New regulations are necessary to make useful research possible

Many authorities have expressed reservations about some provisions in the human tissue bill, which parliament will debate again at the end of June. Although these general concerns remain relevant, we must draw attention to another issue that has been largely glossed over—namely, the use of tissue and genetic information obtained from people with mental incapacity. The human tissue bill is one of several pieces of legislation which in their current form are likely to make research involving adult patients with critical illness, learning disability, or mental illness, either difficult or impossible.

One of the central themes of the human tissue bill is that “appropriate consent” or “qualifying consent” must be obtained before tissue from a living person may be used, stored, or genetically analysed. Failure to do so constitutes a criminal offence. Where the tissue comes from a living adult, the person himself or herself must give the consent.1 This indicates it may become a criminal offence to use, store, or genetically analyse human tissue taken from adults who lack capacity to make a decision themselves. Responding to these concerns, the government stated that an additional piece of proposed legislation, the mental capacity bill, would make it possible for a third party …