James Holgate
PFD Report
All Responded
Ref: 2024-0004
All 1 response received
· Deadline: 28 Feb 2024
Coroner's Concerns (AI summary)
An anomaly in the Human Tissue Act prevents body donation for medical research/training when an inquest is held, even if a post-mortem isn't needed, impeding scientific progress.
View full coroner's concerns
This matter was referred to this court and is a case where it is entirely suitable to proceed to inquest without the need for a post mortem examination. Evidence regarding the cause of death will be provided at inquest by way of a statement from the treating clinician with the CT scans showing the sequence of events. The family indicated that it had been Mr HOLGATE’s wishes, and indeed something that they supported, for his body to be donated for medical science/research. This process has long been a way of researching illness and disease as well as assisting in the training of doctors. It is recognised as fundamentally important to progressing the understanding of medicine and treatment.
Each receiving medical research/training establishment have a criteria, one of which is that, unless there are exceptional circumstances, the deceased should not have undergone a post mortem examination. This is understandable, and exceptions allow in certain instances this to be waivered.
In Mr HOLGATE’s case the local medical research/training establishment had full capacity and were unable to accept him. As is normal the family/Coroners Officer were referred to an alternative establishment at Nottingham.
Nottingham politely declined, they indicated that they were prevented from accepting due to what appears to be an anomaly in the law. As the matter was subject of a coronial inquest they could not accept the donation.
In non-inquest matters reported to the coroner, where post mortem examination is not required and the coroner is content there is no requirement to investigate further, a form A is signed to indicate this and the coroner is then able to return the deceased back in to the care of their family/personal representative/funeral director to allow funeral arrangements or body donation to proceed. In these instances medical research/training establishments are able to accept donation.
Where a coroner is likely to hold an inquest in a situation where a post mortem is not necessary as a cause of death statement can be obtained and the coroner is content that there is no further need to retain the deceased for any further examination, the coroner must also ensure that the deceased is returned back to the care of the family/personal representative/funeral director as soon as practicable. This normally allows for funeral arrangements to proceed.
In both instances the coroner authorises release of the deceased, in majority of cases the person is cremated ie they will not be available nor required for the coroner, even when the matter is proceeding to inquest. All relevant enquiries have to be made and sufficient evidence obtained before the release is authorised.
It is surprising therefore that the medical research/training establishments are stating that they are prevented from accepting people that are to be the subject of an inquest due to the Human Tissue Act. I fully accept there may be some circumstances where it would be inappropriate however if the coroner has no reason to object then the fact that the death is the subject of an inquest should not prevent the donation.
On reading the legislation, the establishments are either indicating an anomaly in the law or interpreting it incorrectly and guidance may be required.
Human Tissue Act 2004 covers donation. Section 11 covers permission required from a coroner, it reads: 11 Coroners (1)Nothing in this Part applies to anything done for purposes of functions of a coroner or under the authority of a coroner. (2)Where a person knows, or has reason to believe, that— (a)the body of a deceased person, or (b)relevant material which has come from the body of a deceased person, is, or may be, required for purposes of functions of a coroner, he shall not act on authority under section 1 in relation to the body, or material, except with the consent of the coroner.
However the medical research/training establishments refer to section 1(3) of the act which explicitly states the body cannot be accepted unless the death has been registered. Section 1 Subsection (3) HTA states:
1 Authorisation of activities for scheduled purposes 1(3)The use of the body of a deceased person for the purpose of anatomical examination shall be lawful if done— (a)with appropriate consent, and (b)after the death of the person has been registered— (i)under section 15 of the Births and Deaths Registration Act 1953, or (ii)under Article 21 of the Births and Deaths Registration (Northern Ireland) Order 1976.
Matters that proceed to inquest are not registered until the close of the inquest. Some inquests are dealt with in a very timely manner, however some may take some months to conclude.
It appears that the consent in Section 11 may have the ability to override the consent required in Section 1(3), if it is then organisations are not interpreting it this way.
Each receiving medical research/training establishment have a criteria, one of which is that, unless there are exceptional circumstances, the deceased should not have undergone a post mortem examination. This is understandable, and exceptions allow in certain instances this to be waivered.
In Mr HOLGATE’s case the local medical research/training establishment had full capacity and were unable to accept him. As is normal the family/Coroners Officer were referred to an alternative establishment at Nottingham.
Nottingham politely declined, they indicated that they were prevented from accepting due to what appears to be an anomaly in the law. As the matter was subject of a coronial inquest they could not accept the donation.
In non-inquest matters reported to the coroner, where post mortem examination is not required and the coroner is content there is no requirement to investigate further, a form A is signed to indicate this and the coroner is then able to return the deceased back in to the care of their family/personal representative/funeral director to allow funeral arrangements or body donation to proceed. In these instances medical research/training establishments are able to accept donation.
Where a coroner is likely to hold an inquest in a situation where a post mortem is not necessary as a cause of death statement can be obtained and the coroner is content that there is no further need to retain the deceased for any further examination, the coroner must also ensure that the deceased is returned back to the care of the family/personal representative/funeral director as soon as practicable. This normally allows for funeral arrangements to proceed.
In both instances the coroner authorises release of the deceased, in majority of cases the person is cremated ie they will not be available nor required for the coroner, even when the matter is proceeding to inquest. All relevant enquiries have to be made and sufficient evidence obtained before the release is authorised.
It is surprising therefore that the medical research/training establishments are stating that they are prevented from accepting people that are to be the subject of an inquest due to the Human Tissue Act. I fully accept there may be some circumstances where it would be inappropriate however if the coroner has no reason to object then the fact that the death is the subject of an inquest should not prevent the donation.
On reading the legislation, the establishments are either indicating an anomaly in the law or interpreting it incorrectly and guidance may be required.
Human Tissue Act 2004 covers donation. Section 11 covers permission required from a coroner, it reads: 11 Coroners (1)Nothing in this Part applies to anything done for purposes of functions of a coroner or under the authority of a coroner. (2)Where a person knows, or has reason to believe, that— (a)the body of a deceased person, or (b)relevant material which has come from the body of a deceased person, is, or may be, required for purposes of functions of a coroner, he shall not act on authority under section 1 in relation to the body, or material, except with the consent of the coroner.
However the medical research/training establishments refer to section 1(3) of the act which explicitly states the body cannot be accepted unless the death has been registered. Section 1 Subsection (3) HTA states:
1 Authorisation of activities for scheduled purposes 1(3)The use of the body of a deceased person for the purpose of anatomical examination shall be lawful if done— (a)with appropriate consent, and (b)after the death of the person has been registered— (i)under section 15 of the Births and Deaths Registration Act 1953, or (ii)under Article 21 of the Births and Deaths Registration (Northern Ireland) Order 1976.
Matters that proceed to inquest are not registered until the close of the inquest. Some inquests are dealt with in a very timely manner, however some may take some months to conclude.
It appears that the consent in Section 11 may have the ability to override the consent required in Section 1(3), if it is then organisations are not interpreting it this way.
Responses
Action Planned
The Department of Health and Social Care proposes to discuss with the Human Tissue Authority how they can ensure their guidance provides clarity on the criteria required for the storage and use of bodies for anatomical examination, and its interaction with Section 11 of the Human Tissue Act 2004. (AI summary)
The Department of Health and Social Care proposes to discuss with the Human Tissue Authority how they can ensure their guidance provides clarity on the criteria required for the storage and use of bodies for anatomical examination, and its interaction with Section 11 of the Human Tissue Act 2004. (AI summary)
View full response
Dear Miss. Harris,
Thank you for your letter of 3 January 2024 about the death of Mr. James Arthur Holgate. I am replying as Minister with responsibility for sponsorship of the Human Tissue Authority.
Firstly, I would like to say how saddened I was to read of the circumstances of Mr. Holgate’s death, and I offer my sincere condolences to their family and loved ones. Your report describes the circumstances in which Mr Holgates body was declined for donation because it was subject to an inquest. I am grateful to you for bringing this matter to my attention.
In this case, the research establishment could have accepted Mr. Holgate’s body for lawful storage if certain conditions had been met. The research establishment could have lawfully stored the body in anticipation of potentially using it for anatomical purposes, as per section 1(2) of the Human Tissue Act.
However, Section 11 of the Human Tissue Act 2004 provides that any of the activities specified under section 1 of the Act should not take place where a person knows or has reason to believe that the body is, or may be, required by a coroner unless the coroner consents.
The Department appreciates that the need for coroners’ consent in section 11 of the Human Tissue Act could allow room for confusion with regards to the criteria for storage and use of a deceased body for anatomical purposes under Section 1, particularly where a coroner is holding an inquest but has released the body. We propose therefore to discuss with the Human Tissue Authority how they can ensure that their guidance and codes of practice provide
OFFICIAL OFFICIAL clarity on the criteria required for the storage and use of bodies with regards to each of the specified activities as set out in Schedule 1 of the Human Tissue Act 2004, including anatomical examination, and its interaction with Section 11.
Lastly, I agree that body donation is a vital resource for training healthcare professionals and for research. I would recommend that for any further concerns relating to statutory interpretation of the Human Tissue Act, that you write to my officials at the Department of Health and Social Care (health.ethics@dhsc.gov.uk).
I hope this response is helpful. Thank you for bringing this matter to my attention.
Best Wishes, MARIA CAULFIELD
Thank you for your letter of 3 January 2024 about the death of Mr. James Arthur Holgate. I am replying as Minister with responsibility for sponsorship of the Human Tissue Authority.
Firstly, I would like to say how saddened I was to read of the circumstances of Mr. Holgate’s death, and I offer my sincere condolences to their family and loved ones. Your report describes the circumstances in which Mr Holgates body was declined for donation because it was subject to an inquest. I am grateful to you for bringing this matter to my attention.
In this case, the research establishment could have accepted Mr. Holgate’s body for lawful storage if certain conditions had been met. The research establishment could have lawfully stored the body in anticipation of potentially using it for anatomical purposes, as per section 1(2) of the Human Tissue Act.
However, Section 11 of the Human Tissue Act 2004 provides that any of the activities specified under section 1 of the Act should not take place where a person knows or has reason to believe that the body is, or may be, required by a coroner unless the coroner consents.
The Department appreciates that the need for coroners’ consent in section 11 of the Human Tissue Act could allow room for confusion with regards to the criteria for storage and use of a deceased body for anatomical purposes under Section 1, particularly where a coroner is holding an inquest but has released the body. We propose therefore to discuss with the Human Tissue Authority how they can ensure that their guidance and codes of practice provide
OFFICIAL OFFICIAL clarity on the criteria required for the storage and use of bodies with regards to each of the specified activities as set out in Schedule 1 of the Human Tissue Act 2004, including anatomical examination, and its interaction with Section 11.
Lastly, I agree that body donation is a vital resource for training healthcare professionals and for research. I would recommend that for any further concerns relating to statutory interpretation of the Human Tissue Act, that you write to my officials at the Department of Health and Social Care (health.ethics@dhsc.gov.uk).
I hope this response is helpful. Thank you for bringing this matter to my attention.
Best Wishes, MARIA CAULFIELD
Sent To
- Department of Health and Social Care
Response Status
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56-Day Deadline
28 Feb 2024
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Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 2nd November 2023 I commenced an investigation into the death of James Arthur HOLGATE, aged 89 years. The investigation has not yet concluded, and the inquest has not yet been held. Mr HOLGATE’s medical cause of death has been given as: 1a Traumatic Intracranial Haemorrhage 1b Fall 2 Mitral Valve replacement (on warfarin), Hypertension, Atrial Fibrillation, Frailty
Circumstances of the Death
On 30th October 2023 Mr HOLGATE age 89 years was admitted to Hull Royal Infirmary with recurrent falls, progressive confusion, slurred speech and progressive decline. While in the care of the Emergency Department Mr HOLGATE sustained a fall. A CT scan showed evidence of a traumatic head injury, Mr HOLGATE was deemed very unwell and not for surgical intervention. Mr HOLGATE deteriorated further and another CT scan showed an ongoing bleed with mass shift which had not been evident on the original CT. Mr HOLGATE was reviewed again and still deemed not fit for intervention and placed on a palliative care pathway. Mr HOLGATE died on 1st November 2023.
Action Should Be Taken
This may be by way of clarification or guidance if S11 overrides the need to register before acceptance.
Donations of this kind further the advancement of medicine, treatments and training and as such prevent many deaths. It appears that those people who are subject of an inquest should not be prevented from donating their bodies when the coroner is content it is entirely appropriate to do so and it is the wishes of those making the arrangements.
Donations of this kind further the advancement of medicine, treatments and training and as such prevent many deaths. It appears that those people who are subject of an inquest should not be prevented from donating their bodies when the coroner is content it is entirely appropriate to do so and it is the wishes of those making the arrangements.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.