The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
| Jurisdiction | UK Non-devolved |
| Citation | SI 2006/1260 |
| Year | 2006 |
(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—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. (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) .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, the purpose of qualifying research.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; orthe storage is for a period of less than 48 hours.the person storing it is intending to use it for the purpose of qualifying research; orhas come from premises in respect of which a licence under section 16(2) is in force,is stored by a person intending to use it for the sole purpose of analysis for a scheduled purpose other than research, andwill be returned to premises in respect of which a licence under section 16(2) is in force when the analysis is completed.“organ” means a differentiated ...part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with ... F12a significant level of autonomy F13, 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;research which is ethically approved for the purposes of section 1(9) (a) of the Act; ora specific research project for which such ethical approval is pending;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.A person who has removed transplantable material from a human body (“ 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. (1) Name and address of the hospital or other place at which the transplantable material was removed from the donor.(2) Full name of registered medical practitioner or person who removed the transplantable material, the appointment he holds and the place at which he holds it.
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