Ethical and Social issues in Informed Consent Processes in African Genomic Research

Erisa Sabakaki

Makerere University

Uganda

Sub Saharan Africa (SSA), which bears 24% of the world’s burden of disease, is also home to: the highest human genetic diversity, vast array of environments, and a diversity of cultural practices. Whereas most of this disease burden has till recently been attributed to various infectious diseases like HIV/AIDS, the onset of the new and concurrent non communicable diseases epidemic is creating unique opportunities for the application of genomic research techniques on various health related challenges. The NIH funded the H3Africa studies to provide new opportunities to African scientists to lead research on the genetic and environmental contributors to health and disease issues of importance to Africa through the use of genomics and other cutting-edge approaches. Genomic research thus raises a unique set of ethical, legal and social challenges for further exploration towards ensuring that there is adequate protection of research participants, communities and researchers. The informed consent process is one of the recognized strategies currently in use, aimed at avoiding the exploitation of research participants. However, there are concerns about research participants’ ability to understand the concepts of genomic research, storage, future use of biological samples and the potential risk of stigma or exploitation of study communities. The long term goal of the project is to contribute to a better understanding of the ethical legal and societal issues associated and the eventual protection of various genomic research stakeholders in low resource settings. The study seeks to explore the knowledge, perspectives and experiences of various African study stakeholders on the informed consent processes in on-going genomic research studies so as to explore culturally appropriate strategies of enhancing understanding during the consent and assent process in genetic/genomics research. The study will be conducted at a national referral and university teaching hospital by a well-qualified multi- disciplinary team comprising of seasoned researchers, bioethicists, pediatricians and social scientists. The study proposes a mixed method design that will employ both quantitative and qualitative methods of data collection and analysis. Prospective evaluation will be done using questionnaire surveys; focus group discussions; in-depth interviews; direct observation of informed consent processes; and assessment of the quality of informed consent. Participants will include key stakeholders in genomic research including researchers, bioethicists, REC members, research participants and caregivers/guardians of children participating in genomic research. The proposed project will run for a period of 3 years. We hypothesize that most stakeholders, which includes the caregivers, may have or develop unique, contextualized, and sometimes-unintended misunderstandings of the ethical legal and societal issues associated with genetic/genomic research. The study will also generate preliminary data for the development of follow-up R01 grant applications aimed at answering the new research questions arising from the study findings and building human resource research capacity on this. Finally for long term sustainability, the research team will work closely with the local national research regulatory authorities to eventually influence research related laws and policy.