Presentation on theme: "Human Tissue Act: implications for research"— Presentation transcript:
1Human Tissue Act: implications for research Dr Andrew MainesHead of R&D and Designated Individual for ResearchUniversity Hospital of South Manchester NHS Foundation Trust
2Human Tissue Act 2004The 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.
3Implementation 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)
4Key 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.
5Key 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.
6Key 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.
7Offences 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.
8Offences 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).
9Offences 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.)
10Licensing (1)The HTA will license a number of activities and inspect to ensure compliance with the Act and the associated licences. The activities are:
11Licensing (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 tissueremoval of human tissue from the body of a deceased person for other scheduled purposes, except transplantationstorage and use of human bodies or parts for public displaystorage of human tissue for other scheduled purposes e.g.human tissue banking for transplant purposes or research
12When do we need a licence? Tissue removed and stored for the primary purpose of diagnosis or treatment - no licencePost mortem examinations, including removal and retention of human tissue - licenceTissue removed and stored for the primary purpose of researchDistribution to other researchers (tissue bank) – licenceA specific research project with ethical approval – no licenceA possible project in the future – licence
13The licensing process One activity per licence A licence must specify the premises where the activity is to be carried outA 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
14Compliance reportingLicence application based on compliance reporting i.e. self assessment against standardsOn line application form with narrative and numerical scoring: Scale of 1-4, 1 = standard not met, 4 = fully metEvidence of compliance e.g. SOPsApplication forms open from mid-July 2006 with deadline of 31st August 2006
15Deemed licences: When the HTA receives a suitable application it will issue a “deemed licence” pending a full licenceApplicant and DI submit completed compliance reportHTA check:There is a named DIThe correct licensable activity is selectedAddress provided for licensed activity to take place onHTA issues a letter to inform applicant and DIAllows applicant to continue practising lawfully while HTA evaluate information in compliance report
16The Designated Individual Has specific responsibilities as set out in HT ActThe DI is the person under whose supervision the licensed activity/ies are authorised to be carried outHT Act does not state who should be a DI
17Persons DesignatedThe 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.
19Examples 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
20Record-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.
21TransferSo 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 wherewhat has been consented tothe uses to which the material is put whilst in the establishment’s care andany processes applied to it andwhen the material is transferred elsewhere, and to whom.
22TraceabilityEuropean 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.
23StorageOrgans and tissue should be stored in line with current good practice on:Securitytraceability, including information about risk. Records should detail the location of the materialshealth and safety, including appropriate containment levels for the storage, transportation and handling of materials that may pose a risk to staff or others.
24Disposal Clear and sensitive disposal policy Donors have the right to know how material will be disposed of after useThe Act makes it lawful to treat as ‘waste’ any relevant material which has come from a living person who was participating in researchMaterial taken from the living should normally be disposed of by incinerationSome patients may wish to retain tissue samples or make their own arrangements for disposal
25HTA Inspections Phase 1 - remote paper-based phase Phase 2 - Site visits to test compliance with HT ActRisk-based, random, thematicCan be unannounced
26Trust InspectionsInternal inspection programme via PDs to ensure complianceAudit tool based on Codes of PracticeSOPs to support best practiceInspections at least annually
27HTA Codes of Practice Code of Practice 1: Consent Code of Practice 2: Donation of organs, tissue and cells for transplantationCode of Practice 3: Post mortem examinationCode of Practice 4: Anatomical examinationCode of Practice 5: Removal, storage and disposal of human organs and tissueCode of Practice 6: Donation of allogenic bone marrow and peripheral blood stem cells for transplantationCode of Practice 7: Import and export of human bodies, body parts and tissue
28More information http://www.hta.gov.uk/ FAQs: research_faqs.cfm
29Trust SOPs for HTA compliance http://www. researchdirectorate. org SOP13: Human Tissue Act ComplianceSOP 13a: Human Tissue Sample AnonymisationSOP13b: Using Tissue from a Tissue BankSOP13c: Sample NumberingSOP13d: Sample logging and storage, TrackingSOP13e: R&D Management of Tissue StudiesSOP13f: Import and export of tissueMaterial Transfer Agreement