“It’s all about trust”: reflections of researchers on the complexity and controversy surrounding biobanking in South Africa

Abstract

BackgroundBiobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented.MethodsIn-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors.ResultsResearchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust.ConclusionBuilding trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.Electronic supplementary materialThe online version ...

Perspectives regarding privacy in clinical research among research professionals from the Arab region: an exploratory qualitative study

“…In a large survey in the US, willingness to participate in a biobank was lower in individuals who reported lower levels of trust in the healthcare system and their researchers [46]. In low-and middle-income countries, failure to engage with communities has been recognized as a cause for erosion of trust in researchers [50].…”

Decolonising research methodologies: lessons from a qualitative research project, Cape Town, South Africa

“…Trust is one of the important structures that underpin good research practice and a crucial indicator for sound relationships in a research process [27,28]. As reported by Moodley and Singh [27], colonialism and apartheid has perpetuated the lack of trust of scientists.…”

“…Trust is one of the important structures that underpin good research practice and a crucial indicator for sound relationships in a research process [27,28]. As reported by Moodley and Singh [27], colonialism and apartheid has perpetuated the lack of trust of scientists. The authors further point out that there is a need for a cultural revolution in health research which can be achieved through prioritising community engagement as a strategy to build trust in the research process.…”

Techno-Science and the Scientific Ethos: The Outlines of Ethics of Biobanking Through the Eyes of the Russian Scientific Community (Based on a Survey of Specialists in the Field of Biomedicine and Related Research Activities)

“…При этом подавляющее большинство респондентов указали в качестве основной причины имеющихся затруднений недостаточность нормативно-правовой базы, приводящую к «традиционалистской» модели управления,в каждом учреждении собственные традиции и основания для преодоления разногласий и разрешения нестандартных ситуаций отсутствуют (отметим, что такое положение характерно для «периферийных» с точки зрения развития биобанкинга, бедных и развивающихся стран -см. [Moodley, Singh 2016;Zawati et al 2018 Респондентов, готовых обозначить этические проблемы, с которыми им сталкиваться не приходилось, но которые они считают значимыми, оказалось около половины от общего числа принявших участие в исследовании (47,8 %). Наиболее часто в ответах фигурировала все та же проблема получения информированного согласия (в частности, отмечалась необходимость выработки доступной и понятной донору формы сообщения сведений о возможных траекториях дальнейшего использования биоматериалов, поскольку в настоящее время большинство подписывает согласия «не глядя»), защиты информации о доноре и анонимизация материалов при их использовании в рамках исследовательских проектов, а также возможности злоупотреблений технологиями и материалами коллекций:…”

“…В то время как научные сообщества бедных и развивающихся стран в качестве основных проблем отмечают нехватку доверия между всеми участниками биобанкинга, возможности злоупотреблений в связи со слабо развитым регулированием и беспокойство о защите коммерческих и иных прав в рамках международных проектов (беспокойство вызывает монополизация прав на все результаты таких проектов развитыми странами, коллективы и институты которых имеют для этого ряд серьезных объективных преимуществ, -от нормативно-правовой базы до технологического и научного лидерства) [Moodley, Singh 2016;Zawati et al 2018], научные сообщества стран-лидеров отмечают давление индустрии и сложности в балансировке частных интересов и общественного блага [Kadri 2011]. «Прежде всего утилитарный уклон в отношении норм и руководств, предназначенных для развития коллекций и использования данных пациентов недостаточно уравновешен ориентированным на необходимость защиты прав пациента этическим подходом, -пишут авторы, исследовавшие этические установки представителей швейцарской системы здравоохранения.…”