Mental Capacity Act 2005

33 Additional safeguards

(1) This section applies in relation to a person who is taking part in an approved research project even though he lacks capacity to consent to taking part.

(2) Nothing may be done to, or in relation to, him in the course of the research—

(a) to which he appears to object (whether by showing signs of resistance or otherwise) except where what is being done is intended to protect him from harm or to reduce or prevent pain or discomfort, or

(b) which would be contrary to—

(i) an advance decision of his which has effect, or

(ii) any other form of statement made by him and not subsequently withdrawn,

of which R is aware.

(3) The interests of the person must be assumed to outweigh those of science and society.

(4) If he indicates (in any way) that he wishes to be withdrawn from the project he must be withdrawn without delay.

(5) P must be withdrawn from the project, without delay, if at any time the person conducting the research has reasonable grounds for believing that one or more of the requirements set out in section 31(2) to (7) is no longer met in relation to research being carried out on, or in relation to, P.

(6) But neither subsection (4) nor subsection (5) requires treatment that P has been receiving as part of the project to be discontinued if R has reasonable grounds for believing that there would be a significant risk to P’s health if it were discontinued.