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1 DOCUMENT CONTROL PAGE Title Title: Guidance on Human Tissue Act 2004 consent requirements for the removal, storage and use of human tissue Version: 2 Reference Number: HTA010 Supersedes Supersedes: 1 Description of Amendment(s): Minor changes Originator or modifier Originated By: Dr Judith Rucklidge Designation: Research Practice Co-ordinator Modified by: Dr Jay Brown Designation: Human Tissue Project Manager Approval Approval by: Research Governance Operational Group Research Governance Committee Application All Staff involved in research projects using human tissue. Circulation Review Issue Date: 06/10/2010 Circulated by: Trust Intranet and Internet Issued to: Refer to list Review Date: 06/10/2012 Responsibility of: Human Tissue Project Manager Page 1 of 11

2 POLICY CONTROL PAGE (2) CIRCULATION DOCUMENT Circulation List: DI, Persons Designate and staff working under their supervision For Information Trust: Research Office Staff, Division Research Managers, Division Research Leads Central Manchester University Hospitals NHS Foundation Trust (CMFT) is committed to promoting equality and diversity in all areas of its activities. In particular, the Trust wants to ensure that everyone has equal access to its services. Also that there are equal opportunities in its employment and its procedural documents and decision making supports the promotion of equality and diversity. Refer to section 5 for more detail on undertaking equalities impact assessment. This document must be disseminated to all relevant staff, refer to section 7: Dissemination and Implementation The document must be posted on the intranet. Page 2 of 11

3 Section Contents Page 1 Introduction 3 2 Purpose 3 3 Roles and Responsibilities 3 4 Procedure 4 5 Equality Impact Assessment 8 6 Consultation, Approval and Ratification Process 8 7 Dissemination and Implementation 9 8 Review, Monitoring Compliance With and the 9 Effectiveness of Procedural Documents 9 References and Bibliography Associated Trust Documents Appendices 10 Appendix A: Local Governance Structure 11 1 Introduction 1.1 The Human Tissue Act ( The HT Act ) sets out a new legal framework for the storage and use of tissue from the living and for the removal, storage and use of tissues and organs from the dead. The HT Act applies to all relevant material, defined as material other than gametes, which consists of or includes human cells, but excluding a) embryos outside the human body, or b) hair and nail from the body of a living person. This includes residual tissue following clinical and diagnostic procedures and also covers blood, blocks and slides. The HT Act repeals and replaces previous legislation in this area and establishes the Human Tissue Authority (HTA) 2 as the regulatory body. 2 Purpose 2.1 This document describes the main points of the HTA Code of Practice on consent in relation to research and operating within the law. It should be read in conjunction with the Trust Policy on compliance with the Human Tissue Act 2004 in research (HTA004) the Trust Policy for Consent to Examination or Treatment (CON01), Trust Wide R&D SOP 6 Informed Consent, Trust Wide R&D SOP 7 Informed consent in special circumstances, and the HTA Codes of Practice 3. 3 Roles and Responsibilities 3.1 The Executive Lead on operational HTA matters is the Executive Director of Children s Services. 3.2 The Executive Lead for the Trust on Clinical Governance is the Medical Director. The Medical Director will oversee the clinical governance arrangements for HTA through the Compliance Officer (Associate Director of Page 3 of 11

4 Clinical Governance). The Medical Director will monitor developments further through chairmanship of the Clinical Governance Board. (See Appendix A for Local Governance Structure). 3.3 The Designated Individual (DI) has statutory responsibilities under Section 18 of the HT Act. The Di is accountable to the HTA for research tissue handled under the authority of the Trust Licence and for making relevant Trust staff aware of this policy. 3.4 The Human Tissue Project Manager (HT Project Manager) is accountable to the DI and will act on his behalf to oversee adherence to the Trust Licence and to this policy. 3.5 Persons Designated (PD) are accountable to the DI and are responsible for ensuring that this policy is observed in respect of human tissue which is handled under the authority of the Trust Licence and for which they have responsibility. This includes making all staff that handle such tissue aware of this policy. PDs can direct others in relation to the Act on behalf of the DI. PDs will be assigned to areas of CMFT either geographically, by research area or by collection type. Training and guidance for PDs will be provided by the HT Project Manger, the DI or via online HTA training modules. The HT Project Manager will maintain a list of PDs and their training status. 3.6 All staff collecting, storing or using human tissue for research under the Trust Research Licence are accountable to the relevant PD(s) and the DI for undertaking work in compliance with this policy. In compliance with the Research Licence issued by the HTA, CMFT expects all persons operating on the CMFT sites to comply with the HT Act and its subsequent amendments, and to comply with all Codes of Practice 3 issued by the HTA and relevant Trust Wide and/ or local Standard Operating Procedures (SOPs). 4 Procedure 4.1 General points on consent Consent for storage and use of tissue from the living and/ or deceased for research in connection with disorders or the functioning of the human body is a legal requirement under the HT Act Anyone removing, storing or using material in circumstances for which the HT Act requires consent must be satisfied that the consent is in place. Where possible the person storing the tissue must keep a signed copy of the consent form. Where this is not possible the person must have assurance that consent for the sample exists The giving of consent is a positive act. For consent to be valid it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question. Page 4 of 11

5 4.2 Research without consent Tissue from the living may be stored for use and/ or used without consent, provided that 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 Linking is permissible through a 3 rd party where necessary If members of the clinical team take part in the research, links may be retained to relevant clinical or patient records, but they must not contain information giving direct patient identification Consent is always preferable to complex systems of anonymisation Residual tissue samples from living, competent adults following diagnostic or therapeutic intervention or research can be used for research, education and training without separate consent if these purposes are included within the surgical consent form. 4.3 Tissue from a living adult who lacks capacity Consideration of whether an adult is competent to consent to the use of their tissue for research should be approached on the same basis as considerations of competency to consent to medical procedures, although it should be recognised that an adult may be competent to make decisions about some matters but not others Further guidance is available from the Department of Health publication, Reference guide to consent for examination and treatment 4. Consideration must also be given to the provisions of the Mental Capacity Act Tissue from a living child Consent to obtain tissue from a living child (under 18 years old) should be obtained in accordance with the existing legislation. Guidance is available from the Department of Health publication, Seeking Consent: Working with Children 5. Please also refer to the Trust Policy for Consent to Examination or Treatment. 4.5 Tissue from a deceased adult It is illegal to store relevant material taken after death for any research purposes, unless consent and ethical approval have been obtained. Material may only be stored after death without consent for the purposes of a Coroner or for criminal justice proceedings Consent obtained from the person whilst living and with capacity is valid after death and takes precedence over any other views. Page 5 of 11

6 4.5.3 Consent from a nominated representative can be taken in order to carry out research. The nominated representative must have been appointed by the deceased in a signed document, or orally in front of two witnesses. The consent of the nominated representative cannot be overridden If the deceased has not indicated consent (or refusal) or appointed a nominated representative, or that person is unreachable, consent can be sought from a person in a qualifying relationship, as detailed below and in ranked order: a) Spouse or partner (including civil or same sex partner) b) Parent or child (in this context a child can be of any age) c) Brother or sister d) Grandparent or grandchild e) Niece or nephew f) Stepfather or stepmother g) Half-brother or half-sister h) Friend of long standing If the relationship of each of two or more persons to the deceased is accorded equal highest ranking, it is sufficient to obtain the consent of any one of them A person can be omitted from the hierarchy if they cannot be located in reasonable time for the activity in question to be addressed, declines to deal with the matter or is unable to do so, for example, because they are a child or lack capacity. In such cases, the next person in the hierarchy would become the appropriate person to give consent. 4.6 Tissue from a deceased child The position of a child who, before they died, was competent to reach a decision and gave consent for one or more of the scheduled purposes to take place after their death, is no different from that of an adult. However, this should be discussed with the person with parental responsibility If the child did not make a decision or was not competent to do so, then consent must be sought from the person with parental responsibility. However the HTA recommend that careful thought should be given as to whether to proceed if a disagreement arises between parents or other family members If there is no person with parental responsibility, consent should be sought from a person in a qualifying relationship, as detailed in section Fetal tissue Fetal tissue is regarded as the mother s tissue. Consent and ethical approval must be sought for the use of fetal tissue in research, regardless Page 6 of 11

7 4.8 DNA of gestational age. Consent and ethical approval must also be obtained for research involving non-fetal products of conception It is an offence under the HT Act to have material with the intent of analysing DNA without consent. However, there are exceptions to this, which include existing holdings and material from living people if anonymised and ethical approval is in place. 4.9 Obtaining consent If identifiable tissue is to be used for research, patients should be told about any implications this may have. For example, they may be contacted by researchers, given feedback, or be asked for access to their medical records Patients must be told whether the consent is generic (i.e. for use in any future research project which has ethical approval) or specific Patients should be informed if their samples will or could be used for research in the commercial sector Where consent is sought from a nominated representative or person in a qualifying relationship, information of the same level should be provided. However, care should be taken regarding the disclosure of sensitive information such as genetic information or HIV status Multiple consents When someone has died, it may be appropriate to seek consent for more than one purpose, such as post-mortem, transplantation and/ or research; this should be obtained through a single consent process, and ideally using a single form Relatives can exclude certain purposes from consent. More detailed guidance on the discussion of post mortem examinations and the retention of tissue for research is given in the HTA Codes of Practice on Post Mortem Examination (Code 3) and Research (Code 9) Nature of consent Consent can be: General, i.e. if someone consents to the use of tissue for research, it need not be limited to a particular project; Specific, i.e. a person limits their consent a sample can only be used for research into a particular condition; Both general and specific, i.e. a general consent subject to specific exceptions. Page 7 of 11

8 4.12 Withdrawal of consent A competent person is entitled to withdraw consent at any time. Under such circumstances, no further tests can be done and the samples should be destroyed, unless held for the purpose of maintaining a diagnostic record, audit or quality control. Existing information obtained from the samples does not have to be withdrawn from the research project Consent for research on existing samples The consent requirements of the HT Act are not retrospective. This means it is not necessary to obtain consent for material that was held when the HT Act came into force on 1 September Although there are no statutory requirements to obtain consent for the storage or use of tissue that is an existing holding, this does not mean that all such human tissue can be used freely and without regard to issues of consent or other ethical considerations. If practical, the consent of the participant should be sought and the views of the deceased person or of their family (if known) should be respected, as long as the method of disposal is legal. See the code of practice on Disposal of human tissue for further information on how to dispose of existing holdings Under the HT Act, consent is not required for carrying out research on existing holdings of human tissue and organs (see paragraph 66). Although it does not have an explicit role in the ethical approval of research on such material, the HTA endorses the guidance produced by the National Research Ethics Service (NRES) [ ] Although existing holdings are exempt from the consent provisions in the HT Act, the HTA's licensing requirements may still apply where material is being stored or used for a scheduled purpose. 5 Equality Impact Assessment 5.1 This document has been equality impact assessed by the author using the Trust s Equality Impact Assessment (EqIA), which has been submitted to the Equality and Diversity Department for Service Equality Team Sign Off. 5.2 The EqIA score fell into low priority (0 9); no significant issues in relation to equality, diversity, gender, colour, race or religion are identified as raising a concern. 6 Consultation, Approval and Ratification Process 6.1 Consultation and Communication with Stakeholders Page 8 of 11

9 6.1.1 All Trust-wide Human Tissue Act documents are written by a member of staff with relevant expertise and experience. Additional advice is sought from members of the research community within the Trust or external advisors, as necessary Consultation on this document was provided by Designated Individuals, Persons Designated, Principal Investigators and relevant research staff. 6.2 Approval Process Approved by Research Governance Operational Group Ratified by Research Governance Committee. 7 Dissemination and Implementation 7.1 Dissemination When approved, this document will be posted on the Human Tissue Act pages of the CMFT Clinical Governance and Research & Innovation intranet sites. Only the current version will be available The HT Project Manager will notify Persons Designate when the latest version is available Persons Designate will notify staff in their research areas. 7.2 Implementation of Procedural Documents Training covering the contents of this Policy is included in the GCP training course delivered by the Research Office Support and advice on the implementation of this document can be obtained via the Human Tissue Project Manager or Designated Individuals. 8 Review, Monitoring Compliance With and the Effectiveness of Procedural Documents 8.1 Process for Monitoring Compliance and Effectiveness Document contents will be reviewed against any changes to the applicable guidelines and regulations and taking into account any feedback received from researchers or via the Monitoring Programme The outcome of the review and any resulting amendments - will be reported to the Research Governance Operational Group. 8.2 Standards and Key Performance Indicators KPIs Page 9 of 11

10 8.2.1 This document will be available on the Trust intranet This document must be reviewed at least every two years or when there are significant changes to the document Awareness of the document will be delivered at Trust HT Act training sessions. 9 References and Bibliography 1. The Human Tissue Act 2004: 2. The Human Tissue Authority 3. The Human Tissue Authority Codes of Practice: 4. DoH- Reference guide to consent for examination and treatment. ndguidance/dh_ DoH Seeking consent: working with children. ndguidance/dh_ Associated Trust Documents HTA004 Policy on compliance with the Human Tissue Act 2004 in research CON01 Trust Policy for Consent to Examination or Treatment Trust Wide R&D SOP 6 Informed consent Trust Wide R&D SOP 7 Informed consent in special circumstances 11 Appendices Appendix A: Local Governance structure. Page 10 of 11

11 Appendix A: Local Governance Structure. Trust Board Clinical Effectiveness Committee Chair Medical Director Human Tissue Act Steering Group Chair Executive Director Of Children s Services Children s Divisional Clinical Governance Board (Children s) REH Divisional Clinical Governance Board (REH Therapeutic) Medicine Divisional Clinical Governance Board (Central Site Therapeutic) CSS Divisional Clinical Governance Board (Central Site Pathology) Research Governance Committee Research Governance Operational Group Designated Individual Persons Designated Principal Investigators Laboratory Staff Page 11 of 11