Bmc Med Ethics
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The increasing push to commercialize university research has emerged as a significant science policy challenge. While the socio-economic benefits of increased and rapid research commercialization are often emphasized in policy statements and discussions, there is less mention or discussion of potential risks. In this paper, we highlight such potential risks and call for a more balanced assessment of the commercialization ethos and trends. ⋯ There is growing evidence that the pressure to commercialize is directly or indirectly associated with adverse impacts on the research environment, science hype, premature implementation or translation of research results, loss of public trust in the university research enterprise, research policy conflicts and confusion, and damage to the long-term contributions of university research. The growing emphasis on commercialization of university research may be exerting unfounded pressure on researchers and misrepresenting scientific research realities, prospects and outcomes. While more research is needed to verify the potential risks outlined in this paper, policy discussions should, at a minimum, acknowledge them.
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Evidence-based medicine (EBM) has always required integration of patient values with 'best' clinical evidence. It is widely recognized that scientific practices and discoveries, including those of EBM, are value-laden. But to date, the science of EBM has focused primarily on methods for reducing bias in the evidence, while the role of values in the different aspects of the EBM process has been almost completely ignored. ⋯ In this paper, we address this gap by demonstrating how a consideration of values can enhance every aspect of EBM, including: prioritizing which tests and treatments to investigate, selecting research designs and methods, assessing effectiveness and efficiency, supporting patient choice and taking account of the limited time and resources available to busy clinicians. Since values are integral to the practice of EBM, it follows that the highest standards of EBM require values to be made explicit, systematically explored, and integrated into decision making. Through 'values based' approaches, EBM's connection to the humanitarian principles upon which it was founded will be strengthened.
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International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. ⋯ Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.
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This article is part of a study to gain insight into the decision-making process by looking at the views of the relatives of potential brain dead donors. Alongside a literature review, focus interviews were held with healthcare professionals about their role in the request and decision-making process when post-mortal donation is at stake. This article describes the perspectives of the relatives. ⋯ Discrepancies between willingness to consent to donate and refusal at the bedside can be attributed to an unresolved dilemma: aiding people or protect the body of the deceased. Non-donor families felt incompetent to decide. They refused consent for donation, since their deceased had not given any directive. When ethical considerations do not lead to an unambiguous answer, situational factors were pivotal. Relatives of unregistered eligible donors are more prone to unstable decisions. To overcome ambivalence, coaching during decision-making is worth investigation.
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Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients' and healthy research participants' experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. ⋯ The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved.