Broad Consent for Genomic Research and Biobanking: Perspectives from Low- and Middle-Income Countries.

Abstract

Genomic research and biobanking are increasingly being conducted in the context of collaborations between researchers in high-income countries and those in low- and middle-income countries. Although these scientific advancements have presented unique opportunities for researchers to contribute to cutting-edge scientific projects and address important health problems, they have also challenged existing ethical and regulatory frameworks, particularly in sub-Saharan Africa. Broad consent is a model that allows the use of human biological samples and associated data in future research that may be unrelated to the original study. Drawing on emerging perspectives in low- and middle-income countries, we argue that broad consent is equivalent to consent to governance and that a robust governance framework for genomics and biobanking should seek to promote global health and research equity and take into account five key elements: respect, authentic community engagement and trust building, the preservation of privacy and confidentiality, feedback of results, and capacity strengthening.