The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006

Citation, commencement and interpretationE+W+N.I.

1.—(1) These Regulations may be cited as the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 and shall come into force on 1st September 2006.

(2) In these Regulations—

“the Act” means the Human Tissue Act 2004;

“donor” and “recipient” have the meaning given by regulation 4; and

[F1“research ethics authority” means—

(a)

a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014, or

(b)

any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers or the Department of Health, Social Services and Public Safety in Northern Ireland.]

“transplantable material” has the meaning given in regulation 9 of the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 M1.

Textual Amendments

F1Words in reg. 1 substituted (1.1.2015) by The Care Act 2014 (c. 23), s. 127, Sch. 8, para. 8 (with s. 119(3)); S.I. 2014/2473, art. 5(n)

Marginal Citations

Ethical approval of researchE+W+N.I.

2.  Research is ethically approved for the purposes of section 1(9)(a) and paragraph 10(b) of Schedule 4 to the Act where it is approved by a research ethics authority.

Exceptions from licensing requirementE+W+N.I.

3.—(1) The storage of relevant material by a person who intends to use it for a scheduled purpose is excepted from section 16(2)(e)(ii) of the Act (storage of relevant material which has come from a human body) in the circumstances set out in paragraphs (2) to (4).

(2) Storage of relevant material which has come from the body of a living person is excepted where the person storing it is intending to use it for—

(a)any purpose specified in paragraphs 2 to 5 or 8 to 12 of Part 1 of Schedule 1 to the Act (determining the cause of death, establishing after a person's death the efficacy of any drug or treatment administered to him, obtaining information which may be relevant to another person, public display, clinical audit, education or training relating to human health, performance assessment, public health monitoring, F2... [F2quality assurance, maintaining the requirements of structure and vascularisation)]; or

(b)the purpose of qualifying research.

(3) Storage of relevant material which has come from a human body is excepted where the person storing it is intending to use it for the purpose of transplantation and—

F2(a)the material is an organ or part of an organ if it is to be used for the same purpose as the entire organ in the human body; or

(b)the storage is for a period of less than 48 hours.

(4) Storage of relevant material which has come from the body of a deceased person is excepted where—

(a)the person storing it is intending to use it for the purpose of qualifying research; or

(b)the relevant material—

(i)has come from premises in respect of which a licence under section 16(2) is in force,

(ii)is stored by a person intending to use it for the sole purpose of analysis for a scheduled purpose other than research, and

(iii)will be returned to premises in respect of which a licence under section 16(2) is in force when the analysis is completed.

(5) In this regulation—

(a)“organ” means a differentiated F3...part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with F4... [F4a significant] level of autonomy [F5, and a part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation];

(b)“qualifying research” means—

(i)research which is ethically approved for the purposes of section 1(9)(a) of the Act; or

(ii)a specific research project for which such ethical approval is pending;

(c)an application for ethical approval is pending from when it has been submitted to a research ethics authority until the decision of the authority has been communicated to the applicant.

Textual Amendments

F2Words in reg. 3(2)(a) substituted (12.7.2012 for specified purposes, 1.10.2015 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 27(a)

F3Words in reg. 3(5)(a) omitted (12.7.2012 for specified purposes, 1.10.2015 in so far as not already in force) by virtue of The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 27(b)

F4Words in reg. 3(5)(a) substituted (12.7.2012 for specified purposes, 1.10.2015 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 27(b)

Information about transplant operationsE+W+N.I.

Information to be supplied by medical practitioner who removes transplantable materialE+W+N.I.

4.  A person who has removed transplantable material from a human body (“the donor”) which is proposed to be transplanted to another person (“the recipient”) shall supply to NHS Blood and Transplant M2 the information specified in Schedule 1 to these Regulations.

Marginal Citations

M2NHS Blood and Transplant is a Special Health Authority established by S.I. 2005/2529.

Information to be supplied by medical practitioner who receives transplantable materialE+W+N.I.

5.  A person who has received transplantable material which is proposed to be transplanted to a recipient shall supply to NHS Blood and Transplant the information specified in Schedule 2 to these Regulations.

Rosie Winterton,

Minister of State,

Department of Health