Consent to Autopsy: Are NHS Trusts Falling Short?
Consent to Autopsy: Are NHS Trusts Falling Short?
An internet search of the term 'post mortem consent policy' was performed in order to obtain NHS trusts' policy documents. Policy documents were only included if they related to hospital PM examination in England and Wales and were aimed at staff members. For documents found that did not include information on PM examination, we contacted the trusts through their bereavement offices, the mortuary or their patient advice liaison service teams in an attempt to obtain the correct documents. Policies from 26 NHS trusts were obtained and analysed, using a combination of relevant policies for individual trusts where necessary. It must be acknowledged that some of these documents may have been updated since the time of acquisition.
Policies were analysed against Human Tissue Authority (HTA) guidelines as we assessed their suitability for purpose. From this, we came up with a series of questions which we believe are reasonable to assess whether the trusts policies were appropriate for both clinicians and relatives:
Consent is a well established legal and ethical principle that, through common law and the Mental Capacity Act 2005, is required for any medical intervention in a living person to be lawfully performed.
For medical intervention it is widely accepted that consent means a voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action that will affect him or her. Raanan Gillon
Consent for activities on the deceased, however, has not always been a legal requirement. Under the Human Tissue Act 1961, it was only necessary to demonstrate a 'lack of objection' from relatives to lawfully perform an autopsy. Failure to take adequate consent in life may constitute criminal charges of assault or torts of negligence or battery; however, these charges do not extend to the cadaver, meaning there were no criminal sentences for breaching the 1961 Act. Since the HT Act, consent must be obtained from the individual in life, or failing this, from a nominated representative or a person in a qualifying relationship in order to perform any activities permitted by the Act. If breached, the Act allows a maximum penalty of 3 years imprisonment and a fine.
The HTA was created by the HT Act, with its remit being to function as the regulatory body for all activities permitted under the HT Act, including autopsy. Despite consent being central to the HT Act, it is not defined in statute. Additionally, the HT Act specifies whose consent is needed, but it does not give guidance on the consent process, and this is where the HTA plays a pivotal role. It provides codes of practice which highlight what establishments should do to operate in accordance with the HT Act, and set recommended standards that should be followed by all establishments partaking in activities governed by the HT Act. Failing to comply with the codes of practice is not unlawful, but the HTA can take regulatory action if any breach of a code is found. Of the nine codes, the two relevant to PM examination include Code 1: Consent and Code 3: Post-mortem examination. They offer useful and comprehensive guidance to ensure the consent process is conducted in a sensitive and appropriate manner.
The HTA states that every hospital should provide staff with a documented consent procedure. It does not make specific references to what such policies must contain, but guidance is offered as to how the consent process should be undertaken with an emphasis to meet the needs of clinicians and the bereaved. It states that:
Anyone seeking consent for hospital PM examinations should have relevant experience and a good understanding of the procedure. They should be trained in dealing with bereavement and in the purpose and procedures of PM examinations and they should have witnessed a PM examination … responsibility for obtaining consent should not be delegated to untrained or inexperienced staff. Human Tissue Authority.
As hospital autopsies are performed increasingly infrequently, trusts can employ a small number of trained staff to assist clinicians in the consent process.
The HTA does not specify what must be contained in trust policies with respect to PM examination, but is clear about the nature in which consent should be obtained. When we assessed policies for their suitability for purpose (Table 1), we found that:
While there were examples of excellent policies which fully embraced the HTA guidance, several policies were very brief. In various institutions studied, PM examination was only discussed as a subsection in a 'Consent to Examination and Treatment' policy, and these tended to be far less thorough than policy documents dedicated to PM examination. One trust's policy failed to outline the hierarchy of qualifying relationships required for consent, instead only making reference to the HT Act. Moreover, 12% of policies failed to outline the consent process in full; for example, failing to describe when autopsy should be first suggested to families, or failing to outline which staff members should converse before the families would be presented with the consent form.
For the majority of hospital autopsies it will be the clinician who will make the request, but occasionally they may be performed at the request of the family, if the clinician is in agreement. Either way, as the HTA highlights, it is important for a member of the clinical team to be present so that the family can be supported by someone they have already established a relationship with. Due to the increasing scarcity of hospital autopsies carried out, trusts may employ a small number of trained staff members to support clinicians in the process, allowing them to effectively manage training of the individuals concerned. There is little evidence to suggest which staff members are most effective at taking consent for autopsy; however, some evidence suggests that staff members who regularly take consent can significantly improve autopsy rates. Nonetheless, the HTA highlights the importance of having a sufficiently trained and experienced individual involved in the consent process with a member of clinical staff, although it is possible for one clinician to possess all the required qualities.
When we analysed the methods employed by NHS trusts to take consent (Table 2), we found that:
While most policies outlined a team-based approach involving clinical staff and bereavement staff (such as bereavement officers, specialist nurses or similar), several policies were not specific as to who should take consent, for example, only mentioning a 'healthcare professional', while others had no documented approach for consent taking. Some policies however were excellent and extremely clear as to their specified approach.
The General Medical Council requires all doctors to be trained in consent taking. Although clinicians who take consent should be aware of the requirement to be well informed on that procedure, as set out by the Department of Health and the General Medical Council guidance, the HTA is clear that all staff members involved with taking consent for PM examination need to meet additional requirements. They require staff to be sufficiently experienced and senior, trained in dealing with the bereaved, well informed on PM practices, and should have witnessed a PM examination. When we analysed trust policies by these criteria (Table 3) we found that:
Many of the policies analysed were vague in their description of their training requirements, for example, being 'appropriately trained'. Several only had a requirement of 'consent training'; neither scenario was considered to have met the HTA recommendations. Again, several policies were exemplary, in some cases going beyond the established guidance. For example, specifying that consent takers must have attended courses in equality and diversity, or they must be fully conversant in the trust policy.
Methods
An internet search of the term 'post mortem consent policy' was performed in order to obtain NHS trusts' policy documents. Policy documents were only included if they related to hospital PM examination in England and Wales and were aimed at staff members. For documents found that did not include information on PM examination, we contacted the trusts through their bereavement offices, the mortuary or their patient advice liaison service teams in an attempt to obtain the correct documents. Policies from 26 NHS trusts were obtained and analysed, using a combination of relevant policies for individual trusts where necessary. It must be acknowledged that some of these documents may have been updated since the time of acquisition.
Policies were analysed against Human Tissue Authority (HTA) guidelines as we assessed their suitability for purpose. From this, we came up with a series of questions which we believe are reasonable to assess whether the trusts policies were appropriate for both clinicians and relatives:
Does the policy fully explain the law behind consent to PM examination?
Does the policy explain the consent process for PM examination?
Does the policy explain which staff members should take consent for PM examination?
Does the policy explain the training requirements of consent takers?
Consent and the Human Tissue Act
Consent is a well established legal and ethical principle that, through common law and the Mental Capacity Act 2005, is required for any medical intervention in a living person to be lawfully performed.
For medical intervention it is widely accepted that consent means a voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action that will affect him or her. Raanan Gillon
Consent for activities on the deceased, however, has not always been a legal requirement. Under the Human Tissue Act 1961, it was only necessary to demonstrate a 'lack of objection' from relatives to lawfully perform an autopsy. Failure to take adequate consent in life may constitute criminal charges of assault or torts of negligence or battery; however, these charges do not extend to the cadaver, meaning there were no criminal sentences for breaching the 1961 Act. Since the HT Act, consent must be obtained from the individual in life, or failing this, from a nominated representative or a person in a qualifying relationship in order to perform any activities permitted by the Act. If breached, the Act allows a maximum penalty of 3 years imprisonment and a fine.
Human Tissue Authority
The HTA was created by the HT Act, with its remit being to function as the regulatory body for all activities permitted under the HT Act, including autopsy. Despite consent being central to the HT Act, it is not defined in statute. Additionally, the HT Act specifies whose consent is needed, but it does not give guidance on the consent process, and this is where the HTA plays a pivotal role. It provides codes of practice which highlight what establishments should do to operate in accordance with the HT Act, and set recommended standards that should be followed by all establishments partaking in activities governed by the HT Act. Failing to comply with the codes of practice is not unlawful, but the HTA can take regulatory action if any breach of a code is found. Of the nine codes, the two relevant to PM examination include Code 1: Consent and Code 3: Post-mortem examination. They offer useful and comprehensive guidance to ensure the consent process is conducted in a sensitive and appropriate manner.
The HTA states that every hospital should provide staff with a documented consent procedure. It does not make specific references to what such policies must contain, but guidance is offered as to how the consent process should be undertaken with an emphasis to meet the needs of clinicians and the bereaved. It states that:
Anyone seeking consent for hospital PM examinations should have relevant experience and a good understanding of the procedure. They should be trained in dealing with bereavement and in the purpose and procedures of PM examinations and they should have witnessed a PM examination … responsibility for obtaining consent should not be delegated to untrained or inexperienced staff. Human Tissue Authority.
As hospital autopsies are performed increasingly infrequently, trusts can employ a small number of trained staff to assist clinicians in the consent process.
Suitability of Trust Policies
The HTA does not specify what must be contained in trust policies with respect to PM examination, but is clear about the nature in which consent should be obtained. When we assessed policies for their suitability for purpose (Table 1), we found that:
One policy failed to fully explain the law governing consent to PM examination
12% of policies did not outline a clear process of how PM consent should be obtained
12% of policies did not specify which staff members should take consent for PM examination
23% of policies failed to state the training requirements of those responsible for taking consent for PM examination.
While there were examples of excellent policies which fully embraced the HTA guidance, several policies were very brief. In various institutions studied, PM examination was only discussed as a subsection in a 'Consent to Examination and Treatment' policy, and these tended to be far less thorough than policy documents dedicated to PM examination. One trust's policy failed to outline the hierarchy of qualifying relationships required for consent, instead only making reference to the HT Act. Moreover, 12% of policies failed to outline the consent process in full; for example, failing to describe when autopsy should be first suggested to families, or failing to outline which staff members should converse before the families would be presented with the consent form.
Approaches to PM Consent
For the majority of hospital autopsies it will be the clinician who will make the request, but occasionally they may be performed at the request of the family, if the clinician is in agreement. Either way, as the HTA highlights, it is important for a member of the clinical team to be present so that the family can be supported by someone they have already established a relationship with. Due to the increasing scarcity of hospital autopsies carried out, trusts may employ a small number of trained staff members to support clinicians in the process, allowing them to effectively manage training of the individuals concerned. There is little evidence to suggest which staff members are most effective at taking consent for autopsy; however, some evidence suggests that staff members who regularly take consent can significantly improve autopsy rates. Nonetheless, the HTA highlights the importance of having a sufficiently trained and experienced individual involved in the consent process with a member of clinical staff, although it is possible for one clinician to possess all the required qualities.
When we analysed the methods employed by NHS trusts to take consent (Table 2), we found that:
Only 65% of trusts followed a team approach
12% of trusts followed a model that did not provide support for the clinician
12% of trusts had no clear method for taking consent.
While most policies outlined a team-based approach involving clinical staff and bereavement staff (such as bereavement officers, specialist nurses or similar), several policies were not specific as to who should take consent, for example, only mentioning a 'healthcare professional', while others had no documented approach for consent taking. Some policies however were excellent and extremely clear as to their specified approach.
Training Requirements of Consent Takers
The General Medical Council requires all doctors to be trained in consent taking. Although clinicians who take consent should be aware of the requirement to be well informed on that procedure, as set out by the Department of Health and the General Medical Council guidance, the HTA is clear that all staff members involved with taking consent for PM examination need to meet additional requirements. They require staff to be sufficiently experienced and senior, trained in dealing with the bereaved, well informed on PM practices, and should have witnessed a PM examination. When we analysed trust policies by these criteria (Table 3) we found that:
35% of trusts had no requirements for consent takers to be sufficiently experienced
58% of trusts had no requirements for consent takers to be trained in bereavement
42% of trusts did not specify that consent takers must be well informed on PM practice
69% of trusts failed to recommend that consent takers should have witnessed a PM.
Many of the policies analysed were vague in their description of their training requirements, for example, being 'appropriately trained'. Several only had a requirement of 'consent training'; neither scenario was considered to have met the HTA recommendations. Again, several policies were exemplary, in some cases going beyond the established guidance. For example, specifying that consent takers must have attended courses in equality and diversity, or they must be fully conversant in the trust policy.
