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Consent Procedure (consent + procedure)
Selected AbstractsCONSENT, COMMODIFICATION AND BENEFIT-SHARING IN GENETIC RESEARCH1DEVELOPING WORLD BIOETHICS, Issue 2 2004DONNA DICKENSON ABSTRACT The global value of the biotechnology industry is now estimated at 17 billion dollars, with over 1300 firms involved as of the year 2000.2 It has been said that ,What we are witnessing is nothing less than a new kind of gold rush, and the territory is the body.' As in previous gold rushes, prospectors are flooding into unexplored and ,wide open' territories from all over the world, with possible ramifications for exploitation of Third World populations. These territories are also the Wild West of bioethics insofar as the law has very little hold on them: existing medical and patent law, such as the Moore and Chakrabarty cases, exert little control over powerful economic interests in both the United States and Europe. In the absence of a unified and consistent law on property in the body, the focus is increasingly on refining the consent approach to rights in human tissue and the human genome, with sensitive and promising developments from the Human Genetics Commission and the Department for International Development consultation on intellectual property. These developments incorporate the views of vulnerable genetic communities such as Native Americans or some Third World populations, and should be welcomed because they recognise the power imbalance between such groups and First World researchers or firms. However, they also highlight the continued tension about what is really wrong with commodifying human tissue or the human genome. Where's the injustice, and can it be solved by a more sophisticated consent procedure? [source] Genetic research into Alzheimer's Disease: a European focus group study on ethical issuesINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 1 2008Anco van der Vorm Abstract Background Nowadays, there is an increasing interest in the heritable aspects of Alzheimer's Disease (AD). The ethical implications of this kind of research are also attracting attention. However, relatively few open-ended qualitative studies have been carried out to study these aspects. Objective To explore and analyse ethical issues raised by genetic research into AD. Methods A modified focus group technique. Results Participants stressed the importance of relatives in genetic research and suggested a family consent procedure. The consent procedure ought to be more uniform within Europe and should allow for variation in the types of research being done. The long-term results of genetic research into AD are expected to be positive while the short-term results seem likely to be negative. The perception of AD as a disease could be changed by the results from genetic research into AD, and this could have effects at the individual level (feelings of guilt and responsibility for one's own health). Conclusions (1) The role of the family in genetic AD research differs from its role in other biomedical research into AD. The development of a family consent procedure might solve some informed consent problems. (2) Negative social consequences of genetic AD research are expected in the short term, but there are hopes of positive consequences in the long term. Copyright © 2007 John Wiley & Sons, Ltd. [source] Informed Consent for Research: Current Practices in Academic Emergency MedicineACADEMIC EMERGENCY MEDICINE, Issue 6 2008Edward Monico MD Abstract Background:, The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research. Objectives:, The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs. Methods:, Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME). Results:, Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects. Conclusions:, It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines. [source] Active Parent Consent for Health Surveys With Urban Middle School Students: Processes and Outcomes,JOURNAL OF SCHOOL HEALTH, Issue 2 2010Molly Secor-Turner PhD BACKGROUND: To achieve high participation rates and a representative sample, active parent consent procedures require a significant investment of study resources. The purpose of this article is to describe processes and outcomes of utilizing active parent consent procedures with sixth-grade students from urban, ethnically diverse, economically disadvantaged K-8 public schools involved in an evaluation of a middle school service-learning program. METHODS: As part of the evaluation of the Lead Peace-Plus service-learning program, active parent consent was obtained for participation in school-based health surveys conducted with sixth graders in 3 schools. To achieve acceptable rates of parent permission, we employed multiple procedures including regular communication with school staff, incentives for involved schools and teachers, a multipronged approach for reaching parents, and direct encouragement of students to return forms through repeated classroom visits, individual and classroom incentives. We used Fisher's exact tests to compare selected characteristics among students whose parents weren't reached, those whose parents refused, and those whose parents consented to survey participation. RESULTS: We achieved a parent response rate of 94.6% among sixth-grade students. No significant differences in student gender, race/ethnicity, school, or free/reduced lunch status were identified across parent consent status groups. Rates of absenteeism were significantly higher (p = .03) among students whose parents weren't reached compared to other groups. CONCLUSIONS: Employing a multifaceted active parent consent campaign can result in high rates of parental response with limited sampling bias among an urban, ethnically diverse and economically disadvantaged group of middle school students. [source] The Challenge of Cross-Cultural Clinical Trials Research: Case Report from the Tibetan Autonomous Region, People's Republic of ChinaMEDICAL ANTHROPOLOGY QUARTERLY, Issue 3 2005VINCANNE ADAMS Efforts to conduct Western clinical research in non-Western medical settings with little or no familiarity with such methodologies are on the rise, but documented accounts of the ways that biomedical science requires negotiation and translation across cultures are not plentiful. This article adds to this literature through analysis of an NICHD-funded collaborative research effort in women's health carried out in the Tibetan Autonomous Region of the People's Republic of China. The research involved a feasibility study for an eventual clinical trial comparing Tibetan medicine with misoprostol for preventing postpartum hemorrhage in delivering women. It explores strategies of negotiation and translation in and around notions of the scientific method, informed consent procedures, randomization, blinding, placebo, and concepts of medical standardization. [source] | |||||||||||||