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

Abstract

Background/rationale: Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. Objectives: The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. Methods: A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms ‘HIV/AIDS’, ‘informed consent’, ‘clinical trials’, ‘developing world’. Results: Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Discussion: Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. Conclusions: International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.

Les problèmes éthiques concernant la recherche humaine dans le monde en voie de développement font l'objet d'une évaluation soutenue; un secteur de préoccupation important concerne le consentement éclairé. Ce document passe en revue plusieurs des aspects moraux et pratiques les plus saillants de ce consentement éclairé dans le cadre de la recherche sur le VIH dans les pays en voie de développement. L'amélioration de la compréhension globale de cette problématique pourrait promouvoir un niveau de valeur morale élevé pour le futur de la recherche. Le but principal était d'adresser le consentement éclairé dans le contexte de la recherche humaine dans les sociétés non-occidentales, et particulièrement dans le cas des essais cliniques sur le VIH chez les adultes affectés. Les résultats secondaires incluaient les complexités dans la recherche sur le VIH quant aux populations de patients vulnérables dans les nations à ressources limitées, comme les enfants, les adolescents et les femmes. Une critique systématique de la littérature publiée entre 1998 et décembre 2008, utilisant MEDLINE et EMBASE, a été conduite, en utilisant les termes de recherche ‘HIV/AIDS’, ‘informed consent’, ‘clinical trials’, ‘developing world’. Les complexités morales, comme l'autonomie réduite des participants, la coercition ou la motivation économique, les difficultés de langage, l'illettrisme ou le manque de compréhension de l'étude dans sa totalité, ainsi que les obstacles culturels dus principalement à l'importance de la vie communautaire et des diversités sociales ont été identifiées dans les 44 études qui ont été passés en revue. Dans le cas de populations de patients vulnérables, le consentement éclairé doit être taillé à leur genre et à leur stade de développement et concurremment, l'assistance psychosociale est fondamentale. Le consentement des enfants et des adolescents doit être assuré. La langue locale doit être utilisée et les chefs de communautés de confiance et des représentants culturels devraient transmettre l'information. En dépit de la nature diverse de ces études, des similarités ont été identifiées. Les pré-conditions/pré-requis fondamentaux de cette étude sont la provision adéquate et compréhensive d'informations et l'évaluation de la juste compréhension de la recherche. Des solutions potentielles aux secteurs de préoccupations cruciales sont entre autres l'assistance psychologique par les pairs du groupe lui-même et des réunions avec les chefs des communautés locales ou les représentants culturels. Les chercheurs internationaux dans le domaine de la recherche humaine sur le VIH devraient tenir compte de ces problèmes moraux et de leurs solutions potentielles, quand ils tentent d'assurer le comportement éthique dans la recherche, sur la base d'un consentement véritablement informé et culturellement pertinent.

Keywords:

• HIV/AID
• clinical trials
• developing world
• informed consent

Mots clés:

• VIH/SIDA
• tests cliniques
• monde en voie de développement
• consentement éclairé

Additional information

Notes on contributors

Kyriaki Mystakidou

Dr Kyriaki Mystakidou is Associate Professor at the Department of Radiology, Areteion Hospital, University of Athens and in charge of the Pain Relief and Palliative Care Unit. She has specialised in Pain Relief and Palliative Care since 1989. She is the President of the Hellenic Association of Pain Control and Palliative Care and a member of the European Association of Palliative Care since 1990. She is also a member of the editorial board of 3 international scientific journals, reviewer for 12 international scientific journals and writer in 17 monographs. She has implemented studies related to palliative care (121 articles in international scientific journals; 112 published and 9 in press) and 28 announcement abstracts in Greek conferences and 62 announcement abstracts in European and international conferences. As an Associate Professor she participates in educational lectures (graduate and postgraduate) of the Radiology Department of Medicine at the University of Athens and she is the professor in charge of graduate students. She has been a supervisor for six PhDs.

Irene Panagiotou

Dr Irene Panagiotou graduated with Honours from Athens Medical School in 1995 and received her Board Certification in Internal Medicine in 2005. In 1994, following a grant from the Athens Cultural Foundation, she studied Environmental Medicine for 6 weeks at New York University. During her residency she trained at the Oncology-Haematology Unit of Metaxa Cancer Hospital in Piraeus, Athens and specifically focused on supportive care of cancer patients. During 2002 she spent 7 months at Oregon Health Science University as a clinical research fellow. Her doctoral thesis was graded with ‘High Honours’. Furthermore, she received a postgraduate diploma from the National Ministry of Health in Emergency Medicine Crisis management. From 2008 she has been working as a physician at the Pain Relief and Palliative Care Unit of Areteion Hospital, Department of Athens University Medical School. She currently has 18 publications in peer-reviewed English medical journals, 14 abstracts in international meetings, 38 publications in Greek medical journals and 50 abstracts in Greek meetings. She has published 2 book chapters.

Stelios Katsaragakis

Dr Stelios Katsaragakis is a registered nurse. He works full-time, providing palliative care in the Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, University of Athens. He obtained his PhD in 2006. He participates in educational lectures in the Nursing School at the University of Athens. Dr Katsaragakis is also a writer of 4 chapters in 4 books. He has implemented studies in 7 articles, 20 announcement abstracts in international and Greek conferences and has participated in 34 conferences.

Eleni Tsilika

Eleni Tsilika is a Health Psychologist and she has worked full-time since 2000 providing support to patients and their families at the Department of Radiology, University of Athens, at Areteion Hospital in the Pain Relief and Palliative Care Unit. She has also cooperated with the Oncology Department of the General Hospital ‘G. Gennimatas’ in Athens for the psychological support of the patients who underwent surgery (1996 – 2000). She is also a PhD candidate at the University of Athens, School of Medicine. She has implemented studies related to psychological aspects in palliative care (60 publications in international scientific journals) and has participated in 10 international conferences (abstracts).

Efi Parpa

Efi Parpa is a Clinical Psychologist and she has worked full-time since 2000 providing support to patients and their families at the Department of Radiology, University of Athens, at Areteion Hospital in the Pain Relief and Palliative Care Unit. She participates in educational lectures (graduate and postgraduate) and is specialised in relaxation techniques and in cognitive behaviour skills. She is also a PhD candidate at the University of Athens, School of Medicine. She has implemented studies related to psychological aspects in palliative care (64 publications in international scientific journals). She has participated in 10 international (abstracts) and in 6 national conferences.