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I am very grateful to noble Lords for bringing forward what I know are concerns of distinguished medical bodies. We are sympathetic to these concerns and are grateful to have the opportunity to clarify matters and to tell noble Lords what our intent will be. It is also good that they have welcomed the research clauses of the Bill. We look forward to debating them in due course.
In the meantime, two amendments have been tabled. The amendment of my noble friend Lord Turnberg simply deletes the words "at the material time" and the noble Earl, Lord Howe, has tabled an amendment to the same clause, Clause 2(1), that would provide that the Secretary of State can specify in regulations the meaning of "at the material time". I have been asked to assist in reducing confusion and to give some indication that we are dealing with the problem that researchers are anticipating.
The main problem is establishing whether consent to participating in research that is given while a person has capacity to do so survives loss of capacity or whether the consent ceases to be valid when capacity is lost. Noble Lords have rightly drawn attention to the kinds of research projects that might have begun before the Bill and will be ongoing when the legislation comes into force but which are not adversely affected by its provisions for research. There is, of course, a huge number of major trials involving many people where this situation might occur.
I understand that the term "at the material time" applies when the act that would be unlawful without consent—for example, taking blood—is done. So the material time is the time of the act; in this case, carried out in the context of research. I understand that it will be difficult and, in some cases, impossible for existing and ongoing projects to meet the requirements of Clause 31, which covers approval. In some cases, especially in long-term projects, consent to use and retain samples and data is given by participants in advance for research that is conducted over many years and that may well continue beyond the onset of loss of capacity.
We are concerned to achieve a smooth transition from the current practice to that in the Bill. If, for example, an ongoing research project has already been approved and the participants have consented in advance, we do not want the project to be brought to an untimely or unintentional stop because of the formulation of the Bill. Indeed, it could be detrimental to a project if a participant could no longer take part because he lacked capacity. However, it would be burdensome, possibly excessively so, to put the whole project through an additional set of safeguards required by the Bill if there is a risk that there is one participant who might lose capacity during the project. We have to get the balance right. We do not want to be unfair and move the goalposts in that way. So, in looking for the best of both worlds, we need to ensure that research is not subject to excessive interference, while simultaneously ensuring that we protect the rights and dignity of individuals.
We intend to clarify whether consent given in advance to an ongoing or long-term research project continues to be valid when the person loses capacity. We need to be absolutely sure that adequate safeguards are in place to protect individuals who may lose capacity. Of course, under Clause 33, there is a very important raft of safeguards concerning the withdrawal of people wishing to leave a research project.
We also need to be sure that any changes we make are the right ones. Making changes to key Clause 2, which provides a definition of people who lack capacity, would have implications for the whole of the Bill. Simply deleting the words, "at the material time", as my noble friend proposes, would undermine the Bill's time-specific approach to capacity, which we need to keep. I am sure that Members of the Committee would not want us to do that.
I suggest that we take this away and look at how we might bring forward an amendment that expresses the notion of continuing consent in those circumstances. We will certainly consult widely with the bodies that have made their concerns known. I also take the noble Lord's point about guidance, which we will think about. With those assurances, I hope that the noble Lord will be able to withdraw his amendment.