Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006

My Lords, I support and agree with everything that the noble Earl, Lord Howe, has said about the remarks of the Merits Committee. We on these Benches broadly support the principles behind the statutory instrument, but perhaps find them a little puzzling in the detail. I certainly read and re-read them, and was still somewhat unclear about them, to put it mildly. The Minister entered this House at the same time as I did. We came in towards the end of the passage of the Human Tissue Bill, so we missed some of the detail of the debate, but some of the questions that were asked in the original debate on the Bill come up again in our consideration of this statutory instrument. I should like to add a couple of questions to those asked by the noble Earl, Lord Howe. One was pointed out to me very recently, so I could not give the Minister warning of it. Alison Hall of the Strangeways Research Laboratory at the Cambridge Genetics Knowledge Park asked whether there had been any change in the definition of exemptions from a research ethics authority from that given in the earlier statutory instrument, the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, which I am afraid I only printed out today. Some people seem to be arguing that the definition in those regulations was restrictive, because it does not cover bodily material expressly. The idea here is that bodily material is defined separately in the Act because a substantive part of the Act applies only to England and Wales, whereas the DNA analysis provisions apply to Scotland, which now has its own human tissue Act. If the definition of bodily material is used, that includes hair and nail clippings taken from living people. The definition of relevant material, arguably at least, does not include that. If that is true in Statutory Instrument No. 1260—I am simply asking the Minister for clarification—what does it mean for this statutory instrument? Does ““relevant material”” include bodily material, such as the hair and nail clippings, taken from the living? I am very grateful to Alison Hall for pointing this out to me. We would like clarification. Even if it is not possible to give that today, it needs to be given. I have a second question, which goes back to some of the issues that were debated when the Human Tissue Bill was debated originally. I particularly want to draw your Lordships’ attention to Regulation 3(2)(b), in which someone is deemed to have given consent when,"““the activity is done for the purpose of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations””." I think that it is unclear here, as it was in all the debates on the Human Tissue Bill, what provision is being made for those people who simply do not wish to be part of such a study but are not fully able to give consent. A classic example is children who express a view but who are not old enough to give consent. But it also applies—this is where it is relevant—to older people who slip in and out of dementia. How does being deemed to be incompetent work if at some stage a person has expressed a preference against being included, but does not have an advance directive in place? I should like to reassure the Minister that these questions are only for clarification, as are the questions raised by the noble Earl, Lord Howe, and the Merits Committee. Broadly, in principle, we are content on these Benches with the statutory instrument.