Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)

ABSTRACTThe concept of ‘vulnerability’ is well established within the realm of research ethics and most ethical guidelines include a section on ‘vulnerable populations’. However, the term ‘vulnerability’, used within a human research context, has received a lot of negative publicity recently and has been described as being simultaneously ‘too broad’ and ‘too narrow’.1 The aim of the paper is to explore the concept of research vulnerability by using a detailed case study – that of mineworkers in post‐apartheid South Africa. In (...) particular, the usefulness of Kipnis’s taxonomy of research vulnerability will be examined.2In recent years the volume of clinical research on human subjects in South Africa has increased significantly. The HIV and TB pandemics have contributed to this increase. These epidemics have impacted negatively on the mining industry; and mining companies have become increasingly interested in research initiatives that address these problems. This case study explores the potential research vulnerability of mineworkers in the context of the South African mining industry and examines measures that can reduce this vulnerability. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.

BackgroundFor over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/aids pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders’ perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared.MethodsThe study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively (...) selected participants. This included researchers, institutional review board members, a policymaker, HIV/aids advocates, and community advisory board members. The data obtained were inductively and deductively analyzed.Results Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness.ConclusionFair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region. (shrink)

This essay explores the claim that bioethics has become a mode of biopolitics. It seeks to illuminate one of the myriad of ways that bioethics joins other institutionalized discursive practices in the task of producing, organizing, and managing the bodies—of policing and controlling populations—in order to empower larger institutional agents. The focus of this analysis is the contemporary practice of transnational biomedical research. The analysis is catalyzed by the enormous transformation in the political economy of transnational research that has occurred (...) over the past three decades and the accompanying increase in the numbers of human bodies now subjected to research. This essay uses the work of Michel Foucault, particularly his notion of docile bodies, to analyze these changes. Two loci from the bioethics literature are explored—one treating research in the United States and one treating research in developing countries. In the latter, we see a novel dynamic of the new biopolitics: the ways in which bioethics helps to create docile political bodies that will police themselves and who will, in turn, facilitate the production of docile human bodies for research. (shrink)

This bibliographical study involved first the exploitation of four data-banks: Medline, CNRS, Bioethics and AIDS, with the following key words (in conjunction with AIDS): ethics, human rights, confidentiality, legislation, jurisprudence. A total of 412 references were listed between 1983 and the end of 1987. Examination of the quantitative increase of articles over these years shows that, while references to AIDS and/or HIV infection--referred to as 'AIDS' for brevity--increased by about one third per year, the number of papers treating ethical problems (...) linked to AIDS doubled each year. This increase makes it clear that these problems are important and pressing, that they are evolving rapidly and can be given no easy solution. After reading and analysis of accessible articles in readily comprehensible languages, the different themes can be classified in two categories: 1: Measures intended to protect society (starting with the most coercive); quarantine and isolation; discriminatory measures concerning specific groups; non-respect of the confidential nature of medical information; application of the penal code; screening; obligatory declaration and registration; testing of blood given by donors; vaccination and medical innovations, therapeutic assays; information, education. 2. Measures intended to protect the individual: fundamental rights of the patient: his/her right to confidentiality, to information and to treatment; civil rights: civil liberty, right to education, right to work, etc...; rights of the healthy individual: right of those in contact with the patients, safety of hospital staff, of those receiving blood-transfusions, etc... The legislation adopted in the various countries and the main opinions to be found in these articles are listed and analysed, and for each particular theme it is possible to refer to a list of the 232 most important articles. While the debate seems to concentrate on the conflict between the right of society to protect itself against the spread of infection and the 'civil' rights of the infected minorities, our conclusion tends to reduce this antagonism, showing that, particularly as far as the confidential nature of medical information is concerned, measures intended to protect the individual also protect society. (shrink)

No discussion of the informed consent process would be adequate without attention to dilemmas and challenges arising in research in foreign countries, particularly in the less developed countries. In an era of the human immunodeficiency virus and acquired immunodeficiency syndrome, for example, much attention to research issues concerning devastating health conditions in developed and less developed countries has occurred with renewed vigor.

We conducted and analyzed qualitative interviews with 12 persons working on the Healthy Public Housing Initiative in Boston, Massachusetts in 2001. Our goal was to generate ideas and themes related to the ethics of the community-based participatory research in which they were engaged. Specifically, we wanted to see if we found themes that differed from conventional research that is based on an individualistic ethics. There were clearly distinct ethical issues raised with respect to projects and individuals who engage in community-based (...) collaborations. The differences that arose from the interviews were seeking equality between the partners, the need for the community partner to defend the community, dealing with unflattering data, meeting community expectations and producing tangible benefits to the community. (shrink)