Nowadays, the increasing value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. As we all know sharing data and bio-specimens is essential for the discovery, the knowledge creation and translation of various biomedical research findings into improved diagnostics, biomarkers, treatment development, patient care, health service planning and general population health. There is a constantly increasing international agreement on the urgency to provide access to research datasets, to advance their use and fully apply their long term value. All of this has been clearly noted in many documents such as the OECD Principles and Guidelines for Access to Research Data from Public Funding, the Toronto Statement, and more recently the Global Alliance for Genomics and Health’s White Paper.
Even though sharing of data and samples is confirmed to be favourable for most health-related research, it is of highest importance for rare-disease research because of the high deficiency of research participants, samples, data, resources and researchers for any given RD.
Thinking in the most perfect way, data and bio-specimens should be made broadly available, but often failed because of institutions and individuals fearing, they will not receive recognition for their investment in building collections. What brings real and widely recognised risk is the discrimination of vulnerable patients groups and there data-sharing must be considered in any legislation or guidelines. Collecting data and storing biological samples in accordance with ethical and scientific standards requires intellectual, institutional and economic resources and, critically, the participation of patients and the wider community including otherwise healthy volunteers.
A recently published paper by Deborah Mascalzoni et al called International Charter of principles for sharing bio-specimens and data describes the best practices in doing this and provides the common overview and the foundational framework of the practice of sharing. The charter results our of careful negotiation of different stakeholder’s interest: that includes a stakeholders workshop held in Brussels in October 2013. During this two-day workshop, RD patient representatives, legal experts, ethical experts, industry representatives and scientists discussed the issues and produced a general agreement that informed the Charter. The model is the result of further analysis and is built on earlier consensus documents and position statements.
The common thesis for the Charter appeared to be the following five principles for the custodianship of bio-specimen repositories and data:
- Respect for privacy and autonomy: custodianship implies protection of participants’ privacy. Privacy protection measures should be in place and informed consent must provide provisions for future as yet unspecified research using data and bio-specimens.
- Reciprocity: custodianship also implies giving back. Feedback of general results should be channelled to institutions and patients.
- Freedom of scientific enquiry: custodianship should encourage openness of scientific enquiry, and should maximize data and bio-specimen use and sharing so as to exploit their full potential to promote health.
- Attribution: the intellectual investment of investigators involved in the creation of data registries and bio-repositories is often substantial, and could be acknowledged by mutual agreement.
- Respect for intellectual property: the sharing of data and bio-specimens needs to protect proprietary information and address the requirements of institutions and third-party funders.
The authors of the article and the Charter conclude:
The sharing of data and bio-resources must be done in a way that protects proprietary information and addresses the interests of institutions and third-party funders. These parties may have legitimate proprietary interests associated with data collected by researchers.
The intellectual investment of investigators involved in the creation and maintenance of data registries and bio-repositories is often substantial, and should be appropriately acknowledged.