This section sets out the matters of which the appropriate body must satisfy itself before approving a research project involving a person who is 16 or over and lacks capacity. The research must be connected with an impairing condition (one that is, or may be, attributable to, or which causes or contributes to an impairment of, or disturbance in the functioning of, the mind or brain) that affects P, or with the treatment of his or her condition. There must also be reasonable grounds for believing that the research project cannot be carried out as effectively if it only involves people who have capacity to consent to taking part in it.
The research must have the potential to benefit P without imposing a disproportionate burden; or provide knowledge of the causes or treatment of P’s condition, or of the care of people who have the same or similar condition. Where the latter applies, there must also be reasonable grounds for believing that the risk to P is negligible and the research must not interfere with P’s freedom of action or privacy in a significant way, or be unduly invasive or restrictive.
Importantly the section also sets out that there must be a reasonable belief that no serious intervention will be carried out in respect of P as part of the research project unless the intervention could be lawfully carried out if it were not part of the project (for example, under Part 2). This in effect means that for a serious intervention, whether part of a research project or not, all the applicable safeguards in Part 2 must be met.