Sharing bio-specimens and data is essential for the discovery, new knowledge creation and translation of various biomedical research findings into improved diagnostics, biomarkers, treatment development, patient care, health service planning and general population health. The need for effective and ethically grounded sharing is evident for rare disease research for which data sets and bio-specimen collections continue to be scarce, fragmented and scattered.
Ideally, bio-specimens and data should be made widely available to the most inclusive and ethically responsible research community but there is often resistance by institutions and individuals, who fear that they will not receive recognition for their investment in building collections. 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.
All data and material sharing agreements should be ethically robust and mindful of the responsibilities owed to the donors to make best ethical use of the samples and data consistent with their consent.
The international charter of principles for sharing bio-specimens and data, developed by RD-Connect, provides guidance for effective legally and ethically grounded sharing. The charter is inspired by the following principles:
- privacy and autonomy.
- freedom of scientific inquiry.
- attribution of intellectual contribution.
- respect for Intellectual Property.
The charter, together with the template for general Material Transfer Agreement (MTA) and Data Transfer Agreement (DTA) constitutes an enabling tool to improve the governance and audit of sharing data and specimens across multiple international settings. It is written in simplified language to make it accessible and usable by scientists and other stakeholders, and provides a consistent set of principles that will improve interoperability nationally and internationally.