1. Human Tissue Authority: Codes of Practice - Consent Dr Kirstin Goldring Biobank Facilitator

2. Human Tissue Act 2004 HT Act implemented 1 st September 2006: –Regulates removal, storage and use of tissue and organs from the deceased, and the storage and use of tissue from the living HT Act: General Information Covers England, Wales and Northern Ireland. Separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 HT Act does not apply retrospectively Foetal tissue is treated as any other tissue under the Act, although embryos and gametes are excluded Consent is the overarching principle

3. Human Tissue Authority – Regulatory Authority HTA provides advice and guidance about two laws: the Human Tissue Act 2004, and the EU Tissue and Cells Directives - European laws that have been implemented in the UK via the Quality and Safety Regulations These laws ensure human tissue is used safely and ethically, with proper consent. HTA was set up to regulate removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes HTA was established on 1 st April 2005 HTA - Regulation 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. The HTA does not regulate the diagnosis or treatment of illnesses in living people, as this is not covered by the HT Act.

4. Licences for following sectors – Tissues and cells for human treatment Human application stem cells and cord blood transplants Post mortem services Research Anatomy Public Display HTA - Licensing

5. Codes of Practice - provide practical guidance and lay down expected standards for each of the sectors Code of practice 1 - Consent Code of practice 2 - Donation of solid organs for transplantation Code of practice 3 - Post-mortem examination Code of practice 4 - Anatomical examination Code of practice 5 - Disposal of human tissue Code of practice 6 - Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation Code of practice 7 - Public display Code of practice 8 - Import and export of human bodies, body parts and tissue Code of practice 9 – Research

6. HTA – Consent – Research Legal requirements for consent for use and storage for research vary, depending on Samples from living or post mortem Samples imported from outside England Wales or N.Ireland - exempt Existing holdings - exempt From living, anonymous and Approval from NHS REC - exempt Conducting DNA analysis (bodily material) Although seeking free, fully informed consent always best practice If using samples collected from others always check: before 1st Sept 2006, if not, was the donor alive when taken? will be anon and get ethics approval

7. Consent falls within the HTA’s statutory remit. When is consent required? Consent under the HT Act relates to the purposes for which material might be removed, stored or used. These purposes are set out in Schedule 1 of the HT Act (see paragraph 72) and are called scheduled purposesparagraph 72 In broad terms, the HT Act and the HTA's codes of practice require that consent is required to: store and use dead bodies remove, store and use relevant material from a dead body store and use relevant material from the living HTA – Consent

8. Under the HT Act, consent from the living is needed for storage and use of tissue for:tissue obtaining scientific or medical information which may be relevant to any person including a future person public display research in connection with disorders, or the functioning, of the human body transplantation Under the HT Act, consent from the living is not needed for storage and use of tissue fortissue clinical audit education or training relating to human health (including training for research into disorders, or the functioning, of the human body)research performance assessment public health monitoring quality assurance Consent to treatment and examination is covered by the common law Under the HT Act, consent is needed for the removal, storage and use of material from the deceased for all scheduled purposes Although consent is not required for a coroner's post mortem, consent is required under the HT Act for the continued storage or use of tissue, for scheduled purposes, once the coroner's purposes are complete HTA – Consent

9. HTA – Consent for Research The HTA encourages the taking of informed and generic consent at the outset, as the default position. ‘It is accepted as good practice to seek “broad consent” to store and use tissue/data prospectively in a number of future projects, potentially in a range of research fields. The principle of broad consent has been endorsed in Parliamentary debates. It may not be possible to give donors specific information about the projects that will be carried out, but information sheets should give an indication of the types of research that might be conducted and the potential benefits.’ (NRES)

10. HTA – Consent for Research - Living *Although consent is not legally required under the HT Act, it is good practice to obtain consent wherever practicable. For existing holdings, although not legally required, a decision should be taken as to whether consent should be sought. From MRC Regulatory Support Center Guidance: Research and the Human Tissue Act 2004 - Consent

11. HTA – Consent for Research - Deceased Consent IS REQUIRED for research involving both identifiable and anonymous samples of human tissue from the deceased, including histology blocks and slides, unless the following exemptions apply: If material; comes from a person who died before 1 September 2006 and if 100 years have passed since their death, comes from an existing holding i.e. material being held or stored prior to the commencement of the HT Act (1 September 2006), or has been imported or comes from an imported body

12. *Consent relevant for Tissue collected after 2006 *Consent requirements (of the Act) apply to storage and use - living, removal, storage and use - Dead *Consent is not required for residual tissue from the living for: Public health monitoring, education and training (including training in research techniques), Clinical audit, performance assessment (e.g. testing medical devices), Quality assurance Storage is licensable ‘Storage’ does not include storage incidental to transportation (hours or days)

16. When consent is taken it is important to consider the following: appropriate consent - who may give consent valid consent – voluntarily, appropriately informed, capacity scope of consent – may differ, generic or specific duration of consent – may differ, enduring or time limit withdrawal of consent – at any time but implications make clear Format - The HT Act does not specify, except for anatomical examination or public display which must be in writing. Need clear documentation of consent, what for and protocols for how obtained HTA – Consent for research

17. HTA – Consent for research: Appropriate Consent Living adults with capacity to consent Consent should be obtained from the individual concerned. Living adults who lack capacity to consent The HT Act makes it lawful in certain circumstances to store, or use tissue (for a Scheduled Purpose such as research), where tissue is from an adult who lacks capacity to consent, and where consent can be ‘deemed’ to be in place. For research purposes, these circumstances are: For purposes of a clinical trial authorised and conducted under UK Medicines for Human Use (Clinical Trials) Regulations 2004. When research is allowed under clauses 30-34 of the Mental Capacity Act 2005 (which came into force in October 2007). In the case of adults lacking capacity to consent, consent should be obtained according to local legislation. Mental Capacity Act 2005 (England & Wales, comes into force 2007). Adults with Incapacity (Scotland) Act 2000. Living Children Under the HT Act, a child is defined as being under 18 years old. If a child is considered competent, then consent should be sought from the child (it is good practice to involve person(s) with parental responsibility in this process

18. HTA – Consent for research: Appropriate Consent Deceased adults 1. Consent is appropriate from the individual if given whilst alive and competent. 2. If the individual did not make a decision to consent (or refuse) prior to death but did appoint a nominated representative, consent for research can be obtained from the nominated representative. 3. If the deceased individual did not appoint a nominated representative, appropriate consent can be sought from a person in a ‘qualifying relationship’ (also known as ‘qualifying relative’), according to the following hierarchy (highest ranking first): a) Spouse or partner (including civil or same sex partner) b) Parent or child (in this context a child can be 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. Deceased children 1. Consent is appropriate from the child if given whilst alive and considered competent. 2. If the child did not make a decision or was not competent, the appropriate consent should come from a person(s) with parental responsibility. 3. If there is no such person(s), consent should be sought from someone in a qualifying

19. Individuals unable to consent to participation in a research project due to a lack of mental capacity are a particularly vulnerable group. Their interests must therefore be protected. They should be given the same opportunities to participate in ethically designed research projects as those who do not lack capacity but must not be put at unwarranted risk. Their participation needs to be agreed by someone who is independent of the study and who can assess the potential participant’s interests in accordance with current legislation and guidance. This person may be a relative, a carer or an independent representative. HTA – Consent: Children and Adults Lacking capacity Advice on MH Act

20. HTA – Consent: Children and Adults Lacking capacity Children may consent to a proposed medical procedure or the storage and use of their tissue if they are competent to do so. In the Gillick case, the court held that a child was considered competent to give valid consent to a proposed intervention if they had sufficient intelligence and understanding to enable them fully to understand what was involved.tissue The HT Act does not specify the criteria for considering whether an adult has capacity to consent But under the MC ACT they are considered to lack capacity if they cannot do one or more of the following things: understand the information given to them that is relevant to the decision retain that information long enough to be able to make the decision use or weigh up the information as part of the decision-making process communicate their decision by any means The first core principle of the MC Act is that an adult must be assumed to have capacity to make a decision for themselves, unless it is established that they lack capacity HTA: Code of Practice on Consent

21. 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. For consent to be valid, the person should understand what the activity involves and, where appropriate, what the risks are. To ensure that the removal, storage or use of any tissue is lawful, it is important to establish clearly that consent has been given. Consent may be expressed in various ways, and does not necessarily need to be in writing, unless the HT Act requires it to be. (for anatomical examination or public display must be in writing) HTA – Consent for research: Valid Consent

22. HTA – Consent – Record keeping The information required and the manner in which consent is obtained and recorded may vary depending on the particular circumstances Records for research should generally 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)

23. HTA – Consent for research: Scope and Duration of Consent Consent may differ in its scope as it may be generic or specific Consent may differ in its duration. It may be enduring or time-limited Enduring consent means that it remains in force unless consent is withdrawn. A person may, however, specify a time limit for how long they wish their consent to remain in force. In both cases, the decision should be clearly documented in the patient's records, the laboratory records or both The HTA encourages the taking of informed and generic consent at the outset, as the default position

24. HTA – Consent for research: Withdrawal of Consent Consent may be withdrawn at any time whether it is generic or specific. Withdrawal should be discussed at the outset when consent is being sought. The practicalities of withdrawing consent and the implications of doing so should be made clear, for example, for potential recipients if the donated tissue is for clinical use. Withdrawal of consent cannot be effective where tissue has already been used. If someone gives consent for their tissue to be stored or used for more than one scheduled purpose and then withdraws consent for a particular scheduled purpose (e.g. research), this does not necessarily mean that the sample or samples have to be removed or destroyed. However, the samples may no longer be stored or used for the particular purpose for which consent has been withdrawn. In addition, if someone withdraws consent for samples to be used in any future projects, this does not mean that information and research data should be withdrawn from any existing projectsresearch

25. HTA – Consent: Information sheets Information leaflets and consent forms are useful and recommended for: post-mortem examination anatomical examination organ and tissue donation Establishments should provide appropriate information on the activities for which they are seeking consent. The information might be in the form of leaflets or information sheets, or might be contained within the consent form. Many establishments, including Trusts, have policies on consent that include the use of standard documentation. Such documentation should make reference to the HT Act and the role of the HTA and be reviewed to ensure that it is consistent with this code Patient information sheets should be provided about research projects and these are also usually required by ethics committees approving research projects. The National Research Ethics Service (NRES) has issued guidance [www.nres.npsa.nhs.uk/rec-community/guidance/#InformedConsent] on developing model consent forms and information sheets for research establishments to use when obtaining consent.research Researchwww.nres.npsa.nhs.uk/rec-community/guidance/#InformedConsentresearch HTA: Code of Practice on Consent

26. It is advisable to give donors specific information about the following potential uses of samples or data: –Export for use in research outside the UK –Animal research??? –Research involving human embryos and stem cells –Research into termination of pregnancy or contraception –Research involving genetic analysis –Commercial research. The informed consent process should also deal with: Confidentiality of personal data Withdraw consent and what the effect of this would be The rights of donors in the event of financial gain from the results of research, and the “gifting” of samples. HTA – Consent: Information sheets

27. HTA – Seeking Consent Consent is often sought in a clinical setting for treatment, research, or following the death of a patient. But this is not always the case. Where possible, it is good practice to seek the person's consent to the proposed procedure in advance. Sufficient time should be allowed for questions and discussion. Equally, discussions with families may often take place in hospital before a person's death. They may know the person's wishes in respect of, for example, donating organs for transplantation. It should be made clear to them, however, that knowing and understanding the dying person's wishes is different from consenting on their behalf following their death The seeking and obtaining of consent from patients before death or from those close to them after their death requires sensitivity. Attitudes towards the use of tissue and especially towards post mortems may vary widely among cultures and religions. All healthcare professionals should be sensitive to this. However, each case and decision is an individual and personal one, and should be treated as such. Trusts and other establishments should ensure that their employees are given the necessary training and support to help them identify and meet the widest possible range of needs and wishes Consent is valid only if proper communication has taken place. Particular consideration should be given to the needs of individuals and families whose first language is not English. Any difficulties in communicating with the person interviewed (e.g. because of language, literacy or hearing difficulties), and an explanation of how these difficulties were overcome (e.g. through an independent translator), should be recorded.

28. HTA – Seeking Consent – Who? It is usually the responsibility of the healthcare professional to seek consent from the person concerned, the person with parental responsibility, or a partner, relative or close friend. It is important to have procedures in place which clearly set out the responsibilities of all those involved in the process of seeking valid consent. Good practice example: Eye banks have formal agreements in place with transplant coordinators who obtain consent from donor families on their behalf. The system clearly sets out the responsibilities of the parties involved and documents the procedure for recording consent. This ensures that valid consent is obtained by appropriately trained staff in accordance with the HT Act and codes of practice. Staff seeking consent should have a good understanding of the activities they are seeking consent for. They should also be in a position to answer questions that donors or their families may ask. Healthcare professionals should obtain the support and guidance of their managers to develop the necessary skills in the implications and essential requirements of seeking consent. Even if consent is not sought in a clinical setting, the person seeking consent should still be appropriately trained to ensure that the consent is valid. Seeking consent may be assigned to someone else, as long as they are suitably trained. In particular, they should know enough about the proposed procedure, the intended use of the tissue and the risks involved, for the subject to make an informed decision. For example, a transplant coordinator or an appropriately trained member of a bereavement services team could be involved in the consent-seeking process.

29. HTA – Consent: Existing holdings and imported tissue Existing 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 2006 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. Imported The consent provisions of the HT Act do not apply to material that has been imported. Nonetheless, the HTA considers it good practice for mechanisms to be in place which provide assurance that human tissue which is to be imported is obtained with valid consent. This also applies where the intention is to analyse DNA in the material. Guidance for those wishing to import human bodies, body parts and tissue from abroad into England, Wales and Northern Ireland, is provided in another HTA code of practice.

30. HTA - Consent DNA To summarise: In most circumstances it is an offence to have any bodily material (vs relevant material) with intent to analyse the DNA in it without qualifying consent Qualifying consent is legally required for research if the tissue is: From a living person and samples are identifiable; or From a living person and samples are anonymised (see Definitions) but NHS REC approval has not been obtained or is not pending; or From a deceased person and collected after 1 September 2006 (for both anonymous and identifiable samples). Existing holdings from living or dead (stored before 01 Sept 2006) - consent not required Deceased holdings (since after 01 Sept 2006) – consent required (qualifying relationship) Living (since after 01 Sept 2006) – consent required (generic and enduring) Unless: ethically approved project (specific) and person carrying out the analysis is not in and not likely to come into possession of ID information or excepted purpose - consent not required

31. 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) [www.nres.npsa.nhs.uk/rec- community/guidance/].research Researchwww.nres.npsa.nhs.uk/rec- community/guidance/ It should be noted that consent is normally required to use identifiable patient data in research. In cases where researchers do not have consent to use identifiable patient data for research, they should refer to the National Information Governance Board for Health and Social Care (NIGB) [http://www.nigb.nhs.uk/].http://www.nigb.nhs.uk/ Researchers intending to use patient data in research should be aware that such information is subject to the common law duty of confidentiality and the requirements of the Data Protection Act 1998research HTA – Other approvals

32. HTA - Consent Fetal Tissue The law does not distinguish between fetal tissue and other tissue from the living; fetal tissue is regarded as the mother's tissue. Consequently, fetal tissue is subject to the same consent requirements under the HT Act as all other tissue from the living. However, because of the sensitivity attached to this subject, it is good practice to always obtain consent for the examination of fetal tissue and for its storage or use for all scheduled purposes. It is also good practice to obtain consent for research on non-fetal products of conception (i.e. placenta, membranes, umbilical cord, amniotic fluid), even where the tissue is non-identifiable.research It should be noted that the reference to fetal tissue within this code does not include stillbirths (babies born dead after 24 weeks gestation), or neonatal deaths (babies or fetuses of any gestational age which are born showing signs of life and die before the age of 28 days). Obtaining consent for the removal, storage or use of the tissue of babies from stillbirths or neonatal deaths should be handled in accordance with provisions for gaining consent for use of the tissue of the deceased. It is recommended that, whenever possible, the consent process for the examination of stillbirths and neonatal deaths involves the mother, and that, where appropriate, both parents are involved

33. Useful Links UCL HTA: http://www.ucl.ac.uk/slms/research/human-tissue-acthttp://www.ucl.ac.uk/slms/research/human-tissue-act Data protection: http://www.ucl.ac.uk/efd/recordsoffice/data-protection/ http://www.ucl.ac.uk/efd/recordsoffice/data-protection/ http://www.ucl.ac.uk/joint-rd-unit/keydocs2/DPAGuidance HTA http://www.hta.gov.uk/aboutus.cfm ETHICS National Research Ethics Service (NRES): http://www.nres.npsa.nhs.uk/http://www.nres.npsa.nhs.uk/ Integrated Research Application System (IRAS): https://www.myresearchproject.org.uk/Signin.aspx MRC Toolkits: Data and Tissue toolkit: http://www.dt-toolkit.ac.uk/home.cfm About us Licensing and inspections Donations Legislation, policies and codes of practice Training and conferences Publications Consultations News and events

34. Test your knowledge! http://www.rsclearn.mrc.ac.uk/ Thank you For further information, please contact me k.goldring@ucl.ac.uk