In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting.

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To (...) gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. (shrink)

The recent desperation to clone human embryos may be seriously undermining accepted ethical principles of medical research, with potentially profound wider consequencesIn her editorial in the February 2005 issue of this journal, Nikola Biller-Andorno questioned whether the effort and resources that have been invested in debates about cloning at the United Nations might have been somewhat disproportionate, if a binding universal agreement on reproductive cloning cannot be reached.1 Although most of the overt disagreement has centred around “therapeutic” cloning, rather than (...) the potential use of nuclear transfer for reproduction, it is none the less clear that the delay and ultimate failure to date in achieving consensus on the former has also increased the likelihood of the latter becoming a foreseeable reality in the absence of a legally binding global convention. Whilst the much heralded promise of therapies has now been severely undermined by scandals of fraud,2 the available evidence from various primate studies3–5 and the history of similar work with other mammalian species6,7 have provided little reason to doubt that human reproductive cloning might be possible in principle . I completely agree with Dr Biller-Andorno’s appeal that we need to “foster a genuine, worldwide discourse on bioethical issues” and not let our debate get completely derailed by vested interests, whether politically or economically motivated. If we don’t, we can probably expect dire consequences for the future of biomedical research and its impact on society at large.Prior to the United Nations’ discussions regarding a ban on human cloning in October 2004, the Human Fertilisation and Embryology Authority in Great Britain announced that they had granted their first licence to clone human embryos by nuclear transfer,8 though no other applications had apparently been made following the legalisation …. (shrink)

Most agree that, if all else is equal, patients should be provided with enough information about proposed medical therapies to allow them to make an informed decision about what, if anything, they wish to receive. This is the principle of informed choice; it is closely related to the notion of informed consent. Contemporary clinical trials are analysed according to classical statistics. This paper puts forward the argument that classical statistics does not provide the right sort of information for informing choice. (...) The notion of probability used by classical statistics is complex and difficult to communicate. Therapeutic decisions are best informed by statistical approaches that assign probabilities to hypotheses about the benefits and harms of therapies. Bayesian approaches to statistical inference provide such probabilities. (shrink)

A mark of our modern age is the translation of the non-digital to the digital, an evolution likely only to accelerate and to demand the proactive development of robust ethical guidance to navigate...

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research (...) setting—the one of clinico-genomic research—we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings. (shrink)

In “Artificial Intelligence, Social Media and Depression: A New Concept of Health-Related Digital Autonomy,” Laacke and colleagues posit a revised model of autonomy when using digital algori...

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by (...) questionnaires. Results The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Discussion Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. Conclusion The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors. (shrink)

In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research (...) with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Current informed consent practices conform to the informed consent paradigm. Our intention is finally to promote patient autonomy through the provision of information intended to remove the information differential between doctor and patient. ICP is fundamentally flawed, since it is impossible to comprehensively and explicitly inform. A fundamental problem is our reliance on the container-conduit metaphor of informing. As a linguistic act, this metaphor conceptualises the process of informing as passive, when in reality informing and consequent sense-making are parts of (...) an individualised, personal and active process. The difficulties of the ICP are discussed, as are possible alternative strategies. Alternative models are also discussed. Concluding suggestions include drawing on an ethics of responsibility, incorporating the notion of informed consent as a transaction, debating the issues raised here and promoting the ethical empowerment of practising doctors. (shrink)