Criminal sanctions linked to opaque legislation threaten research

The new human tissue bill is making its way towards the statute book for England, Wales, and Northern Ireland. Although a necessary response to the organ retention scandal involving the Royal Liverpool Children's NHS Trust, this bill goes far wider than tissues derived from post mortems.1 It applies to any material that contains human cells—even urine and sputum. Using such material for research or for training not “incidental to the diagnostic process” will be a criminal offence unless “appropriate” consent has been obtained. Possible penalties include three years in jail. Punitive criminal sanctions coupled with opaque legislation threaten ethical and essential research as well as routine NHS activities. Incidental and appropriate have yet to be defined by a new human tissue authority, which will have powers of licensing and inspection. But the government has repeatedly said that consent must be explicit,2 even in relation to medical training using residual blood samples that would otherwise be incinerated.3

We know that the public does not regard surgically resected tissue in the same way as postmortem tissue.4 Putting aside the question of whether residual urine samples really …