LAUSR

The ethical conduct of research in any setting hinges on the voluntary and informed consent of research participants. Working towards consent that is truly voluntary and informed, however, is far from straightforward, and requires attention to contextual factors that may complicate achievement of this ideal in specific research settings. This paper is based on Madagascar’s first “Consent complexities in health research in Madagascar” workshop, held in Antananarivo, Madagascar, in October 2018. It identifies a number of challenges encountered by individuals responsible for the conduct or oversight of health research in Madagascar related to informed and voluntary consent. Key challenges identified included: adaptation of consent tools into local dialects and for limited literacy populations; perceived acquiescence of potential participants regardless of actual preference based on cultural norms; perceived time pressures within tight project timelines to collect data as quickly as possible, limited time for consent processes; fears and taboos related to specific research procedures or topics; and, uncertainty about how best to approach and verify the validity of individual consent in contexts where traditional leaders’ influence is conventionally sought out and respected. Potential strategies for responding to each of these challenges are proposed, as are key questions meriting further study. Abstract La conduite éthique de la recherche, quel que soit le contexte, dépend du consentement volontaire et éclairé de ses participants. Cependant, assurer un consentement volontaire et éclairé est loin d’être facile, et nécessite une compréhension des facteurs contextuels qui peuvent compliquer sa réalisation dans des contextes de recherche particuliers. Cet article est basé sur le premier atelier sur les « Complexités du consentement à la recherche en santé à Madagascar », qui s’est tenu à Antananarivo, Madagascar, en octobre 2018. Y sont présentés différents défis liés au consentement libre et éclairé auxquels font face les personnes chargées de la mise en œuvre ou de la surveillance de la recherche en santé à Madagascar. Les défis clefs identifiés lors de l’atelier comprennent : la traduction et l’adaptation des protocoles pour usage en dialectes locaux et auprès de populations peu scolarisées; l’acquiescence perçue des participants à la recherche, conformément aux normes culturelles, et qui pourrait masquer leurs préférences réelles; les contraintes de temps engendrées par des échéanciers de recherche serrés qui allouent peu de temps à la collecte de donnée, et donc aux processus de consentement; l’existence de craintes et de tabous par rapport à certaines procédures ou certains sujets de recherche; et l’incertitude quant à comment approcher et comment s’assurer de la validité du consentement individuel dans des contextes où l’avis des chefs traditionnels est communément cherché et respecté. L’article propose des stratégies pour faire face à ces défis et des questions devant faire l’objet de recherches plus poussées. The ethical conduct of research in any setting hinges on the voluntary and informed consent of research participants. Working towards consent that is truly voluntary and informed, however, is far from straightforward, and requires attention to contextual factors that may complicate achievement of this ideal in specific research settings. This paper is based on Madagascar’s first “Consent complexities in health research in Madagascar” workshop, held in Antananarivo, Madagascar, in October 2018. It identifies a number of challenges encountered by individuals responsible for the conduct or oversight of health research in Madagascar related to informed and voluntary consent. Key challenges identified included: adaptation of consent tools into local dialects and for limited literacy populations; perceived acquiescence of potential participants regardless of actual preference based on cultural norms; perceived time pressures within tight project timelines to collect data as quickly as possible, limited time for consent processes; fears and taboos related to specific research procedures or topics; and, uncertainty about how best to approach and verify the validity of individual consent in contexts where traditional leaders’ influence is conventionally sought out and respected. Potential strategies for responding to each of these challenges are proposed, as are key questions meriting further study. tracked the points raised by each group on a flip chart, asking attendees to confirm the accuracy of these notes as she proceeded. All attendees had the opportunity to add to challenges, norms, and recommendations for next steps identified by members of other groups as their colleagues presented them, and these comments were also recorded on the flip chart. A summary of the workshop was prepared in the days following the workshop, based on the large group discussion recorded on flip chart notes. This report was circulated to all workshop attendees for their review, to provide the opportunity for additional suggestions and comments, and to ensure it represented an accurate record of key points raised in the workshop. Small suggestions on wording were obtained in this process. The revised report forms the basis for the present article.