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Confronting the Liminal Spaces of Health Research Regulation

The subject of regulation of health research has become something of a hot topic recently. The history of health research itself is long and chequered, and the tone for regulation was unfortunately set against 20th century abuses that led to the Helsinki Declaration (1964), now in its 10th iteration (2013). However, that instrument was originally concerned with interventions that involved direct interference with humans and their bodies, while today health research can be conducted equally (and often better) using human tissue, cells, and data. Regulation has struggled to keep up.

An additional challenge is that our legal and social approaches to regulation have created – and perpetuated – silos of regulation. Compare, for example, in the United Kingdom, the Human Tissue Act 2004 (tissues) and the Data Protection Act 1998 (data). Consider too the roles of the Human Tissue Authority with the Information Commissioner’s Office, and add the Human Fertilisation and Embryology Authority (eggs, sperm and embryos), and the Medicines and Healthcare Products Regulatory Agency (drugs and medical devices).