Licensing and consent exemptions from the Human Tissue Act
This section explains the licensing and consent exemptions from the Human Tissue Act (2004).
There are two elements of exemptions included in the Act and associated Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006.
- Licensing exemptions
- Consent exemptions
A. Licensing exemptions
There are two licensing exemptions in the Act and further specific exemptions in the Human Tissue Act (HT Act) 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. These regulations came into force on 1 September 2006. The exemptions are summarised below according to whether the material is from the living or deceased.
1. Licensing exemptions – deceased
Material more than 100 years old (footnote 1)
Storage of material which has come from the body of a deceased person is exempted if the licensed activity relates to the body of a person who dies before the day on which the Section comes into force, or to material which has come from the body of such a person and at least 100 years have elapsed since the date of the person’s death.
Research (footnote 2)
Storage of relevant material which has come from the body of a deceased person, is exempted from licensing if the person storing it is intending to use it for the purpose of “qualifying research” or for a specific research project for which such ethical approval is pending. Qualifying research means research which has been ethically approved by a Research Ethics Committee (REC). The REC giving the approval must be a committee recognised under the Medicines for Human Use (Clinical Trials) Regulations 2004 or a committee which is established and recognised under existing systems for ethical review of health research in England, Wales or Northern Ireland. The committee will normally be a NHS Research Ethics Committee.
Transfer to tertiary centre for specialised analysis other than research (footnote 2)
Storage of relevant material which has come from the body of a deceased person, is exempted from licensing if 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 under the HT Act 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.
2. Licensing exemptions – living or deceased
(footnote 3,4)
The licensing requirements for storage do not include storage which is incidental to transportation. This means that the storage of material while it is being conveyed from one place to another does not need to be licensed. This would normally be a matter of hours or days rather than a week or longer.
Storage of relevant material is exempt from licensing where the person storing it is intending to use the material for transplantation:
- and 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
- the storage is for a period of less than 48 hours.
These exemptions continue to apply under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 which come into force on 5 July 2007.
3. Licensing exemptions – living
(footnote 5)
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:
- 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 related to human health
- Performance assessment
- Public health monitoring
- Quality assurance
- Qualifying research (see definition above).
B. Consent exemptions
Section 9 of the HT Act indicates that existing holdings are exempt from the consent provisions of the HT Act. An existing holding is defined as the body of a deceased person or relevant material from a human body (whether living or dead) held before the day on which the Act is commenced (1 September 2006) for use for a Scheduled Purpose. This exemption does not apply to the storage or use of dead bodies held for anatomical examination, which are dealt with separately under Section 10 of the HT Act (see below). This means that existing holdings of, for example, pathological and former anatomical specimens can continue to be stored and used for education and training related to human health without the need for appropriate consent under the HT Act.
Section 10 deals with existing anatomical specimens, which are different from former anatomical specimens, and essentially comprise bodies or body parts donated for dissection under the Anatomy Act 1984 (AA 1984) (in the 3 years pre commencement of HT Act) but where the anatomical examination has not been completed by 1 September 2006. The effect of section 10 is that there is deemed to be appropriate consent under the HT Act for the storage and use of these dead bodies for anatomical examination where an authority exists under the Anatomy Act 1984. Likewise, where the authority under the AA 1984 extended to possession of parts of the body, appropriate consent will be deemed to exist for the storage and use of such parts for research, and education and training.
Schedule 1, Part 2 of the HT Act details that consent is required from deceased person for the following scheduled purposes: Clinical audit; Education or training relating to human health; Performance assessment; Public health monitoring; Quality assurance. However consent is not required to use or store material from the living for the above purposes.
Footnotes
1. Section 16 (4)(a) and (b) of the HT Act (2004)
2. Regulation 3 (4) of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
3. Section 16 (7)(a) of the HT Act (2004)
4. Regulation 3 (3) of the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
5. Regulation 3 (2) of the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006
Issued 06 June 2007
Research and ethical approval
An exemption in the Human Tissue Act 2004 (HT Act) allows tissue and cells to be stored without a licence for a research project that has appropriate ethics approval. In addition, consent is not required to store and use tissue from the living for an ethically approved research project if it has been anonymised. The HTA encourages the taking of informed and generic consent at the outset, as the default position. This allows tissue to be used for different research projects over an unspecified period of time. It is preferable to developing complex systems for keeping the samples unlinked and mitigates the need to obtain repeat consent for each research project. More information is available in the Code of Practice on consent.
The newly-established National Research Ethics Service (NRES) (which incorporates the former Central Office for Research Ethics Committees and NHS RECs in England) has made a series of changes to facilitate ethical review of research involving human tissue. These include:
- A new REC approval process for licensed tissue banks, allowing tissue to be released to research projects without further REC approval within the conditions agreed in the original ethical approval.
- Where this “generic ethical approval” applies, storage of the tissue by the end user researcher will not need an HTA licence. Once the research project is finished the researcher will need to transfer the tissue to a licensed tissue bank, seek their own licence, apply to a REC for ethical approval of a new research project or, as a last resort, dispose of the material.
- The establishment of 'flagged' RECs which specialise in research tissue bank applications. Applications to undertake specific research projects involving tissue may continue to be submitted to any REC (clinical trials of investigational medicinal products must go to a UKECA-recognised REC).
To apply for ethical review either for a specific project or a tissue bank, go to http://www.nresform.org.uk. Select the relevant option on the sieve page to generate the appropriate version of the NHS REC Application Form.
Question-specific guidance is available for applicants on-line. It is recommended that applications for the review of research tissue banks should be booked via the NRES Central Allocation System – see http://www.nres.npsa.nhs.uk/applicants/review/apply/apply.htm#where. Guidance on the application process and form can be found at: http://www.nres.npsa.nhs.uk/applicants/review/apply/
Further guidance is available in Section 11 of the SOPs for Research Ethics Committees in the United Kingdom (v 3.3, April 2007), available at http://www.nres.npsa.nhs.uk/applicants/help/guidance.htm#sops or by emailing queries@nationalres.org.uk or accessing http://www.nres.npsa.nhs.uk/applicants/help/faqs.htm#tissue