2.—(1) In these Regulations—
“the Act” means the Human Fertilisation and Embryology Act 1990;
“additional conditions” mean conditions imposed under regulation 8(2);
“application” except in regulation 9, means an application made under regulation 4 and “applicant” shall be construed accordingly;
“authorisation” means authorisation by the Authority under regulation 3;
“the Authority” means the Human Fertilisation and Embryology Authority;
“the Data Protection Act” means the Data Protection Act 1998(1);
“the NHS Act” means the National Health Service Act 2006(2);
“the NIGB” means the National Information Governance Board for Health and Social Care established by section 250A of the NHS Act(3);
“parental responsibility” has the same meaning as in section 33B(6) of the Act(4) (consent required to authorise certain disclosures);
“processing” except in regulation 14, means using the disclosable protected information authorised under regulation 3 and “process” and “processed” shall be construed accordingly;
“relevant individual” has the same meaning as in section 31(4) of the Act(5) (register of information);
“research establishment” means a university or other body or institution that carries out medical or other research within the United Kingdom;
“research ethics committee” means—
an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(6); or
any other committee established to advise on the ethics of research investigations in human beings and recognised for that purpose by or on behalf of the Secretary of State; and
“research project” has the meaning given in regulation 4(4)(c).
(2) In these Regulations, “disclosable protected information” means information falling within section 31(2) of the Act(7) (register of information) which—
(a)is entered by the Authority on its register during the period from 1st August 1991 to 30th September 2009 (both dates inclusive) but does not fall within an exclusion in paragraph (3) of this regulation; or
(b)is entered by the Authority on its register on or after 1st October 2009 and is about a relevant individual but does not fall within an exclusion in paragraph (4) of this regulation.
(3) For the purposes of paragraph (2)(a), information is excluded where it—
(a)identifies or relates to an individual who has donated gametes other than for research purposes only;
(b)identifies or relates to an individual (or a person treated with that individual) who has received treatment services with donated gametes;
(c)identifies or relates to an individual who has donated (whether alone or with another) an embryo other than for research purposes only;
(d)identifies or relates to an individual (or a person treated with that individual) who has received treatment services with a donated embryo;
(e)identifies or relates to an individual who was conceived as a result of assisted conception using donated gametes or a donated embryo; or
(f)is in respect of—
(i)an individual who has refused to give consent for disclosure for the purposes of research;
(ii)an individual who has not attained the age of 16 years, where the parents of, or other persons with parental responsibility for, that child indicated in writing that information relating to that child could not be disclosed for the purposes of research; or
(iii)an individual who has not attained the age of 16 years, where at the time that treatment services or non-medical fertility services were being provided to the persons who became the parents of that child, those persons indicated in writing that information relating to any child born as a result of those treatment services could not be disclosed for the purposes of research.
(4) For the purposes of paragraph(2)(b), information is excluded where it—
(a)is in respect of a relevant individual who has attained the age of 16 years unless the relevant individual has consented to the disclosure of the information by the Authority for research purposes in accordance with regulations made under section 33D of the Act (disclosure for the purposes of medical or other research);
(b)is in respect of a relevant individual who has given written notice to the Authority that they do not consent to the disclosure for research purposes by the Authority of information about them provided at the time of giving that notice the relevant individual was competent to give it;
(c)is in respect of a relevant individual where a person having parental responsibility for the relevant individual has given written notice to the Authority that they do not consent to the disclosure for research purposes by the Authority of information about the relevant individual;
(d)is in respect of a relevant individual where, at the time treatment services or non-medical fertility services were being provided to the persons who became the parents of the relevant individual, those persons indicated in writing that information relating to any child born as a result of those treatment services could not be disclosed by the Authority for research purposes in accordance with regulations made under section 33D of the Act (disclosure for the purposes of medical or other research);
(e)identifies or relates to an individual who has donated (whether alone or with an individual) an embryo other than for research purposes only; or
(f)identifies or relates to an individual who has donated gametes other than for research purposes only.
(5) Any notice given under these Regulations shall be—
(a)in writing; or
(b)transmitted by electronic means in a legible form which is capable of being used for subsequent reference.
2006 c. 41. Section 250A was inserted by section 157 of the Health and Social Care Act 2008 (c. 14).
Section 33B of the Act was inserted by section 25 of the 2008 Act.
1990 c. 37. Section 31(4) of the Act was substituted by section 24 of the 2008 Act.
S.I. 2004/1031; relevant amending instruments are S.I. 2006/1928 and 2008/941.
1990 c. 37. Section 31(2) was substituted by section 24 of the 2008 Act.