Human Tissue Act: implications for research

Dr Andrew MainesHead of R&D and Designated Individual for ResearchUniversity Hospital of South Manchester NHS Foundation Trust

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.

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)

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.

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.

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.

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.

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).

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.)

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:

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

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

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

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

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

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

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.

Standards

Consent Storage Cataloguing Traceability Transfer Disposal

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

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.

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.

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.

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.

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

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

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

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

More information

http://www.hta.gov.uk/ FAQs: http://www.hta.gov.uk/about_hta/faqs/

research_faqs.cfm http://www.researchdirectorate.org.uk/ http://www.rdforum.nhs.uk/home.htm

Trust SOPs for HTA compliancehttp://www.researchdirectorate.org.uk/sop.html

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