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.

The alliance between genetic biobanks and patient organisations: the experience of the telethon network of genetic biobanks

“…Furthermore, as we mentioned in the previous section, the participation of a PO representative on the TNGB Advisory Board has been an effective way for patients to be actively involved in drafting TNGB policies and in sharing their perspectives on procedures concerning ethical issues such as transparency, informed consent, privacy, sample use and transfer, data sharing, commercialisation, return of results and incidental findings [11–13]. …”

Patient/family views on data sharing in rare diseases: study in the European LeukoTreat project

“…Experts are also working to establish general principles and tools to reach a consensus on promoting ethical regulation at international level. [8][9][10] The principles of information and initial consent have gained consensus, but there is ongoing debate over the information content. 11 The challenge is to determine what kind of consent would cover future research and what changes in research orientations would require fresh consent.…”

The impact of integrated omics technologies for patients with rare diseases

“…RD-Connect [37], EURenOmics [38] and NeurOmics [39] are three flagship IRDiRC projects funded by the European Union from 2012 onwards that provide a proof-of-concept for these harmonisation and sharing policies. RD-Connect is an infrastructure project that is developing data sharing mechanisms and omics analysis and bioinformatics tools that are incorporated into an integrated platform connecting registries, biobanks and clinical bioinformatics for rare disease research [40,41]. The central platform will make accessible rich omics datasets connected with clinical phenotypic information to enable generation of a more complete picture of rare disease causes and mechanisms, enabling research on pooled datasets towards the eventual goal of improved diagnostics and therapy.…”