title: 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.
authors.affiliation: Deptartment of Human Genetics, Faculty of Medicine, Centre of Genomics and Policy, McGill University, 740 Dr. Penfield Avenue, Suite 5101, Montreal, QC H3A 1A4, Canada. yann.joly@mail.mcgill.ca
authors.forename: Yann
authors.initials: Y
authors.lastname: Joly
authors.forename: Nik
authors.initials: N
authors.lastname: Zeps
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D032763:Behavior Control; D018070:Biological Specimen Banks; D003159:Community-Institutional Relations; D032962:Consent Forms; D030541:Databases, Genetic / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D057766:Policy