The Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010

Annual reports and provision of information

19.—(1) A research establishment which is granted an authorisation shall submit an annual report to the Authority for each relevant year, which shall include—

(a) a declaration that the research establishment has in place appropriate systems to ensure compliance with these Regulations or reasons why it cannot give such a declaration;

(b) details of the system it has in place to ensure compliance; and

(c) an account of how it has used the information provided under these Regulations.

(2) The report shall be published as soon as possible after the end of each relevant year.

(3) For the purposes of this regulation, “relevant year” means—

(a) the period beginning with the date on which notice of the decision is given under regulation 11 or where applicable regulation 12 and ending 12 months thereafter; and

(b) for the duration of the authorisation, each successive period of 12 months ending with the anniversary of the date on which the decision is notified notwithstanding the expiry of the authorisation before that date in that relevant year.

(4) Where a research establishment processes disclosable protected information under these Regulations, it shall make available to the Authority within the period specified by the Authority such information as the Authority may reasonably require to assist the Authority in any investigation and audit of that processing within the period specified by the Authority.