Data policies for GWAs in developing countries

27 November 2009

Genome-wide-association (GWA) studies aim to pinpoint the genetic differences that correlate with and perhaps play a causative role in disease. Genetic variants associated with disease are identified by comparing DNA samples from a group of patients who share a particular disease with samples from those who do not (controls). The data from these studies are usually stored in publicly accessible databases so that they can be used by other researchers. Open access data requires balancing the availability of genomic research and its potential public benefit with ethical principles relating to consent, confidentiality and privacy. Several consortia such as the Wellcome Trust Case Control Consortium and National Institutes of Health have created data sharing policies and regulatory procedures taking into consideration the ethical issues raised by such research. In addition, such issues have been extensively discussed in the literature along with the proposal of models for data sharing. However, this has mainly been in the context of research carried out in higher-income countries and may not be applicable to developing countries, where an increasing number of GWA studies are being conducted.

A recent article in PLoS Medicine, outlines some of the challenges of developing guidelines for data sharing in developing countries, using the Malaria Genomic Epidemiology Network (MalariaGEN) as an example  [Parker et al. (2009) PloS Medicine 6(11) e1000143. doi:10.1371/journal.pmed.1000143]. The key issues that were raised in developing data release policies for MalariaGEN were in relation to the format of data, its acceptable uses and timing of release all of which have implications for local communities as well as individual researchers. Entirely open access to GWA data on individuals along with phenotypic data was considered to be inappropriate, as factors such as ethnicity may allow de-identification of data sets, especially if it related to the frequency of gene variants. With relation to MalariaGEN, an independent data access committee (IDAC) was set-up to mediate data-access, which required signing a legally binding access agreement. The data-sharing policy also allowed for a delay in data release in order to give researchers at study sites in developing countries time to analyse newly available data. This was to address the imbalance in analytic capabilities between developed and developing countries.

The authors state that there is a need for genetic researchers to work together with ethics committees, social scientist and local communities to ensure their views are respected with respect to open access data. In addition they state that ethical data release policies should also ensure that the research aspirations of developing countries are attained, this may be through mechanisms that allow data produced in developing countries to be analysed locally and ensuring that they address local health needs.

 

More from us

Genomics and policy news