The Public Project in Population Genomics (P3G) has identified several important roadblocks in effective population-based genetic and genomic studies. In the January Ethics Watch article in this journal we focused on policy barriers. Here we focus on aspects of current practice and guidance that relate to the sharing of tools and other pre-competitive matters of mutual benefit to those who propose or carry out such large-scale studies.

There seem to be several systematic problems for those who wish to share freely the basic tools for the construction of large research databases for the study of gene–gene and gene–environment interactions (including socio-demographic data).

Some of these barriers stem from a failure to construct data or sample-collection handling frameworks that would make data sharing technically possible, whereas others arise from ethical concerns or guidelines on the use of information that are beyond the purposes for which the data were initially assembled.

The current failure to achieve semantic interoperability and common quality-assurance standards for data collection, entry, security and access could be mitigated by the creation of common lexicons and procedures that recognize equivalency. Such comparable data-sharing policies should not treat all genetic data as equally sensitive. Rather, they should differentiate between them according to the sensitivity of the information that is revealed by the analysis.

The sharing of finite biological samples requires explicit guidelines about who can access samples, and for what purposes. The sharing of immortalized cell lines also requires similar guidelines if public support is to be sustained. Moreover, concerns over property rights and ownership issues demonstrate the need for international principles that are specific to intellectual property-rights issues in large population databases.

No less urgent for the construction of this population-aimed toolbox is an appropriate ethical framework and level of ethical review. Although often not explicit in discussions on the development and management of such population-wide databases by ethics review boards, perceptions of potential legal liability for privacy (identifiability) or property claims are influential. Such anxieties might be addressed by the publication of aggregated data sets and by recourse to broad anti-discrimination laws. Indeed, adoption of 'genetic-specific' norms will only exacerbate the presaged stigmatization that is associated with genetic profiles of regions, communities and populations. The monogenic ethics model, as a basis for policies and tools, is inappropriate and inadequate to meet the practical and socio-ethical challenges that are inherent in population-based research. Uncritical adoption of such a model will hinder the realization of health gains in ways that would be widely regarded as unnecessary and undesirable by those who volunteer to contribute to these large-scale resources.

P3G's International Working Group on Ethics, Governance and Public Engagement favours a shift towards prospective harmonization and pre-competitive tool-sharing within a transparent governance framework that responds to and reflects the true nature of these resources for research.