117Approval for processing confidential patient information
(1)The Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438) are amended as follows.
(2)In regulation 5 (the title to which becomes “Approval for processing information”)—
(a)the existing text becomes paragraph (1), and
(b)in sub-paragraph (a) of that paragraph, for “both the Secretary of State and a research ethics committee” substitute “the Health Research Authority”.
(3)After paragraph (1) of that regulation insert—
“(2)The Health Research Authority may not give an approval under paragraph (1)(a) unless a research ethics committee has approved the medical research concerned.”
(4)After paragraph (2) of that regulation insert—
“(3)The Health Research Authority shall put in place and operate a system for reviewing decisions it makes under paragraph (1)(a).”
(5)In regulation 6 (registration requirements in relation to information), in paragraph (1)—
(a)before “the Secretary of State” insert “the Health Research Authority or”, and
(b)before “he” insert “it or”.
(6)In paragraph (2)(d) of that regulation, before “the Secretary of State” insert “the Health Research Authority or (as the case may be)”.
(7)In paragraph (3) of that regulation, for the words from the beginning to “in the register” substitute “The Health Research Authority shall retain the particulars of each entry it records in the register, and the Secretary of State shall retain the particulars of each entry he records in the register,”.
(8)For paragraph (4) of that regulation substitute—
“(4)The Health Research Authority shall, in such manner and to such extent as it considers appropriate, publish entries it records in the register; and the Secretary of State shall, in such manner and to such extent as he considers appropriate, publish entries he records in the register.”