Part 1Persons who lack capacity
Research
I130Research
1
Intrusive research carried out on, or in relation to, a person who lacks capacity to consent to it is unlawful unless it is carried out—
a
as part of a research project which is for the time being approved by the appropriate body for the purposes of this Act in accordance with section 31, and
b
in accordance with sections 32 and 33.
2
Research is intrusive if it is of a kind that would be unlawful if it was carried out—
a
on or in relation to a person who had capacity to consent to it, but
b
without his consent.
3
A clinical trial which is subject to the provisions of clinical trials regulations is not to be treated as research for the purposes of this section.
4
“Appropriate body”, in relation to a research project, means the person, committee or other body specified in regulations made by the appropriate authority as the appropriate body in relation to a project of the kind in question.
5
“Clinical trials regulations” means—
a
the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) and any other regulations replacing those regulations or amending them, and
b
any other regulations relating to clinical trials and designated by the Secretary of State as clinical trials regulations for the purposes of this section.
6
In this section, section 32 and section 34, “appropriate authority” means—
a
in relation to the carrying out of research in England, the Secretary of State, and
b
in relation to the carrying out of research in Wales, the National Assembly for Wales.