Part 12Amendment to the Schedules

Amendment to Schedule 1

regulation 37 + 37.—(1) Schedule 1 (conditions and principles of good clinical practice and for the protection of clinical trial subjects) is amended as follows.

(2) In the heading, for “subjects” substitute “participants”.

(3) In Part 1 (application and interpretation)—

regulation 37 3 a + (a)for “any subject”, in each place where it occurs, substitute “any participant”;

regulation 37 3 b + (b)for “that subject”, in each place where it occurs, substitute “that participant”;

regulation 37 3 c + (c)for “a subject”, in each place where it occurs, substitute “a participant”;

regulation 37 3 d + (d)in paragraph 1(7)(1)—

regulation 37 3 d i + (i)for “the subject” substitute “the participant”;

regulation 37 3 d ii + (ii)omit “or by an appeal panel appointed under Schedule 4”;

regulation 37 3 e + (e)in paragraph 2, in the definition of “Declaration of Helsinki” omit “, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989 and October 1996”;

regulation 37 3 f + (f)in paragraph 3—

regulation 37 3 f i + (i)in sub-paragraph (1)—

regulation 37 3 f i aa + (aa)at the beginning, insert “Subject to sub-paragraph (3),”;

regulation 37 3 f i bb + (bb)in paragraph (b)(ii), for “given orally” substitute “communicated (whether by talking, using sign language or any other means);

regulation 37 3 f ii + (ii)after sub-paragraph (2), insert—

“(3) Where sub-paragraph (4) applies, the protocol for the clinical trial for which consent is given may make provision for simplified arrangements for obtaining and evidencing consent, which shall include—

(a)the reason for obtaining consent using simplified arrangements;

(b)the information to be provided to the participant, and the means of providing that information; and

(c)the means by which consent shall be evidenced.

(4) This sub-paragraph applies where—

(a)the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the United Kingdom and is used in accordance with that authorisation;

(b)the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is given to the participant in the course of that participant’s routine health care; and

(c)the participant receives no additional medication and undergoes no additional intervention or diagnostic procedure, solely for the purposes of the clinical trial.

(5) For the purposes of sub-paragraph (4)—

“intervention” includes complementary or alternative therapies, the taking of tissue samples, and requirements in relation to imaging and radiotherapy; and

“medication” includes nutritional products and alternative remedies.”.

(4) For Part 2 (conditions and principles which apply to all clinical trials) substitute(2)—

“Part 2CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS

1.  Clinical trials must be conducted in accordance with the principles of good clinical practice set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time(3).

2.  Except where it would be a contravention of these Regulations, clinical trials must be conducted in accordance with the principles of the Declaration of Helsinki.

3.  The investigator and sponsor must have regard to all relevant guidance with respect to commencing and conducting a clinical trial.

4.  Provision must be made for insurance or indemnity to cover all liabilities of the investigator and sponsor which may arise in relation to the clinical trial.”.

(5) In Part 3 (conditions which apply in relation to an adult able to consent or who has given consent prior to the onset of incapacity), for “the subject”, in each place where it occurs, substitute “the participant”.

(6) In Part 5 (conditions and principles which apply in relation to an incapacitated adult)—

regulation 37 6 a + (a)for “the subject”, in each place where it occurs, substitute “the participant”;

regulation 37 6 b + (b)in paragraph 1, for “the subject’s” substitute “the participant’s”;

regulation 37 6 c + (c)in paragraph 7, for “a subject” substitute “a participant”.