The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 1U.K.APPLICATION AND INTERPRETATION

1.—(1) The conditions and principles specified in Part 2 apply to all clinical trials.U.K.

(2) If any subject of a clinical trial is—

(a)an adult able to give informed consent, or

(b)an adult who has given informed consent to taking part in the clinical trial prior to the onset of incapacity,

the conditions and principles specified in Part 3 apply in relation to that subject.

(3) [F1Subject to sub-paragraphs (6) and (7), if] any subject of a clinical trial is a minor, the conditions and principles specified in Part 4 apply in relation to that subject.

(4) [F2Subject to sub-paragraphs (6) and (7), if] any subject—

(a)is an adult unable by virtue of physical or mental incapacity to give informed consent, and

(b)did not, prior to the onset of incapacity, give or refuse to give informed consent to taking part in the clinical trial,

the conditions and principles specified in Part 5 apply in relation to that subject.

(5) If any person—

(a)is an adult unable by virtue of physical or mental incapacity to give informed consent, and

(b)has, prior to the onset of incapacity, refused to give informed consent to taking part in the clinical trial,

that person cannot be included as a subject in the clinical trial.

[F3(6) Sub-paragraph (7) applies if treatment is being, or is about to be, provided for a subject who is [F4a minor or] an incapacitated adult as a matter of urgency and, having regard to the nature of the clinical trial and of the particular circumstances of the case—

(a)it is also necessary to take action for the purposes of the clinical trial as a matter of urgency; but

(b)it is not reasonably practicable to meet the conditions set out in paragraphs 1 to 5 of [F5Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult].

(7) Where this sub-paragraph applies, paragraphs 1 to 5 of [F6Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult] shall not apply in relation to the subject if the action specified in sub-paragraph (6) is carried out in accordance with a procedure approved by an ethics committee or by an appeal panel appointed under Schedule 4 at the time it gave its favourable opinion.]

Textual Amendments

2.  In this Schedule—U.K.

“Declaration of Helsinki” means the Declaration of Helsinki adopted by the World Medical Assembly in June 1964, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989 and October 1996;

“guardian” shall be construed in accordance with section 51(8) of the Adults with Incapacity (Scotland) Act 2000 F7;

“legal representative” means, in relation to a minor or to an adult unable by virtue of physical or mental incapacity to give informed consent, and who is, or is being considered as, a subject for a clinical trial—

(a)

in relation to adults and minors in England, Wales and Northern Ireland, and minors in Scotland—

(i)

a person, other than a person [F8connected with] the conduct of the trial, who—

(aa)

by virtue of their relationship with that adult or that minor, is suitable to act as their legal representative for the purposes of that trial, and

(bb)

is available and willing to so act for those purposes, or

(ii)

if there is no such person, a person, other than a person connected with the conduct of the clinical trial, who is—

(aa)

the doctor primarily responsible for the medical treatment provided to that adult [F9or that minor], or

(bb)

a person nominated by the relevant health care provider; and

(b)

in relation to adults in Scotland—

(i)

any guardian or welfare attorney who has power to consent to the adult’s participation in research, or

(ii)

if there is no such guardian or welfare attorney, the adult’s nearest relative, or

(iii)

if it is not reasonably practicable to contact a guardian or welfare attorney or the adult’s nearest relative before the decision to enter the adult as a subject of the clinical trial is made, a person, other than a person connected with the conduct of the clinical trial, who is—

(aa)

the doctor primarily responsible for the medical treatment provided to that adult, or

(bb)

a person nominated by the relevant health care provider;

“nearest relative” has the meaning given by section 87(1) of the Adults with Incapacity (Scotland) Act 2000;

“parental responsibility”—

(a)

in relation to England and Wales, has the same meaning as in the Children Act 1989 F10,

(b)

in relation to Scotland, has the same meaning as in the Children (Scotland) Act [F111995] F12, and

(c)

in relation to Northern Ireland, has the same meaning as in the Children (Northern Ireland) Order 1995 F13;

“person connected with the conduct of the trial” means—

(a)

the sponsor of the trial,

(b)

a person employed or engaged by, or acting under arrangements made with, the sponsor and who undertakes activities in connection with the management of the trial,

(c)

an investigator for the trial,

(d)

a health care professional who is a member of an investigator’s team for the purposes of the trial, or

(e)

a person who provides health care under the direction or control of a person referred to in paragraphs (c) and (d) above, whether in the course of the trial or otherwise;

“relevant health care provider” means—

(a)

in relation to a person receiving services in pursuance of the National Health Service Act 1977 F14, the National Health Service (Scotland) Act 1978 F15, or the Health and Personal Social Services (Northern Ireland) Order 1972 F16—

(i)

in a case where a health service body is providing those services, that body, or

(ii)

in any other case, the health service body which entered the arrangements under which those services are provided, or

(b)

in relation to any other person receiving health care, the person primarily responsible for providing that health care; and

“welfare attorney” shall be construed in accordance with section 51(8) of the Adults with Incapacity (Scotland) Act 2000.

Textual Amendments

F101989 c. 41; see, in particular, sections 3(1) and 5(6).

F121995 c. 36; see, in particular, sections 1(3) and 7(5).

F13S.I. 1995/755 (N.I.2); see, in particular, article 6.

3.—(1) For the purposes of this Schedule, a person gives informed consent to take part, or that a subject is to take part, in a clinical trial only if his decision—U.K.

(a)is given freely after that person is informed of the nature, significance, implications and risks of the trial; and

(b)either—

(i)is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or

(ii)if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.

(2) For the purposes of this Schedule, references to informed consent—

(a)shall be construed in accordance with paragraph (1); and

(b)include references to informed consent given or refused by an adult unable by virtue of physical or mental incapacity to give informed consent, prior to the onset of that incapacity.