The Medicines for Human Use (Clinical Trials) Regulations 2004

Interpretation

1.  In this Schedule—

“appointing authority” means—

(a)

in relation to an ethics committee established under regulation 6, the Authority,

(b)

in relation to an ethics committee recognised by the Authority after an application in accordance with regulation 7(1), the person who applied for recognition, or

(c)

in relation to an ethics committee recognised without an application for recognition being submitted in accordance with regulation 7(3), the Authority;

“expert member” means a member of an ethics committee who—

(a)

is a health care professional,

(b)

has professional qualifications or experience relating to the conduct of, or use of statistics in clinical trials, unless those professional qualifications or experience relate only to the ethics of clinical research or medical treatment, or

(c)

is not a health care professional, but has been a registered medical practitioner or a person registered in the dentists register under the Dentists Act 1984;

“financial year” means the twelve months ending with 31st March; and

“lay member” means a member of an ethics committee, other than an expert member.