Research studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005. This includes persons with dementia, learning disabilities, mental health problems, stroke or head injuries who may lack capacity to make certain decisions, including consenting to participate in a research study. The act does not apply to studies falling under the Clinical Trials Regulations (CTIMPs).
Any research involving a person lacking capacity that would otherwise have required consent from participants may only be lawfully carried out if an NHS REC in England or Wales has given a favourable opinion. This includes research that would otherwise fall outside the remit of an NHS REC. The REC can only approve the research if it meets the following criteria:
- It is connected to an impairing condition affecting the incapacitated patient or its treatment
- Research of equal effectiveness cannot be carried out if confined to participants with capacity
- The research must have the potential to benefit the patient without imposing a disproportionate burden
- It must provide knowledge of the causes or treatment of others with the same condition, and involve negligible risk to the incapacitated patient, not interfere significantly with their freedom of action or privacy, or be unduly invasive or restrictive.
The MCA also includes provisions for the REC to issue an emergency waiver of consent to allow the recruitment of adults lacking capacity into emergency studies where the patient is incapacitated and it would not be feasible or safe to attempt to consult them on their inclusion in the study. In such cases, the adult patient could be incapacitated because they are unconscious, acutely confused or intoxicated or because they are experiencing shock, severe anxiety, terror or severe pain etc. In such cases, consultee advice must be sought or the patient consented to continued study participation as soon as is reasonable practicable after the emergency has passed.