1. Human Tissue Act: implications for research
Dr Andrew Maines
Head of R&D and Designated Individual for Research
University Hospital of South Manchester NHS Foundation Trust

2. Human Tissue Act 2004
The Human Tissue Act 2004 gives a legislative framework for the collection and storage of human tissue, including body parts, organs, tissue, blood etc (broadly anything containing cells) from the living or deceased.

3. Implementation of the Act
The HT Act makes consent the fundamental principle.
The Human Tissue Authority (HTA) is the regulatory body for implementation of the HT Act.
HTA’s regulatory aim: “To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence.”
Proportionate approach i.e. according to risk (e.g. tissue for use is higher risk)

4. Key points of the Human Tissue Act 2004 (1)
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. It is unlawful to carry out these licensable activities without a licence.

5. Key points of the Human Tissue Act 2004 (2)
The HT Act creates a new offence of DNA ‘theft’. Having human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came is unlawful.

6. Key points of the Human Tissue Act 2004 (3)
The HT Act makes it lawful to take minimum steps to preserve the organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased, or, in the absence of their known wishes, obtaining consent from someone in an appropriate relationship.

7. Offences under the HT Act (1)
Removing, storing or using human tissue for Scheduled Purposes without appropriate consent.
Storing or using human tissue donated for a Scheduled Purpose for another purpose.
Trafficking in human tissue for transplantation purposes.

8. Offences under the HT Act (2)
Carrying out licensable activities without holding a licence from the HTA (with lower penalties for related lesser offences such as failing to produce records or obstructing the HTA in carrying out its power or responsibilities).

9. Offences under the HT Act (3)
Having human tissue, including hair, nail, and gametes (i.e. cells connected with sexual reproduction), with the intention of its DNA being analysed without the consent of the person from whom the tissue came or of those close to them if they have died. (Medical diagnosis and treatment, criminal investigations, etc., are excluded.)

10. Licensing (1)
The HTA will license a number of activities and inspect to ensure compliance with the Act and the associated licences. The activities are:

11. Licensing (2)
storage and use of human bodies for anatomical examination and related research (previously licensed by HM Inspector of Anatomy under the Anatomy Act 1984)
the carrying out of post mortem examinations, including removal and retention of human tissue
removal of human tissue from the body of a deceased person for other scheduled purposes, except transplantation
storage and use of human bodies or parts for public display
storage of human tissue for other scheduled purposes e.g.human tissue banking for transplant purposes or research

12. When do we need a licence?
Tissue removed and stored for the primary purpose of diagnosis or treatment - no licence
Post mortem examinations, including removal and retention of human tissue - licence
Tissue removed and stored for the primary purpose of research
Distribution to other researchers (tissue bank) – licence
A specific research project with ethical approval – no licence
A possible project in the future – licence

13. The licensing process One activity per licence
A licence must specify the premises where the activity is to be carried out
A licence cannot authorise licensed activity on premises at different places (but generally sites with the same postcode are regarded as the same place e.g. labs at different locations at a hospital)
One person (Designated Individual) supervises the activities under a licence

14. Compliance reporting
Licence application based on compliance reporting i.e. self assessment against standards
On line application form with narrative and numerical scoring: Scale of 1-4, 1 = standard not met, 4 = fully met
Evidence of compliance e.g. SOPs
Application forms open from mid-July 2006 with deadline of 31st August 2006

15. Deemed licences: When the HTA receives a suitable application it will issue a “deemed licence” pending a full licence
Applicant and DI submit completed compliance report
HTA check:
There is a named DI
The correct licensable activity is selected
Address provided for licensed activity to take place on
HTA issues a letter to inform applicant and DI
Allows applicant to continue practising lawfully while HTA evaluate information in compliance report

16. The Designated Individual
Has specific responsibilities as set out in HT Act
The DI is the person under whose supervision the licensed activity/ies are authorised to be carried out
HT Act does not state who should be a DI

17. Persons Designated
The compliance report asks for named ‘designated persons’. This is defined as individuals designated and consented by the DI who can reasonably assist in developing and implementing procedures and systems agreed by the DI to comply with the HT Act. Persons Designated do not have a legal duty as with those set out for the DI but the role requires the ability to direct others in relation to the HT Act.

18. Standards
Consent
Storage
Cataloguing
Traceability
Transfer
Disposal

19. Examples of consent issues
The HT Act is not retrospective regarding consent. It is lawful to keep and use tissue samples without consent if they were held before 1 September 2006 (but a licence is needed for research collections).
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 can be generic and enduring

20. Record-Keeping (1)
Must ensure there are systems in place to maintain proper records and documentation for all tissue and organs acquired and/or passed on to others.
The duty to create and maintain proper records starts with the establishment where the material is removed from the body.

21. Transfer
So that an audit trail can be maintained, each establishment that handles human organs or tissue must have systems that can record:
when the material was acquired,
and from where
what has been consented to
the uses to which the material is put whilst in the establishment’s care and
any processes applied to it and
when the material is transferred elsewhere, and to whom.

22. Traceability
European Directive 2004/23/EC requires that adequate systems be set up to ensure the traceability of human tissue and cells intended for human applications. The Directive will be transposed into law by Regulations.

23. Storage
Organs and tissue should be stored in line with current good practice on:
Security
traceability, including information about risk. Records should detail the location of the materials
health and safety, including appropriate containment levels for the storage, transportation and handling of materials that may pose a risk to staff or others.

24. Disposal Clear and sensitive disposal policy
Donors have the right to know how material will be disposed of after use
The Act makes it lawful to treat as ‘waste’ any relevant material which has come from a living person who was participating in research
Material taken from the living should normally be disposed of by incineration
Some patients may wish to retain tissue samples or make their own arrangements for disposal

25. HTA Inspections Phase 1 - remote paper-based phase
Phase 2 - Site visits to test compliance with HT Act
Risk-based, random, thematic
Can be unannounced

26. Trust Inspections
Internal inspection programme via PDs to ensure compliance
Audit tool based on Codes of Practice
SOPs to support best practice
Inspections at least annually

27. HTA Codes of Practice Code of Practice 1: Consent
Code of Practice 2: Donation of organs, tissue and cells for transplantation
Code of Practice 3: Post mortem examination
Code of Practice 4: Anatomical examination
Code of Practice 5: Removal, storage and disposal of human organs and tissue
Code of Practice 6: Donation of allogenic bone marrow and peripheral blood stem cells for transplantation
Code of Practice 7: Import and export of human bodies, body parts and tissue

28. More information http://www.hta.gov.uk/
FAQs: research_faqs.cfm

29. Trust SOPs for HTA compliance http://www. researchdirectorate. org
SOP13: Human Tissue Act Compliance
SOP 13a: Human Tissue Sample Anonymisation
SOP13b: Using Tissue from a Tissue Bank
SOP13c: Sample Numbering
SOP13d: Sample logging and storage, Tracking
SOP13e: R&D Management of Tissue Studies
SOP13f: Import and export of tissue
Material Transfer Agreement