Population Biobanking and International Collaboration

Abstract

Population-based biobanks promise to be important resources for genetic research. However, the study of normal genomic variation across populations requires the collection of data and biological samples from individuals on a large scale. While international collaboration has become both a scientific and an ethical imperative, international sharing of data and samples poses many challenges. Significant variation persists among the legal and ethical norms governing population biobanks in different jurisdictions. Many of these norms do not clearly provide for international access. To illustrate these problems, we collected and compared applicable legislative instruments, as well as ethical guidelines issued by national, regional, and international bodies. In addition, harmonization is faced with important limitations and may not be sufficient to ensure effective international sharing. Population biobanks are therefore looking for new ways to promote sharing and improve interoperability. The formation of biobank networks and the development of common governance tools are two approaches that are setting the groundwork for international collaboration in genetic research.

Beyond Our Borders? Public Resistance to Global Genomic Data Sharing

“…The human genes initially sequenced and kept as a proprietary resource by Celera Corporation, for example, were cited by 20%–30% fewer research papers—and led to fewer diagnostic tests for those genes—than the genes first mapped by the Human Genome Project and rapidly made public under the Bermuda Principles [8]. Global collaboration is particularly valuable for complex studies of gene—gene and gene—environment interactions [9]. Furthermore, some biomedical research (e.g., rare disease research) is simply not feasible unless case data are collected and shared internationally.…”

“…They must also remedy gaps by pushing for stronger laws and other measures to address vulnerabilities and to penalize unauthorized re-identification and breaches of privacy. Most countries do not strictly prohibit export of biospecimens or data, but many impose restrictions such as compliance with EU standards for receipt of data and biospecimens, de-identification (typically compatible with use of a non-identifying code) or anonymization of data before transfer, and review and approval of the proposed transfer by a research ethics board [9,34]. A few countries require a special permit or collaboration with a local researcher, and requests for access to genetic data may be subject to additional approval requirements (e.g., China, France, India, Mexico, Nigeria) [34].…”

Ethics Governance Outside the Box: Reimagining Blockchain as a Policy Tool to Facilitate Single Ethics Review and Data Sharing for the 'omics' Sciences

“…2 The current demands for data of adequate volume, veracity and validity to make sound scientific associations between the human genome and disease are far greater than any one scientist or institution can meet alone. [3][4][5] An ethical imperative to share genomic and associated clinical data complements this scientific rationale. Participants accept informational risk(s), albeit minor, as part of their involvement in genetic/genomic research.…”

Phasing Out Voluntary Donation in Clinical Trials: The Ethics of Mandating Biospecimen Collection

“…In turn, new opportunities for drug discovery and other scientific investigations built on these associations are forged. Both a scientific and utilitarian defense can be made to support the expansion of biomarker research considering the collaborative nature of genomics [19,20] and the necessary volume of sequence data needed [21].…”