H.R.1532 - National Institutes of Health Revitalization Amendments of 1991102nd Congress (1991-1992)
|Sponsor:||Rep. Waxman, Henry A. [D-CA-24] (Introduced 03/20/1991)|
|Committees:||House - Energy and Commerce|
|Latest Action:||House - 05/07/1991 Clean Bill, H.R. 2507 Forwarded by Subcommittee to Full Committee in Lieu. (All Actions)|
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Summary: H.R.1532 — 102nd Congress (1991-1992)All Information (Except Text)
Introduced in House (03/20/1991)
National Institutes of Health Revitalization Amendments of 1991 - 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 to 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: Offices of Women's Health Research - Establishes within each of the Office of the Director of NIH and the Office of the ADAMHA Administrator an Office of Women's Health Research to identify projects of women's health (and, for ADAMHA, mental health) research and promote sufficient resource allocation for the conduct or support of the projects by NIH and ADAMHA.
Requires the Directors of each Office to establish a Women's Health Research Coordinating Committee and a Women's Health Research Advisory Committee.
Requires the Director of NIH to: (1) establish a single 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 and ADAMHA relating to women's health and gender differences.
Directs the Secretary: (1) through the Directors of the Offices of Women's Health Research, to contract for a study of how women's health research can be facilitated by the NIH Director and the ADAMHA Administrator; 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 on Scientific Integrity. Provides for the protection of whistleblowers and for the avoidance of conflicts of interest.
Title II: Protection of Health Facilities - Prohibits stealing or otherwise converting personal property or damaging real property of a health facility assisted under the Public Health Service Act, or deterring, through physical restraint, any individual from entering or exiting the facility. Includes in the prohibitions various acts interfering with the use of animals for research. 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.
Mandates preparation and implementation of a plan, regarding biomedical research and experimentation conducted or supported by NIH, for methods that: (1) do not require the use of animals; (2) reduce the number of animals used; and (3) produce less pain and distress in animals. Requires measures to encourage acceptance by and training scientists in such methods.
Establishes the Interagency Coordinating Committee on the Use of Animals in Research.
Repeals similar provisions, relating to a plan on animal research and a coordinating committee, of the Health Research Extension Act of 1985.
Removes provisions of the Public Health Service Act allowing members of advisory councils to serve after the expiration of their terms until successors have taken office.
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.
Title VII: National Institute on Aging - Transfers provisions of the Health Research Extension Act of 1985 establishing an Alzheimer's disease registry to provisions of the Public Health Service Act relating to the National Institute on Aging (NIA).
Authorizes appropriations for the NIA.
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: 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 centers to conduct contraception research and 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 B: Program Regarding Obstetrics and Gynecology - Requires the Director of the NICHHD to establish an intramural laboratory and clinical research program in obstetrics and gynecology.
Subtitle C: Child Health Research Centers - Requires the Director of the NICHHD to develop and support centers for conducting research on child health, giving priority to clinical applications of basic research findings.
Title X: National Institute of Neurological Disorders and Stroke - Requires the Director of the National Institute of Neurological Disorders and Stroke to conduct and support research on multiple sclerosis.
Title XI: National Institute of Environmental Health Sciences - Establishes in the National Institute of Environmental Health Sciences the Applied Toxicological Research and Testing Program.
Title XII: National Library of Medicine - Subtitle A: General Provisions - Adds to the list of functions of the National Library of Medicine (NLM) that of publicizing NLM products and services and promoting the use of computers and telecommunications by health professionals.
Allows the 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 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 education technologies.
Subtitle C: National Center for Biotechnology Information - Authorizes appropriations for the National Center for Biotechnology Information.
Subtitle D: National Information Center on Health Services Research, Health Care Technology, and Health Care Technology Assessment - Establishes in the NLM the National Information Center on Health Services Research and Health Care Technology. Removes similar provisions from provisions relating to the Agency for Health Care Policy and Research.
Title XIII: 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 XIV: Awards and Training - Subtitle A: National Research Service Awards - Directs the Secretary to make grants for comprehensive programs to recruit women and individuals from disadvantaged backgrounds into fields of biomedical or behavorial research and to provide research training to women and such individuals.
Authorizes appropriations for payments and grants under National Research Service Awards.
Subtitle B: Acquired Immune Deficiency Syndrome - Allows the Secretary, under a loan repayment program for research with respect to acquired immune deficiency syndrome (AIDS) established by existing provisions, to enter into a repayment agreement with a health professional who agrees to conduct AIDS research at NIH for at least three years, provided other conditions are met. Authorizes appropriations.
Subtitle C: Scholarship and Loan Repayment Programs Regarding Professional Skills Needed by National Institutes of Health and by Alcohol, Drug Abuse, and Mental Health Administration - Directs the Secretary, through the Director of NIH and the Administrator of ADAMHA, to establish programs of scholarships for undergraduate education for individuals from disadvantaged backgrounds who are underrepresented in professions needed by NIH and ADAMHA in return for the scholarship recipient's agreeing to serve as employees of NIH or ADAMHA for a prescribed period. Requires that the Director and the Administrator: (1) carry out activities to facilitate the interest of the individuals in pursuing careers as employees of NIH and ADAMHA; and (2) approve the academic program of each individual.
Directs the Secretary, through the Director and the Administrator, to establish programs for repaying educational loans for individuals from disadvantaged backgrounds who have a substantial amount of education loans relative to income in return for the repayment recipients agreeing to conduct clinical research as employees of NIH or ADAMHA.
Limits the NIH scholarship and loan programs to an aggregate of 40 contracts and the ADAMHA programs to an aggregate of 10 contracts.
Title XV: 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 treatments 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 XVI: Miscellaneous Provisions - Directs the Secretary to report to specified congressional committees on the appropriateness and impact of NIH's 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.
Designates each member of the Senior Biomedical Research as a Conte fellow. Increases the maximum number of members of the Service.
Title XVII: Effective Date - Sets forth the effective date of this Act.