Genomic databases access agreements: legal validity and possible sanctions

Abstract

Large-scale, public genomic databases have greatly improved the capacity of researchers to do genomic research. In order to ensure that the scientific community uses data from these public resources properly, data access agreements have been developed to complement already existing legal and ethical norms. Sanctions to address cases of data misuse constitute an essential part of this compliance framework meant to protect stakeholders in genomic research. Yet very little research and community debate has been done on this most important topic. This paper presents a review of different sanctions that could be invoked in cases of non-compliance from data users. They have been identified through comprehensive research and analysis of over 450 documents (journal articles, policy, guidelines, access policies, etc.) related to this topic. Given the considerable impact on users of even the milder sanctions considered in our paper, it is essential that stakeholders strive to achieve the highest degree of standardization and transparency when designing controlled-access agreements. It is only fair, after all, that users be able to expect that the border between acceptable and unacceptable conduct is clearly delineated and predictable in controlled-access policies. This suggests the importance for researchers to undertake additional empirical studies on the clarity and accessibility of existing database access agreements and related policies in the near future.

Appendix

Genomic databases/biobanks whose policies were reviewed for this article: International Cancer Genome Consortium, International Human Microbiome Consortium, International Serious Adverse Event Consortium, 1000 Genomes Project, GenomeEUtwin, Canadian Partnership for Tomorrow Project, The Tomorrow Project, Atlantic Partnership for Tomorrow’s Health, BC Generations Project, Ontario Health Study, OICR—Ontario Tumour Bank, Avon Longitudinal Study of Parents and Children (ALSPAC), UK Data Banking Network, Generation Scotland, UK Biobank, UK10K, Wellcome Trust Case–Control Consortium, Australasian Biospecimen Network, Western Australian DNA Bank, Biomarkers Consortium, The Cancer Genome Atlas, ENCODE, Genetic Association Information Network (GAIN), Human Microbiome Project, Kaiser-Permanante Research Program on Genes, Environment and Health, NUgene Project, NIH Genome-wide association studies, The database of Genotypes and Phenotypes (dbGaP), deCode Genetics, Danubian Biobank Consortium, KORA-gen, Cohort of Norway (CONOR), Norwegian Mother and Child Cohort Study (MoBa), Norwegian Twin Registry, Karolinska Institute Biobank, LifeGene, Estonian Genome Project, Integrated BioBank of Luxembourg, LifeLines, String of Pearls Initiative, INMEGEN, King Abdullah International Medical Research Center—Saudi Bio-Bank, National DNA Bank (Spain), Taiwan Biobank.