Human Tissue Act 2004 Explanatory Notes

Human Tissue Act 2004

2004 CHAPTER 30

Commentary on Sections

Part 1 - Removal, Storage and Use of Human Organs and Other Tissue for Scheduled Purposes

Section 6: Activities involving material from adults who lack capacity

22. This section enables the Secretary of State to specify in regulations the circumstances in which there is to be deemed to be consent to activities regulated by the Act in relation to adults who lack capacity to consent for themselves, where a decision of theirs about such matters is not already in force. It is envisaged that the regulations will provide for consent to be deemed to be in place where the activity would be in the adult's best interests - for example, it could be in their best interests to donate tissue to a close relative for transplantation.  The regulations will also be able to provide that where consent has been given by a proxy in accordance with Schedule 1 to the Medicines For Human Use (Clinical Trials) Regulations 2004/1031, storage and use of material from the adult lacking capacity as part of the trial should be treated as done with consent.  The regulations will also be able to take account of the Mental Capacity Bill, introduced in the House of Commons on 17 June 2004, in particular in relation to research involving those who lack capacity to consent, which will be regulated by that Bill.