We are all agreed that emergency treatment research is an important part of the Bill, and we all want to get this right. I will make a few remarks of context before dealing with the amendments. The clauses as they stand recognise that some research inevitably takes place in situations where a person is temporarily incapacitated as a result of a sudden trauma, such as a car accident, stroke, or a serious infection. It is important that such people can have urgent medical attention. It is also sometimes the case that vital research can be done in these situations to understand what changes the body undergoes during the first few moments after the event.
In such cases of urgency the next of kin, to use a simple term, is often not with the person when the emergency happens. In such circumstances, the researchers need alternative arrangements for seeking the agreement to P's involvement in the study. This may be a doctor who has no responsibility for treating the person, or it may be another person, if that has been agreed in advance with the research ethics committee. Once the need for urgency has passed, the researchers must, under Clause 32(10), follow the normal arrangements for consent to continue in the research, or consultation with the next of kin if the person still lacks capacity.
The effect of Amendment No. 119 is greatly to limit research to non-invasive procedures that do not go beyond those required for P's treatment and care. While I understand the reasoning behind this amendment, I fear that it will prevent a good deal of vital research. It could be argued that this amendment would mean that if the researchers required a few millilitres of blood that is slightly more than that necessary for P's clinical care they would not be permitted to take it, because that would be additionally invasive. Perversely, it may also prevent the research procedures that are likely to improve P's survival or recovery.
I am aware of some research that involves using an experimental probe to measure oxygen levels in the brain of those who have experienced major head injuries. The research uses the same skull incision that is made for the clinically necessary purpose of measuring brain pressure. Initial findings suggest that maintaining correct oxygenation of the brain is important in promoting recovery. However, under this amendment it would be considered to be unlawful as it is invasive and goes beyond what is necessary for P's care.
On Amendment No. 122, I am again grateful to noble Lords for attempting to specify clearly in the Bill the steps that a researcher must take as soon as possible after the emergency passes. It is, of course, accepted by all researchers that the next of kin must be identified as soon as possible, given information about any research, and asked for their views on whether P should remain in the trial. Researchers must respect that view and, if necessary, withdraw P from the research. This is already the effect of the provision in Clause 32(10), which says that the researcher cannot continue to rely on the emergency provisions for longer than is necessary. If he has reasonable grounds for believing that it is not necessary to take action as a matter of urgency he must, retrospectively, consult with a carer and respect their views. While I agree with the steps outlined in the amendment, with respect, they do not take sufficient account of the alternative scenarios that I have mentioned.
For example, it might be the case that shortly after the emergency the person regains sufficient capacity to give or withhold their consent in the normal manner, or they may make it known that they do not wish to continue in the research. The researcher may become aware of the existence of a previous statement of wishes that affects the research. In those circumstances, he would be obliged, under Clause 33, to respect these views. I hope that noble Lords will accept my assurances that the Government want to strike a balance between protecting vulnerable people while permitting important medical research. I hope that noble Lords will be reassured by what I have said.
I have a good deal of sympathy with Amendments Nos. 120 and 121, which attempt to widen the category of doctor who might agree to P's involvement in emergency research. We had already sought to achieve that by means of Clause 32(9)(b), which allows much flexibility in deciding who may agree, provided that the research ethics committee approves the proposed approach when deciding whether to approve the research.
The clauses recognise that some research takes place in the kinds of situations of urgency that I mentioned. However, I accept that Members of the Committee think that they do not go far enough. We already have provisions that might enable an attending emergency healthcare worker—perhaps a paramedic—to make an initial decision to include a person with a heart attack in a trial of better ways of performing heart massage. In such cases, the decisions need to be made in seconds, not minutes, and a doctor may not always be on hand.
In that regard, it is worth noting that we have announced a consultation on a possible amendment to the clinical trials regulations to provide for emergency research where it is not possible to get consent from a legal representative. I raise that again because the Government feel that we have to make the final arrangements for research in emergencies under the Bill and the clinical trials regulations absolutely consistent. That is important to enable trusts to implement properly the necessary systems for those to be consulted and agree or give consent to a person being included in research or a clinical trial in an urgent situation. It was with that in mind that we sought the ability to produce guidance on the appropriate local approaches to the matter. We have included in Clause 32(3) a provision for the Secretary of State to issue guidance on nominating a person who may be consulted on research involving a person without capacity in such circumstances.
I accept that there is more work to be done in the area, but we want to make everything consistent between the clinical trials regulations, the Bill and the code of practice. I therefore suggest that we take away Amendments Nos. 120 and 121 and come back on Report with a considered view on the matter, to try to meet the concerns expressed on them.