Briefing Note on the Human Tissue Bill

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1 Briefing Note on the Human Tissue Bill Introduction pending Second Reading in the House of Lords on 22 July 2004 The Human Tissue Bill was introduced to Parliament in December This legislation regulates the storage and use of human organs and tissue for purposes including teaching, research, transplantation, public health monitoring, clinical audit and public display. The Bill is intended to clarify requirements governing the use of human tissue for these purposes and provide a consistent legislative framework under which they can be conducted. We fully endorse the aim of the Human Tissue Bill to promote public confidence and provide clarity in the requirements relating to the use of human organs and tissue. Our view We welcome the amendments introduced into the Bill at Report Stage in the House of Commons, which addressed the majority of our concerns that the Bill was unduly restrictive in relation to medical research. We believe the Bill is now greatly improved and goes a substantial way towards achieving a balance between the rights of patients and their families, and the need for biomedical research for public and patient benefit. However, there is still more to be done to ensure that the Bill is workable, effective and proportionate and achieves the clarity and public confidence to which it aspires. We look forward to working with Government and Parliamentarians to improve and refine the Bill and address our remaining concerns. Our proposals for addressing these concerns are summarised below and described in detail on the following pages. Principal proposals 1 Clarify that consent to use tissue for research can be generic and enduring. 2 Ensure that essential secondary legislation and Codes of Practice are in place before the substantive provisions of the Bill commence. 3 Allow time for those affected to implement changes to comply with the new regulations before commencing key provisions of the Bill. 4 Confirm that research using reversibly anonymised tissue will continue to be permitted.

2 5 Reconsider the consent requirements for education and training on research techniques. 6 Clarify the suitability of using the High Court as a mechanism to make exceptions to consent requirements. 7 Reduce the scope of the licensing regime in relation to ante mortem tissue. 8 Clarify the meaning of certain scheduled purposes and the treatment of purposes that fall into both Part 1 and Part 2 of Schedule 1. 9 Qualify the requirements to establish absence of an effective decision before undertaking research involving mentally incapacitated adults. 10 Clarify the role, duties and liabilities of designated individuals. 11 Include carers of long-standing in the list of qualifying relationships. 12 Clarify professional interest in relation to members of the Human Tissue Authority. This briefing represents the views of the Academy of Medical Sciences, the Association of Medical Research Charities, Cancer Research UK, the Medical Research Council and the Wellcome Trust. July 2004

3 Principal issues of concern and proposals 1 Clarify that consent to use tissue for research can be generic and enduring. Consent under the Bill as drafted is not defined. The interpretation of the term therefore falls back on common law. For research, this raises two potential problems breadth (or specificity) and duration of consent. Ethically, we believe it is appropriate, and as a matter of practicality, we consider it is essential, that the requirement under the Bill for consent to research is satisfied by consent that is generic and enduring. The Government appears to accept this. During the second reading of the Bill in the House of Commons, Dr Ladyman stated that the Bill does not limit the duration and breadth of the consent, so we would not expect patients to have to be revisited for further consents 1. We propose that it is made absolutely clear on the face of the Bill that consent to use tissue for research may be both generic and enduring. At the very least, this should be made explicit in the relevant Code of Practice. 2 Ensure that essential secondary legislation and Codes of Practice are in place before the key provisions of the Bill commence. Many of the Codes of Practice and regulations referred to in the Bill will need to be in place when the Bill enters into force if the legislation is to work in practice. For example, the exemption from the consent requirement for anonymised, ethically approved research is entirely dependent on subordinate legislation. To our knowledge these Codes of Practice and regulations are yet to be drafted. We seek assurances that the substantive provisions of the Bill will not commence until essential subordinate legislation and the relevant Codes are in place. Of the subordinate legislation that is specific to research, the following is essential: 1. Regulations specifying who is authorised to give ethical approval to research. 2. Regulations setting out circumstances where there can be deemed to be consent in relation to adults who lack capacity. 3. Regulations enabling the High Court to make exception orders for research. 4. Regulations specifying exceptions to the licensing requirements. 3 Allow time for those affected to implement changes to comply with the new regulations before commencing key provisions of the Bill. The implementation of the Bill will depend upon the existence of the Human Tissue Authority ( HTA ) and of key Codes of Practice. Compliance with the new requirements will require education and training of individuals and the implementation of new procedures. If the Bill is to be effective, it is essential that time is allowed for all of these things to happen and that sufficient resources are made available within the NHS for this purpose. We propose that the Bill makes explicit that there will be a fixed time lag before the substantive provisions enter into force to enable these set-up arrangements to be made. 1 Hansard, column 1044

4 4 Confirm that research using reversibly anonymised tissue will continue to be permitted. We welcome the introduction in section 1(9) of an exemption from the consent requirements for research that is ethically approved and uses anonymised tissue taken ante mortem. We are pleased that the Minister, Ms Winterton 2 acknowledged at Report Stage in the House of Commons that: Anonymisation does not mean that the patient and the tissue would be permanently unlinked. Further information could be sought from the records. This means that, subject to suitable safeguards to avoid identification by the researcher, vital research that involves linking information derived from tissue with other health related information about the patient concerned can continue for public and patient benefit. However, we remain concerned that the HTA Codes may take a more restrictive approach than that which is set out in the Bill itself and further limit the ability of researchers to conduct research using reversibly anonymised tissue. We seek confirmation that the Bill is intended to enable research using reversibly anonymised tissue taken ante mortem without consent. We also seek assurance that the HTA will consult with researchers and others with expertise in this area in drafting Codes of Practice relating to the use of reversibly anonymised tissue. 5 Reconsider the consent requirements for education and training relating to research techniques. We welcome the recent amendments to the Bill to bring education and training relating to health within Part 2 of Schedule 1, thus removing the requirement for consent for this activity. However, we are concerned that education and training relating to research remains within Part 1 of Schedule 1, and therefore falls under different consent requirements. It is unclear why this distinction has been made. We have doubts about the underlying ethical basis of the distinction and foresee considerable practical difficulties in distinguishing between teaching for research and teaching for health, since these purposes are very frequently combined in one activity. We recommend that all education and training, whether it relates to health or research, is included in Part 2 of Schedule 1 (purposes that do not normally require consent). 6 Reduce the scope of the licensing regime in relation to ante mortem tissue. We believe the scope and impact of the proposed licensing regime has been severely underestimated. The requirement for a licence to store tissue for scheduled purposes applies however little tissue is being stored. Thus, a researcher storing a single blood spot for research would appear to require an HTA licence. In the short to medium term, we have serious reservations about the feasibility of the HTA taking on such an extensive licensing role. This may jeopardise its effectiveness in relation to post mortem activities. We recommend that the storage of tissue taken ante mortem is removed from the licensing regime. To satisfy the EU Tissue and Cells Directive, the Medicines and Healthcare Products Regulatory Agency could be designated as the competent authority in relation to tissue taken ante mortem for transplantation. As an absolute 2 Hansard, column 97

5 minimum, we propose the licensing regime is limited to tissue banks storing tissue on a significant scale predominantly for use by third parties. In addition, tissue collections for research use are routinely divided and stored in more than one site, for example for security or back-up purposes. These sites may be no more than a mile or so apart. As currently drafted, the Bill would require separate licences for each site, with corresponding cost and administrative implications. We propose that the Bill enables multi-site licences for single collections. 7 Clarify the suitability of using the High Court as a mechanism to make exceptions to consent requirements. We are pleased to note the introduction in the Bill of a power for the Secretary of State to make regulations to enable the High Court to dispense with the need for consent in certain circumstances. A power of this nature is vital to ensure that important research using human tissue can proceed (subject to safeguards) where consent cannot be obtained, where this is clearly in the public interest. However, we question whether the High Court is the most suitable mechanism for such an application. We fear potential delays and costs associated with seeking such an order may deter researchers from undertaking this important research. This is particularly relevant where tissue is used in research projects in conjunction with patient identifiable data, without the necessary consent. In addition it is unclear how this mechanism will link up with the existing provisions on access to patient identifiable data, and the role of the Patient Information Advisory Group under the Health and Social Care Act In particular we question whether researchers would now be required to go to the High Court for approval to use the tissue in addition to seeking the approval of the Secretary of State to use patient identifiable data. We ask for consideration of whether the High Court is the most appropriate mechanism for exceptions to consent requirements to be made. 8 Clarify the meaning of certain scheduled purposes and the treatment of purposes that fall into both Part 1 and Part 2 of Schedule 1. We are concerned that some of the purposes in Schedule 1 are unclear in definition and scope. In particular, there are a number of purposes listed in Parts 1 and 2 of Schedule 1 that we believe are overlapping. Two key examples of this are: (a) Public health monitoring and public health research. (b) Drug efficacy testing and clinical audit. We ask that the definitions in Schedule 1 are clarified and the Bill states that where an activity falls into both Part 1 and 2, the requirements applicable to Part 2 only apply. 9 Qualify the requirements to establish absence of an effective decision before undertaking emergency research involving mentally incapacitated adults. We welcome the recent introduction in section 6 of provision to enable adults who lack capacity to consent to be involved in research. However, we are concerned that, as drafted, this may impede the conduct of research into medical conditions or treatments associated with emergencies or critical care. Section 6 only applies if neither a decision of [the patient] to consent to the activity, nor a decision of [the patient] not to consent to it, is in force. The researcher concerned is unlikely to be in a position to

6 establish these facts beyond doubt, particularly in the context of emergency medicine research where time constraints are severe. We propose that section 6 is modified to qualify the requirement to establish whether a decision is in force. The requirement could be to take such steps as are reasonable in the circumstances to establish whether a decision is in force. An additional safeguard is provided by the requirement for review by an NHS research ethics committee. 10 Clarify the role, duties and liabilities of designated individuals. We are concerned by the description in the Bill of the role and duties of the designated individual named on an HTA licence. Although we recognise the need for an individual to have overall responsibility for compliance with the duties of a licensee, we do not believe this need necessarily amount to them directing or supervising activities carried out under their authority. We are concerned that the terminology of direction and supervision currently used in the Bill may prove overly prescriptive. This may encourage researchers and others to take out individual licences rather than rely on organisational licences, with corresponding administrative and cost implications. We are also concerned that the designated individual does not currently have a defence to any claim against him or her personally for breach of HTA licence conditions by a third party, if he or she has complied with the conditions and has taken all reasonable steps to ensure compliance by such third parties. We propose amendments to sections 17 and 18 respectively. In section 17(c), replace direction with authority. In section 18, replace under whose supervision the licensed activity is authorised to be carried on to secure with under whose authority the licensed activity is to be carried on to take all reasonable steps to secure. 11 Include carers of long-standing in the list of qualifying relationships. We believe carers of long-standing are in an appropriate position to play this role and to understand and represent the views of the deceased. We propose carers of long-standing are added as a new category in the list of those in qualifying relationships, after friends of long-standing. This inclusion would further reduce the risk of there being no one to consent on behalf of the deceased. 12 Clarify professional interest in relation to members of the Human Tissue Authority. The purpose of section 1(2) of Schedule 2 is to ensure those with a professional interest are in a minority on the HTA. However, it is not clear that this refers to professions such as medicine and scientific research, rather than other disciplines with a professional interest in the subject of the Bill, such as social science, law, bioethics, or consumer representation. We believe it should be limited to the former and this should be made clear on the face of the Bill. We propose that the Bill is amended by replacing professional interest in any of the kinds of activity within the remit of the Authority with professional involvement in the removal, storage or use of human bodies, organs or tissue. This briefing was prepared by Tara Camm at The Wellcome Trust, in collaboration with The Academy of Medical Sciences, Association of Medical Research Charities, Cancer Research UK, and the MRC.

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