Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...) third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Considered to be one of the most important philosophical works of all time, the History of Western Philosophy is a dazzlingly unique exploration of the ideologies of significant philosophers throughout the ages – from Plato and Aristotle through to Spinoza, Kant and the twentieth century. Written by a man who changed the history of philosophy himself, this is an account that has never been rivalled since its first publication over 60 years ago. This special collector’s edition features: a brand new (...) foreword by Anthony Gottlieb, who is Executive Editor of The Economist, a Visiting Fellow at Harvard University, and a regular contributor to the New York Times Book Review. He studied Philosophy at Cambridge University and is the author of The Dream of Reason – A History of Philosophy from The Greeks to The Renaissance a number of beautiful colour plates. Sumptuous fine art paintings such as Dufresnoy’s Death of Socrates and Raphael’s School of Athens depict the importance and influence of philosophy, and the centrality of the western philosophical tradition throughout the ages. The History of Western Philosophy is a definitive must-have title that deserves a revered place on every bookshelf. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Jurisprudence explores fundamental questions about law and justice from a philosophical and theoretical perspective. Rather than merely describing the field, the book provides rigorous evaluation of jurisprudential arguments and explains in clear, accurate and accessible terms, the complex and cutting-edge debates which define the field of contemporary jurisprudence.

Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub-Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an ‘African worldview’, hence, demand for their strict implementations reeks of ‘bioethical imperialism’. Two, they have other discernible inadequacies – lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non-Western societies. Consequently, these guidelines (...) have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies. This framework is proposed using an analogy of Legal Realism, specifically its key assertions on how, in reality, judicial systems operate using general legal rules to settle specific cases. Legal realists assert that in judicial decision-making, general legal rules do not totally dictate court decisions in specific cases. This analogy is used to coin a new term, ‘Bioethical Realism.’ The framework suggests that local Research Ethics Committees ought to be construed as analogues of judicial courts with the resulting implications. Consequently, just like legal rules are general rules that do not always dictate court decisions, similarly international bioethical guidelines are general ethical rules that should not always dictate local RECs’ decisions and such decisions (ought to) enjoy considerable immunity from outsiders. (shrink)

BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation were (...) randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.ResultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.ConclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612. (shrink)

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)

Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant’s autonomy. (...) The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics. (shrink)

We conducted a study to review the consenting process in a vaginal Microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not (...) attained from most of the participants since 77% of the participants had numerous questions about the study and 34% did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations. (shrink)

Abstract:This article deals with the question as to what makes bioethics a critical discipline. It considers different senses of criticism and evaluates their strengths and weaknesses. A primary method in bioethics as a philosophical discipline is critical thinking, which implies critical evaluation of concepts, positions, and arguments. It is argued that the type of analytical criticism that restricts its critical role to critical thinking of this type often suffers from other intellectual flaws. Three examples are taken to demonstrate this: premature (...) criticism, uncritical self-understanding of theoretical assumptions, and narrow framing of bioethical issues. Such flaws can lead both to unfair treatment of authors and to uncritical discussion of topics. In this context, the article makes use of Häyry’s analysis of different rationalities in bioethical approaches and argues for the need to recognize the importance of communicative rationality for critical bioethics. A radically different critical approach in bioethics, rooted in social theory, focuses on analyses of power relations neglected in mainstream critical thinking. It is argued that, although this kind of criticism provides an important alternative in bioethics, it suffers from other shortcomings that are rooted in a lack of normative dimensions. In order to complement these approaches and counter their shortcomings, there is a need for a bioethics enlightened by critical hermeneutics. Such hermeneutic bioethics is aware of its own assumptions, places the issues in a wide context, and reflects critically on the power relations that stand in the way of understanding them. Moreover, such an approach is dialogical, which provides both a critical exercise of speech and a normative dimension implied in the free exchange of reasons and arguments. This discussion is framed by Hedgecoe’s argument that critical bioethics needs four elements: to be empirically rooted, theory challenging, reflexive, and politely skeptical. (shrink)

Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...) do not necessarily invalidate consent by phase 1 trial participants. (shrink)