Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007

rose to move, That the Grand Committee do report to the House that it has considered the Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007. 6th Report from the Statutory Instruments Committee. The noble Lord said: These regulations make transitional arrangements to ease the introduction of new safeguards relating to research involving people who lack capacity to consent. The Mental Capacity Act 2005 provides a statutory framework for people who lack capacity: those who cannot make their own decisions because of an impairment or disturbance of the mind or brain, for instance, dementia, brain injury or mental health problems. The Act includes a statutory framework for research involving people who lack capacity to consent to their participation. The provisions in Sections 30 to 34 of the Act balance the importance of properly conducted research into the treatment and care of people who lack capacity with the need to protect their interests and respect their current and previously expressed wishes and feelings. The Act applies to research that is defined as intrusive, which would normally require a person’s consent in order to be lawful—for example, their consent to the taking of blood during a medical check-up which is part of a research project. The Act applies to a wide range of research into treatment and care and is particularly relevant to health and social care research. The Act does not cover clinical trials of medicines, which are governed by separate regulations that implement EU directives. The Act requires the researcher to obtain approval from an appropriate body: a properly recognised research ethics committee, as defined in separate regulations made on 19 December 2006. The committee must be satisfied that the research project meets certain requirement set out in the Act: that it is necessary, safe and cannot be done as effectively using people who have mental capacity. It must also be satisfied that arrangements are in place to consult a suitable person, as set out in the Act, about the participant’s previous wishes and feelings and to ensure the participant’s safety. If the person says no, or shows any sign of distress or dissent, the researcher must not include them. The person can also change his mind at any time. The general policy intent of these regulations was signalled during the passage of the Act and was prompted by points made by noble Lords. The Government recognise the importance of a smooth transition to the new arrangements to give protection to people without capacity without stopping long-term research studies or causing unnecessary bureaucracy for researchers or research ethics committees. Noble Lords will be aware of a number of extremely important long-term health studies that track thousands of people over many years or decades. An example is the outstanding Whitehall study of 10,000 civil servants to study links between work, lifestyle and heart disease. It is of profound importance and has had a great impact on public health issues. It is essential that it continues. In it, people do not have capacity to consent to participate. They attend regular check-ups, perhaps annually, and provide health information and blood samples. Between the check-ups, researchers analyse the information and the blood samples in the laboratory. There may also be links to the patients’ medical records, perhaps identifying particular diagnoses, such as heart disease or angina. Over time, some of the participants may suffer injury or ill health and lose the capacity to consent to check-ups carried out as part of the research or to the collection of data from their medical records. When the Act is fully in force in October this year, researchers will need to comply with the arrangements that I have described. If they cannot comply with them— approval by a research ethics committee, consultation with an appropriate person and the other protections—they will have to withdraw the person from further medical check-ups as part of the study. However, we have used powers in Section 34 to make these regulations enabling researchers in certain circumstances to continue research on the information and blood samples taken before the person lost capacity. We have listened carefully to the debate in Parliament and to the views of research groups, such as the MRC and the Wellcome Trust, about the status of consent given by a person with capacity. When we developed the process for consultation, we took full account of those views. We are proposing a mechanism that allows researchers to continue research where the Act would otherwise have applied if a person has consented to participate in an existing study and then loses capacity. This transitional easement applies only to information and material that was collected prior to the person’s loss of capacity. It does not cover any new intervention or collection of any new material. If a researcher wants to take more samples or carry out another health check, he will have to meet the full requirements of the Act. It applies only where the research was started before 1 October 2007 and the person in question consented to take part in it before 31 March 2008. I should explain that although the regulations are transitional, they will have a long-term effect. I reiterate that they apply only when before 31 March 2008 a person consented to take part in a research project that started before 1 October 2007. They allow for projects that have started when the Act comes into force but have not finished recruiting participants. As long as those conditions are met, the regulations will apply regardless of when the person loses capacity. So a person could join an existing study in October 2007 or January 2008 and lose capacity in the 2020s, and, if the study is continuing, the regulations would apply. Regulation 3 states that in cases where the regulations apply a researcher can continue to use information obtained before loss of capacity if he satisfies the requirements set out in Schedules 1 and 2. ““Information”” means ““data”” as defined in the Data Protection Act, or material containing ““human cells or human DNA””. Schedule 1 requires that the research ethics committee has approved a protocol and is satisfied that there are suitable arrangements for complying with it. We see a central role for the expertise on research ethics committees to make judgments about what is appropriate for different types of research. Schedule 2 sets out what the researcher needs to put in place when he becomes aware that a participant has lost the capacity to consent. The schedule repeats the relevant safeguards from Section 32 and 33 of the Act, which mean that a suitable consultee who cares for the person or is interested in his welfare must be identified and given information about the project. He will be asked to advise on whether the person would want the samples or data already taken to continue to be used in the research in line with the arrangements set out in the protocol. The consultee will be expected to consider the facts that the person without capacity would originally have consented to take part and that that should be a powerful indication of his wishes and feelings at that time. However, they might also be aware of other factors relevant to the decision, such as other views made known by the person who now lacks capacity. The researcher must also respect the wishes and feelings expressed by the persons themselves. They must not do anything which contradicts any advance statement of wishes of which the researcher knows and must not continue if the person indicates in any way that he has an objection. The interests of the person must be assumed to outweigh the interests of science and of society. On a practical note, the Government have made clear to the research community that there is not a new duty to monitor the capacity of all the research subjects continually. It must be assumed, in keeping with Section 2 of the Act, that a person has capacity unless shown otherwise. If, however, information becomes known to the researcher—perhaps through contact from next of kin, direct observation or from other medical diagnoses—they will need to apply the protocol. I am aware that researchers and research ethics committees need further advice and guidance on how to apply the Mental Capacity Act. We shall be including a chapter on research in the Mental Capacity Act code of practice that will shortly be laid before Parliament. We are also working with the Central Office of Research Ethics Committees to provide guidance and training materials. The transitional provisions are intended to help researchers on existing projects with the transition to the new requirements of the Act. I remember the debates in which I participated when the Mental Capacity Bill was debated in 2005. We must of course have safeguards, but it is absolutely essential to reflect on the challenges facing eminent researchers who bring a responsible and strong ethos to the conduct of research. We do not want to erect barriers which may be difficult for them to meet. The transitional regulations before the Committee reflect that balance in the best possible way, and I commend them to your Lordships. I beg to move. Moved, That the Grand Committee do report to the House that it has considered the Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007. 6th Report from the Statutory Instruments Committee.—(Lord Hunt of Kings Heath.)