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Consent requirements - Part 2: Tissue from the deceased

When is consent required?

Written consent

72. Under the HT Act, consent is needed for the removal, storage and use of material from the deceased for all scheduled purposes as listed below: [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_6#sch1]

  1. anatomical examination
  2. determining the cause of death
  3. establishing, after a person's death, the efficacy of any drug or other treatment administered to them
  4. obtaining scientific or medical information, which may be relevant to any person including a future person
  5. public display
  6. research in connection with disorders, or the functioning, of the human body
  7. transplantation
  8. clinical audit
  9. education or training relating to human health
  10. performance assessment
  11. public health monitoring and
  12. quality assurance

(see Appendix A)

73. 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 (see paragraphs 108-112). See the code of practice on Post-mortem examination for further guidance.

Who may give consent?

Adults

74. Where an adult has, whilst alive, given valid consent for any particular donation or the removal, storage or use of their body or tissue for scheduled purposes [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_6#sch1] to take place following their death, then that consent is sufficient for the activity to be lawful.

75. If those close to the deceased person object to the donation, for whatever purpose, when the deceased person (or their nominated representative, see paragraphs 77-82) 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 veto or overrule those wishes (see the code of practice on Donation of solid organs for transplantation).

76. 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. Healthcare professionals should also consider the impact of going ahead with a procedure in light of strong opposition from the family, despite the legal basis for doing so. For example, healthcare professionals may consider that carrying out an anatomical examination would leave relatives or family members traumatised (or lead to their objections), despite the deceased person having consented to this whilst alive.

Nominated representatives

77. If a deceased adult had neither consented to, nor specifically refused, any particular donation or the removal, storage or use of their body or tissue for scheduled purposes, those close to them should be asked whether a nominated representative was appointed to take those decisions.

78. 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 body or tissue for any of the scheduled purposes, other than anatomical examination or public display.

79. 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.

80. If the deceased 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.

81. The nominated representative's consent cannot be overridden by other individuals, including family members. It is advisable, nevertheless, to ensure that appropriate consultation and discussion takes place between all those involved.

82. 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 paragraphs 83-88).

Qualifying relationships

83. If the deceased person has not indicated their consent (or refusal) to post-mortem removal, storage or use of their body or tissue for scheduled purposes, or appointed a nominated representative, then the appropriate consent may be given by someone who was in a ‘qualifying relationship' with the deceased person immediately before their death. Those in a qualifying relationship are found in the HT Act in the following order (highest first) [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_3#pt2-pb3-l1g27] :

  1. spouse or partner (including civil or same sex partner) The HT Act [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54] 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.
  2. parent or child (in this context a child may be of any age and means a biological or adopted child)
  3. brother or sister
  4. grandparent or grandchild
  5. niece or nephew
  6. stepfather or stepmother
  7. half-brother or half-sister
  8. friend of long standing

84. 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 high 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 others in the family wish to give consent, the wishes of the spouse must be respected. However, the guidance in paragraphs 85 and 87 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 or tissue for scheduled purposes.

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

86. 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.

87. Where there is a conflict between those accorded equal ranking, then this needs to be discussed sensitively with all parties (see also paragraphs 75-76 which provide further guidance on handling difficult situations), 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.

88. In applying the principles set out above, a person's relationship shall be left out of account if:

  1. they do not wish to deal with the issue of consent
  2. they are not able to deal with the issue
  3. in relation to the activity for which consent is sought, it is not practical to communicate with that person within the time available if consent in relation to the activity is to be acted on [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_3#pt2-pb3-l1g27]

This means a person may 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 to consent. In such cases, the next person in the hierarchy would become the appropriate person to give consent.

Children

89. Under the HT Act, a child is defined as being under 18 years old [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_5#pt3-pb2-l1g54]. Under the HT (Scotland) Act, a child is defined as being under 16 years old [www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_8#pt7-l1g60].

90. The position of a child who, before they died, was competent to reach a decision and gave consent for one or more scheduled purposes to take place after their death, is no different from that of an adult. Their consent is sufficient to make lawful the removal, storage or use of tissue for that purpose. 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. The principle of ‘Gillick competence' does not exist in Scottish law. Since there are extra sensitivities to take into consideration where the deceased donor is a child, the situation should be managed accordingly.

91. If a child consents to a procedure, then this consent carries over into adulthood unless they withdraw their consent.

92. In the case of anatomical examination or public display, written, witnessed consent is required from the child [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_2#pt1-l1g2]. As with adults, the next of kin cannot agree to the use of a child's body after death for these purposes.

93. 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 [www.opsi.gov.uk/acts/acts1989/ukpga_19890041_en_2#pt1-l1g3]. Clearly, 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 family.

94. If a child did not make a decision, or was not competent to make a decision, the HT Act makes clear that the appropriate consent will be that of a person with parental responsibility for the child [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_2#pt1-l1g2]. The consent of only one person with parental responsibility is necessary.

95. 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 family members. Any previously stated wishes of the deceased child should be considered, taking into account their age and understanding. Further guidance is included in the codes of practice on Post-mortem examination and Donation of solid organs for transplantation.

96. If there is no person with parental responsibility (e.g. if the parents have also died, perhaps at the same time as the child), then consent should be sought from someone in a qualifying relationship, (see section on qualifying relationships, paragraphs 83-88). Under the HT Act, children cannot appoint nominated representatives and therefore provisions related to seeking consent from nominated representatives do not apply.

Steps to take

Providing information about the process

97. Where no decision was made by the deceased, when seeking consent from a 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.

98. Healthcare professionals need to tailor the information they provide to each specific situation, as some people may insist on in-depth detail, whereas others would prefer to consent having only had the basics of the procedure explained to them. Trust policy should set out a minimum amount of information for healthcare professionals to provide, see the HTA's Directions 001/2006 [www.hta.gov.uk/guidance/licensing_guidance/expected_standards.cfm] which set out requirements for establishments licensed under the Q&S Regulations. Some people will want more detail than others about, for example, post mortem procedures and this information should be provided in accordance with their wishes (see the code of practice on Post-mortem examination). Further information may be found in the sections on the duration of consent, paragraphs 37-38 and use of documentation, paragraphs 62-64.

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

  1. honest, clear, objective information
  2. the opportunity to talk to someone of whom they feel able to ask questions
  3. reasonable time to reach decisions (about a hospital post mortem and about any donation of organs or tissue)
  4. privacy for discussion between family members, if applicable
  5. support if they need and want it, including the possibility of further advice or psychological support

Disclosing information about the deceased

100. Care should be taken regarding the possible disclosure of information, such as genetic information (see section on consent and the use of DNA, paragraphs 152-156) or HIV status, which the deceased person may not have wished to be disclosed, or which may have significant implications for other family members. Healthcare professionals will have to make a decision based on the individual circumstances of each case about whether it is appropriate or not to disclose information about the deceased's medical history, as well as any other sensitive information that the Trust may hold (about the deceased), that the family may not necessarily be aware of. In making decisions, healthcare professionals will have to have regard to their duty of patient confidentiality and may have to consider the provisions of the Data Protection Act 1998 [www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1]. In certain circumstances, it may be necessary to share sensitive information with the family if the results of the activity have the potential to affect them or other relatives.  For further guidance see GMC guidance on confidentiality [www.gmc-uk.org/guidance/ethical_guidance/index.asp] and the Department of Health's guidance on confidentiality [www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4069253] which deals with disclosing information after a patient has died. See also the Welsh Assembly Government's guidance on confidentiality [http://wales.gov.uk/cssiwsubsite/newcssiw/publications/ourfindings/allwales/2005/code_practice?lang=en].

Written consent

101. Written, witnessed consent [www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_2#pt1-l1g3] is always needed for anatomical examination and for public display of dead bodies or body parts (see the codes of practice on Anatomical examination and Public display for detailed guidance).

102. Written consent should be obtained wherever possible for all other post mortem activities.

103. If verbal consent is obtained, this should be clearly documented in the patient's records (see paragraph 58).

104. Model consent forms are available for post -mortem and anatomical examination on the HTA's website [www.hta.gov.uk/guidance/model_consent_forms.cfm]. In Northern Ireland, HSC Trusts and other relevant organisations should use the standardised consent forms agreed with the DHSSPS [www.dhsspsni.gov.uk/index/hss/hoi-home/hoi-postmortem.htm]. HTA model consent forms provide a suggested format for Trusts obtaining consent for the above purposes. 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. Consent forms are only one part of the consent process and should be completed after appropriate discussion and explanation.

Seeking consent for multiple activities

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 appropriate to seek the relevant consent to both activities. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking consent on repeated occasions. Research is one example (for further guidance about tissue to be used for research see paragraphs 148-149).

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

107. In the case of post mortem tissue, and unless authorised by a coroner, all storage and use for scheduled purposes requires consent. But, if consent to the storage or use of post mortem samples by whoever originally consented to their storage or use 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 (see the code of practice on Disposal of human tissue).

Exceptions for coroners and criminal justice purposes

108. The guidance in this section should be read in conjunction with the relevant sections relating to coroners in the codes of practice on Donation of solid organs for transplantation, Post-mortem examination and Disposal of human tissue.

109. For tissue from the deceased, consent is not needed for:

  1. carrying out an investigation into the cause of death under the authority of a coroner
  2. retention of material after a post mortem under the authority of a coroner, for a period no longer than the time needed by the coroner to discharge their statutory functions, if certified in writing with an explanation by the pathologist that it bears on evidence concerning the cause of death. See Coroners Rules for further detail

110. However, consent is required for research or other scheduled purposes where the coroner's authority to retain the material has ended and the deceased's family have not opted to dispose of the material. This applies to all tissue removed at post mortem, including small samples such as blocks and slides, and samples that might include relevant material such as toxicology and microbiology specimens. For detailed guidance, see the code of practice on Post-mortem examination, the Coroners Rules (see the Ministry of Justice (MoJ) website for information on coroners [www.justice.gov.uk/whatwedo/coroners.htm]) and the Coroners Practice and Procedure Rules (Northern Ireland) [http://www.coronersni.gov.uk/].

111. Once the coroner's authority has ended, if the material is not disposed of, the further storage and use of post mortem samples fall within the remit of the HT Act. The complexities surrounding disposal following a coroner's post mortem and subsequent communication with families are explored in further detail in the code of practice on Disposal of human tissue. Once the coroner's authority has ended, it is not lawful to use or store tissue for a scheduled purpose without consent. The code covers communication between coroners, pathologists and the family of the deceased.

112. Keeping material in connection with a criminal investigation or following a criminal conviction falls outside the remit of the HT Act.