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T Lemmens

Publications and source records attributed to T Lemmens.

9 recordsLinked to original sources

Ethics review for sale? Conflict of interest and commercial research review boards.

Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules are essential because of the absence of clear substantive rules in research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process.

Canada↗

Selective justice, genetic discrimination, and insurance: should we single out genes in our laws?

This article discusses the desirability of legislation focusing on genetic discrimination, in particular in the context of insurance. Many American states and some European countries as well as the Council of Europe have introduced protective measures against discrimination on the basis of genetic susceptibility. The author questions their effectiveness and queries whether they may be inequitable, because they fail to address more fundamental underlying issues related to the nature of insurance, access to health care, and unequal distribution of wealth. There is also a problem of definition in these statutes. They fail to capture what constitutes genetic information. Nonetheless, the author argues it is important to consider the social consequences of genetic testing. Michael Walzer's theory of justice is used to examine the role of insurance and health care. Using this approach, the author finds the American system of distribution for health care to be problematic. This is then used to inform the author's discussion of the future of health care in Canada. Anti-discrimination provisions could be used in a way that is consistent with Walzer's theory of justice. They would encompass both genetic and non-genetic health factors. These can be modelled on current anti-discrimination statutes in Canada. The author then proposes administrative committee structures to regulate the use of genetic data in Canada.

Advisory Committees↗

Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin.

OBJECTIVE: To investigate the effectiveness of aspirin and coumarin in preventing thromboembolism in patients with non-rheumatic atrial fibrillation in general practice. DESIGN: Randomised controlled trial. PARTICIPANTS: 729 patients aged >/=60 years with atrial fibrillation, recruited in general practice, who had no established indication for coumarin. Mean age was 75 years and mean follow up 2. 7 years. SETTING: Primary care in the Netherlands. INTERVENTIONS: Patients eligible for standard intensity coumarin (international normalised ratio 2.5-3.5) were randomly assigned to standard anticoagulation, very low intensity coumarin (international normalised ratio 1.1-1.6), or aspirin (150 mg/day) (stratum 1). Patients ineligible for standard anticoagulation were randomly assigned to low anticoagulation or aspirin (stratum 2). MAIN OUTCOME MEASURES: Stroke, systemic embolism, major haemorrhage, and vascular death. RESULTS: 108 primary events occurred (annual event rate 5.5%), including 13 major haemorrhages (0.7% a year). The hazard ratio was 0.91 (0.61 to 1.36) for low anticoagulation versus aspirin and 0.78 (0.34 to 1.81) for standard anticoagulation versus aspirin. Non-vascular death was less common in the low anticoagulation group than in the aspirin group (0.41, 0.20 to 0.82). There was no significant difference between the treatment groups in bleeding incidence. High systolic and low diastolic blood pressure and age were independent prognostic factors. CONCLUSION: In a general practice population (without established indications for coumarin) neither low nor standard intensity anticoagulation is better than aspirin in preventing primary outcome events. Aspirin may therefore be the first choice in patients with atrial fibrillation in general practice.

Aged↗

Bioethics for clinicians: 17. Conflict of interest in research, education and patient care.

A conflict of interest occurs in a situation in which professional judgement regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial gain or personal prestige. Conflicts of interest exist in every walk of life, including medicine and science. There is nothing inherently unethical in finding oneself in a conflict of interest. Rather, the key questions are whether one recognizes the conflict and how one deals with it. Strategies include disclosing the conflict, establishing a system of review and authorization, and prohibiting the activities that lead to the conflict.

Bioethics↗

Towards the right to be killed? Treatment refusal, assisted suicide and euthanasia in the United States and Canada.

This chapter describes some dominant trends of American and Canadian law in relation to treatment refusal, physician-assisted suicide and euthanasia. Although common law in both countries recognizes the right of patients to refuse treatment, problems have arisen, especially in the US, over treatment refusal on behalf of incompetent patients. One response has been to enact advance-directive legislation, promoting the use of living wills and proxy appointments. Courts have also specified criteria for withholding and withdrawing treatment from incompetent patients. The notion of a "right to die', developed in court cases on treatment refusal, is now being invoked to support the legalization of assisted suicide. Courts are generally reluctant to recognize an extention of this right. Debates and court cases following the recent initiative to legalize assisted suicide in Oregon and the Sue Rodriguez case in Canada's Supreme Court, which resulted in a special report of a Canadian Senate Committee, are of major importance for the development of law in this area.

Canada↗