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Biomedical subjects

E M Meslin

Publications and source records attributed to E M Meslin.

At least 19 recordsLinked to original sources

Law and policy in the era of reproductive genetics.

The extent to which society utilises the law to enforce its moral judgments remains a dominant issue in this era of embryonic stem cell research, preimplantation genetic diagnosis, and human reproductive cloning. Balancing the potential health benefits and diverse moral values of society can be a tremendous challenge. In this context, governments often adopt legislative bans and prohibitions and rely on the inflexible and often inappropriate tool of criminal law. Legal prohibitions in the field of reproductive genetics are not likely to reflect adequately the depth and diversity of competing stakeholder positions. Rather, a comprehensive and readily responsive regulatory policy is required. Such a policy must attend to the evolving scientific developments and ethical considerations. We outline a proposal for effective, responsive, and coherent oversight of new reproductive genetic technologies.

Attitude to Health↗

Of clones, stem cells, and children: issues and challenges in human research ethics.

In the past 3 years, five scientific stories captivated the media and public attention: a sheep, Dolly, was cloned in Scotland; two scientific teams in the United States reported that they had isolated human stem cells; Jesse Gelsinger, an 18-year-old patient, died in a gene transfer experiment at the University of Pennsylvania; Vanderbilt University reported that it is providing fetal surgery for meningomyelocele; and researchers announced that a herd of previously cloned cows appears to be genetically younger than had been expected. These reports illustrate important issues in the ongoing discussion about research on children; indeed some of them challenge the breadth of the definition of research on children. This article, originally presented at an International Symposium sponsored by UNESCO on Bioethics and the Rights of the Child, describes how the National Bioethics Advisory Commission (NBAC) addressed two of these subjects-cloning and stem cell research-and identifies five challenges that science and society must address in the face of such emerging research technologies.

Animals↗

Hereditary hemochromatosis: gene discovery and its implications for population-based screening.

OBJECTIVE: To evaluate the role of genetic testing in screening for hereditary hemochromatosis to help guide clinicians, policymakers, and researchers. PARTICIPANTS: An expert panel was convened on March 3, 1997, by the Centers for Disease Control and Prevention (CDC) and the National Human Genome Research Institute (NHGRI), with expertise in epidemiology, genetics, hepatology, iron overload disorders, molecular biology, public health, and the ethical, legal, and social implications surrounding the discovery and use of genetic information. EVIDENCE: The group reviewed evidence regarding the clinical presentation, natural history, and genetics of hemochromatosis, including current data on the candidate gene for hemochromatosis (HFE) and on the ethical and health policy implications of genetic testing for this disorder. CONSENSUS PROCESS: Consensus was achieved by group discussion confirmed by a voice vote. A draft of the consensus statement was prepared by a writing committee and subsequently reviewed and revised by all members of the expert group over a 1-year period. CONCLUSIONS: Genetic testing is not recommended at this time in population-based screening for hereditary hemochromatosis, due to uncertainties about prevalence and penetrance of HFE mutations and the optimal care of asymptomatic people carrying HFE mutations. In addition, use of a genetic screening test raises concerns regarding possible stigmatization and discrimination. Tests for HFE mutations may play a role in confirming the diagnosis of hereditary hemochromatosis in persons with elevated serum iron measures, but even this use is limited by uncertainty about genotype-phenotype correlations. To address these questions, the expert group accorded high priority to population-based research to define the prevalence of HFE mutations, age and sex-related penetrance of different HFE genotypes, interactions between HFE genotypes and environmental modifiers, and psychosocial outcomes of genetic screening for hemochromatosis.

Female↗

Bioethics for clinicians: 13. Resource allocation.

Questions of resource allocation can pose practical and ethical dilemmas for clinicians. In the Aristotelian conception of distributive justice, the unequal allocation of a scarce resource may be justified by morally relevant factors such as need or likelihood of benefit. Even using these criteria, it can be difficult to reconcile completing claims to determine which patients should be given priority. To what extent the physician's fiduciary duty toward a patient should supersede the interests of other patients and society as a whole is also a matter of controversy. Although the courts have been reluctant to become involved in allocation decisions in health care, they expect physicians to show allegiance to their patients regardless of budgetary concerns. The allocation of resources on the basis of clinically irrelevant factors such as religion or sexual orientation is prohibited. Clear, fair and publicly acceptable institutional and professional policies can help to ensure that resource allocation decisions are transparent and defensible.

Canada↗

Bioethics for clinicians: 10. Research ethics.

Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics.

Beneficence↗

An ethics framework for assisting clinician-managers in resource allocation decision making.

In response to continued pressure on the Canadian healthcare system, hospitals are implementing structural changes to address issues of cost containment, utilization, and resource allocation. One strategy has been to decentralize managerial decision making to clinicians, creating "clinician-managers" (CMs). We surveyed 3,000 hospital-based CMs in Ontario, Canada (including physicians, nurses, and other health professionals), in order to understand the nature and frequency of the ethical issues they face as a consequence of their involvement in resource allocation decisions, and to identify mechanisms for dealing with these problems in their hospitals. Based on the survey results, we developed a Management Ethics Framework to assist CMs to reach an ethically justifiable resolution of these types of problems, both individually, and in the context of their membership in the healthcare team. The results, and particularly the discussion that follows, represent a confluence of philosophical, clinical, and organizational perspective on ethics and resource allocation by clinicians.

Attitude of Health Personnel↗

Bioethics for clinicians: 4. Voluntariness.

In the context of consent, "voluntariness" refers to a patient's right to make health care choices free of any undue influence. However, a patient's freedom to make choices can be compromised by internal factors such as pain and by external factors such as force, coercion and manipulation. In exceptional circumstances--for example, involuntary admission to hospital--patients may be denied their freedom of choice; in such circumstances the least restrictive means possible of managing the patient should always be preferred. Clinicians can minimize the impact of controlling factors on patients' decisions by promoting awareness of available choices, inviting questions and ensuring that decisions are based on an adequate, unbiased disclosure of the relevant information.

Aged↗

Agreement on disease-specific criteria for do-not-resuscitate orders in acute stroke. Members of the Canadian and Western New York Stroke Consortiums.

BACKGROUND AND PURPOSE: The do-not-resuscitate (DNR) order is a mechanism of withholding cardiopulmonary resuscitation (CPR). The lack of DNR guidelines specific for acute stroke may result in many stroke patients receiving unnecessary and futile resuscitation and ventilator-assisted breathing. METHODS: A prospective multicenter evaluation of disease-specific criteria for DNR orders in acute stroke was initiated using a modified Delphi process. The participants were the Canadian and Western New York Stroke Consortium members who are closely involved in caring for acute stroke patients and conducting clinical trials at the academic centers. Previously published provisional criteria were reviewed by the participants. Modifications were made to the criteria until statistically significant agreement (P < .05, z score, or 67% similar answers) was achieved. RESULTS: Disease-specific criteria for DNR orders in acute stroke were discussed by 26 physicians in three rounds of the opinion survey. An agreement was reached that a "no resuscitation" decision is appropriate when any two of the following three clinical criteria are present (the degree of agreement is given in parentheses): severe stroke (88%, P = .00007), life-threatening brain damage (73%, P < .01), and significant comorbidities (92%, P = .00003). The poor prognosis implied by these criteria should be discussed whenever possible among physician(s), the patient, and family members before the decision to withhold CPR is made. Eighty-one percent of the participants agreed that these disease-specific criteria are appropriate for clinical use (P = .0008). CONCLUSIONS: Disease-specific criteria for DNR orders were developed to supplement general DNR policies for patients with hemispheric brain infarction and intracerebral hemorrhage during the first 2 weeks of stroke. A significant agreement was reached by a panel of physicians that patients with acute stroke should not be resuscitated if these disease-specific criteria are met.

Acute Disease↗

Public opinion regarding end-of-life decisions: influence of prognosis, practice and process.

The purpose of this study was to examine the effect of changing key factors in survey questions on public opinion regarding end-of-life decisions. These factors were: (a) patient prognosis (likely vs unlikely to recover from the illness); (b) end-of-life practice (foregoing treatment vs assisted suicide vs euthanasia); and (c) and decision making process (competent patient vs incompetent patient based on living will vs incompetent patient based on family wishes). A representative quota sample of 2019 Canadians 18 years of age or older were surveyed using a 13-item questionnaire with 12 items eliciting attitudes towards end-of-life decisions. The questions were systematically varied according to three key factors; patient prognosis, end-of-life practice and decision making process. One item assessed whether respondents had completed a living will. In the case of a decision to forgo life-sustaining treatment in a competent patient, public approval was 85% if the person was unlikely to recover and 35% if the person was likely to recover. In the case of a competent patient unlikely to recover, public approval was 85% for forgoing life-sustaining treatment, 58% for assisted suicide, and 66% for euthanasia. In the case of forgoing life-sustaining treatment for a patient unlikely to recover, public approval was 85% for a competent patient, 88% for an incompetent patient who had expressed his/her wishes in advance through a living will, and 76% for an incompetent patient based on a family's request. The influence of these key factors was similar in other cases examined. Ten percent of Canadians said they had completed a living will. It was concluded that patient prognosis has a major effect, end-of-life practice a moderate effect, and decision making process a minor effect on public opinion regarding end-of-life decisions.

Adult↗

Do-not-resuscitate orders in acute stroke.

Although the general guidelines for do-not-resuscitate (DNR) orders apply to acute stroke patients, few data are available to aid decision-making. With a view to developing specific guidelines for use in patients with acute stroke, we decided to evaluate the clinical factors associated with DNR orders at our university teaching hospital. We prospectively studied 450 consecutive patients with acute hemispheric strokes (237 men and 213 women, mean age 75 +/- 12 years). Thirty-six patients (8%) had intracerebral hemorrhage (ICH) and 414 (92%) had ischemic strokes. Overall inhospital mortality was 26%. DNR status was given to 31% of all patients at some time during their admission (83% of those died). DNR decision-making was closely associated with the severity of the neurologic deficit (Canadian Neurological Scale score < or = 5); the patient's incapacity for informed DNR decision-making; age (> 60 years); and devastating ICH unsuitable for surgery (p < 0.001). Fifty-three percent of DNR orders were given on admission (first 24 hours of the hospital stay), 35% during the first week of the hospital stay, due to brain damage, and 12% at any time between days 8 and 44 due to systemic complications. Once DNR status was given, 53% of patients continued to receive normal nutrition and 60% still received medical or surgical treatment. Although the current practice of DNR orders in patients with acute stroke is generally satisfactory, some criteria (eg, age and operable ICH) need revision.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗

Hospital policies on life-sustaining treatments and advance directives in Canada.

OBJECTIVE: To determine the prevalence and content of hospital policies on life-sustaining treatments (cardiopulmonary resuscitation [CPR], mechanical ventilation, dialysis, artificial nutrition and hydration, and antibiotic therapy for life-threatening infections) and advance directives in Canada. DESIGN: Cross-sectional mailed survey. SETTING: Canada. PARTICIPANTS: Chief executive officers or their designates at public general hospitals. MAIN OUTCOME MEASURES: Information regarding the existence of policies on life-sustaining treatments or advance directives and the content of the policies. RESULTS: Questionnaires were completed for 697 (79.2%) of the 880 hospitals surveyed. Of the 697 respondents 362 (51.9%) sent 388 policies; 355 (50.9%) sent do-not-resuscitate (DNR) policies (i.e., policies that addressed CPR alone or in combination with other life-sustaining treatments). Of the 388 policies 327 (84.3%) addressed CPR alone, 28 (7.2%) addressed CPR plus other life-sustaining treatments, 10 (2.6%) addressed advance directives, and the remaining 23 (5.9%) addressed other life-sustaining treatments. Of the 355 DNR policies 1 (0.3%) stated that routine discussion with patients is required, 315 (88.7%) restricted their scope to terminally or hopelessly ill patients, 187 (52.7%) mentioned futility, 29 (8.2%) mentioned conflict resolution, 9 (2.5%) and 13 (3.7%) required explicit communication of the decision to the competent patient or family of the incompetent patient respectively, 110 (31.0%) authorized the family of an incompetent patient to rescind the DNR order, 224 (63.1%) authorized the nursing staff to do so, and 217 (61.1%) authorized physicians to do so. CONCLUSIONS: Although about half of the public general hospitals surveyed had DNR policies few had policies regarding other life-sustaining treatments or advance directives. Existing policies could be improved if hospitals encouraged routine advance discussions, removed the restriction to terminally or hopelessly ill patients, scrutinized the use of the futility standard, stipulated procedures for conflict resolution, explicitly required communication of the decision to competent patients or substitute decision-makers of incompetent patients and scrutinized the provision allowing families and health care professionals to rescind the wishes of now incompetent patients.

Attitude to Health↗