A template for development of a policy for access to data and/or biological samples


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Michael Chapman2, Karen Groot1, Chris Carrigan2, Brian Clark3, Jane Cope1, William Lowrance4

1National Cancer Research Institute, London, UK, 2National Cancer Intelligence Network, London, UK, 3onCore UK, London, UK, 4Independent Consultant, La Grande Motte, France

Abstract

There is growing awareness that without the sharing of data and samples medical research will become increasingly inefficient. At the same time, it is recognised that there must always be safeguards around the movement of samples and data to protect the interests of the donors or data subjects. Protection is provided by a regulatory and ethical framework which sets the boundaries for access. However, we believe that the lack of practical resources in this area is leading to duplication of effort as researchers and funders repeat the same background work each time a policy is needed for a new study or collection.

We present a template for access policy development that can be considered by a variety of funding and research organisations for adaptation to their purposes. This is not intended to impose policy and practice but rather to provide a practical instrument which (i) reflects established good practice, (ii) can be tailored to circumstances, and (iii) helps avoid unnecessary duplication of effort. It differs from existing guidelines which simply (though usefully) state principles by providing example text that can be used directly in a policy or MTA.

The template has been informed by a consultation, which received responses from research funders, regulatory bodies and biobanks, as well as individual researchers, healthcare professionals and patient representatives. The consultation responses strongly supported our aims and indicate a surprising degree of agreement on the general principles whilst highlighting the need to allow flexibility and minimise bureaucracy.