Department of Pathology: Administration: Policies & Procedures: Human Tissue Act

Human Tissue Act

The Human Tissue Act (HT Act) became effective from 1st September 2006. The HT Act regulates removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells. This means that it is now unlawful to carry out these activities without an appropriate licence. The Act is upheld and regulated by the Human Tissue Authority which is an independent watchdog with the remit of protecting public confidence by ensuring that human tissue is used safely and ethically, and with proper consent. Organisations that store and use human tissue for the purposes listed below must have a licence to do so:

teaching about or studying the human body
carrying out post-mortem examinations
using human tissue to treat patients
carrying out research on human tissue
displaying human bodies or tissue in public (e.g. in a museum)

Please refer to the Frequently Asked Questions (below) for further advice on the Act or to see if you are affected. Further information may be obtained from Frances McLoughlin, Departmental Secretary for Academic Services, Department of Pathology at fam27@cam.ac.uk

Minutes of the Human Tissue Act (Research) Committee can be found at
www.path.cam.ac.uk/administration/policies-and-procedures/hta-minutes-260310.pdf

Frequently Asked Questions about the Human Tissue Act research licence held by the Department of Pathology.

1. What is the HTA?; 2. What is a "Scheduled Purpose"?; 3. What type of licence is required?; 4. Has the School of Biological Sciences (SBS) applied for a licence?; 5. What does the Act mean to my research?; 6. What is 'relevant' human material?; 7. Is there a list of 'relevant material' as defined under the HT act?; 8. How do I know whether the tissue or cells I store should be classed as relevant material under the HT Act and is licensable?; 9. What is "storage"?; 10. How is the HTA research licence administered in the University?; 11. What does ‘Designated Individual’ mean?; 12. What does ‘Persons Designated as a person to whom a licence applies’ mean?; 13. Do I need a licence to store tissue or cells for a specific research project if it has ethical approval?; 14. If I did not get consent for my research project and have archived tissue, including blocks and slides, will I have to get consent all over again? And will I need to have a licence?; 15. I have already collected material for a research project. What do I need to do?; 16. I would like to start a research project that involves collecting human material. What do I need to do?

17. What constitutes ethical approval?; 18. My research project was ethically approved but the project is now complete and the approval has expired. What do I do?; 19. I am currently undertaking research on samples that have been imported from overseas. How does the HT Act affect me?; 20. Does the Act affect the storage of DNA?; 21. I am storing tissue and DNA to undertake genetic tests. Do I need consent and/or a licence to carry out genetic tests?; 22. I am storing material that has been used for the primary purpose of diagnosis. I am receiving the residual material for research. Do I need a licence?; 23. Can consent from a patient be generic and enduring?; 24. Can clinicians do research using tissue from their own patients?; 25. Can I keep organs or tissue following Coroners’ autopsies for research, for example to check the prevalence of CJD in the population?; 26. Do I need a licence to store stem cells (including bone marrow stem cells) to treat patients?; 27. What are the HTA Codes of practice?; 28. Are there any activities which are exempt from requiring a licence?; 29. Are there any activities which are exempt from requiring Consent?; 30. Further information

1. What is the HTA?

The HTA (Human Tissue Authority) is a Government organisation set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training.

2. What is a ‘Scheduled Purpose’?

For living and deceased persons:

anatomical examination;
determining the cause of death;
establishing after a person’s death the efficacy of any drugs or other treatment administered;
obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
public display;
research in connection with disorders, or the functioning, of the human body;
transplantation;

For deceased persons:

clinical audit;
education or training relating to human health;
performance assessment;
public health monitoring;
quality assurance.

The HTA regulates these activities by providing establishments with an appropriate licence to carry out a ‘scheduled purpose’. As of 1st September 2006 it became unlawful to carry out licensable activities without a licence.

3. What type of licence is required?

There are different types of licence to regulate work under the HTA as follows:

Human application licences for establishments storing human tissue for human application
Anatomy licences for establishments carrying out anatomical examinations or storing anatomical specimens
Research licences for establishments storing human organs, tissues and cells for research purposes other than for a specific ethically approved research project
Post mortem licences for establishments carrying out post mortems, storing human bodies or organs, tissues or cells from a deceased person and / or removing relevant material from a deceased person other than in the course of a post mortem
Public Display licences for establishments storing bodies or organs, tissues or cells obtained from a deceased person for the purpose of public display

4. Has the School of Biological Sciences (SBS) applied for a licence?

Yes. The School has two licences

A pathology licence to cover removal, storage and use of human tissue for education from the deceased, with the Designated Individual as Prof Bill Harris (Department of Physiology, Development and Neuroscience).
A research licence to cover storage and use of relevant human tissue for research with a lead Designated Individual, Professor Andrew Wyllie (Department of Pathology).

The Department of Pathology (TCR site)** is the main research licence holder and, through Service Level Agreements, also provides cover to a number of satellite sites. A satellite licence allows Departments, through their Persons Designated, to store relevant human material for research under the conditions of the licence and the Service Level Agreement with the Department of Pathology. The following institutions currently hold a satellite licence under the Department of Pathology’s research licence:

**The Department of Pathology Divisions of Virology and Molecular Histopathology, based at Addenbrooke’s Hospital, come under Addenbrooke’s research licence.

5. What does the Act mean to my research?

It means that you need a licence to store relevant human material (unless you have ethical approval from the local NHS Research Ethics Committee (LREC) for a specific research project) and, that you must obtain informed consent for the removal, use and storage of relevant human material for your research, from the living and the dead.

a. Licence Requirements

A licence is required to store relevant human material, unless you have ethical approval from the local NHS Research Ethics Committee (LREC) for a specific research project. This includes where tissue is being stored for distribution to other researchers or, where tissue samples were collected before 1 Sept 2006 and were less than 100 years old on that date or, where tissue samples are imported.

A licence is not required if storing tissue solely for use in a specific NHS REC-approved project or, to store extracted DNA for use in research i.e. where no whole cells remain or, if storing tissue for the purpose of research from persons who died at least 100 years before 1 September 2006.

If researchers wish to retain tissue for future, unspecified research, then a licence under the HT Act will be required. The samples will need to be transferred to an existing licensed store until either a licence is granted or LREC ethical approval has been obtained. Human tissue is an invaluable resource for research, and disposal should be a last resort. However, in such cases please also refer to the requirements for consent.

The School of Biological Sciences (SBS) Human Biology Research Ethics Committee does not give licence exemption under the Human Tissue Act but, as the Department of Pathology and those institutions listed under 4. already operate under an HTA licence, LREC approval is not generally required as the SBS ethical review process is appropriate. Please refer to the SBS ethical approval process for further information at http://www.bio.cam.ac.uk/sbs/hbrec/

b. consent requirements

Consent is required if tissue is from a living person and samples are identifiable and the samples were obtained after 1st September 2006 or, if tissue is from a deceased person collected post mortem (both identifiable and anonymised* samples) and tissue is not imported and is not an existing holding or, if DNA analysis is intended and samples are identifiable and were obtained after 1st September 2006.

Consent is not required if tissue is an existing holding (from living or deceased persons) or, if tissue was obtained from a living person after 1st September 2006 and samples are anonymised* and the project is LREC approved, or for imported tissue (from living or deceased persons).

When LREC approval expires samples should be stored on licensed premises or renewed approval must be sought. If the samples are stored under the licence for the purpose of future research, the samples must normally have ‘generic’ consent from the donor. If consent was solely given for use within a specific project then leftover material must be disposed of. It is possible to ask for renewed consent, but this is usually not practical. For this reason obtaining generic consent in addition to project specific consent is encouraged.

*It is good practice to ensure that where possible consent is obtained even when it is not required.

6. What is “relevant” human material?

The definition of relevant material for the purposes of a research licence in the HT Act is set out as follows:

1. In this Act, "relevant material" means material, other than gametes, which consists of or includes human cells.

2. In this Act, references to relevant material from a human body do not include:

embryos outside the human body, or
hair and nail from the body of a living person.

The HTA considers it helpful to divide potentially relevant material into four categories. This categorisation helps in determining whether a sample is relevant material. However, the fundamental principle remains that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material.

The categories of relevant material are:

a. Specifically identified relevant material

This includes material like bodily organs and tissues, consisting largely or entirely of cells, and clearly identifiable and regarded as such. This category of relevant material includes human bodies, internal organs and tissues, skin and bone.

b. Processed material

Where a processed material is generally agreed – as a result of the process – to leave it always either cellular or acellular, then the presumption should be that all examples should be regarded as such. The HTA would rely on an assurance that the process in question had been carried out. Under this category plastinated tissue and plastinated body parts (where the cellular structure is retained by the plastination process) are to be regarded generically as relevant material; while plasma or serum, for example, will be regarded as not. The two latter processed materials, widely produced from blood taken for diagnostic investigations, are however examples of where ‘normal expectations’ may well need to be exercised.

c. Bodily waste products (including excretions and secretions)

Bodily waste is a less well characterised group of material. Nevertheless the HTA considers it important to provide a framework of guidance. The HTA considers bodily waste should normally be regarded as relevant material: the Act cannot be denied on this point. The Act’s wording is clear and reflects the possibility that even a single cell can be subject to research. However the HTA may be able to offer nuanced advice in specific instances. There will be cases where a researcher believes that material, intended for a scheduled purpose, is actually acellular. In such cases the researcher would need to consult the Authority, to refer the case for advice to a members’ panel if necessary.

d. Cell deposits and tissue sections on microscope slides

In general cell deposits or tissue sections on microscope slides are considered to constitute relevant material. This is because such deposits or sections are likely to contain whole cells or are intended to be representative of whole cells.

7. Is there a list of ‘relevant material’ as defined under the HT Act?

To supplement the HTA's broader policy framework on relevant material, a list has been produced to provide stakeholders with guidance on whether specific materials fall within the definition of relevant material under the HT Act. This Supplementary List of Materials for the Purposes of the Human Tissue Act 2004 can be found by following the link below:

http://www.hta.gov.uk/_db/_documents/Supplementary_list_of_materials_200811252407.pdf

8. How do I know whether the tissue or cells I store should be classed as relevant material under the HT Act and is licensable?

The general guidance is that if it contains human cells, then it is licensable. Things such as primary human cell cultures, bodily waste (including excretions and secretions), sera and breast milk are all considered licensable under the Human Tissue Act. Specifically identified material that is NOT considered relevant under the Act are:

Cultured cells which have divided outside the human body
Artificially created embryonic stem cells
Cell lines
Extracted DNA
Plasmid extracted DNA

Please refer to the HTA Codes of Practice for the removal, use and storage of relevant human material. (http://www.hta.gov.uk/guidance/codes_of_practice.cfm)

9. What is “storage”?

If you are storing relevant human material, for which you do not have ethical approval for a specific research project, then this is regarded as “storing” tissue, for which a licence is required.

Storage should be regarded as anything which needs to be ‘put away’ at the end of a day for future use. There is no exemption of up to 48 hours under the HTA research licence, for storage purposes.

If you are storing tissue without ethical approval at one of the sites listed above for the purposes of research, then you are already covered by a Research licence.

Please note that a licence covers premises rather than a whole institution, in that the licensed activity shall be carried on only on the premises specified in the licence. Institutes on split sites wanting to store tissue on all sites must have a licence for each site. [top]

10. How is the HTA research licence administered in the University?

The HTA framework provides a model of governance based on three key roles,as outlined in the HT Act. These three roles are:

Licence Holder (the University of Cambridge)
Designated Individual (Professor Andrew Wyllie, Head of the Department of Pathology)
Person Designated as a person to whom the licence applies (Heads of satellite departments)

11. What does ‘Designated Individual’ mean?

The Designated Individual (DI) in relation to a licence, means the person under whose supervision the licensed activity is authorised to be carried on. The role of the DI is crucial to the successful implementation of the HTA’s licensing systems. Section 18 of the HT Act provides that it shall be the duty of the DI to secure:

that the other persons to whom the licence applies are suitable persons to participate in the carrying on of the licensed activity
that suitable practices are used in the course of carrying on that activity, and;
that the conditions of the licence are complied with.

12. What does ‘Persons Designated as a person to whom a licence applies’ mean?

An establishment can designate particular individuals in a Notice to the HTA. They will then be regarded as Persons Designated as a person to whom the licence applies (PD), ie. to whom the HTA conferred by the licence extends. However such Notice to the HTA does not constitute a licence application.

The names of PDs should be provided in a Notice given by the DI to the HTA.

Other people can work under the direction of Persons Designated. PDs do not have a legal duty comparable with those set out for the DI. However the role of Person Designated carries with it the ability to “direct” others in relation to the HT Act. There are Service Level Agreements in place to ensure that the requirements of the HT Act are met and it is the responsibility of PDs in the satellite sites to direct HTA activities on behalf of the DI.

It is expected that the PD will be the Head of the Department/Institute.

13. Do I need a licence to store tissue or cells for a specific research project if it has ethical approval?

An HTA licence is not needed for storage of tissue for LREC ethically approved research or a specific research project for which ethical approval is pending – the majority of research in the UK. It is required for material stored (e.g. in large biobanks) for which there is no ethical approval.

14. If I did not get consent for my research project and have archived tissue, including blocks and slides, will I have to get consent all over again? And will I need to have a licence?

The HT Act is not retrospective regarding consent. It is lawful to keep and use tissue samples without consent if they were held before 1st September 2006 – the date on which the requirement for consent comes into force, but a licence would be required for any sample that requires storage for a Scheduled Purpose (eg. research).

15. I have already collected material for a research project. What do I need to do?

If you have already collected material for an undefined research project you will need to gain ethical approval to undertake that research (see below). If you collected that material prior to 1st September, 2006, you will not need to show that you gained consent for the collection. If, however, you collected that material after 1st September 2006, you will need to show that you gained consent.

16. I would like to start a research project that involves collecting human material. What do I need to do?

Any research project that involves the use of human material requires ethical approval.

17. What constitutes ethical approval?

For the purposes of licence exemption the HTA regards ethical approval as approval gained from the local NHS research ethics committee (or the equivalent in devolved countries) or UKECA-recognised ethics committees. You should contact Cambridge LREC (Local Research Ethics Committee) for details. They will ask you to fill in a LREC approval form, and submit an application, see http://www.nres.npsa.nhs.uk/

The School of Biological Sciences (SBS) Human Biology Research Ethics Committee does not give licence exemption under the Human Tissue Act but, as the Department of Pathology and those institutions listed under FAQ4 already operate under an HTA licence, LREC approval is not generally required as the SBS ethical review process is appropriate. Please refer to the SBS ethical approval process for further information at http://www.bio.cam.ac.uk/sbs/hbrec/

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18. My research project was ethically approved but the project is now complete and the approval has expired. What do I do?

For anything collected post-HT Act: storage after the end of an approved project requires consent by the individual from whom the tissue was collected to store for the purpose of using in a future research project.

For anything collected pre-HT Act the consent requirements will not need fulfilling as above but there would need to be a good case to retain indefinitely.

Samples should be stored on licensed premises or renewed approval must be sought. If the samples are stored under the licence for the purpose of future research, the samples must normally have ‘generic’ consent from the donor. If consent was solely given for use within a specific project then leftover material must be disposed of. It is possible to ask for renewed consent, but this is usually not practical. For this reason obtaining generic consent in addition to project specific consent is encouraged.

It is good practice to ensure that where possible consent is obtained even when it is not required.

Subject to above you would then need to either:

negotiate with one of the Departments that is covered by the licence to bank the material with them. (see FAQ “Has the School of Biological Sciences (SBS) applied for a licence?”)
apply to the Department of Pathology to obtain satellite site status by contacting the SBS HTA Steering Committee (Frances McLoughlin, Departmental Secretary, Department of Pathology, fam27@cam.ac.uk).
dispose of the material in a manner that is sensitive and complies with regulatory bodies such as Health and Safety and the Environmental Protection Agency. See (http://www.hta.gov.uk/guidance/codes_of_practice.cfm for further information relating to the disposal of human material.

19. I am currently undertaking research on samples that have been imported from overseas. How does the HT Act affect me?

There is an HTA Code of Practice on the import and export of human bodies, body parts and tissue. The code provides guidance to those carrying out activities which lie within the HTA’s remit and lays down the standards expected. Failure to follow the guidance is not in itself an offence under the HT Act. Nevertheless, failure to observe the principles set out in the Code may influence licensing decisions made by the HTA. The guidelines relating to imported samples can be found at:

Code of Practice 8 Import and export of human bodies, body parts and tissue

20. Does the Act affect the storage of DNA?

Stored DNA is exempt from the HT Act. HOWEVER, if you are storing material with the purpose of using it to extract DNA, then you are required to obtain informed consent and to have a licence to store this material.[top]

21. I am storing tissue and DNA to undertake genetic tests. Do I need consent and/or a licence to carry out genetic tests?

You need both consent and a licence to store tissue with the purpose of undertaking genetic tests. You do need informed consent to undertake DNA analysis (to protect the families) but you do not need a licence to store DNA.

22. I am storing material that has been used for the primary purpose of diagnosis. I am receiving the residual material for research. Do I need a licence?

If the material has been obtained from the deceased, you must always obtain consent from them or a nominated representative, called a “qualifying person”, which is typically a member of the family specified in a decreasing order of qualification (e.g. spouse, mother, sister, uncle etc).

‘Residual’ blood or tissue from the living can be used without consent as long as the research is ethically approved and the researcher cannot link the blood or tissue to the patient. Consent is not needed to use surplus or residual tissue from living patients left over from diagnosis or surgery for the purposes of:

Public health monitoring
Education and training (including training in research techniques)
Clinical audit
Performance assessment (e.g. testing medical devices)
Quality assurance

Consent is needed for any of the HT Act’s Scheduled Purposes (e.g. research) where the tissue is from a deceased person.

23. Can consent from a patient be generic and enduring?

Consent can be generic and enduring. The HT Act sets the baseline, saying simply that for storage and use of tissue for Scheduled Purposes to be lawful, consent must be obtained from the appropriate person. The scope of that consent is not limited by the HT Act. Consent can be whatever is agreed in different circumstances, and guidance for obtaining consent is provided in the HTA’s codes of practice and other guidance. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking repeated consents – for example for research after the patient has had surgery.

24. Can clinicians do research using tissue from their own patients?

Yes. They are particularly well-placed to ask for their patients' consent. If they wish to do research without asking their patients' consent the research project will need to be LREC ethical approval and they must arrange the research so that they do not have access to information identifying the person from whom the tissue came. This does not mean that the records and tissue must be permanently unlinked.

25. If my research takes place without consent, because I use anonymised tissue and have ethical approval, does it mean the information cannot be linked to clinical data?

No, it doesn’t. The linked data would need to be anonymised so that the researcher could not know the identity of the person whose tissue was involved. But it does not need to be permanently unlinked. A treating clinician should make arrangements for anonymisation or preferably get consent.

26. Can I keep organs or tissue following Coroners’ autopsies for research, for example to check the prevalence of CJD in the population?

According to the HT Act, consent from the deceased person, a person nominated by them, or a ‘qualifying person’ (usually family members) will be needed to carry out any research or public health monitoring on tissue from the deceased. After Coroners have completed their work the body and tissue must either be

Disposed of sensitively
Returned to the family
Consented for use for another Scheduled Purpose such as research, plus health monitoring.

27. What are the HTA Codes of practice?

One of the HTA’s statutory functions is to issue Codes of Practice. The codes give practical guidance and lay down the standards expected.

28. Are there any activities which are exempt from requiring a licence?

The exemptions are summarised below according to whether the material is from the living or deceased.

a: Licencing exemptions - deceased

Material more than 100 years old

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

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. See d. Licence exemption for research through ethical approval below

Transfer to tertiary centre for specialised analysis other than research

Storage of relevant material which has come from the body of a deceased person, is exempted from licensing if the relevant material:

has come from premises in respect of which a licence under Section 16 (2) is in force, and
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
will be returned to premises in respect of which a licence under Section 16 (2) is in force when the analysis is completed

b: Licencing exemptions - living or deceased

Transportation

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.

Transplantation

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.

c: Licencing exemptions - living

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).

d: Licence exemption for research through ethical approval

An exemption in the 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 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. 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.

29. Are there any activities which are exempt from requiring Consent?

Existing holdings

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 commenced (1st September 2006) for use for a Scheduled Purpose. Existing holdings are exempt from the consent provisions of the HT Act. 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.

Consent exemption for material from the living for certain Scheduled Purposes

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 but that consent is not required to use or store material from the living for the above purposes.

Anonymised tissue

If the research is ethically approved and the tissue is anonymised such that the researcher is not in possession of information identifying the person from whose body the material has come and is not likely to come into possession of it

30. Further information

Further information can be obtained from:

Frances McLoughlin
Departmental Secretary
Department of Pathology
Tel: x33693
e-mail fam27@cam.ac.uk
Or by visiting the HTA website: www.hta.gov.uk

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