Sharing of biosamples and data

Developing effective and ethically grounded sharing mechanisms is particularly important for rare disease research, where data sets and biosample collections are scarce, fragmented and scattered.

 

Collecting data and storing biosamples 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 Transfer Agreements (DTAs and MTAs) 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
  • reciprocity
  • 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. The documents introduce in simplified language a consistent set of principles that will improve interoperability nationally and internationally.

To ensure that data on the RD-Connect Platform are shared only in an ethical way, all users are required to sign the RD-Connect Code of Practice according to legal requirements, ethical principles as well as patient and scientific needs.

Using biological materials in research: response to Council of Europe’s recommendations

The Council of Europe  is a human rights organisation which works directly with the European Parliament. In light of recent developments in technologies such as whole genome sequencing and the increasing practice of sharing samples and data across borders, the Council of Europe Committee on Bioethics updated its 2006 Recommendation on The use of biological materials of human origins in research. The Recommendation aims to protect the rights and privacy of those who donate biosamples (like blood or skin) for research and gives guidance to researchers on how to store and use them.

In March 2014, the Council issued a consultation document and asked for views on the proposed amendments. A collaborative response was coordinated by the Rare Disease Patient and Ethics Council (RD-PEC). It emphasised the importance of balancing individual citizen's right to privacy and their right to benefit from medical treatment and prevention of disorders through scientific progress. We emphasised the scarcity of biological materials within rare disease research and the importance of being able to re-use samples for more than one research project, including making samples available across different countries and different disease groups.

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