Human genetic research, DNA banking and consent: a question of 'form'?
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Biomedical subjects
Publications and source records attributed to K C Glass.
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Public debate over the use of techniques that result in heritable changes to human germ cells (i.e., sperm and ova), called germ-cell gene interventions, lags far behind the development of such therapies. Such a debate is particularly needed now because the first steps in somatic-cell, or non-heritable, gene therapy have taken place and may accelerate the beginning of germ-cell gene therapy trials. Because germ-cell therapy affects future generations, its moral status differs considerably from that of somatic-cell therapy. To stimulate and inform public discussion, the authors review the major ethical arguments for and against germ-cell therapy that are found in the literature. (These arguments include the dangers of "playing God," of moving on the "slippery slope" to germ-cell manipulations for enhancement rather than therapy, and of causing irreversible changes to the genomes of future generations.) They demonstrate that these arguments do not apply uniquely to such therapy, since most of the properties of germ-cell therapy are present in other medical interventions or elsewhere in social interactions. For example, there are many examples of human activities that are irreversible and have effects on future generations. However, this lack of uniqueness does not necessarily imply that the moral status of germ-cell gene therapy is unique, or that it should be banned forever. The public, and especially health policymakers, researchers, and clinicians, must reflect on and discuss the issues outlined in this article before efforts are made to introduce changes into the germ cells of human beings.
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This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.
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The standard of professional candour with patients has undergone a significant change over the past 30 years. Independent of their obligation to disclose information necessary for informed consent, physicians are increasingly expected to communicate important information to patients that is not immediately related to treatment decisions. The purpose of truth telling is not simply to enable patients to make informed choices about health care and other aspects of their lives but also to inform them about their situation. Truth telling fosters trust in the medical profession and rests on the respect owed to patients as persons. It also prevents harm, as patients who are uninformed about their situation may fail to get medical help when they should.
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The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research.
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We examined how adult children in Canada whose parents were hospitalized in an acute care setting perceived responsibility for their parents' care. Using a visual analogue scale, adult children rated the amount of financial, emotional, and physical support families "should" and "could" give to elderly persons described in four vignettes. All scores were high, with "should" consistently higher than "could" for every vignette and for each of the three types of support. For daughters, the more aggressive the parent, the lower the "should" score for financial support. The same relationship was observed for incontinence and these findings were consistent over all four vignettes.
OBJECTIVE: To examine the lengths of stay of chronic status patients in an acute care hospital, to identify discharge stages that contribute to excessive stays, to estimate the length of stay at each discharge stage and to link hospital bed-day utilization by the discharge stage to the experience of the patient. DESIGN: Two-year prospective cohort study. The number of hospital days retrospective to the date of the current admission were included in the analysis. SETTING: University hospital. PATIENTS: All 115 inpatients formally declared as achieving chronic status by July 31, 1987. OUTCOME MEASURES: Lengths of stay (total days and days at acute and chronic status) for chronic status patients, including those still in hospital at the end of the study period. Each bed-day was assigned to a discharge stage that corresponded to the patient's status. The disposition of each patient by the end of the study period was reviewed. RESULTS: The study population spent a total of 101 585 days in hospital. The total length of stay per patient was nearly four times that stated in the hospital's annual report, in which the figure was calculated only on the basis of discharge data. On average only 77.2 (8.7%) of the days were spent in acute care. The remaining days were at the chronic level: 24.1% were spent waiting for completion of an application to a long-term care facility, 25.3% for application approval and 41.9% for an available bed in the assigned long-term care institution. For 30 patients no initiation of the discharge process was ever undertaken. As the number of patients in each progressive discharge stage decreased, the wait per patient increased. By the end of the study period only 32 patients had been transferred to a public long-term care facility; 22 were still in hospital, and 35 had died waiting for placement. CONCLUSIONS: Although considered to be a useful measure of hospital efficiency, length of stay determined from discharge data creates an iceberg effect when applied to chronic status patients in acute care hospitals. Lack of access to the assigned resource is the most important reason for a delay in discharge. Interventions, whether undertaken at the patient, hospital or provincial level, must to some degree address this issue. Further study is required to determine which risk factors will predict lags at each discharge stage. Since our discharge staging reflects not only the experience of the patient but also the utilization of hospital bed-days and access to provincial resources, it provides a common language for clinicians, hospital administrators and systems planners.
In Weiss vs Solomon, the heirs of a subject who died while a volunteer in a nontherapeutic study successfully sued the investigator and his university-affiliated hospital. Without referring to any 'standard of practice', including the MRC Guidelines, the judge found the principal investigator and the hospital (for its research ethics committee) equivalently responsible for not disclosing a rare but fatal complication caused by fluorescein dye and not adequately screening the subject, who suffered from undisclosed hypertropic cardiomyopathy. From the point of view of research institutions, members of research committees, and the investigators themselves, the judgement has left serious uncertainty and ambiguity concerning their responsibilities for subject selection and safety, and disclosure for the purposes of informed consent.
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