631. Requirements for approval.

631.     Requirements for approval.

The appropriate body1 may not approve a research project for the purposes of the Mental Capacity Act 20052 unless satisfied that the following requirements will be met in relation to research carried out as part of the project on, or in relation to, a person who lacks capacity3 to consent to taking part in the project ('P')4:


    (1)     the research must be connected with an impairing condition5 affecting P, or its treatment6;


    (2)     there must be reasonable grounds for believing that research of comparable effectiveness cannot be carried out if