Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future.

Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic-human genetic engineering-was the subject of sustained public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)-the Recombinant DNA Advisory Committee (RAC)-agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.

The Belmont Report at 40: Reckoning With Time.

It was the summer of 1972 when a stunned nation first learned of the infamous Tuskegee Syphilis Study, during which hundreds of poor, disease-stricken black men from Macon County Alabama, had been deliberately left untreated for 40 years. Coming on the heels of multiple, earlier examples of unethical human experimentation, the Tuskegee Syphilis Study made it plain that the moral foundation of human subject research was in desperate need of repair. Blind reliance on the Nuremberg Code and the Declaration of Helsinki was no longer going to suffice. It was against this backdrop that Congress resolved to act. Numerous hearings and multiple spirited discussions later, an agreement was struck to constitute the "Commission." The outgrowth of a retreat held at the Smithsonian Institution's Belmont Conference Center, the Belmont Report lays out a principled analytical framework to "guide the resolution of ethical problems arising from research involving human subjects." Durable and ever-present, the Belmont Report, which is the foundational document that reset the ethics of human subject research, must now reckon with all-important novel issues of the day that could not have been foreseen by its drafters.

Genetics and bioethics: how our thinking has changed since 1969.

In 1969, the field of human genetics was in its infancy. Amniocentesis was a new technique for prenatal diagnosis, and a newborn genetic screening program had been established in one state. There were also concerns about the potential hazards of genetic engineering. A research group at the Hastings Center and Paul Ramsey pioneered in the discussion of genetics and bioethics. Two principal techniques have emerged as being of enduring importance: human gene transfer research and genetic testing and screening. This essay tracks the development and use of these techniques and considers the ethical issues that they raise.

Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.

Data Safety Monitoring Committees (DSMB) for large, long-term randomized trials of agents in common use face challenging problems especially when the emerging data indicate unanticipated effects. The DSMB for the Women's Health Initiative Clinical Trials, on observing early indication of a surprising adverse cardiovascular effect of post-menopausal hormones, spent several years deliberating what recommendations it should make. This paper describes the dilemmas faced by the DSMB and the considerations it made over the course of its existence. The paper concludes with some recommendations for other DSMBs.

Paul Braune confronts the National Socialists' "euthanasia" program.

On July 9, 1940, asylum director Paul Braune completed a twelve-page memorandum, or Denkschrift, on the National Socialists' T-4 "euthanasia" program. The memorandum identified three killing centers within a carefully planned, Reich-wide program and summarized what Braune's research had uncovered about the fate of asylum patients at various T-4 facilities. Braune estimated that several thousand disabled people had been murdered between February and June 1940. After Protestant church leaders formally submitted Braune's memorandum to the Reich Chancellery, Braune was arrested by the Gestapo-pursuant to a direct order by Reinhard Heydrich-for having "sabotaged measures of the state in an irresponsible way." Despite Braune's protest, the killing of German asylum patients continued unabated. This article shows what a determined German citizen, assisted by an extensive network of information sources, was able to learn about the "euthanasia" program during the first six months of its implementation, and reveals the formidable difficulties that opponents of the program faced in their efforts to stop the killing of disabled people.

Human embryonic stem cell research: an intercultural perspective.

In 1998, researchers discovered that embryonic stem cells could be derived from early human embryos. This discovery has raised a series of ethical and public-policy questions that are now being confronted by multiple international organizations, nations, cultures, and religious traditions. This essay surveys policies for human embryonic stem cell research in four regions of the world, reports on the recent debate at the United Nations about one type of such research, and reviews the positions that various religious traditions have adopted regarding this novel type of research. In several instances the religious traditions seem to have influenced the public-policy debates.

Safety issues in cell-based intervention trials.

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established.

An analysis of the bacterial flora of meat carcasses

Meat production at the Kingston and St. Andrew and Orchard Farm Abattoir is undertaken under grossly unsatisfactorily conditions. Extensive microbial contamination could have adverse implications for the health of consumers of meat produced at the abattoirs. This study sought to determine the microbial quality and safety of the carcasses produced at the abattoirs as well as the knowledge, attitude and practice of abattoir workers with respect to sanitary slaughter and processing of animals. Samples were taken from approximately 25 percent bovine and porcine carcasses produced at the abattoir over a two-week period. Laboratory analyses were performed on these samples to determine the coliform count, E. coli count and the presence of salmonella. The condition under which slaughtering took place was observed. Informal interviews with butchers to determine their knowledge, attitude and practice with respect to sanitary slaughter were also conducted. The results showed extensive contamination of the carcasses produced. The E. coli count on carcasses, fell well outside acceptable standards. The presence of Salmonella also fell outside the limits of acceptable standards at one of the abattoirs. The presence of salmonella was detected on meat from the other abattoir though within acceptable limits. Poorly maintained facilities and equipment and lack of aseptic technique in processing and the use of untreated water in the abattoir were factors which impacted on the quality of meat produced. The study concluded that the meat produced at the Kingston and St. Andrew and Orchard Farm abattoirs places consumers at risk of contracting food borne disease. There were no significant differences between quality and safety of meat produced at the two establishments. There is need for effective quality control systems to be established in the abattoirs with a view to correcting process defects and ultimately reduce the levels of contamination of the carcass.(Au)

Current and future issues in assisted reproduction.

The last quarter of the twentieth century has given rise to reproductive technologies and arrangements that in the earlier part of the century could only be dreamed of by the authors of science fiction. We stand in the middle of this reproductive revolution, trying to cope with the developments that have already occurred but with an uneasy sense that the future may be even more complicated ethically than the past and the present. In this brief essay, I will survey recent ethical and public-policy discussions of two reproductive techniques (assisted insemination and in vitro fertilization) and one reproductive arrangement (surrogate motherhood). After distinguishing three phases in the normative debate, I will briefly comment on some of the characteristics of, and continuing ambiguities in, the ethical debate of the past 25 years. At the conclusion of the essay, I will attempt to anticipate three future issues in ethics and reproduction.

Management and administration of the Environmental Control Division of the Ministry of Health [Jamaica]

Examines the administration practices of the Environmental Control Division (ECD) of the Ministry of Health to determine the extent to which administrative defiencies inhibit the carrying out of the organizational functions. Looks at the prescribed functions of the ECD; the extent to which these functions are carried out; the organizational structures strengths and weaknesses and the administrative practices. (AU)

Ethics and new reproductive technologies: an international review of committee statements.

KIE: Walters examines the statements of advisory committees in eight countries on new practices involving human reproduction: clinical in vitro fertilization; surrogate motherhood; and human embryo research. He analyzes the positions taken by the committees on the general acceptability of the new technologies, as well as on specific issues involved in assisted human reproduction. In chronological order, the statements examined are those of the U.S. Ethics Advisory Board; the Waller committee in Victoria, Australia; a South Australian committee; the Demack committee in Queensland; Britain's Council for Science and Society; Britain's Warnock committee; a Tasmania, Australia, committee; the Ontario Law Reform Commission; Australia's Family Law Council; West Germany's Benda committee; the American Fertility Society; a Western Australia committee; the Dutch Health Council; and the National Ethics Committee of France.^ieng