Seeking consent to genomic research in developing countries

While there is explicit recognition in much of the international and national guidance that consent processes must be appropriately tailored to the research population and proposed study, there is relatively little advice about how this should be done in practice. In addition, much of the guidance is at a relatively general level, and does not provide specific advice about how to address issues such as those arising when seeking consent to genomic research in developing countries.

Examples of issues raised by MalariaGEN investigators when seeking consent to genomic research include:

• difficulties with explaining complex topics such as biomedical research and genetics;
• debates about how much detail consent processes should contain and when populations need to be reconsented for specific genomic analyses;
• appropriate timings to seek consent from parents of children with severe malaria; and
• the role of communities and research ethics committees in approving future uses of samples.

Susan Bull is leading a qualitative study with partners enrolling participants at three separate sites for the MalariaGEN Consortial Project 1 study (Navrongo, Bamako and Madang). This study aims to review the issues arising when seeking consent to Consortial Project 1 research at each site and the responses of the research teams when seeking to develop appropriate consent processes. Methods of data collection include semi-structured interviews and focus-group discussions with members of research teams, field-staff and research participants, as well as observation of consent processes. Findings from the study are expected to provide insights into best practice in seeking consent to genomic research in future studies. They are also expected to contribute to consortial considerations about potential ongoing engagement with research participants and their communities with regard to research results and future uses of genomic data.