical research community, including the Ad Hoc Group for Medical Research Funding and Research!America, to advocate for an National Institutes of Health [NIH] appropriations $18 billion in FY 2000. This 15% increase is the second step toward doubling the NIH by FY 2003. However, it is important this increase must not come at the expense of other vital public health services and programs.

Pediatric Research Initiative: Now in its fourth year, the Pediatric Research Initiative (PRI) provides money to fund new NIH extramural research devoted to the illnesses and conditions of children. Currently, the money is located in the Office of the NIH Director. In FY 1999, report language instructed NIH to fund the PRI at a level greater than FY 1998 ($38.5 million). Staff is currently working with the National Association of Children’s Hospitals and with congressional staff to seek authorizing language for the PRI. In addition, this year the pediatric research community will pursue adding funds to increase pediatric clinical research training and the number of pediatric researchers. Senator Mike Dewine (R-OH) has expressed interest in proposing authorizing language for this initiative. On March 11, Senator Kit Bond (R-MO) included authorizing language for the PRI in his omnibus Healthy Kids 2000 Act (S.592) introduced without cosponsors. This legislation would retain the PRI in the Office of the NIH Director and authorize $100 million for FY 2000 and FY 2001. Senator Bond’s bill would also authorize $20 million, $25 million and $30 million in FY 2000, 2001 and 2002 respectively to be used through the National Institute of Child Health and Human Development to advance training and careers of pediatric researchers through various loan repayment opportunities. It is unclear at this time how this legislation will proceed during this Congress.

Research data availability under the Freedom of Information Act – OMB Circular A-110: Included in Public Law 105-227, the Omnibus Appropriations bill from the 105^th Congress, was a provision to instruct the Office of Management and Budget [OMB] to amend Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and other Non-Profit Organizations) "to ensure that all data produced under a [research] award will be made available to the public through the Freedom of Information Act" [FOIA].

Prior to the release of the February 4, 1999, Federal Register notice, members of the research community, including the AAMC, the National Academy of Sciences, the Association of American Universities, as well as several members of Congress, submitted letters of concern about the potential adverse impact this provision could have on research. In addition, in January Representative George Brown (D-CA) introduced H.R. 88, a bill to repeal the legislative provision. This legislation currently has 27 cosponsors. It is unclear at this time if the bill will move independently or as part of another legislative proposal.

While the OMB’s proposed revision was less damaging than rumors predicted, there is still substantial cause for concern about the potential adverse impact and detrimental effect that this provision could have on federal research, especially the potential premature or inappropriate release of research data as well as patient confidentiality. In response to this potentially dangerous provision, the American Academy of Pediatrics and the Public Policy Council prepared comments to the proposed revision recommending significant modifications to if not the repeal of the entire provision. The comments also raised concerns about patient confidentiality, the dangers of releasing unreviewed and potentially erroneous findings to the public, and the future risks to researchers who may do research on "controversial" issues.

On the other side of the debate, groups such as the Chamber of Commerce generated substantial grassroots activity to support the proposed revision. Viewing this rule as an opportunity to hold government more accountable for expensive regulations, the Chamber advised its membership that "with such data in public hands, agencies will have a much harder time imposing regulations on the business community without substantial evidence."

Bruce Alberts, President of the National Academy of Sciences, issued the NAS’s comments on April 5, in which he recommended that "instead of a one-sentence policy statement, OMB should develop comprehensive guidance for federal agencies on public access to federal grantee research data in a manner that fully provides for public access but does not damage or infringe upon equally important aspects of performing, and publishing the results of, federal grant-funded research." The comment period concluded on April 5, 1999, although many research groups advocated for an extension of the comment period. The PPC will continue to closely monitor this issue.

Stem cell research: Last summer’s discoveries of human pluriopotent stem cells through non-Federally funded human embryo research have generated an extensive political, legal and ethical debate. President Clinton, also concerned about this issue, requested that the National Bioethics Advisory Committee [NBAC] convene and examine the issue closely. During the January 19 NBAC meeting, Harold Varmus, MD, Director, NIH, presented the determination of the Department of Health and Human Services [DHHS] General Counsel that the NIH could legally fund research with existing human stem cells under the current ban on human embryo research. NBAC hopes to complete a draft of their report by May and finalize this report by June.

Senate Arlen Specter (R-PA) and Tom Harkin (D-IA) held hearings in the Senate Labor/Health and Human Services Appropriations Subcommittee in December 1998 and January 1999. Another hearing will be held in the Senate later this spring. The Senators remain very interested in the potential benefits of future stem cell research and are closely examining the value of permitting federally funded research in this field. However, opposition to stem cell research is gaining some momentum.

In February, the Public Policy Council joined approximately 50 other organizations to endorse a sign-on letter, generated at the request of members of Congress, supporting the decision of the DHHS General Counsel.

On April 8, the Working Group of the Advisory Committee to the NIH Director involving pluripotent stem cells met to discuss their draft NIH-wide guidelines and appropriate oversight mechanisms to advance Federally-funded research with existing stem cells. The draft guidelines outlined the procedures that providers of stem cells must follow so that cells may be used by federally funded scientists. The draft document addresses informed consent, ineligible research, the definition of stem cells and the derivation of cells. NIH has indicated its intent to finalize these guidelines by the fall 1999.

Several patient-groups, such as the Juvenile Diabetes Foundation, the Aging Alliance and others are actively encouraging the pursuit of this promising research. Staff will continue to closely monitor this issue. [Note: Background information is available on the NIH web-site at www.nih.gov.]

Medical Records Privacy: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was signed into law on August 21, 1996, by President Clinton. This legislation required the Department of Health and Human Services to issue numerous regulations on administrative simplification of health care transactions. Additionally, the law mandated that the Congress must enact legislation dealing with the privacy of the medical record within three years, otherwise the Secretary of HHS would have the authority to issue regulations addressing that issue.

As required by the legislation, the Department of HHS reviewed the issues surrounding medical records privacy and presented recommendations to the Senate Committee on Labor and Human Resources on September 11, 1997.

During the 105^th Congress several pieces of legislation were introduced in an attempt to meet the requirements of HIPAA, however, none were enacted. In general, members of Congress examined eight different areas: patient access, consent, notice, security, research, law enforcement access, preemption, and penalties.

Preemption is shaping into the most controversial of these issues. Should new federal rules preempt protections already enacted in the states? Some would like to allow states to enact tougher rules than those developed at the federal level in order to provide maximum protection to consumers. However, in a health care system that operates across state lines, dealing with differing levels privacy requirements could prove excessively difficult for large employers, researchers, and payers.

Another area of particular concern is in the area of research where identifiable health care information is required. A February 1999 report by the General Accounting Office, "Medical Records Privacy: Access Needed for Health Research, but Oversight of Privacy Protections Is Limited", noted that current arrangements for IRB review of research subject to the common rule might not be sufficient to guarantee confidentiality. Additionally, a great deal of private research is carried out with no federal regulations over the use of identifiable health care information. Final legislation will need to address the question of how much regulation of this research is required. Most of the bills proposed in the 105^th Congress called for additional study of these issues. Researchers are particularly concerned with potentially excessive requirements on notification and/or consent of the patient before their individual medical record maybe used for research purposes. Proposals on consent range from a single, broad statutory consent through requiring the periodic consent of every individual.

Following an initial hearing in the Senate Health, Education, Labor and Pensions Committee on February 24, legislation has been introduced or is close to introduction.

On March 10, 1999, Senators Jim Jeffords (R-VT) and Chris Dodd (D-CT) introduced S. 578, the Health Care Personal Information Nondisclosure Act of 1999 or the Health Care PIN Act. Similar to legislation introduced in the 105^th Congress by Senator Bob Bennett (R-UT), this legislation upholds the Common Rule and FDA confidentiality procedures. In addition, under the Jeffords proposal, the Secretary of Health and Human Services is required to make recommendations on the Common Rule. The Secretary also has 12 months to develop specific recommendations on the privacy of individually identifiable health information. The Congress is to follow with legislation to deal with the privacy of individually identifiable health information with research within 24 months of the enactment of Jeffords’ bill.

Senators Patrick Leahy (D-VT) and Edward Kennedy (D-MA) introduced S. 573, the Medical Information Privacy and Security Act, also on March 10, 1999. Leahy’s bill focuses more on the interaction between the Secretary of Health and Human Services and the IRBs under the Common Rule, requiring submission of the names of IRB members to the Secretary and requiring the Secretary’s periodic monitoring of and technical assistance to these boards. Assurance of confidentiality protection is on the researcher in Leahy’s legislation, which requires the researcher to remove identifiers at the earliest possible time consistent with the purpose of the research unless an IRB determines that there is reason to keep identifiers and the information is protected. Finally, the Secretary is required to make recommendations on informed consent for research purposes within 24 months of the enactment of this legislation.

It is anticipated that Senator Bennett will again introduce confidentiality legislation in the near future. At the conclusion of the 105^th Congress, Senator Bob Bennett (R-UT) introduced S.2609, the Medical Information Protection Act of 1998. The health research provision of S. 2609 continues to employ the Common Rule for protected health information [the "Common Rule" or the Federal Policy for the Protection of Human Subjects was adapted in 1991 and subjects federally funded or regulated research to federal oversight requirements including local institutional review boards or IRBs]. Under Bennett’s bill from the 105^th Congress, researchers examining health care records or medical archives may use protected health information if such procedures are consistent with the existing contracts or safeguards of the institution. Information may also be disclosed to a manufacturer of a drug, biologic or medical device for safety or efficacy studies. Finally, Bennett’s legislation would require the review of these safeguards by the Secretary after 18 months.

It is very likely that this issue will be dealt with this year, although Congress does have the option of extending the deadline beyond August 21. Staff will continue to monitor these and future legislative proposals

Animal Research/Legislation: For the third time, Representative Charles Canady (R-FL) has re-introduced the Pet Safety and Protection Act of 1999, H.R. 453. The bill currently has 31 co-sponsors. This legislation is based on the erroneous notion that research institutions obtain stolen pets for use in research activities. The bill would have an adverse impact on the ability of medical schools to obtain random-source animals for research and teaching.

Animal Research/Appropriations: On February 26, the PPC joined with the National Association for Biomedical Research [NABR], American Veterinary Medical Association, the AAMC and others to request a $3.825 million increase to $13 million for FY 2000 funding for the USDA’s Animal Care unit of the Animal and Plant Health Inspection Service (APHIS). This essential program is dedicated to requiring minimum standards of humane care and treatment for animals bred for commercial sale, used in research, transported commercially, or exhibited to the public. Funding for the Animal Care unit has fallen below the levels appropriated at the beginning of the decade. The Public Policy Council will continue to work with both NABR and the animal research community to ensure that this program receives adequate funding.

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Last Modified: March 14, 2001