Draft Regulations laid before Parliament under section 65(4) of the Mental Capacity Act 2005, for approval by resolution of each House of Parliament.
2006 No.
The Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2006
Made
Coming into force
for the purpose mentioned in regulation 1(1)(a)
for all other purposes
The Secretary of State for Health makes the following Regulations in exercise of the powers conferred upon her by sections 30(6)(a), 34(1), (2) and (3)(b), 64(1) and 65(1)(c) of the Mental Capacity Act 20051.
In accordance with section 65(4) of that Act, a draft of this instrument was laid before Parliament and approved by a resolution of each House of Parliament.
Citation, commencement, territorial application and interpretation1
1
These Regulations may be cited as the Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2006 and shall come into force on—
a
1 February 2007 for the purpose of enabling applications for approval for the purposes of Schedule 1 to be made to, and determined by, an appropriate body,
b
1 April 2007 for all other purposes.
2
These Regulations apply in relation to the carrying out of research in England.
3
In these Regulations—
“the Act” means the Mental Capacity Act 2005;
“appropriate body” has the meaning given by section 30(4) of the Act and the Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 20062.
Application2
These Regulations apply where—
a
a person (“P”)—
i
has consented before 31 December 2007 to take part in a research project (“the project”) begun before 1st April 2007, but
ii
before the conclusion of the project, loses capacity to consent to continue to take part in it, and
iii
research for the purposes of the project in relation to P would, apart from these Regulations, be unlawful by virtue of section 30 of the Act.
Research which may be carried out despite a participant’s loss of capacity3
Despite P’s loss of capacity, research for the purposes of the project may be carried out using information or material relating to him if—
a
that information or material was obtained before P’s loss of capacity,
b
that information or material is either—
i
data within the meaning given in section 1(1) of the Data Protection Act 19983, or
ii
material which consists of or includes human cells or human DNA,
c
the project satisfies the requirements set out in Schedule 1, and
d
the person conducting the project (“R”) takes in relation to P such steps as are set out in Schedule 2.
Signed by authority of the Secretary of State for Health
SCHEDULE 1Requirements which the project must satisfy
1
A protocol approved by an appropriate body and having effect in relation to the project makes provision for research to be carried out in relation to a person who has consented to take part in the project but loses capacity to consent to continue to take part in it.
2
The appropriate body is satisfied that there are reasonable arrangements in place for ensuring that the requirements of Schedule 2 will be met.
SCHEDULE 2Steps which the person conducting the project must take
1
R must take reasonable steps to identify a person who—
a
otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P’s welfare, and
b
is prepared to be consulted by R under this Schedule.
2
If R is unable to identify such a person he must, in accordance with guidance issued by the Secretary of State, nominate a person who—
a
is prepared to be consulted by R under this Schedule, but
b
has no connection with the project.
3
R must provide the person identified under paragraph 1, or nominated under paragraph 2, with information about the project and ask him—
a
for advice as to whether research of the kind proposed should be carried out in relation to P, and
b
what, in his opinion, P’s wishes and feelings about such research being carried out would be likely to be if P had capacity in relation to the matter.
4
If, at any time, the person consulted advises R that in his opinion P’s wishes and feelings would be likely to lead him to wish to withdraw from the project if he had capacity in relation to the matter, R must ensure that P is withdrawn from it.
5
The fact that a person is the donee of a lasting power of attorney given by P, or is P’s deputy, does not prevent him from being the person consulted under paragraphs 1 to 4.
6
R must ensure that nothing is done in relation to P in the course of the research which would be contrary to—
a
an advance decision of his which has effect, or
b
any other form of statement made by him and not subsequently withdrawn,
of which R is aware.
7
The interests of P must be assumed to outweigh those of science and society.
8
If P indicates (in any way) that he wishes the research in relation to him to be discontinued, it must be discontinued without delay.
9
The research in relation to P must be discontinued without delay if at any time R has reasonable grounds for believing that the requirement set out in paragraph 1 of Schedule 1 is no longer met or that there are no longer reasonable arrangements in place for ensuring that the requirements of this Schedule are met in relation to P.
10
R must conduct the research in accordance with the provision made in the protocol referred to in paragraph 1 of Schedule 1 for research to be carried out in relation to a person who has consented to take part in the project but loses capacity to consent to continue to take part in it.
(This note is not part of the Regulations)