Mom, dad, clone: implications for reproductive privacy.
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Biomedical subjects
Publications and source records attributed to L B Andrews.
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BACKGROUND: Data about the frequency of adverse events related to inappropriate care in hospitals come from studies of medical records as if they represented a true record of adverse events. In a prospective, observational design we analysed discussion of adverse events during the care of all patients admitted to three units of a large, urban teaching hospital affiliated to a university medical school. Discussion took place during routine clinical meetings. We undertook the study to enhance understanding of the incidence and scope of adverse events as a basis for preventing them. METHODS: Ethnographers trained in qualitative observational research attended day-shift, weekday, regularly scheduled attending rounds, residents' work rounds, nursing shift changes, case conferences, and other scheduled meetings in three study units as well as various departmental and section meetings. They recorded all adverse events during patient care discussed at these meetings and developed a classification scheme to code the data. Data were collected about health-care providers' own assessments about the appropriateness of the care that patients received to assess the nature and impact of adverse events and how health-care providers and patients responded to the adverse events. FINDINGS: Of the 1047 patients in the study, 185 (17.7%) were said to have had at least one serious adverse event; having an initial event was linked to the seriousness of the patient's underlying illness. Patients with long stays in hospital had more adverse events than those with short stays. The likelihood of experiencing an adverse event increased about 6% for each day of hospital stay, 37.8% of adverse events were caused by an individual, 15.6% had interactive causes, and 9.8% were due to administrative decisions. Although 17.7% of patients experienced serious events that led to longer hospital stays and increased costs to the patients, only 1.2% (13) of the 1047 patients made claims for compensation. INTERPRETATION: This study shows that there is a wide range of potential causes of adverse events that should be considered, and that careful attention must be paid to errors with interactive or administrative causes. Healthcare providers' own discussions of adverse events can be a good source of data for proactive error prevention.
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Genetic tests are available for an increasing array of disorders. Although the doctrine of informed consent requires that physicians provide sufficient information to patients in advance of testing and allow them to make decisions in a noncoerced way, some studies have shown that physicians do not provide adequate information about the nature of genetic testing and its risks. Some physicians test patients without their consent. This article recommends that physicians address the limitations on their knowledge about genetics and about life with genetic disorders. It also analyzes how the informed consent process for genetic testing can be improved.
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This Article analyzes existing legal protections for the confidentiality of information collected through genetic screening or genetic monitoring in the workplace. It notes that there are a variety of protections, such as ethical codes for occupational physicians, statutes protecting health care information in the hands of the employers, and tort, contract and constitutional principles. It describes defenses to suits based on improper disclosure of medical information. The Article then analyzes legal bases for employee and third party access to the employee's genetic information. In response to gaps in existing legal protections, it suggests parameters for a model law protecting the confidentiality of genetic information collected in the workplace.
The Vatican Instruction advocates laws banning in vitro fertilization, gamete donation, embryo donation, and surrogate motherhood. The OTA Report Infertility provides a range of policy choices for handling these reproductive procedures. The choice among these alternative regulations needs to be developed within the framework of the right to privacy of the U.S. Constitution, which provides support for an approach that allows the progenitors to control the uses made of their generative materials and to receive compensation for them, subject to laws which facilitate informed consent and attempt to assure quality.
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All areas of medical practice are shaped by ethical and legal mandates. When a physician provides infertility services, however, ethical and legal concerns reach an even greater prominence. The infertility specialist is in the awesome role of facilitating the creation of new life. A task of that level of importance brings with it responsibilities of an equal magnitude. Clinicians performing in-vitro fertilization and artificial insemination should be especially sensitive to the ethical and legal concerns raised by the selection of patients and donors, the informed consent process, and record-keeping. As reproductive technologies such as these develop, the clinician not only has a duty to monitor their safety and efficacy, but also to provide extensive information to the participants and to society at large to make possible informed decisions about how best to enhance the benefits and avoid the risks of these new technologies.
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Two recent cases raise the question: Should the body be considered a form of property? Patients generally do not share in the profits derived from the applications of research on their body parts and products. Nor is their consent for research required so long as the body part is unidentified and is removed in the course of treatment. A market in body parts and products would require consent to all categories of research and ensure that patients are protected from coercion and given the chance to be paid fairly for their contributions. Such a market might force us to rethink our policies prohibiting organ sales. Donors, recipients, and society will benefit from a market in body parts so long as owners--and no one else--retain control over their bodies.
Physicians who intend to perform in vitro fertilization--or the newer alternative, in vivo fertilization and embryo transfer--should be aware of the plethora of laws that potentially cover their work. In perhaps no other area of medicine are there so many separate statutes and regulations that potentially apply. State fetal research laws, abortion statutes, human subject protection laws, and specific in vitro fertilization statutes can determine whether and how the procedure can be undertaken. When donor gametes or a surrogate carrier is used, additional laws governing artificial insemination, paternity, or adoption may come into play to determine the child's legal status and its relationship to the parties involved. This article is designed to guide physicians through the legal maze.