ALBERT

Keywords: Advisory Committees ; Costs and Cost Analysis ; Embryo Transfer ; Ethical Review ; Ethics ; Fallopian Tube Diseases/therapy ; Federal Government ; Female ; Fertilization in Vitro/*methods ; Humans ; Infertility, Female/therapy ; Infertility, Male/therapy ; Legislation, Medical ; Male ; Obstetrics/economics/standards ; Oocyte Donation ; Pregnancy ; Resource Allocation ; *Risk Assessment ; during its first five years. Efficacy, safety, costs, demand and supply, and ; feasible extensions of the basic procedure are discussed. The authors contend ; that, while Australia and Great Britain have made progress toward formulating ; public policy on IVF, efforts in the United States have not gone beyond a 1979 ; report and recommendations issued by the Department of Health, Education, and ; Welfare's Ethics Advisory Board. Given the ready clinical and public acceptance ; of IVF, there is need for an oversight mechanism at the federal level, perhaps ; via a forum concerned also with the overlapping area of human genetic ; intervention.

Keywords: *Abnormalities, Multiple ; Civil Rights ; *Disabled Persons ; Federal Government ; Female ; *Government Regulation ; Humans ; Infant, Newborn ; *Judicial Role ; *Jurisprudence ; United States ; *Withholding Treatment ; Department of Justice suit in November 1983 against the State University Hospital ; in Stony Brook, New York, to obtain the infant's medical records. Parents and ; physicians had decided against treatment for the severely handicapped newborn, ; but legal action was begun by right-to-life advocates to appoint a guardian for ; the child and to order surgery. The Department of Justice became involved after ; two New York courts ruled against the action ; the Department's intervention is ; based on Section 504 of the Rehabilitation Act, which forbids discrimination ; against the handicapped.

Keywords: Child Advocacy/legislation & jurisprudence ; *Congenital Abnormalities ; Ethics Committees, Clinical ; Federal Government ; *Government Regulation ; Humans ; Infant, Newborn ; United States ; *United States Dept. of Health and Human Services ; Withholding Treatment ; the Department of Health and Human Services is preparing a second version of ; federal rules designed to ensure appropriate treatment of handicapped newborns ; with life-threatening but correctible conditions. While child advocacy groups ; support the regulations with some reservations about the intrusive style of ; enforcement, most medical organizations, led by the American Academy of ; Pediatrics, are strongly opposed. Both houses of Congress have become involved ; with the issue by proposing to include handicapped infants under the Child Abuse ; and Treatment Act.

Keywords: *Biomedical Research ; Cell Line ; Copyright ; DNA, Recombinant ; Economic Competition ; Federal Government ; *Genetic Engineering ; *Genetics, Microbial ; Government Regulation ; Legislation as Topic ; Ownership ; *Patents as Topic ; Research ; *Technology ; United States ; as a question of intellectual property rights. Attention is focused on the major ; role played by the U.S. patent system in establishing such rights, as illustrated ; by the case of products of recombinant DNA research. Trade secret, copyright, and ; trademark protections are also considered, as are policy issues such as ; international competition in the development of biomedical technologies and ; financing arrangements.

Keywords: Animal Experimentation ; Bone Marrow ; Containment of Biohazards ; DNA Viruses/genetics ; *DNA, Recombinant ; Ethics Committees, Research ; Ethics, Medical ; Federal Government ; Gene Expression Regulation ; *Genes ; Genetic Diseases, Inborn/*therapy ; *Genetic Engineering ; Genetic Vectors ; Government Regulation ; Humans ; Microinjections ; Operon ; Plasmids ; Retroviridae/genetics ; Risk Assessment ; Skin ; Transcription, Genetic ; future clinical trials in humans are being debated among scientists and policy ; makers. Anderson, chief of the Laboratory of Molecular Hematology at the National ; Heart, Lung, and Blood Institute, examines how soon gene therapy might be ; available for the treatment of diseases in humans, and what criteria should be ; met before experimentation with human subjects begins. He identifies delivery, ; gene expression, and safety as the three requisites that must be satisfied, and ; reviews the animal work that has been done in these areas. Human trials should ; begin only after more animal studies have demonstrated to local and federal ; review committees that gene therapy is safe and offers the possibility of benefit ; to patients.

Keywords: *Advisory Committees ; *DNA, Recombinant ; Federal Government ; *Government Regulation ; *National Institutes of Health (U.S.) ; *Professional Staff Committees ; United States

Keywords: *Animal Experimentation ; *Animal Welfare ; Animals ; Chimera ; *DNA, Recombinant ; Federal Government ; *Genetic Engineering ; Government ; *Hormones ; Humans ; *Jurisprudence ; Politics ; Public Policy

Keywords: Academies and Institutes ; *Embryo Research ; *Embryo, Mammalian ; Federal Government ; *Fertilization in Vitro ; Fetus ; Government ; *Government Regulation ; Humans ; *National Institutes of Health (U.S.) ; *Research ; *Research Personnel ; *Social Control, Formal

Keywords: Advisory Committees ; DNA, Recombinant ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Humans ; Legislation as Topic ; National Institutes of Health (U.S.) ; United States ; United States Environmental Protection Agency

Keywords: *Biomedical Research ; Federal Government ; Financial Support ; *Fraud ; Government ; *Government Regulation ; Humans ; International Cooperation ; Internationality ; National Institutes of Health (U.S.) ; Public Policy ; Punishment ; *Research ; Research Personnel ; *Scientific Misconduct ; *Social Control, Formal ; Switzerland ; United States

Keywords: Acquired Immunodeficiency Syndrome/*blood ; Antibodies, Viral/*analysis ; Blood Donors ; Blood Transfusion/adverse effects ; Deltaretrovirus/*immunology ; Federal Government ; Humans ; United States ; United States Dept. of Health and Human Services ; epidemiological study by the National Heart, Lung and Blood Institute. Blood ; samples from 200,000 presumably healthy donors will soon be drawn and stored, to ; be screened when the test becomes available. Donors and recipients of blood which ; tests AIDS-positive will then be followed to see if AIDS develops. The study ; raises ethical issues in the areas of obtaining informed consent from donors and ; notifying donors and recipients of test results. The plan now is to obtain ; consent from donors and notify them of positive test results, and to decide later ; about notifying recipients.

Keywords: *Abortion, Induced ; Capitalism ; Coercion ; Developing Countries ; Economics ; *Family Planning Services ; Federal Government ; *Financing, Government ; Government ; Government Agencies ; Humans ; *International Cooperation ; *Internationality ; Political Systems ; *Population Control ; *Public Policy ; United Nations ; United States ; paper to be presented at the August 1984 United Nations world population ; conference in Mexico City. The paper dismisses population growth in developing ; countries as a cause of unemployment, illegal migration, or famine, and asserts ; that population programs are no substitute for ending government controls that ; stifle economic growth. It also contains a strong statement against abortion, ; states the U.S. position against coercion in family planning, and declares the ; Reagan administration's resolve not to fund programs advocating abortion. The ; U.S. stance is expected to antagonize developing countries and isolate the United ; States at the U.N. conference.

Keywords: *Abnormalities, Multiple ; Federal Government ; *Government Regulation ; Humans ; Infant, Newborn ; *Jurisprudence ; Legislation, Medical ; United States ; other medical organizations, a federal district court judge has struck down the ; February 1984 version of the Department of Health and Human Services' "Baby Doe" ; regulations. It was the second time a court had denied the government's claim ; that federal statutes forbidding discrimination against the handicapped give it ; the authority to intervene in treatment decisions concerning handicapped ; newborns. At the time of the ruling, no complaints about the care of any infant ; had been handled by DHHS under the provisions of this latest set of regulations.

Keywords: *Biomedical Research ; *Crime ; Federal Government ; *Fraud ; *Government Regulation ; *National Institutes of Health (U.S.) ; Research/*standards ; United States ; look into institutional procedures at Emory University, where an internal ; investigation had revealed extensive data fabrication by John Darsee, found a ; pattern of lax supervision of Darsee's research. Rather than prescribe action for ; Emory alone, the panel recommended seven procedural steps that should be taken by ; all NIH-supported research centers to guard against similar occurrences. These ; recommendations are being reviewed by NIH.

Keywords: Advisory Committees ; DNA, Recombinant ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Jurisprudence ; *National Institutes of Health (U.S.) ; United States ; recommended to NIH director James B. Wyngaarden on 1 June 1984 that two ; companies, Cetus Corporation and Advanced Genetic Sciences, Inc., be allowed to ; proceed with experiments involving release into the environment of organisms ; altered by gene splicing. The recommendation followed by two weeks a ruling by ; federal judge John J. Sirica which halted a very similar experiment by ; federally-funded University of California researcher Steven Lindow. The ruling ; did not apply to experiments conducted by private companies. Wyngaarden thus ; faces the political dilemma that, if he accepts the advisory committee's ; recommendation, a dual standard will be established allowing industry to conduct ; experiments that university scientists are currently barred from doing.

Keywords: Agriculture ; *Containment of Biohazards ; DNA, Recombinant ; Federal Government ; *Genetic Engineering ; Government Regulation ; *Jurisprudence ; Pseudomonas/genetics ; researchers at the University of California at Berkeley involving genetically ; engineered bacteria. A field test was originally scheduled for 1983 after ; approval by the National Institutes of Health's Recombinant DNA Advisory ; Committee, but was delayed after legal action by Rifkin. With that suit still ; pending, Rifkin filed another when plans were made to go ahead with the test in ; spring 1984. A ruling on the recent action is expected at the end of April, and ; the first suit may go to trial in summer 1984.

Keywords: Advisory Committees ; *DNA, Recombinant ; Federal Government ; *Government Regulation ; Jurisprudence ; National Institutes of Health (U.S.) ; United States ; University of California experiment, already approved by the National Institutes ; of Health's Recombinant DNA Advisory Committee, which would have involved the ; first deliberate release into the environment of genetically modified bacteria. ; Agreeing with social activist Jeremy Rifkin's charge that NIH had failed to ; comply with the National Environmental Policy Act when it approved the ; experiment, Sirica strongly suggested that he would also rule in Rifkin's favor ; on a suit to block all similar federally funded experiments until NIH has ; conducted an exhaustive evaluation of their potential environmental impact. ; Sirica's decision, however, left the NIH Recombinant Advisory Committee free to ; approve privately-funded experiments, which are not covered by the same ; environmental laws.

Keywords: *Advisory Committees ; *Bioethical Issues ; *Bioethics ; Federal Government ; Government ; Institute of Medicine (U.S.) ; *Public Policy ; Commission for the Study of Ethical Problems in Medicine and Biomedical and ; Behavioral Research have been made in the Senate by Edward Kennedy (D-Mass.) and ; Jeremiah Denton (R-Ala.). Denton favors a panel within the Office of Technology ; Assessment (OTA), while Kennedy favors sponsorship by the Institute of Medicine. ; Congress may find the OTA suggestion more attractive because of greater ; congressional control over the panel's agenda and recommendations.

Keywords: *Biological Warfare ; Biomedical Research ; Federal Government ; Genetic Engineering ; Humans ; Internationality ; Ussr ; United States ; Advancement of Science addressed concerns that recent developments in molecular ; biology have undermined the 1972 Biological and Toxin Weapons Convention, ; necessitating compliance verification changes in this international treaty ; banning the development and use of biological weapons. A group of scientists, ; military analysts, and arms control experts discussed types of biological ; research projects funded by the Department of Defense which could be diverted to ; the production of relatively efficient, inexpensive new weapons. Most of the ; panelists challenged the Pentagon's claim that biological weapons are currently ; being developed by the Soviet Union.

Keywords: *Biomedical Research ; *Crime ; Federal Government ; *Fraud ; *National Institutes of Health (U.S.) ; Research ; Schools, Medical ; United States ; Medical School, from the first known act of fraud to recent evidence that ; implicates Darsee's earlier work at Emory University and Notre Dame. Darsee's ; Harvard data were eventually re-examined both by Harvard and by a panel appointed ; by the National Heart, Lung, and Blood Institute (NHLBI), which had funded much ; of his research. The NHLBI findings, which were reviewed by senior staff at the ; National Institutes of Health, faulted the supervisory practices of Darsee's ; mentor, Dr. Eugene Braunwald. Braunwald acknowledges the need for change but ; believes that his pattern of supervision is common to many laboratories.

Keywords: *Biomedical Research ; Ethics Committees ; Ethics Committees, Research ; Federal Government ; Financial Support ; *Fraud ; Government ; Government Regulation ; Human Experimentation ; Humans ; *National Institutes of Health (U.S.) ; *Research ; Research Personnel ; *Scientific Misconduct ; Social Control, Formal ; Universities

Keywords: *Advertising as Topic/legislation & jurisprudence ; Drug Prescriptions ; Federal Government ; *Government Regulation ; Humans ; Information Dissemination ; *Pharmaceutical Preparations ; Risk Assessment ; United States ; *United States Food and Drug Administration ; companies would like to be allowed to advertise their prescription drugs to the ; general public as well as to health professionals. The Food and Drug ; Administration, concerned about the legal and ethical implications of ; direct-to-consumer advertising, has asked for time to study the proposal.

Keywords: Confidentiality ; *Congenital, Hereditary, and Neonatal Diseases and Abnormalities ; *Euthanasia, Passive ; Expert Testimony ; Federal Government ; Government ; *Government Regulation ; Humans ; *Infant, Newborn ; Jurisprudence ; Medical Records ; New York ; *Physicians ; *Social Control, Formal ; *United States Dept. of Health and Human Services ; *Withholding Treatment

Keywords: Congenital Abnormalities/therapy ; *Euthanasia ; Federal Government ; *Government Regulation ; Humans ; Infant, Newborn ; Judicial Role ; Parental Consent ; United States ; *United States Dept. of Health and Human Services ; *Withholding Treatment ; as "arbitrary and capricious," a Department of Health and Human Services ; regulation that required hospitals to post notices concerning the illegality of ; denying life-saving care to handicapped infants and encouraged anyone with ; knowledge of such a case to report it to HHS via a telephone hotline. This ; article reviews the evolution and implementation of the HHS regulation, the legal ; challenge to it, and the judge's ruling.

Keywords: *Biomedical Research ; Federal Government ; *Financial Support ; *Financing, Government ; *Fraud ; Government ; Humans ; *National Institutes of Health (U.S.) ; *Public Policy ; *Punishment ; *Research ; Research Personnel ; *Scientific Misconduct

Keywords: *DNA, Recombinant ; *Ecology ; Federal Government ; Government ; *Government Regulation ; Humans ; Industry ; *Jurisprudence ; *National Institutes of Health (U.S.) ; *Plants, Genetically Modified ; Politics ; Research Personnel ; *Risk ; *Risk Assessment ; *Social Control, Formal ; Universities

Keywords: Academies and Institutes ; *Biomedical Research ; DNA, Recombinant ; Federal Government ; Financial Support ; *Fraud ; Government ; Humans ; International Cooperation ; Internationality ; *Research ; Research Personnel ; *Scientific Misconduct ; Universities

Keywords: Advisory Committees ; Cell Line ; *Ethics, Medical ; Federal Government ; Genetic Diseases, Inborn/therapy ; *Genetic Engineering ; *Germ Cells ; *Government Regulation ; Human Characteristics ; Humans ; Risk Assessment ; United States ; cells has been signed by leaders of almost every major church group in the United ; States. Some of the religious leaders, while not certain that a total moratorium ; should be placed on altering germline cells, signed the statement in order to ; stimulate public debate on the issue. Legislation has recently been introduced in ; Congress to set up a committee to monitor genetic engineering and its human ; applications, but author Jeremy Rifkin, the impetus behind the church leaders' ; resolution, argues that such tampering threatens the gene pool and should be ; banned altogether.

Keywords: *DNA, Recombinant ; *Ecology ; Federal Government ; Government ; *Government Regulation ; Humans ; Jurisprudence ; National Institutes of Health (U.S.) ; *Plants, Genetically Modified ; Politics ; Research Personnel ; *Risk ; *Risk Assessment ; *Social Control, Formal ; Universities

Keywords: Federal Government ; *Genetic Engineering ; *Government Regulation ; Judicial Role ; *Jurisprudence ; *National Institutes of Health (U.S.) ; United States ; of genetically engineered bacteria, the National Institutes of Health will ; conduct the simpler of two ecological analyses required by the National ; Environmental Policy Act on three proposed experiments. In May 1984 a federal ; district court ruling halted a University of California field test pending a ; decision on Rifkin's 1983 suit, which alleged that NIH had violated the Act by ; approving experiments without studying the ecological consequences. Still to be ; decided by the U.S. Court of Appeals is whether NIH must also issue full-scale ; environmental impact statements.

Keywords: Containment of Biohazards ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Legislation as Topic ; *Technology ; United States ; two federal acts to regulate the products of genetic engineering, and has worked ; closely with members of the biotechnology industry to develop draft regulations. ; The Office of Management and Budget now contends that the Federal Insecticide, ; Fungicide, and Rodenticide Act and the Toxic Substances Control Act do not cover ; living organisms, suggests that it chair a working group to review the issues, ; and recommends four other regulatory options. Some industry officials have ; reservations about OMB's involvement in regulating biotechnology, and there could ; also be opposition from Democratic members of Congress.

Keywords: Advisory Committees ; Federal Government ; *Genetic Engineering ; *Government Regulation ; Jurisprudence ; National Institutes of Health (U.S.) ; United States ; of Health, and the Environmental Protection Agency in a campaign to prevent ; private companies, as well as universities, from releasing genetically modified ; organisms into the environment until the possible environmental impact of these ; experiments has been analyzed. Rifkin is seeking to stop Advanced Genetic ; Sciences and Cetus Corporation from conducting field tests respectively of ; modified frost-resistant bacteria and disease-resistant plants. His efforts have ; already led scientists at Stanford University to postpone voluntarily the ; planting of corn seed containing recombinant DNA.

Keywords: *Congenital, Hereditary, and Neonatal Diseases and Abnormalities ; Decision Making ; *Euthanasia, Passive ; Federal Government ; Government ; *Government Regulation ; Humans ; *Infant, Newborn ; Legislation as Topic ; *Organizational Policy ; Pediatrics ; *Physicians ; *Social Control, Formal ; *Societies ; Withholding Treatment

Keywords: Advisory Committees ; Containment of Biohazards ; Ethics Committees, Research ; Federal Government ; Genetic Diseases, Inborn ; *Genetic Engineering ; Government Regulation ; Judicial Role ; Jurisprudence ; *National Institutes of Health (U.S.) ; United States ; Administration, the first authorized experiments in human gene therapy are ; expected to begin sometime in 1985. Anticipating approval, the congressional ; Office of Technology Assessment (OTA), at the request of then Representative ; Albert Gore, Jr. (D-Tenn), compiled a report on the scientific and ethical issues ; involved. OTA found no unique ethical obstacles to somatic cell therapy if ; conducted safely and with a reasonable expectation of efficacy. It reached no ; agreement concerning the necessity, feasibility, or ethical acceptability of ; germline therapy, and recommended further evaluation and public discussion.

Keywords: *DNA, Recombinant ; Ecology ; Federal Government ; Government ; *Government Regulation ; Industry ; Legislation as Topic ; *Social Control, Formal ; *United States Environmental Protection Agency ; genetic engineering. Unlike the Recombinant DNA Advisory Committee of the ; National Institutes of Health, which oversees federally funded researchers, the ; EPA has the power to regulate industry and to concern itself with the health ; risks and environmental impact of commercial ventures. Claiming authority to ; regulate geneticaly engineered pesticides and organisms under the Federal ; Insecticide, Fungicide and Rodenticide Act, and under the Toxic Substances ; Control Act, EPA officials expect industry to contest in court the agency's ; controversial extension of its regulatory powers.

Keywords: Federal Government ; Female ; *Government Regulation ; Humans ; Neural Tube Defects/*diagnosis ; Pregnancy ; Pregnant Women ; *Prenatal Diagnosis/instrumentation ; Risk Assessment ; United States ; United States Food and Drug Administration ; Administration on 17 June to approve the wider use of diagnostic kits for the ; detection of fetal neural tube defects. The American College of Obstetricians and ; Gynecologists and the American Academy of Pediatrics are among the critics who ; favor tighter restrictions on use of the kits, which measure levels of ; alpha-fetoprotein in serum samples taken from expectant mothers, on the grounds ; that false positive results are common, necessitating careful quality control ; monitoring of physicians, manufacturers, and laboratories performing the test.

Keywords: *Editorial Policies ; Evaluation Studies as Topic ; Federal Government ; *Fraud ; Government ; *Human Experimentation ; Humans ; Public Policy ; *Publishing ; *Research Personnel ; *Scientific Misconduct

Keywords: *Biological Warfare ; Federal Government ; Government Regulation ; *Laboratories ; Research ; United States ; devoted to testing highly infectious, lethal biological agents in aerosol sprays. ; The proposed $1.4 million laboratory is a small part of an ongoing effort to ; modernize and expand chemical and biological facilities at Dugway Proving Ground. ; Several eminent biologists who reviewed the Pentagon's proposal at the request of ; Science are concerned that the facility will eventually be used to develop ; prohibited offensive weapons, particularly genetically modified pathogens of ; enhanced virulence and antibiotic resistance, though some scientists think the ; danger can be averted through surveillance by an independant panel. The Pentagon ; denies that such development is planned and claims that the facility is urgently ; needed to test defensive military equipment.