Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS research and recent controversies (...) about revisions to the Helsinki Declaration, which have been seen by some to be motivated by the desire to facilitate exploitative research in countries, have stimulated renewed interest in the ethics of clinical research. (shrink)

ABSTRACTIn Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96.1 Consent must be obtained through a specific structured process.Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods.Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women living in the (...) metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women’s health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed.Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long‐term effects. The use of audiovisual aids to provide information was suggested.Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided. (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with a (...) very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

ABSTRACTBuilding trust between researchers and communities involved in research is one goal of community engagement. This paper examines the implications of community engagement for trust within communities, including trust among community volunteers who assist with research and between these volunteers and other community members. We describe the experiences of two groups of community volunteers recruited as part of an HIV and TB intervention trial in Malawi: cluster representatives, recruited both to act as key informants for TB suspects and mortality reporting (...) and to identify and report community concerns, and community counsellors, recruited to provide semi-supervised HIV self-testing. We examine tensions experienced due to playing multiple roles, and the implications of volunteer responsibilities for short- and long-term community relationships. Data was collected through a workshop, in-depth interviews and focus group discussions with volunteers and community members. While the volunteer system init... (shrink)

ABSTRACTLaws in China relating to HIV disclosure are inconsistent. After a patient has tested HIV‐positive, service providers struggle to decide who should be informed first: patients, family members, or both. To understand service providers' attitudes and practices regarding the HIV notification process in China, 1101 service providers from a southwestern province of China were surveyed. Opinions were gathered from providers at five different levels of health care facilities . A mixed methods approach was used to analyze perceptions of informing family (...) members of a patient's HIV status. Quantitative analysis was used to examine whether providers held a favorable attitude toward notifying family members first and qualitative analysis was used to explore the reasons and consequences of notifying family members first. Nearly half of service providers felt family members should be informed of a patient's HIV status first. Providers who were older, had contact with HIV patients, or had less medical education were more likely to agree with a family‐first notification practice. Psychological pressure, concern about protecting family members, the need for family support, and consideration for local regulations were cited as the main reasons for this practice. There is an immediate need to re‐examine HIV notification policies so that there are consistent guidelines and procedures for providers throughout China. (shrink)

ABSTRACTIn the novel Racists by Kunal Basu , two competing scientists initiate an experiment that they believe will prove which race is superior. The research subjects, one white and one black infant, are sequestered on an isolated island in the care of a mute nurse. The contest must be waged in a ‘natural laboratory’ with no artificial interventions and with the prospect that one will die at the hands of the other. The politics of empire, the slave trade and the (...) advent of a new scientific way of viewing life, Darwinism, set the stage for the fictional experiment, but the ramifications of such thinking extend into the present. Coming from the disciplines of nursing, philosophy and science, we discuss how a novel can illuminate the moral dimensions of science and healthcare.The critical distance afforded by the novel provides a rich terrain for the examination of issues such as race, care and the purity of science. Despite the recent dominance of social explanations of race, science requires the examination of the differences between human beings at the biological level. The view that biology is destiny is a powerful one with dangerous consequences, especially since the belief that certain human beings' destinies are far worthier than others is a corollary of such a view. In this paper, we present the cross‐disciplinary conversation, which has been facilitated by this novel. We hope this will inform ethics educators of the rich potential of using fiction as a pedagogical tool. (shrink)

Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.Method: Four to 12 months after completion of the trials, participants were contacted to (...) return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration.Results: A total of 334 participants completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication.Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored. (shrink)

ABSTRACTMedical students, subject to unique challenges and stressors, frequently engage in misconduct. In this observational study, carried out in a medical school in Colombia, we developed a survey to explore the association between misconduct and stress, potential stressors and other possible contributing factors, such as sex, age and academic year. Of the 433 students that responded to our survey, 97.9% did not fully disagree with at least one of the mentioned misconducts and 99.8% admitted to at least one transgression. Based (...) on a scale we developed, 61.4% of the students consistently agreed with misconduct and 44.9% frequently engaged in misconduct. A logistic regression model suggests that being male and stress may increase the likelihood of misconduct. In a subgroup of students, excluding those in their last year of studies, higher academic semester may also be a risk factor for misconduct. Most of the observed variation in the data, however, is not explained by these factors. Other modifiers, such as student personality and sub‐culture, may play a greater role in determining misconduct. The proportion of medical students that engage in misconduct is very high and warrants the attention of the medical education community. (shrink)

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...) too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

ABSTRACTThis article aims to compare the national legal systems that regulate biomedical research in an industrialized country and a developing country . A new international order is emerging in which Europe, Japan and the United States are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In (...) contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards , which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have been made (...) in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research. (shrink)