The HRA must publish guidance about—
the cases in which, in its opinion, good practice requires a person proposing to conduct health or social care research that involves individuals to obtain the approval of a research ethics committee recognised or established by the HRA under this Chapter, and
the cases in which an enactment requires a person proposing to conduct research of that kind to obtain that approval.
Before publishing guidance under subsection (1), the HRA must—
consult the devolved authorities and such other persons as the HRA considers appropriate, and
obtain the approval of the Secretary of State.
The HRA may revise guidance under subsection (1) and, where it does so, it must publish the guidance as revised; subsection (2) applies to revised guidance in so far as the HRA considers the revisions significant.
Schedule 8 (which amends various references to research ethics committees in secondary legislation) has effect.