The Medicines for Human Use (Clinical Trials) Regulations 2004

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 F1 ;

“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 [F2 connected 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 [F3 or 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 F4 ,

(b)

in relation to Scotland, has the same meaning as in the Children (Scotland) Act [F5 1995] F6 , and

(c)

in relation to Northern Ireland, has the same meaning as in the Children (Northern Ireland) Order 1995 F7 ;

“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 F8 , the National Health Service (Scotland) Act 1978 F9 , or the Health and Personal Social Services (Northern Ireland) Order 1972 F10 —

(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

F1 2000 asp 4.

F2 Words in Sch. 1 Pt. 1 para. 2 substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 27(1)(i)(aa)

F3 Words in Sch. 1 Pt. 1 para. 2 inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 27(1)(i)(bb)

F4 1989 c. 41; see, in particular, sections 3(1) and 5(6).

F5 Word in Sch. 1 Pt. 1 para. 2 substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 27(1)(ii)

F6 1995 c. 36; see, in particular, sections 1(3) and 7(5).

F7 S.I. 1995/755 (N.I.2); see, in particular, article 6.

F8 1977 c. 49.

F9 1978 c. 29.

F10 S.I. 1972/1265 (N.I. 14).