Since its inception the MRC Centre for Genomics and Global Health (CGGH) has maintained a strong focus on creating ethical frameworks for undertaking genomics research, often working with international networks including researchers in the developed and developing world who are in turn working with communities in diverse political and cultural landscapes.
One aspect of this work involves engaging with local ethics committees that are charged with evaluating and approving the study design for biomedical research projects. Dr Susan Bull, formerly the CGGH Senior Ethicist, says, “The broader aspects of my work involved talking to ethics committees and taking what they wanted to learn on board.”
Bull found that local ethics committees were increasingly asked to review genomics research or projects with a genomics component. Committee members often had no prior training in genetics or genomics; those that did had to grapple with rapid advances in the science itself.
While there are similarities between genomic studies and other types of biomedical research, there are also some important differences—differences that are directly relevant to the ethical review of genomic studies. These issues include the complexity of the studies, size of data sets, focus on long-term studies, and the international nature of collaborations.
Meeting a growing demand
“We had a remit for broader capacity building around these issues. We’d run trainings for ethics committees on an ad hoc basis, but wanted to make a resource more widely available, particularly with H3 Africa starting up,” recalls Bull.
H3 Africa is the abbreviation for Human Heredity & Health in Africa, a large-scale network of researchers undertaking genomics studies in Africa—and a clear indicator that this type of research is intensifying across the continent.
Reflecting on the impact that initiatives like H3 Africa are having on research ethics in Africa, Dr Clement Adebamowo, Director of the West African Bioethics training program, says, “We are witnessing a rapid increase in genomics research on the African continent. This has increased demand for ethical review of research protocols, continuing oversight of genomics research and engagement of the society. We therefore need to invest in educational resources that ethics committees and society needs for a successful engagement.”
Through prior work with MalariaGEN, the CGGH had developed a deep understanding of the ethical issues at play, and sought to develop a resource based on this experience that could be easily shared.
A flexible and accessible resource
“An opportunity appeared with Global Health Reviewers to make an online course at a low-cost. We also sought to make it more widely available by translating it into French, Spanish and Portugese, which we have done,” says Bull.
The resulting course, ‘Reviewing Genomics Research,’ was officially launched at the 2012 Forum for Ethical Review Committees in the Asian & Western Pacific Region (FERCAP), where it was well received.
To date more than 100 people have completed the course online. But Bull and her colleagues want to dig deeper than the download statistics. Working through Global Health Reviewers and in collaboration with the West African Bioethics training program, they’re trialling and assessing the course with ethics committees in Nigeria.
“Course participants normally complete a multiple choice test to receive certification. As part of this trial, we’re undertaking a pre-course test in addition to the post-course test. That gives us some baseline information and assesses the efficacy of the course. There’s also a satisfaction survey to see what participants’ value about the course,” explains Bull. “The course is being studied in a setting for which it was designed to assess the value and efficacy.”
While this research is ongoing, there is plenty to be proud of. “This course is a hugely significant intervention that takes advantage of the web to deliver the education that members of these committees need. Of course, it will need to be supplemented by other resources, but its fundamental importance and potential reach are undeniable,” says Adebamowo.
Informing efforts to build capacity
Reflecting on the impact of the course, Bull says, “It has been a good case study in its own right, leading us to confirm our policy at Global Health Reviewers to focus on advanced courses. General resources about medical research ethics are out there already. This specific course was sufficiently valued that it’s worth focusing on developing advanced courses on specific topics to supplement the general materials and online courses on research ethics that are currently available.”
The Global Health Reviewers website has since created an accompanying resource centre, a virtual space that aggregates information on the science and ethics of genomic research—providing additional resources for researchers and members of committees reviewing complex genomics research.
To access the ‘Reviewing Genomics Research’ course, create an account or login to the Global Health Trials website and follow the link below:
About Global Health Reviewers
Global Health Reviewers is an online community for those who review health-related research proposals, providing an expert guidance, information, support, training and resources. It is a part of the Global Health Network websites.
About West African Bioethics
The West African Bioethics (WAB) training program is funded by the U.S. National Institutes of Health through the Fogarty International Center to provide training and support for the development of international research bioethics in West Africa. To date, WAB has conducted training for up to 5,000 biomedical researchers in Nigeria and other West African countries in order to increase their awareness of bioethics and informed consent issues in research.