Negotiating the informed‐consent process in developing countries: a comparison of Swaziland and Pakistan

Abstract

Protecting the rights of research participants when conducting studies within an international context presents many challenges. The purpose of this article was to compare and contrast the process of obtaining informed consent in two very different countries - Swaziland and Pakistan. Major aspects of the informed-consent process presented included identification of gatekeepers, seeking permission from officials, negotiating with these officials and Institutional Review Board (IRB) committees in regard to the type of data to be collected, and explaining informed consent to participants in the field. Data for this article is based upon qualitative research of collaboration between nurses and healers in Swaziland and from a variety of studies completed in Pakistan. These studies demonstrate the inadequacy and complexity of applying western-based concepts of informed consent to developing countries.

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries

“…Ethical conduct of human research in settings of the developing world, where rights are not protected, is crucially important (Abdool Karim, 2000;Karim et al, 1998;Kass & Hyder 2001;Pace et al, 2005;Shapiro & Meslin, 2001;Upvall & Hashwani, 2001). …”

“…For example, in comparing the negotiation of informed consent in Pakistan and Swaziland (Upvall & Hashwani, 2001) participants were uncomfortable signing the form to participate in the study if they were illiterate or did not understand its content. Signing a consent form was particularly threatening to those patients, since signatures were only used for documenting major events such as marriage.…”

“…In any case, obtaining a signed informed consent is no guarantee that the participant has truly understood the proposed research (Pace et al, 2005;Shapiro & Meslin, 2001;Upvall & Hashwani, 2001). Research conducted on populations in developing nations often challenges the ability of participants to understand sufficiently the research and its implications (Crigger et al, 2001).…”

Informed consent in genetic research and biobanking in India: some common impediments

“…Several common hindrances are encountered while exercising informed consent in the context of developing countries. 4 ' 5 This paper has two objectives. It: (a) tries to map the common forms of hindrances encountered while exercising the principles of informed consent in defined social settings in India, and (b) attempts to suggest remedial measures that can strengthen the application of the principle of informed consent in the context of tribal and small scale communities in India.…”

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

“…Nesses países, comumente se evidenciam características que podem prejudicar a compreensão das informações da pesquisa e a voluntariedade desses participantes, como as precárias condições socioeconômicas 15,16,17 e as múltiplas interpretações de conceitos cientí-ficos, como: "voluntariedade", "randomização" e "benefícios e riscos" 18,19 . Diante dessas características, os participantes de pesquisas clínicas realizadas em países em desenvolvimento podem estar sujeitos à exploração de seus direitos 20,21,22 .…”