The Comprehensibility of Informed Consent Documents in HIV-related Clinical Trials: A Case Study of the Consent Document Used in a South African HIV Antiretroviral Drug Trial

By Annelize G Nienaber.

Published by The Humanities Collection

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Article: Print $US10.00
Article: Electronic $US5.00

Informed consent to participation in clinical research is an ethical and legal requirement. In order to achieve consent that is informed research participants need to understand the information that has been provided. Moreover, they have to understand the impact of that information on all aspects of their lives, such as its impact on their physical, emotional and social well-being. A research participant’s ability to comprehend or understand information is a function of her intelligence, maturity and linguistic abilities. Information of a scientific or technical nature is difficult to understand for lay people all over the world, no matter their levels of education. In the context of the developing world, where poverty, low levels of education and illiteracy are the order of the day, the comprehension of scientific and technical information poses significant challenges to the research participant. In South Africa, due to their socio-economic background, preventive HIV-related clinical trial participants are likely to be illiterate, to have little medical or scientific knowledge and to be second-language speakers of English. There are also likely to be cultural differences between the researcher and the research participants. In this context the paper explores the comprehensibility of the informed consent document used in the XYZ-123 HIV antiretroviral drug trial. The paper concludes that, although efforts were made to increase the document’s readability, these added little to the comprehensibility of the document, so that many obstacles to comprehension remained.

Keywords: Applied Ethics, Informed Consent, Comprehensibility, HIV, Clinical Research, Africa, Drug Trial

International Journal of the Humanities, Volume 8, Issue 9, pp.183-196. Article: Print (Spiral Bound). Article: Electronic (PDF File; 657.309KB).

Prof. Annelize G Nienaber

Professor, Department of Legal History, Comparative Law and Legal Philosophy, Faculty of Law, University of Pretoria, Pretoria, South Africa

Professor Annelize Nienaber holds a Masters’ degree in constitutional and human rights law and a Doctorate in human rights law and medical law and ethics. Her doctoral thesis was entitled ‘Ethics and human rights in HIV-related clinical trials in Africa with specific reference to informed consent in preventive HIV vaccine efficacy trials in South Africa’. She is the legal advisor to the Clinical Research Ethics Committee of the Faculty of Health Sciences at the University of Pretoria and Chairperson of the Faculty of Law’s Research Ethics Committee. She is the editor of the African Human Rights Law Journal and the assistant editor of the Journal of Contemporary Roman Dutch Law. She works for the Center for Human Rights (a NGO) on a part-time basis. She has published widely in the field of human rights law and the law pertaining to clinical research.

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