This project is funded by the Wellcome Trust started in May 2005. Below is an overview of the aims of the project. For more information click on the following link Governing Genetic Databases

The Problem
There is no one piece of legislation that relates specifically to human genetic databases in England and Wales. Instead, the law that applies to genetic databases is a complex web of legislation, common law principles, codes of practice, circulars, guidelines, international instruments and ethical codes—all of which have some bearing on how genetic samples and personal information may be collected, stored and used. This incomplete, fragmented, overlapping and sometimes contradictory legal framework creates confusion and uncertainty, leaving genetic database operators and researchers at risk of legal liability. There is also no clear idea of the different types of genetic databases that exist or an agreed model for how genetic databases should be governed and regulated. Researchers are in the difficult position of having to ‘re-invent the wheel’ every time they start collecting samples and information. Normative principles can be drawn from existing debates; but there is uncertainty over how these should apply to different types of genetic databases.

Patient- centred
This research is patient-centred as it will lead to some models for genetic databases that will protect the privacy interests of participants in research. This means that participants involved in genetic research, whose personal information is aggregated, cross-referenced and kept for research in the future, can be assured that there are mechanisms in place to safeguard their privacy .

Relevance to practice
This project came out of discussion with genetic researchers collecting samples and personal information as part of their research. This project will combine an empirical social research study with a legal review. We will ascertain whether (or how far) existing governance practices and procedures accord with legal requirements, and/or the extent to which they require adaptation. From this we will make recommendations for more appropriate and effective governance methods and models that could be used for genetic databases. The aim is that these are coherent and practically workable, but also based on a sound principled foundation, compliant with existing legal requirements, and easily adaptable to reflect future reforms in a clear, coherent, logical and consistent manner.

This research will provide essential guidance for those who operate and use genetic databases, as well as providing a firm foundation for future rules and guidelines to be developed by regulatory bodies such as the new Human Tissue Authority.