title: International Charter of principles for sharing bio-specimens and data.
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.
authors.affiliation: 1] Center for Research Ethics and Bioethics Uppsala University, Uppsala, Sweden [2] Center for Biomedicine, EURAC Research, Bolzano, Italy.
authors.forename: Deborah
authors.initials: D
authors.lastname: Mascalzoni
authors.affiliation: Centre of Genomics and Policy, Mc Gill University, Montreal, Quebec, Canada.
authors.forename: Edward S
authors.initials: ES
authors.lastname: Dove
authors.affiliation: Office for Rare Diseases Research, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Yaffa
authors.initials: Y
authors.lastname: Rubinstein
authors.affiliation: 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.
authors.forename: Hugh J S
authors.initials: HJ
authors.lastname: Dawkins
authors.affiliation: EURORDIS, Rare Disease Europe, Paris, France.
authors.forename: Anna
authors.initials: A
authors.lastname: Kole
authors.affiliation: PEALS (Policy, Ethics & Life Sciences) Research Centre, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Pauline
authors.initials: P
authors.lastname: McCormack
authors.affiliation: PEALS (Policy, Ethics & Life Sciences) Research Centre, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Woods
authors.affiliation: Institute of Medical Genetics and Applied Genomics, University of Tübingen, Tübingen, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Riess
authors.affiliation: 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.
authors.forename: Franz
authors.initials: F
authors.lastname: Schaefer
authors.affiliation: PEALS (Policy, Ethics & Life Sciences) Research Centre, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Hanns
authors.initials: H
authors.lastname: Lochmüller
authors.affiliation: Centre of Genomics and Policy, Mc Gill University, Montreal, Quebec, Canada.
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
authors.affiliation: Center for Research Ethics and Bioethics Uppsala University, Uppsala, Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Hansson
mesh_terms: D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D032982:Contracts; D005060:Europe; D033181:Information Dissemination / Q000941:ethics / Q000331:legislation & jurisprudence*; D007391:International Cooperation / Q000331:legislation & jurisprudence*