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Eur J Hum Genet. 2015 Jun;23(6):721-8. doi: 10.1038/ejhg.2014.197. Epub 2014 Sep 24.

International Charter of principles for sharing bio-specimens and data.

Author information

1
1] Center for Research Ethics and Bioethics Uppsala University, Uppsala, Sweden [2] Center for Biomedicine, EURAC Research, Bolzano, Italy.
2
Centre of Genomics and Policy, Mc Gill University, Montreal, Quebec, Canada.
3
Office for Rare Diseases Research, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.
4
1] Office of Population Health Genomics, Department of Health, Perth, Western Australia, Australia [2] Centre for Population Health Research, Curtin Health Innovation Research Institute, Curtin University of Technology, Bentley, Western Australia, Australia [3] School of Pathology and Laboratory Medicine, University of Western Australia, Nedlands, Western Australia, Australia [4] Center for Comparative Genomics, Murdoch University, Murdoch, Western Australia, Australia.
5
EURORDIS, Rare Disease Europe, Paris, France.
6
PEALS (Policy, Ethics & Life Sciences) Research Centre, Newcastle University, Newcastle upon Tyne, UK.
7
Institute of Medical Genetics and Applied Genomics, University of Tübingen, Tübingen, Germany.
8
1] Pediatric Nephrology Division at Heidelberg University Hospital, Heidelberg, Germany [2] Institute of Genetic Medicine, Newcastle University International Centre for Life, Newcastle upon Tyne, UK.
9
Center for Research Ethics and Bioethics Uppsala University, Uppsala, Sweden.

Abstract

There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Contradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues.

PMID:
25248399
PMCID:
PMC4795058
DOI:
10.1038/ejhg.2014.197
[Indexed for MEDLINE]
Free PMC Article

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