United States · Bill · HR
H.R. 5661 (101st)
National Institutes of Health Revitalization Amendments of 1990
Introduced
18 September 1990
Last action
—
Status
For Further Action See S.2857.
Sponsors
—
Subjects
Discovery layer
Source updated
5 February 2024
Summary
National Institutes of Health Revitalization Amendment of 1990 - Title I: General Provisions Regarding Title IV of Public Health Service Act - Subtitle A: Research Freedom - Part I: Review of Proposals for Biomedical and Behavioral Research - Amends the Public Health Service Act to require review and approval, by an Institutional Review Board, a peer review group, or other entity, of research before the Secretary of Health and Human Services may approve the research or fund applications. Prohibits the Secretary from withholding funding, on ethical grounds, from research which has been so approved unless an ethics advisory board recommends withholding. Part II: Research on Transplantation of Fetal Tissue - Allows the Secretary to conduct or support research on the transplantation of human fetal tissue for therapeutic purposes, regardless of whether the tissue is obtained from a spontaneous abortion, an induced abortion, or a stillbirth, in accordance with State and local law. Establishes criminal penalties for knowingly acquiring, receiving, or otherwise transferring any human fetal tissue for valuable consideration. Excludes from the term "valuable consideration" reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue. Prohibits any official of the executive branch from imposing a policy that the Department of Health and Human Services is prohibited from conducting or supporting any research on the transplantation of human fetal tissue for therapeutic purposes. Prohibits the Secretary from withholding funds for research which meets requirements of this subtitle. Deems a specified report of the Human Fetal Tissue Transplantation Research Panel to: (1) be issued by an ethics advisory board under provisions of this subtitle; and (2) find that there are no ethical grounds for withholding funds for research on transplantation of human fetal tissue for therapeutic purposes. Part III: Technical and Conforming Amendments - Removes provisions requiring a study of the nature, advisability, and biomedical and ethical implications of exercising any waiver of a specified risk standard relating to fetal research. Subtitle B: Clinical Research Equity Regarding Women and Minorities - Part I: Women and Minorities as Subjects in Clinical Research - Requires the Director of the National Institutes of Health (NIH) and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), in conducting and supporting research, to ensure that: (1) women and minorities are included as subjects in each project; and (2) research is conducted so as to provide for a valid analysis of whether the variables being tested affect women or minorities differently than other research subjects. Requires technical and scientific peer review to include an evaluation of compliance with these requirements. Part II: Office of Women's Health Research - Establishes within the Office of the Director of NIH the Office of Women's Health Research to ensure that research on women's health conditions is identified and addressed by NIH. Requires the Director of the Office to establish the Women's Health Research Coordinating Committee and the Women's Health Research Advisory Committee. Requires the Director of NIH to: (1) establish a data system regarding women's health research conducted or supported by NIH or ADAMHA; and (2) establish and operate a program to provide information on research and prevention activities of NIH relating to women's health and gender differences. Directs the Secretary: (1) through the Director of the Office of Women's Health Research, to contract for a study of how to remove obstacles to and advance and encourage research on women's health; and (2) to request the Institute of Medicine of the National Academy of Sciences to enter into the contract. Subtitle C: Scientific Integrity - Amends provisions relating to scientific fraud or scientific misconduct to establish within the Office of the Director of NIH the Office of Scientific Integrity. Provides for the protection of whistleblowers and for the avoidance of conflict of interest. Title II: Protection of Health Facilities - Prohibits specified acts interfering with the use of animals for research by a health facility assisted under the Public Health Service Act. Provides for fines, imprisonment, restitution, and private civil actions. Title III: National Institutes of Health in General - Directs the Secretary to establish in the Office of the Director of NIH the Advisory Committee on Health Sciences to periodically review the missions of each of the agencies of NIH for the purpose of advising the NIH Director, the Secretary, and the Congress on any modifications in the organizational structure of NIH. Requires the approval of the Committee in order for the Secretary to establish, reorganize, or abolish a national research institute. Title IV: General Provisions Respecting National Research Institutes - Requires that the Secretary, through the director of each of the national research institutes, receive directly all funds appropriated for the institute. Removes provisions allowing the Director of the National Cancer Institute (NCI) to directly receive NCI funds. Excludes peer review groups under specified provisions from the application of the Federal Advisory Committee Act. Requires the Director of NIH to: (1) carry out a program to expand and intensify research on osteoporosis, Paget's disease, and related bone disorders in addition to research authorized under other Federal law; (2) establish the Advisory Board on Osteoporosis, Paget's Disease, and Related Bone Disorders; and (3) enter into a grant, cooperative agreement, or contract to establish an information clearinghouse on osteoporosis and related bone disorders. Authorizes appropriations. Title V: National Cancer Institute - Authorizes appropriations for the National Cancer Institute. Title VI: National Heart, Lung, and Blood Institute - Authorizes the National Heart, Lung, and Blood Institute (NHLBI) to conduct programs of training and education, including continuing education and laboratory and clinical research training. Authorizes appropriations for the NHLBI. Title VII: National Institute on Aging - Authorizes appropriations for the National Institute on Aging. Title VIII: National Institute of Allergy and Infectious Diseases - Authorizes the Director of the National Institute of Allergy and Infectious Diseases to make grants or enter into contracts for the development and operation of centers to conduct basic and clinical research on chronic fatigue syndrome. Title IX: National Institute of Child Health and Human Development - Subtitle A: National Center for Medical Rehabilitation Research - Requires that there be in the National Institute of Child Health and Human Development (NICHHD) the National Center for Medical Rehabilitation Research to conduct and support research and research training, the dissemination of health information, and other programs with respect to rehabilitation regarding physical disabilities resulting from diseases or disorders of any physiological system. Requires the Director of NIH to establish the Medical Rehabilitation Coordinating Committee and the National Advisory Board on Medical Rehabilitation Research. Requires the Secretary and the heads of other Federal agencies to jointly review programs being carried out with respect to medical rehabilitation research and enter into agreements for preventing duplication. Subtitle B: Research Centers With Respect to Contraception and Research Centers With Respect to Infertility - Requires the Director of the NICHHD to make grants and enter into contracts for the development and operation of three centers to conduct contraception research and two centers to conduct infertility research. Directs the Secretary to establish a program of educational loan repayments for health professionals who agree to conduct research on contraception or on infertility. Authorizes appropriations. Subtitle C: Program Regarding Obstetrics and Gynecology - Requires the Director of the NICHHD to establish an intramural laboratory and clinical research program in obstetrics and gynecology. Title X: National Library of Medicine - Subtitle A: General Provisions - Allows the National Library of Medicine (NLM) to make available its materials, facilities, or services under licensing arrangements that provide for quality control and full recovery of access costs. Authorizes appropriations to carry out provisions relating to: (1) the NLM and to other medical libraries, including regional medical libraries; (2) training in medical library sciences; and (3) biomedical publications. Subtitle B: Financial Assistance - Directs the Secretary to make grants for research on, and development and demonstration of, new educational technologies. Subtitle C: National Center for Biotechnology Information - Authorizes appropriations for the National Center for Biotechnology Information. Title XI: Other Agencies of National Institutes of Health - Subtitle A: Division of Research Resources - Redesignates the Division of Research Resources as the National Center for Research Resources. Authorizes the Director of NIH to reserve up to a specified sum to improve regional centers for research on primates. Subtitle B: National Center for Human Genome Research - Adds the National Center for Human Genome Research to the list of agencies of NIH. Declares that the purpose of the Center is to characterize the structure and function of the human genome, including the mapping and sequencing of individual genes. Requires the Director of the Center to make available a minimum percentage of funds for carrying out provisions relating to ethical issues associated with the genome project. Title XII: Awards and Training - Authorizes appropriations for payments and grants under National Research Service Awards. Title XIII: Research with Respect to Acquired Immune Deficiency Syndrome - Modifies the duties of the AIDS Clinical Research Review Committee, including requiring the Committee to give advice to other agencies of NIH as well as to the National Institute of Allergy and Infectious Diseases (NIAID). States that the requirement that the clinical evaluation units at the National Cancer Institute and NIAID conduct evaluations of treatments for acquired immune deficiency syndrome (AIDS) includes evaluations of treatment for opportunistic cancers and infectious diseases. Authorizes appropriations for model protocols for the clinical care of individuals infected with the etiologic agent for AIDS. Requires the Director of NIH to develop and implement a comprehensive plan for the conduct and support of AIDS research by NIH agencies. Title XIV: Senior Biomedical Research Service - Requires that there be in the Public Health Service a Senior Biomedical Research Service to consist of individuals outstanding in the field of biomedical research or clinical research evaluation. Title XV: Miscellaneous Provisions - Directs the Secretary to report to specified congressional committees on the appropriateness and impact of NIH assuming responsibility for all Federal research, development, testing, and evaluation functions relating to the medical aspects of biological agents in the development of defenses against biological warfare. Title XVI: Effective Date - Sets forth the effective date of this Act.
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4 official files
Reported in House (text)
Reported in House (text)
Reported in House · EN
Introduced in House (text)
Introduced in House · EN
Reported to House with amendment(s)
summary · EN · 15 October 1990
Introduced in House
summary · EN · 18 September 1990
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Sources
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- Official source: https://www.congress.gov/bill/101st-congress/house-bill/5661
- Open data entity: https://api.congress.gov/v3/bill/101/hr/5661