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Key points

Though cataract missions perform an obvious good of restoring sight, this in itself does not ethically sanction their existence due to an intersection with cultural, social, and economic factors of the host country.
Current guidelines do not adequately address the many ethical issues that may arise during these missions necessitating further ethical consideration.
Not all countries beset by high rates of cataract‐related blindness are similar in their need. The specific context of the host country ought to inform the purpose and execution of cataract missions.

Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom ( phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues.

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider-initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse ('opt out'). While these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of 'provider-initiated' testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource-poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS.

The human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic, and responses to it, have exposed clear political, social and economic inequities between and within nations. The most striking manifestations of this inequity is access to AIDS treatment. In affluent nations, antiretroviral treatment is becoming the standard of care for those with AIDS, while the same treatment is currently only available for a privileged few in most resource-poor countries. Patients without sufficient financial and social capital -- i.e., most people with AIDS -- die each day by the thousands. Recent AIDS treatment initiatives such as the UNAIDS and WHO "3 by 5" programme aim to rectify this symptom of global injustice. However, the success of these initiatives depends on the identification of people in need of treatment through a rapid and massive scale-up of HIV testing. In this paper, we briefly explore key ethical challenges raised by the acceleration of HIV testing in resource-poor countries, focusing on the 2004 policy of routine ("opt-out") HIV testing recommended by UNAIDS and WHO. We suggest that in settings marked by poverty, weak health-care and civil society infrastructures, gender inequalities, and persistent stigmatization of people with HIV/AIDS, opt-out HIV-testing policies may become disconnected from the human rights ideals that first motivated calls for universal access to AIDS treatment. We leave open the ethical question of whether opt-out policies should be implemented, but we recommend that whenever routine HIV-testing policies are introduced in resource-poor countries, that their effect on individuals and communities should be the subject of empirical research, human-rights monitoring and ethical scrutiny.

Dans les régions marquées par un contexte socioéconomique difficile, les difficultés sont plus nombreuses qu'ailleurs pour ceux qui se donnent pour tâche de former à la réflexion éthique les professionnels de la santé et les chercheurs. Pour le montrer, nous évoquons dans cet article nos expériences en République Démocratique du Congo. Une première difficulté est à chercher du côté linguistique. En effet, la langue et la culture anglo-saxonnes dominent largement la discipline, compliquant la tâche de ceux qui maîtrisent mal l'anglais. Une deuxième difficulté à surmonter est d'ordre conceptuel. Les objectifs et le champ d'application de la bioéthique sont souvent mal compris, ce qui peut conduire à confondre les spécialistes de la discipline tantôt avec des moralistes surtout préoccupés par le progrès biotechnologique, tantôt avec des référents religieux. La troisième difficulté évoquée est de nature politique et culturelle. Lorsqu'elle entre en interaction avec des communautés très hiérarchisées et conservatrices, la posture critique de la bioéthique peut susciter des réactions de rejet. Ce sont sans doute ces difficultés qui ont alimenté certaines critiques acerbes sur la pertinence des formations à l'éthique dans des zones marquées par les urgences sanitaires et alimentaires ou certaines accusations présentant ces démarches comme un avatar de plus de l'impérialisme occidental. Tout en prenant au sérieux ces difficultés, nous montrons par nos expériences qu'elles peuvent être transformées en défis à relever. ; In regions marked by socio-economic turmoil, the task of teaching bioethics to health professionals and researchers can be more challenging than elsewhere. To demonstrate this, in this article we describe some of our teaching experiences in the Democratic Republic of Congo over the past decade. A first difficulty is linguistic. Anglo-Saxon language and culture largely dominates the field of bioethics, complicating teaching and education for those who do not master the language. A second obstacle is conceptual. Bioethics is often misunderstood as reflection on technological developments in medicine, which distorts its objectives and narrows its scope, particularly in resource-constrained settings. A third difficulty is cultural and political. Ethics in this setting is difficult to distinguish from common morality and the work of moralists, who comment on problems in medicine from a religious standpoint. Moreover, when interacting with communities and institutions that are strongly hierarchical, the critical stance of bioethics can give rise to resistance and rejection. These are among the array of difficulties that undoubtedly have given rise to sharp critiques of bioethics training initiatives in developing countries, where the introduction of bioethics has been depicted as a form of Western imperialism. While taking these criticisms seriously, our experiences in the field show how these seemingly insurmountable difficulties can be transformed into (more or less) manageable challenges.

BackgroundThe objective of this study was to develop a culturally appropriate approach for obtaining assent from children aged eight to 17 years to participate in paediatric HIV‐related operational research in Kinshasa, Democratic Republic of Congo (DRC). Included within this objective was to determine whether or not HIV disclosure should be included as part of the assent process prior to research participation, a component of research participation, or not incorporated in any aspect of the child's involvement in the research. Factors that influence parents' and caregivers' decisions to disclose HIV status to children in non‐research contexts were also explored.MethodsA qualitative formative study was conducted. Semi‐structured interviews were conducted with 19 youth living with HIV, 36 parents and caregivers of youth living with HIV, and 17 health professionals who provide care and support to youth living with HIV and their families. Participants were purposefully selected from three HIV care, treatment and/or psychosocial support programmes in Kinshasa, DRC.ResultsMost youth interviewed believed minors participating in HIV‐related research should be informed of their HIV‐positive status. Parents and caregivers and health professionals had varied perspectives on if and when HIV status should be disclosed to minors during research participation. The age of the youth influenced parents and caregivers' responses, and disclosure to adolescents was more frequently supported than disclosure to children.Several parents and caregivers, as well as some health professionals, suggested that minors should never be told their HIV‐positive status when participating in HIV‐related research, regardless of their age. Within the context of treatment programmes, disclosure of HIV status to minors was supported by youth, parents and caregivers, and health professionals as a means to improve adherence to medication.ConclusionIn settings where most minors are unaware of their HIV infection, researchers should consider excluding the term, "HIV", when explaining HIV‐related research to minors, and omitting it from assent forms or informational sheets related to research participation. However, an individualized disclosure plan should be initiated with parents and caregivers at the time of enrolment in HIV‐related research, particularly in research that involves treatment.

AbstractIntroductionStakeholder engagement is an essential component ofHIVclinical trials. We define stakeholder engagement as an input by individuals or groups with an interest inHIVclinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to informHIVclinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement forHIVclinical trials and compare it to the recommendations of theUNAIDS/AVACGood Participatory Practice (GPP) guidelines.MethodsWe used thePRISMAchecklist and identified English language studies describing stakeholder engagement to informHIVclinical trials. Four databases (PubMed, Ovid,CINAHLand Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on theGPPguidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow‐up, results and dissemination.Results and discussionOf the 917 citations identified, 108 studies were included in the analysis. Forty‐eight studies (44.4%) described stakeholder engagement in high‐income countries, thirty (27.8%) in middle‐income countries and nine (8.3%) in low‐income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty‐five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engagingHIV‐affected community stakeholders (e.g. people living withHIV, at‐risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post‐trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%).ConclusionsOur findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages ofHIVclinical trials compared to later stages. In order to meet recommendations established in theGPPguidelines, greater stakeholder engagement across all clinical trial stages is needed.

ABSTRACTThe relationship between risks and benefits is central to the ethics of research involving human participants. Traditionally, to be ethically justifiable, risks should be reasonable in relation to anticipated benefits (if any) to subjects and to the potential social benefits resulting from research. This calculus is being further complicated by findings from an increasing number of social science studies that reveal that prospective and actual research participants frequently describe various types of inclusion benefits (for example, personal benefits such as access to or improved health care, increased knowledge about their disease or condition, and greater solidarity with the local community) as important to them. What is the ethical significance of such inclusion benefits, particularly those nonmedical in nature, for research ethics committees' risk‐benefit assessment of research studies? We argue that, unless participants are clearly mistaken in their perceptions, ethics committees should take these types of inclusion benefits into account, and we suggest a few ways this might look in practice.

Assessment of benefits is traditionally regarded as crucial to the ethical evaluation of research involving human participants. We conducted focus group discussions (FGDs) with health and other professionals engaged with adolescents, caregivers/parents, and adolescents in Siaya County, Kenya, to solicit opinions about appropriate ways of conducting HIV research with adolescents. Our data revealed that many focus group participants have a profoundly positive conception of participation in health research, including studies conferring seemingly few benefits. In this article, we identify and analyze five different but interrelated types of benefits as perceived by Kenyan adolescent and adult stakeholders in HIV research, and discuss their ethical significance. Our findings suggest that future empirical and conceptual research should concentrate on factors that may trigger researcher obligations to improve benefit perceptions among research participants.