An Approach to Addressing Ethical Issues in a Community-Based Risk Assessment for HIV: A Case from Chennai, India

By Sivaram, Sudha; Srikrishnan, Aylur Kailasom et al. | Journal of Health Population and Nutrition, June 2005 | Go to article overview

An Approach to Addressing Ethical Issues in a Community-Based Risk Assessment for HIV: A Case from Chennai, India


Sivaram, Sudha, Srikrishnan, Aylur Kailasom, Murgavel, Kailapuri G., Mayer, Kenneth H., Anand, S., Celentano, David D., Solomon, Suniti, Journal of Health Population and Nutrition


INTRODUCTION

Classical principles of epidemiology are the cornerstones of medical research. Epidemiology is concerned with the distribution of diseases and factors that influence their prevalence (1). Data from epidemiological research often inform public-health programmes and practices (2). Epidemiology of HIV, by extension, explores the risk factors associated with prevalence of HIV and its incidence in communities. Such findings have been used for planning prevention programmes for communities at elevated risk (3), to evaluate new diagnostic procedures for detecting HIV (4), and to plan services that cater to the needs of those living with HIV/AIDS.

Collecting information from individuals for epidemiological research on HIV is a challenging task. Given the stigma associated with HIV in most societies and the lack of a cure, many individuals may hesitate to participate in research programmes that require disclosure of personal behaviour or blood testing. Further, when it comes to assessing behavioural risk factors that influence the spread of HIV, participants may feel uncomfortable and even offended when asked to share information about personal sexual or other behaviours that many perceive as taboo subjects. Research conducted irresponsibly, thus, has the potential to harm many persons. It is here that medical ethicists underscore the importance of upholding human rights of potential study participants.

Three principles of medical ethics have been outlined (5). The first principle is the requirement of respect for all participants. Here, the role of informed consent becomes vital. Informed consent refers to a process of providing potential research participants with necessary information about a study to allow them to decide their participation (6). In addition to voluntary participation, ethics mandates that research data be kept confidential and that researchers disclose the risks and benefits arising from participation in the study. The second bioethical principle is to undertake research only where the benefits outweigh the risks to the participant, and the third is the principle of justice where study participants are treated equitably and with respect. These principles offer guidance to clinicians as they begin a clinical trial so that they can brainstorm about methodologies to ensure that human rights are upheld.

However, as Kass argues (7), these principles assume a certain level of autonomy of an individual that may not always be a practical reality in many public-health research contexts, such as those in developing countries. In several societies in the developing world, a married woman may have to seek permission from her family to take part. Along the same lines, administering questions on sexual behaviour to unmarried women in HIV studies might be considered offensive to some, where social mores dictate virginity until marriage. Thus, in community-based epidemiological research in developing countries, ethical principles need to go beyond the individual and encompass the cultural context within which study participation takes place.

Proposing guidelines for ethics in international health research, Bhutta outlines some issues for consideration in conducting clinical research (8). These include priority setting in the unique local context, community participation in the research process, agreements ensuring access to the benefits of research before the study is conducted, and developing research protocols that conform to local standards of care. These guidelines have had their applications. An example is a trial to evaluate the efficacy of neonatal care administered by health workers in India (9). The efficacious results set the stage for an approach to reducing neonatal mortality, which is different from standards of care in the developed world. Despite these developments in clinical trials in the developing world, there is still very little evidence of the ethical conduct of social science and epidemiological research in the context of developing countries. …

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