Explanatory note

These Regulations make provision as to the circumstances in which certain activities may be carried out in relation to material from the body of a person who lacks capacity to consent for the purposes of certain provisions of the Human Tissue Act 2004 (c.30) (“the Act”). Provision is also made in connection with the restrictions on transplants involving a live donor in section 33 of the Act. This covers the definition of the transplantable material to which those restrictions apply and the circumstances in which live donor transplants are permitted.

Regulations 3, 4 and 8 make provision as to the circumstances in which an adult who lacks capacity is deemed to consent to the storage and use of relevant material for the purposes in Part 1 of Schedule 1 to the Act. Separate provision is made for England and Wales, and for Northern Ireland. In both cases the circumstances in which consent is deemed to have been given include any case where storage and use are in the best interests of the adult who lacks capacity and any case where those activities are carried out for the purpose of an authorised clinical trial. In addition, consent is deemed to have been given where the activities are carried out for the purpose of certain approved research. Different provisions apply in England and Wales depending on whether the research is carried out before or after section 30 of the Mental Capacity Act 2005 comes into force (see regulation 3(2)(c) to (e) and regulation 8). That section makes provision as to research that may be carried out involving, or in relation to, persons who lack capacity and applies to England and Wales only. Before the commencement of section 30, the research must be approved by a research ethics authority. For Northern Ireland, the research must be approved by a research ethics authority (see regulation 4(2)(c) and regulation 8).

Regulations 5 to 7 prescribe the excepted purposes for which the results of DNA analysis may be used where the analysis is of DNA that has been manufactured by the body of an adult who lacks capacity to consent. Separate provision is made for England and Wales, for Northern Ireland and for Scotland. The results of DNA analysis are permitted to be used in specified circumstances that are equivalent to those specified for the purposes of regulations 3 and 4 (use in best interests of person who lacks capacity, use for the purpose of an authorised clinical trial and use for the purpose of certain approved research).

Regulation 9 provides a definition of “transplantable material” for the purposes of section 34 and regulation 10 provides a definition of “transplantable material for the purposes of section 33 of the Act. Regulation 11 specifies the circumstances in which transplants of such material from the body of a live donor may be carried out without contravening the restrictions set out in that section. The restrictions are disapplied if the matter has been referred to the Human Tissue Authority and if, after certain required interviews have taken place, the Authority is satisfied that certain specified conditions have been met. These relate to consent, information given to the donor and lack of reward for the donor of transplantable material.

Regulation 12 provides that a panel of at least three members of the Human Tissue Authority must make the decision on transplants from live donors in any case of organ donation where a child is involved, where the donor is an adult who lacks the capacity to consent or where the donor is an adult who has capacity to consent but where there are paired donations, pooled donations or altruistic donation.

Regulations 13 and 14 provide a right of reconsideration of the Authority’s decision as to the matters specified in regulation 11(3). This right may be exercised by the Authority (where it is satisfied that there has been a material change in the circumstances since the decision was made or that any information given to it was in a material respect false or misleading), the donor, the recipient or the registered medical practitioner who referred the matter to the Authority. Regulation 14 makes provision about the procedure to be followed for reconsideration.

A Regulatory Impact Assessment was prepared for the Human Tissue Act 2004 and a copy has been placed in the library of each House of Parliament. Copies of the Regulatory Impact Assessment are published on the Department of Health’s website (www.dh.gov.uk) and can be obtained from room 611, 6^th Floor North, Wellington House, Waterloo Road, London SE1 8UG.