Valid consent to research partitipation is usually said to require that the participant has been adequately informed about and understood the nature of the research. In the context of genomics research bringing together partners in many countries in both high-income and low-income countries, it seems unrealistic to expect that research participants will 'fully' understand the nature of the research project. Indeed, many of the scientists participating in the research will themselves not fully understand all of the different aspects of the research project. Given this, what level of understanding should be considered necessary for the participants to be considered to have given their valid consent to, for example, a project using genomic approaches to understanding susceptibility to malaria which requires a blood sample and associated clinical information from their sick child?
Hi Mike. Just to add some extra food for thought: when discussing these issues in the context of MalariaGEN research, myself and colleagues seem to have come to the opinion that relying on consent only is not sufficient for genomics research. Not only is it important that consent is tied in with some form of community engagement, but also that sufficient mechanisms exist that protect the interests of research participants later in the study. One example, very relevant for genomics research, relates to data sharing. Current practice in genomics is that data is shared with other researchers. Different views exist about the extent to which such access to data should be regulated. Some would argue that in order to promote the re-use of such data (and therefore to speed up scientific discovery), it is paramount that data is shared without restriction. For others, it is important that data sharing is regulated. I think that the example of 'imperfect consent' in the case of genomics research, shows us that it is important to regulate data sharing.