In the paper appearing in Plos Medicine researchers from MalariaGEN outlined the challenges of coming up with data release guidelines for genome-wide association studies in developing countries. In particular, the team discussed the rationale behind the timing of data release, uses of the data, and data access oversight in MalariaGEN, highlighting the need to balance these factors with research ethics.
"It's about being committed to open access and data sharing without endangering scientific capacity in developing countries," lead author Michael Parker, a bioethics researcher and director of the University of Oxford's Ethox Centre, told GenomeWeb Daily News.
Although the Bermuda Principles and Fort Lauderdale agreement emphasize open access to data from large genomic studies, the authors explained, there are few, if any, real-life examples of how such data release models apply to research in developing countries.
"While arguments for open access emphasize the ethical importance of promoting the availability of the results of genomic research to the scientific community and its potential to generate important public benefits," the authors noted, "moves towards open access have also generated a significant literature concerning the compatibility of open access in genomic research with important ethical principles and values."
For instance, they noted, open data access must also be balanced with ethical goals, such as building scientific capacity in countries where data is collected, establishing trust with communities involved, and sharing the benefits of scientific research with individuals in the developing countries.
In an effort to ensure appropriate access to MalariaGEN data, for instance, the team decided to put an independent data access committee in charge of determining who should have access to MalariaGEN datasets.
Finding independent but knowledgeable individuals to serve on the committee was challenging but not impossible, Parker said, noting that members of the data access committee not only have expertise in the research area but also liaise with representatives from communities involved in the research. By getting input from local ethics committees and other concerned ethics groups, the data access committee is also addressing questions about what constitutes acceptable use of the data.
The authors also noted that safeguards are needed to ensure that researchers in developing countries aren't scooped as a result of early, open data release policies. To do this, MalariaGEN researchers have committed to releasing data within at least nine months - a window intended to build scientific capacity in developing countries without compromising the team's commitment to early, open data access.
Members of MalariaGEN have also set up programs to train and engage researchers in places where the research is taking place. The team has already been training local people - mostly young, early career researchers - to play leadership roles in data management for several years, Parker explained.
"MalariaGEN takes the view that capacity building in developing country research is important both to the future success of addressing the health care needs of developing countries through the development of local expertise, and to promoting the trust underpinning the viability of multi-national scientific networks upon which such success to a large degree depends," Parker and his co-authors wrote.
MalariaGEN is an international effort aimed at understanding the genetics and genomics behind various aspects of malaria infection and immune response. The project, funded by the Wellcome Trust, the Bill & Melinda Gates Foundation, the US National Institutes of Health, and other funding agencies, is involved in research in 21 countries so far, mainly in Africa and Southeast Asia.
This spring, researchers from MalariaGEN and elsewhere published a GWAS paper in Nature Genetics, based on a study of almost 6,000 Gambian children, on the genetics behind severe malaria cases in West Africa.
Parker et al. Ethical data release in genome-wide association studies in developing countries. PLoS Med. 2009 Nov;6(11):e1000143. doi: 10.1371/journal.pmed.1000143. Epub 2009 Nov 24.