Code A: Section two - The fundamental guiding principle of consent

17. The guidance outlined in this section highlights the importance of consent, which is a legal requirement under the HT Act. The following topics are central to the application of the consent provisions:

• the legal concept of consent
• the activities for which consent is required
• appropriate consent
• valid consent
• conditions on consent
• duration of consent
• withdrawal of consent

18. The HT Act establishes the concept of appropriate consent (defined in terms of who may give consent). The HT Act describes specific circumstances under which appropriate consent is required for removing, storing and using relevant human material for scheduled purposes.

19 The concept of valid consent is established in common law and mental capacity legislation.

20. If appropriate and valid consent has been provided, then this is sufficient for an activity covered by the HT Act to proceed (subject to licensing and other legislative requirements having been met). Throughout this Code, references to consent should be taken to mean appropriate and valid consent. The Human Transplantation (Wales) Act 2013, the Organ Donation (Deemed Consent) Act 2019 and the Organ and Tissue Donation (Deemed Consent) Act (Northern Ireland) 2022 modify the appropriate consent provisions of the HT Act 2004 and allow consent to be deemed in certain circumstances for the purpose of organ and tissue donation after death in England, Wales and Northern Ireland. This is dealt with in depth in the Code of Practice on the Human Transplantation (Wales) Act 2013 for practitioners in Wales, and the Code of Practice F, part two, on Donation of solid organs and tissue for transplantation: Deceased organ and tissue donation; for practitioners in England and Northern Ireland.

21. The existence of consent permits an activity to proceed, but does not mandate that it must. However, once someone has given consent, no other person has a legal right to revoke it and the decision whether to proceed with an activity rests with the person who will be undertaking it.  The HT Act and common law establish the principle that the decision to consent rests first and foremost with the person whose body, organ, tissues or cells are being used. Where that person has died, their nominated representatives or relatives should be sensitively supported to respect that person’s consent to ensure the best chance of their wishes being fulfilled.

22. Where a person with capacity has made the decision not to consent to an activity covered by the HT Act, then the activity must not proceed as there is no consent in place.

23. Consent under the HT Act relates to the purposes for which relevant material might be removed, stored or used. These purposes are set out in Schedule 1 of the HT Act and are called scheduled purposes (see Annex A).

24. The HT Act does not require an activity for which consent has been given to proceed (see paragraph 21).

25. It is not a legal requirement for consent to be obtained for the disposal of material. However, it is good practice for disposal options to be given, and for the wishes of the donor or their relatives obtained during the process of seeking consent (see HTA’s Codes of Practice on Post-mortem examination and Anatomical examination) to be respected, where possible.

26 In broad terms, the HT Act and the HTA's Codes of Practice require that consent must be in place to:

• store and use bodies of the deceased
• remove, store and use tissue from the body of a deceased person
• store and use tissue from the living

27. Annexes B and C set out in detail the purposes for which consent is required under the HT Act.

28. Anyone removing, storing or using material in circumstances for which the HT Act requires consent, must be satisfied that consent is in place. The HTA has set Standards on consent for those working in licensed establishments. The Standards and associated guidance include how the consent process should be governed, the information that should be provided to those from whom consent is sought and the training that staff should receive.

29. There are certain exceptions to the consent provisions set out in the HT Act in relation to the activities of coroners and the police. Further information can be found in the HTA’s Code of Practice on Post-mortem examination. There are also other limited situations where consent may not be required (see Annex B).

30. The HT Act defines ‘appropriate consent' by reference to the person who may give consent. This is broadly either the person concerned, their nominated representative (see paragraphs 79-85), or, in the absence of either of these, a person in a ‘qualifying relationship' with them immediately before they died. In the case of anatomical examination and public display, consent can only be given, in writing, by the person concerned.

31. An adult may appoint one or more nominated representatives to carry out their wishes after death in relation to activities for which consent under the HT Act is required.  An executor is not automatically classified as a nominated representative and would need to be specifically appointed to this role in line with the requirements of the HT Act.

32. Those in a qualifying relationship are found in the HT Act in the following order (highest first):

• spouse or partner (including civil or same sex partner). The HT Act states that, for these purposes, a person is another person's partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship;
• parent² or child (in this context a child may be of any age, but must be competent if under the age of 18, and means a biological or adopted child);
• brother or sister;
• grandparent or grandchild;
• niece or nephew;
• stepfather or stepmother;
• half-brother or half-sister;
• friend of long standing.

33. Consent is needed from only one person in the hierarchy of qualifying relationships and should be obtained from the person ranked highest. If a person higher up the list refuses to give consent, it is not possible to act on consent from someone further down the list. For example, if a spouse refuses but other relatives wish to give consent, the wishes of the spouse must be respected. However, the guidance in paragraphs 34 and 36 should be observed in line with this principle. If there is no one available in a qualifying relationship to make a decision on consent (and consent had not been indicated by the deceased person or a nominated representative), it is not lawful to proceed with removal, storage or use of the deceased person's body, organs or tissue for scheduled purposes.

34. While the HT Act is clear about the hierarchy of consent, the person giving consent should be encouraged to discuss the decision with other relatives. This may include people not on the list, for example, an aunt or uncle.

35. Relationships listed together, for example ‘brother or sister', are accorded equal ranking, in which case it is sufficient to obtain consent from just one of them, provided they are ranked equal highest. For example, if the deceased person has no spouse or partner, but has several children, the consent of only one child is required.

36. Where there is a conflict between those accorded equal ranking, this should be discussed sensitively with all parties, whilst explaining clearly that so far as the HT Act is concerned, the consent of one of those ranked equally in the hierarchy is sufficient for the procedure to go ahead. This does not mean that the consent of one person must be acted on, and a decision not to proceed may be made on the basis of the emotional impact that this would have on family and friends.

37. If those close to the deceased person object to the activity, for whatever purpose, when the deceased person (or their nominated representative) has explicitly consented, the healthcare professional should seek to discuss the matter sensitively with them. They should be encouraged to accept the deceased person's wishes and it should be made clear that they do not have the legal right to revoke valid consent (see also the Code of Practice F, part two on Donation of solid organs and tissue for transplantation: Deceased organ and tissue donation).

38. The emphasis in these difficult situations should be placed on having an open and sensitive discussion with those close to the deceased where the process is explained fully to them.

39. A person may be omitted from the hierarchy if they cannot be located in reasonable time for the activity in question to be addressed, decline to deal with the matter or are unable to do so, for example, because they are a child or lack capacity to consent. In such cases, the next person in the hierarchy would become the appropriate person to give consent.

40. 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. The person should understand what the activity involves, any reasonable or variant treatment and, where appropriate, what the material risks are. The test of materiality is ‘whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach a significance to it’.

41. Consent may be specific or it may be broader in its scope, sometimes referred to as ‘generic consent’. Specific consent is given in relation to a defined project, treatment and/or use. Generic consent refers to a broader permission, where consent may, for example, be given to allow the storage and use of tissue for an as yet unknown research project. In practical terms, specific and generic consent may be sought at the same time, to derive the greatest benefit from valuable human tissue donated for research.

42. While obtaining broad or generic consent offers the widest benefit for future research, the seeking of such consent should be supported by safeguards and assurances for donors. For example, if a donor expresses objections to specific types of research, these must be respected, and donors should be provided with information about how future research will be approved within the scope of the consent they have given. A donation may not proceed if a donor places conditions on their consent which cannot be met or guaranteed. Further information about conditions on consent can be found in paragraphs 45-48 of this code. Further guidance on consent to research is included in the Code of Practice on Research.

43. To ensure that consent is properly informed, commercial organisations offering services related to the removal, storage and use of human tissue and cells must ensure that materials provided to customers to aid their decision-making, such as marketing and advertising materials, are accurate and abide by the Advertising Standards Agency’s guidelines.  Non-commercial organisations must also ensure that materials provided to individuals to aid their decision-making are accurate.

44. 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; however, it should be recorded wherever possible. Written consent serves as evidence of consent, but a signature on a form will not, in itself, make the consent valid. Valid consent presupposes that individuals, including their families, where appropriate, have had the opportunity to discuss the issue fully, ask questions and make an informed choice. When consent is obtained but it is not in writing, for example for future storage or use of samples, this should be clearly documented in the patient's clinical and/or laboratory records. The record should detail when consent was obtained and the purposes for which the consent was given.

45. Consent may be limited in a variety of ways. The HT Act does not prevent an individual from placing limits on their consent via the imposition of conditions, for example, to particular research studies or to donate specific organs.

46. The HT Act recognises that individuals have the autonomous right to give or refuse consent to the use of relevant material for scheduled purposes.

47. Whilst respecting this autonomous right, no material should be removed, stored or used for a scheduled purpose under a form of consent which seeks to impose restrictions on the class of the beneficiary of the scheduled purpose. For example, a medical practitioner should not remove an organ for transplantation if the donor imposes a condition that the recipient of a transplanted organ must be a man, or must not be an alcoholic. This includes any restriction based on a beneficiary's sex, sexual orientation, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status (including characteristics protected under the Equality Act 2010). This position reflects Article 14 of the European Convention on Human Rights, as set out in the Human Rights Act 1998, and arises from the equality duty placed on the HTA and other public authorities by the Equality Act 2010.

48. Where any conditions attached to consent cannot be acted upon, the person who has attached the condition should be made aware of this and asked whether they are willing to put these conditions aside in order to allow the activity to proceed. It would be an offence to proceed with an activity for a scheduled purpose in the knowledge that a persisting condition on consent could or would not be fulfilled, as valid consent would not be in place. Only the person who has attached the condition to the consent can put the condition aside.

49. Consent may differ in its duration. It may be enduring or time-limited.

50. 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, and/or the records of the establishment holding the material (see section on format of consent, paragraphs 57-60 for further detail).

51. 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. Withdrawal of consent cannot be acted upon where tissue has already been used. In the case of organ donation from the deceased, consent cannot be withdrawn once the retrieval of the organ has commenced.

52. 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, such as 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 projects.

2. Refer to the glossary for the definition of a parent for the purposes of the HT Act.