© imperial college londonpage 1 human tissue act: implications for researchers paula nicholson...

© Imperial College London

Human Tissue Act: Implications for

Researchers

Paula NicholsonResearch [email protected]

Patricia Henley

Research Facilitator

[email protected]


Overview

• History• Human Tissue Act and current regulations• The Act in Detail• The Act in Practice

– Ethics Approval– Consent– Record Keeping– Inspections

• Summary


History

• Alder Hey Children’s Hospital– Between 1988-1995 unconsented removal and

retention of body parts– Redfern report published in 2001– Dutch pathologist Dr Dick Van Velzen ordered the

“unethical and illegal stripping of every organ from every child who had a postmortem”

• Over 104 000 organs, body parts and entire bodies of foetuses and still-born babies stored in 210 NHS facilities.

• Cash for tissues row/ Stolen body parts


Human Tissue Act 2004

• HT Act implemented 1st April 2006: – Regulates removal, storage and use of tissue and

organs from the deceased, and the storage and use of tissue from the living

• ‘Relevant Material’


Relevant Material?

1. Blood

2. Hair

3. Plasma

4. Nails

5. Serum

6. DNA

7. Urine

8. Tissue Arrays

9. Faeces

10. Saliva

11. Brains

12. Sputum

13. Tears

14. Cell lines

15. Embryos

16. Foetus

17. Bile

18. Mucus

19. Nasal lavage

20. Breast Milk

21. Lungs

22. Shoulders


Human Tissue Act 2004

• HT Act implemented 1st April 2006: – Regulates removal, storage and use of tissue and

organs from the deceased, and the storage and use of tissue from the living

• ‘Relevant Material’ – Material from human body consisting of/including

human cells


Relevant Material?

1. Blood √

2. Hair X

3. Plasma X but √ / ?

4. Nails X

5. Serum X

6. DNA X

7. Urine X

8. Tissue Arrays √

9. Faeces ?

10. Saliva ?

11. Brains √

12. Sputum √

13. Tears ?

14. Cell lines X

15. Embryos X

16. Foetus √

17. Bile X

18. Mucus √

19. Nasal lavage √

20. Breast Milk X

21. Lungs √

22. Shoulders √


EU Tissue & Cells Directive (EUTCD)

• Quality & Safety of human tissues and cells for human application– Implemented April 2006 – 1st HTA licences– Includes stem cells– Excludes organs

• Covers:– Donation, Procurement, Testing, Processing,

Preservation, Storage & Distribution


Other Regulations

• Human Fertilisation and Embryology Act (1990) – Governs storage and use of gametes and embryos– Regulated by HFEA

• EU Directive on Blood & Blood Products (2003)– Transposed into UK law as the Blood Safety and Quality

Regulations 2005– Regulated by MHRA– Covers blood banks and transfusion– Cord blood & Haematopoietic Stem Cells covered by EUTCD

& HT Act

• RAFT?


HT Act: General Information

• HT Act does not apply if 100 years have passed since date of donor’s death

• Foetal tissue is treated as any other tissue under the Act, although embryos and gametes are excluded

• Scotland exempt from licensing for storing tissue for human application (EUTCD)

• Specific ethically approved studies are exempt from licensing

• Consent is the overarching principle


Human Tissue Authority

• The Act and EUTCD overseen by HTA– Public Body to inform Public and Parliament on issues

within their remit

• Codes of Practice:– Consent – Donation of organs, tissue and cells for transplantation – Post-Mortem Examination– Anatomical Examination– Removal, storage and disposal of human organs and

tissue – Donation of allogenic bone marrow and peripheral

blood stem cells for transplantation • www.hta.gov.uk/guidance/codes_of_practice.cfm

http://www.hta.gov.uk/guidance/codes_of_practice.cfm


Licensable Activities

Under HTA, certain activities must be licensed:– Anatomical examination – Post-mortem examination – Removal of relevant material from a deceased person – Storage of relevant material from a deceased person (other

than for a specific ethically approved project) – Storage of anatomical specimens – Storage of relevant material from a living person for research

(other than for a specific ethically approved project) or for human application

– Public display of a body or material from a deceased person


Licensing

• 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• One person (Designated Individual)

supervises the activities under a licence


Governance under Act

• Designated Individual• Licence applicant (if different to DI)• Person Designated as a person to whom the

licence applies• Persons acting under the direction of a DI or

Person Designated by DI• Responsible Person under EUTCD


Designated Individuals & License Holder

• DI responsible for supervising the licensed activity. Legally responsible to:– Ensure suitable practices are used to undertake

licensed activity– Those working under license suitably qualified– License conditions are complied with

• License Holder– Could be individual or corporate license– Trusts and Imperial College hold licenses


Local Designated Individuals

• Chelsea & Westminster – Professor Mervyn Maze, Anaesthetics

• Hammersmith Hospitals NHS Trust– Dr Timothy Ryder, Histopathology Department

• NWLH– Michael Burke, Medical Director

• Royal Brompton & Harefield– Professor Martin Cowie, R&D Director

• South Kensington– Mr Gary Roper, IC Research Governance Manager

• St Mary’s– Dr Graham Taylor, Infectious Diseases Department


HT Act Offences

• Anatomy Act and Human Organ Transplants Act offences have been carried forward

• New Offences:– Removing/Storing tissue without consent– Using tissue stored for one purpose for another– Tissue trafficking for transplantation– Carrying out licensable activities without a licence– DNA theft (analysis without consent)


Act in Practice


Are you storing organs, tissue or cells (relevant material) for research purposes (from living or deceased person)

No licence required

No licence required

Licence required

Licence required

Is the material you are storing created outside of the human body e.g. a cell line?

Are you storing material for a specific research project with ethical approval?

Are you storing organs, tissues or cells to distribute to other researchers?

Are you storing organs, tissues or cells for a future undefined project or a project without ethical approval?


Ethics – Approvals for Tissue Work

• Requirement for all tissue research to be ethically approved by a recognised committee, ie COREC

• Taking new samples for research for new studies (Patients or Healthy Volunteers)– Consent, Imperial Sponsorship and Indemnity Needed– COREC Parts A,B and SSA (Part C) needed

• Other NHS Trust Lead Site:– Chief Investigator completes A and B – Main REC– PI completes Part C – Local REC


Ethics – Tissue Supplied for Contract Work

• Tissue Received from external NHS Trust or Organisation

• Standard Tests/Procedures performed (nothing innovative!) and data supplied to organisation

• No SSA needed here as not research

• IC PI named as contractor on ethics form (not collaborator)


Informed Consent – the living• Required:

– Obtaining scientific or medical information which may be relevant to any other person, now or in the future

– Research in connection with disorders, or the functioning, of the human body

– Public display– Transplantation

• Not required:– Clinical audit– Education or training relating to human health– Performance assessment– Public health monitoring– Quality assurance

• Exceptions to obtaining consent in research:– Ethical approval– Anonymised samples


Informed Consent – the deceased

• Required:– After post mortem, continued storage or use of material no

longer required to be kept for coroner’s purposes– Removal, storage and use for:

• Anatomical examination• Determining cause of death• Establishing, after death, efficacy of any drug administered to patient• Obtaining scientific or medical information relevant to any future

person• Public display• Research in connection with disorders, or the functioning, of the

human body• Clinical audit• Education or training relating to human health• Performance assessment• Public health monitoring• Quality assurance


Informed Consent – the deceased

• Not required:– Carrying out investigation into cause of death– Keeping material after a post mortem under the

authority of a coroner– Keeping material in connection with a criminal

investigation


Appropriate consent - genetics

• Offence to have any bodily material with intent to analyse the DNA in it without qualifying consent

• Offence does not apply if results are to be used for one of the ‘excepted’ purposes:– Medical diagnosis or treatment of that person– Coroner purposes– Prevention / detection of crime or prosecution– National security– Court / tribunal– Clinical audit, education, training, performance assessment, etc– Anonymised tissue


Record Keeping

• Systems to maintain records and documentation for all tissues and organs (acquired and passed to others)– Role of DI (may be delegated)– Policies and procedures– QA– Audit trails

• Tissue must be tracked for health and safety e.g. in case of infection– Record should start at site of tissue removal from body


Record Keeping

Records should include:1. Details of who gave consent

2. Exactly what the consent related to; any restrictions on use imposed

3. Processes applied to the tissue

4. If tissue is transferred; when and to whom

5. When and where disposal is undertaken (if relevant)


Inspections

• HTA must be satisfied that:– The DI is suitable to supervise activities authorised

by the license– That those carrying out licensed activities are

suitable to carry out such activities– That suitable practices are used to carry out

activities– That the conditions of the license are complied

with


Inspections Process

Two phased inspection programme:1. Evaluation of Compliance Report (CR) license

application– Whether to grant a license or not

2. Inspection site visits– Risk-based approach i.e. those falling below standard in >1

areas of the CR will be inspected first– Every 2 years for centres affected by the EUTCD– Evidence-based report will be produced– Any recommendations regarding licence conditions

reviewed by licensing panel


What should I have in place?

1. Consent– Consent must be obtained as set out in the HTA Code of

Practice on Consent

2. Governance and quality systems– Systems to ensure the provision of safe tissue with reliable

quality

3. Premises, facilities and equipment– Premises, facilities and equipment must be suitable for the

licensed activity undertaken

4. Disposal– Establishments should develop a clear and sensitive disposal

policy


Scenarios

1. I have just found 4000 brains in the lab in the basement, what do I do with them?

2. We’re using embryos for diagnostic tests and QA of our assays, do we need a licence?

3. I have ethical approval for my project but I plan to keep the tissue as new technologies develop, do I need a licence?


Summary

Reminder:

Penalties of up to 3 years imprisonment for failure to obtain/misuse of ‘appropriate’

consent

If in doubt – check with Clinical Research Office

[email protected]

[email protected]

mailto:[email protected]

mailto:[email protected]

© imperial college londonpage 1 human tissue act: implications for researchers paula nicholson...

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