Code A: Section three - Consent requirements

57. The HT Act does not specify the format in which consent should be given or recorded, except in relation to anatomical examination and public display, when consent must be in writing and witnessed (see sector-specific Codes). The information required and the manner in which consent is obtained and recorded may vary depending on the particular circumstances.

58. Written consent, either in paper or electronic format, serves as evidence of consent, but a signature on a form does not of itself make the consent valid (see section on valid consent, paragraphs 40-44). Protocols should be in place to ensure that the consent process has been completed, that there is valid consent and that the decision has been properly recorded. Establishments seeking to update existing consent forms or develop new protocols should ensure that they comply with this Code and other relevant HTA guidance.

59. When consent is obtained but it is not in writing, this should be clearly documented, for example in the patient's records where applicable. The record should detail when consent was obtained and the purposes for which the consent was given.

60. The NHS Organ Donor Register (ODR) operates throughout the UK to allow people to record their wishes about organ donation. Further information on the ODR as a source of consent can be found in the HTA Code of Practice F, part two on Donation of solid organs and tissue for transplantation: Deceased organ and tissue donation. In addition, the HTA has produced a Code of Practice on the Human Transplantation (Wales) Act 2013, which provides guidance on arrangements in Wales.
 

61. Attitudes towards the use of tissue, and especially towards post-mortem examinations, may vary widely among cultures and religions. All healthcare professionals should be mindful and 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. 

62. Consent is valid only if proper communication takes place and the person has a reasonable understanding of what is being explained to them. 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, (for example, because of language, literacy or hearing difficulties) and an explanation of how these difficulties were overcome should be recorded.

63. Under the MC Act, efforts should be made to provide information that is appropriate in terms of culture and language when assessing capacity; see chapter 3 of the MC Act Code of Practice, MC Act: making decisions, for further information on adults who lack capacity to consent. 
 

64. 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 it might be contained within the consent form.

65. Patient information sheets should be provided about research projects; these are also usually required by ethics committees approving research projects. The Health Research Authority (HRA) has issued guidance on developing model consent forms and information sheets for research establishments to use when seeking consent.

66. 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.

67. Where appropriate, information should be available in a variety of languages and formats such as video, audio or Braille, and in line with other legislation, such as the Equality Act 2010. Wherever possible, professional translators trained in translating for the bereaved and in maintaining confidentiality should be used. 
 

68. The consent requirements of the HT Act are not retrospective. This means it is not necessary to obtain consent for material that was already held for use for a scheduled purpose when the HT Act came into force on 1 September 2006.

69. 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.

70. The views of the deceased person, or of their relatives, (if known) should be respected if the tissue is disposed of.

71. Under the HT Act, consent is not required for carrying out research on existing holdings of human tissue and organs. Ethical approval may be required for research involving existing holdings and, as the HTA’s remit does not include the ethical approval of research, reference should be made to the guidance produced by the HRA.

72. 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
 

73. The making and displaying of images (including photographs, films and electronic images) falls outside the scope of the HT Act. However, the HTA requires Designated Individuals (DIs) to put systems in place to ensure suitable practices are carried out.

74. The HTA endorses the guidance on images provided by the General Medical Council (GMC) in its publication Making and using visual and audio recordings of patients.

75. Ensuring suitable practices where licensable activities are concerned includes the DI ensuring that the dignity of deceased people is maintained at all times. Therefore, the HTA expects DIs to put systems in place to prevent the inappropriate use of images.

78. Where an adult has given valid consent for any particular donation or the removal, storage or use of their body or tissue for scheduled purposes to take place following their death, then that consent is sufficient for the activity to be lawful, subject to any other legislative requirements (for example, written consent or death certification).  Where an adult has refused to give consent this cannot be revoked after their death.

79. If an adult did not consent to, or specifically refused, any particular donation or use of their body or tissue for scheduled purposes prior to their death, their relatives should be asked whether a nominated representative (or an appointed representative in Wales) was appointed to take those decisions.

80. A nominated representative may be empowered to consent to the carrying out of a post-mortem examination and to the removal, storage or use of the tissue for any of the scheduled purposes. They cannot consent to use of the body for anatomical examination or public display. The appointment of a nominated representative may be general or limited to certain activities.

81. The appointment of a nominated representative and its terms and conditions may be made orally or in writing. The HT Act sets out the requirements for a valid appointment. The appointment of a nominated representative may be revoked at any time.

82. If a person appointed more than one nominated representative, only one of them needs to give consent unless the terms of the appointment specify that they must act jointly.

83. If the nominated representative(s) does not consent to an activity, this cannot be overridden by other individuals, including relatives. Where they do give consent, but relatives object, it is advisable to ensure that appropriate consultation and discussion takes place between all those involved; there may be circumstances where the activity for which consent is given does not proceed.

84. The nomination may be disregarded if no one is able to give consent under it. This includes situations where it is not practical to communicate with the nominated representative within the time available if the consent is to be acted upon. In the event that a nomination is disregarded, consent may be given by a person in a ‘qualifying relationship' (see paragraph 32). For organ and tissue donation in England this situation is slightly different. For further information please see Code F.

85. Under the HT Act, children cannot appoint nominated representatives and therefore provisions related to seeking consent from nominated representatives do not apply.

86. If, prior to their death, the deceased person had not indicated their consent (or refusal) to post-mortem examination or removal, storage or use of their tissue for scheduled purposes and had not appointed a nominated representative, then consent may be given by someone who was in a ‘qualifying relationship' with the deceased person immediately before their death (see paragraph 32). 

87. Under the HT Act, a child (except in the context of qualifying relationships) is defined as being under 18 years old. The position of a child who, before they died, was competent to reach a decision and gave consent for one or more scheduled purposes after their death, is no different from that of an adult. Their consent is sufficient for medical practitioners to make lawful under the HT Act the removal, storage or use of tissue for the specified scheduled purpose(s). Additional requirements may apply under other legislation.  For example, clinical research may also be regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and clinical trials regulations.

88. The principle of ‘Gillick competence' applies to the assessment of a child’s competence to consent in these circumstances. 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 to fully understand what was involved.

89. If a competent child consents to an activity, or activities, covered by the HT Act, that consent carries over into adulthood unless it is withdrawn.  This is a principle of common law.

90. If a child did not make a decision, or was not competent to make a decision, before their death, the appropriate consent will be that of a person with parental responsibility for the child. The consent of only one person with parental responsibility is necessary.

91. In some cases it may be advisable to establish with the person who had parental responsibility for the deceased child whether the child was competent to make the decision. A person who has parental responsibility will usually, but not always, be the child's parent (see the Children Act 1989 for the legal position). In any case where a child has consented to the use of their body or tissue, it is essential to discuss this with the child's relatives.

92. The issue should be discussed fully with relatives, and careful thought should be given as to whether to proceed if a disagreement arises between parents or other relatives. Any previously stated wishes of the deceased child should be considered, taking into account the child’s age and understanding at the time of stating the wish. Further guidance is included in the Code of Practice on Donation of solid organs and tissue for transplantation and the Code of Practice on Post-mortem examination.

93. If there is no person with parental responsibility (for example, if the parents died at the same time as the child), then consent should be sought from someone in a qualifying relationship, (see section on qualifying relationships, paragraph 32). Under the HT Act children cannot appoint nominated representatives and therefore provisions related to seeking consent from nominated representatives do not apply.

94. For the anatomical examination or public display of tissue from a deceased child to take place, written (either by the child or at their direction) and witnessed consent is required from the child before they die. Those with parental responsibility at the time of the child’s death cannot agree to the use of the child’s body after death for these purposes.

95. When seeking consent, whether from the person themselves, their nominated representative or from a person in a qualifying relationship, full and clear information should be provided about the purpose for which consent is being sought. This should allow them to make a properly considered decision. This information should include the nature of the intended activities and the reasons for them.

96. Healthcare professionals and other suitably experienced people involved in seeking consent need to tailor the information they provide to each specific situation, considering the above advice and the Montgomery³ case law. Some people may require in-depth detail, whereas others may prefer to give consent having only had the basics of the procedure explained to them. The establishment’s policy should set out a minimum amount of information to be provided in relation to each activity. Further information may be found in the sections on the duration of consent (paragraphs 49-50) and use of documentation (paragraphs 64-67).

97. The way in which the options are discussed with the deceased person's relatives is extremely important. They should be approached with sensitivity and given: 

• honest, clear, objective information;
• the opportunity to talk to someone of whom they feel able to ask questions;
• reasonable time to reach decisions;
• privacy for discussion between relatives, if applicable;
• access to support if they need and want it. 
   

98. Discussions with relatives may take place in hospital before a person's death. The relatives may know the person's wishes in respect of, for example, donating organs and tissues for transplantation. Further information can be found in the Code of Practice on Donation of solid organs and tissue for transplantation. 

99. Consent conversations about death require sensitivity. This is especially true for donations for transplantation, post-mortem examinations and the retention of tissue and organs for research. Further guidance is set out in the Code of Practice on Post-mortem examination and the Code of Practice F, part two, on Donation of solid organs and tissue for transplantation: Deceased organ and tissue donation.

100. Care should be taken regarding the possible disclosure of information, such as genetic information or the presence of an infectious disease, which the deceased person may not have wished to be shared, or which may have significant implications for other relatives. Healthcare professionals will have to make a decision, based on the individual circumstances of each case, about whether or not it is appropriate to disclose information about the deceased's medical history or sensitive information that the Trust may hold about the deceased. In making decisions, healthcare professionals must have regard to their duty of patient confidentiality.

101. In certain circumstances it may be necessary to share sensitive information with the relatives if the results of the activity have the potential to affect them or other relatives. For further guidance see GMC guidance on confidentiality and the Department of Health and Social Care guidance on confidentiality which deals with disclosing information after a patient has died. See also the Welsh Government's guidance on confidentiality.

102. Written, witnessed consent is always needed for anatomical examination and for public display of bodies or body parts (see the Codes of Practice on Anatomical examination and Public display for detailed guidance).

103. Written consent should be obtained wherever possible for all other activities involving the deceased. If verbal consent is obtained, this should be clearly documented in the patient's records (see paragraph 57-60).

104. Model consent forms are available for post-mortem and anatomical examination on the HTA's website. The forms are not prescriptive due to local variations in practice and may be adapted, as necessary, providing they comply with the HT Act and the Codes of Practice. In Northern Ireland, Health and Social Care (HSC) Trusts and other relevant organisations should use the standardised consent forms agreed with the Department of Health. Consent forms are only one part of the consent process and should be completed after appropriate discussion and more detailed explanation, where necessary. 

105. When someone has died, healthcare professionals may wish to seek consent for more than one scheduled purpose. For example, if a post-mortem examination is to be carried out, some tissue samples could also usefully be obtained for research purposes. In this case, it would be necessary to seek consent for both activities. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking consent on repeated occasions.

106. Where consent has been given for the use of tissue or organs after death for transplantation, separate consent is required for storage and use for research purposes. In such cases, the necessary consents should ideally be sought at the same time and recorded in the same place.

107. Unless authorised by a coroner, the storage and use of post-mortem tissue for scheduled purposes requires consent. If consent to the storage or use of post-mortem samples is withdrawn, this must be respected for any samples that are still held. Healthcare professionals should discuss with the person concerned how the samples should be returned to them or disposed of, and tell them about any samples that may have already been used or disposed of. 

113. If an adult has the capacity to make the decision in question, then only they are permitted to give consent. This Code summarises the requirements of the MC Act and the MC Act Code of Practice. However, practitioners working with tissue or organs from an individual who may lack capacity must consider the MC Act and MC Act Code of Practice directly and should not rely solely on Code A.

114. The HT Act does not specify the criteria for considering whether an adult has capacity to consent. The MC Act outlines the criteria to apply in England and Wales. The MC does not apply in Northern Ireland; the legal position for assessing capacity in adults there is outlined in paragraphs 135-138.

115. This Code summarises the requirements of the MC Act and the MC Act Code of Practice. However, practitioners working with tissue or organs from an individual who may lack capacity must consider the MC Act and MC Act Code of Practice directly and should not rely solely on Code A.

116.  Under the MC Act a person aged 16 and over is unable to make a particular decision 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.

117.Full guidance on how the MC Act defines capacity and how it should be assessed is given in chapter 4 of the MC Act Code of Practice.

118. The provisions of the MC Act should be considered together with general principles governing capacity to consent to medical procedures. Guidance is available from the Office of Public Guardian website and in the MC Act Code of Practice. The Welsh Government has published separate guidance, entitled ‘Making decisions’.

119. The MC Act governs decision-making on behalf of adults (aged 16 and over) who lack capacity if unable to make a decision in relation to a matter at the relevant time because of an impairment of, or disturbance of, the mind or brain, whether permanent or temporary. For the purposes of the MC Act, unlike the HT Act, an adult is a person aged 16 or over. The MC Act only applies to people aged 16 or over, with very limited exceptions (see chapter 12 of the MC Act Code of Practice for further information).

120. There are detailed provisions contained in the MC Act concerning decisions made on behalf of adults lacking capacity. All decisions must be made in the person's best interests, as laid out in chapter 5 of the MC Act Code of Practice. Individuals providing care or treatment to a person have a legal duty to have regard to the MC Act Code of Practice when working with or caring for individuals who lack or may lack capacity to make decisions for themselves, as laid out in chapter 6.

121. The MC Act defines a person as lacking capacity in relation to a specific matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or disturbance in the functioning of, the mind or brain (chapter 4 of the MC Act Code of Practice). The MC Act contains a set of key principles and considerations when deciding what is in someone’s best interests (further information is available in chapter 5 of the MC Act Code of Practice). 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 to make the particular decision at the time the decision needs to be made. It should therefore always be assumed that an adult has the capacity to make a decision unless there is reason to believe otherwise.

122. Individuals may sometimes temporarily be unable to make a decision, for example, if they are affected by trauma, illness or shock. It may therefore not be appropriate to seek consent at that time and, in some cases, it may be necessary to delay the decision until the person regains the capacity to make it, as laid out in the MC Act (see chapter 4 of the MC Act Code of Practice for further guidance).

123.  Some adults may have capacity to make decisions about some matters, but not others. The MC Act requires that care be taken to ensure that patients are given every opportunity, and support where needed to make their own decisions (see chapter 3 of the MC Act Code of Practice).

124. A person must not be treated as unable to make a decision unless all practicable steps to help them do so have been taken without success. Nor must they be treated as being unable to make a decision merely because they make an unwise decision.

125. The ability of adults with learning difficulties or with limited capacity to understand, should not be underestimated. Where appropriate, someone who knows the individual well, such as a relative or carer, should be consulted, as they may be able to advise on or assist with communication.

126. Under the MC Act, a person aged 18 or over may make a Lasting Power of Attorney (LPA). This allows for an attorney to make certain decisions in circumstances where the person no longer has capacity. One type is a personal welfare LPA, which provides for the appointment of a person to make welfare, including health and care decisions, on their behalf. Where a LPA exists, it is good practice to check the detail to see if the attorney has the authority to make the decision in question. Detailed guidance on the role of the attorney is set out in chapter 7 of the MC Act Code of Practice.

127. Storage or use of tissue from adults who lack capacity to consent is permitted in certain circumstances specified in the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006. 

128. The HT Act allows children to consent to activities for scheduled purposes if they are competent to do so (see paragraph 87 and Section 2 of the HT Act).

129. Where the child has died and the child had not made a decision to give or withhold consent, the HT Act allows a person with parental responsibility for him or her immediately before he or she died to consent. Where the child is alive and has not made a decision and is either:

• not competent to do so
• competent to do so, but is unwilling to make that decision

a person who has parental responsibility for the child may consent on their behalf.  

130. A person who has parental responsibility will usually, but not always, be the child's parent 2. ⁵. The Children Act 1989 is the relevant legislation for establishing who has parental responsibility.

131. The HT Act is silent on how to assess a child's competence. The responsibility for assessing competence rests with the person seeking consent. The Gillick test (see paragraph 88) is considered to be the appropriate benchmark for assessing a child’s competence.

132. Where there is any dispute between people with parental responsibility or any doubt as to the child's best interests, the matter should be referred to court for approval. For further guidance on court approval in cases of potential donation, see the Code of Practice on Donation of solid organs and tissue for transplantation and Code of Practice on Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation.

133. Where a child has capacity to consent, and agrees to the sharing of their information, it is good practice to consult the person (or people) who have parental responsibility for the child and to involve them in the process of the child making the decision. However, it should be emphasised that, if the child has capacity to consent, the decision to consent and to share their information must be the child’s. It is also essential to make sure that a child has consented voluntarily and has not been unduly influenced by anyone else.

134. If a child does have the maturity or understanding to make a decision about whether to disclose their information to those with parental responsibility for them, you may only disclose information where it is in the best interests of the child.

149. Establishments meeting the consent Standards will be able to demonstrate that their processes for seeking and gaining consent comply with the HT Act and the HTA’s Codes of Practice. The Standards also cover the documentation and information used to support the establishment’s consent procedures, and ensure that staff involved in seeking consent are suitably trained and equipped for the task.

150. Establishments meeting these Standards will be able to demonstrate that they have a suitable governance framework, underpinned by clear and controlled documentation, effective audit, staff training and organised record-keeping. In addition, they will have an effective system of risk management and suitable systems to deal with adverse events.

151. Establishments meeting these Standards will be able to demonstrate full traceability for the human material for which they are responsible, from receipt to final disposal/disposition. HTA inspectors will test this through traceability audits and we expect establishments to take a pro-active approach to assuring themselves of effective traceability throughout the lifetime of their licence. In addition, as the final traceability step, they will have established disposal arrangements which are in accordance with the HTA’s Codes of Practice.

152. Establishments meeting these Standards will be able to demonstrate that their premises and facilities are appropriate for their licensed activities and are safe, secure and clean. In addition, establishments will have systems for on-going monitoring to ensure all key quality specifications are maintained. These Standards also cover equipment, ensuring that it is appropriate, and suitably maintained, and that it does not present an impediment to the staff using it. 

153. The HTA licensing Standards which will be applicable to each sector from April 2017 are included as an Annex in each of the relevant sector Codes and on the HTA website. The Standards are supported by comprehensive guidance notes.