Explanatory Note – Phase 2 – The Independent Inquiry into the issues raised by the David Fuller case

This Explanatory Note is intended to be read in conjunction with the Inquiry’s Terms of Reference and the revised Inquiry Protocol.

The Explanatory Note provides further detail of the Inquiry’s approach to Phase 2 of its Terms of Reference and the scope of its investigations. This note relates solely to Phase 2 of the Inquiry’s work.

Matters to be considered by the Inquiry

1. The Inquiry will prepare a second report centred on the three core modules of work.

(a) A review of the practices and procedures in safeguarding the dignity and security of the deceased in mortuaries and other hospital settings in NHS Trusts and private hospitals in England.

(b) A review of the practices and procedures in safeguarding the dignity and security of the deceased in relevant non-hospital settings, including funeral homes, hospices, local authority mortuaries and medical schools.

(c) The regulatory and legislative frameworks in place to safeguard the dignity and security of the deceased in hospital and relevant non-hospital settings.

2. The topics that will be investigated to address these areas include, but are not limited to, the matters set out in paragraphs 2.1 to 2.10 of this note.

Procedures and practices – hospital settings

2.1 The Inquiry will consider whether current procedures and practices in hospital settings, including in the private sector, where bodies of the deceased are kept, appropriately safeguard the dignity and security of the deceased, and would prevent a recurrence of matters raised by the case of David Fuller.

2.2 The consideration of hospital settings will include, but is not limited to, the following forms of investigation:

• Questionnaires issued to all NHS Trusts in England to request information on the Trust’s facilities, practices and procedures for storing deceased. This information will assist the Inquiry to assess the risks in protecting the dignity and security of the deceased in each hospital setting.

• In-depth investigation(s) into the facilities, practices and procedures for storing the deceased at specific NHS Trusts. These will be identified through responses to questionnaires, Human Tissue Authority inspection reports, media reports, Care Quality Commission inspection reports and other information provided to the Inquiry; and

• Site visits to specific NHS Trusts identified for in-depth investigation to understand their working practices to safeguard the dignity and security of the deceased. The Inquiry will be assisted by subject matter experts to conduct these visits.

2.3 The Inquiry will also review the practices and procedures in private hospitals for storage of deceased. This may include gathering information to assess the safeguarding risks in protecting the dignity and security of the deceased, issuing questionnaires to the largest providers of private hospitals, reviewing documents, site visits and interviews of key individuals.

Procedures and practices – non-hospital settings

2.4 The Inquiry will consider whether procedures and practices in relevant non-hospital settings where bodies of the deceased are kept, appropriately safeguard the dignity and security of the deceased and would prevent a recurrence of matters raised by the case of David Fuller.

2.5 Non-hospital settings shall include in particular those locations where it is considered there is an elevated risk in safeguarding the dignity and security of deceased. The approach to the assessment of risk is explained at section 3 of this note.

2.6 The non-hospital settings that are likely to be investigated in Phase 2 includes, but is not necessarily limited to:

• Local authority mortuaries;
• The funeral care sector;
• The NHS ambulance service;
• Undergraduate and postgraduate Medical training facilities;
• Temporary mortuaries; and
• Hospices.

2.7 The Inquiry will use a variety of methods to gather information about relevant non-hospital settings. This will include, but is not limited to: issuing questionnaires to gather information; reviewing documents; holding seminars with key organisations and stakeholders; conducting interviews with key individuals from those settings; and site visits where appropriate.

The role of regulators and the effectiveness of the regulatory and legislative framework

2.8 The Inquiry will consider the role of healthcare and other regulators to understand how they assist with safeguarding the security and dignity of the deceased in hospital and non-hospital settings and what further regulation, if any, may be appropriate. It will also consider the impact of the current legislative framework on protecting the dignity of the deceased, including but not limited to, safeguarding and the role of police vetting.

2.9 The regulators considered will be kept under review but may include the Human Tissue Authority, the Care Quality Commission and the Independent Funeral Standards Organisation. This may also include other organisations with an oversight function, for example NHS England.

Phase 1

2.10 The Inquiry will consider any other issues that arose during Phase 1 of the Inquiry which are relevant to the Phase 2 investigation for safeguarding the dignity and security of the deceased and preventing a recurrence of the issues raised by the David Fuller case.

Phase 2 scope and assessment of risk

3. The scope of Phase 2 will be kept under review by a risk-based approach to support the investigation methodology. This approach will have regard to the time spent by the deceased in each setting and the protections provided by the procedures and practices in use in those settings.

3.1 Consideration of the dignity and security of the deceased will be focused on how the deceased are stored and looked after in the setting to prevent them being harmed or abused after death. In conducting its Phase 2 investigation, the Inquiry may become aware of other issues arising from safeguarding the security and dignity of the deceased. Whilst these cases may not fall directly within the scope of the Inquiry’s investigation, they will be noted and escalated to the appropriate authority where necessary. The Inquiry may also reference such cases in its Phase 2 report. The Inquiry will not specifically consider as part of its Phase 2 work issues unrelated to the physical safety and dignity of the deceased, including for example allegations of theft. Phase 2 will be limited to whole deceased bodies and will exclude consideration of individual body parts.

Gathering evidence

4. The Inquiry will seek evidence from a range of organisations including, but not necessarily limited to, those listed in section 2 of this Note. For the avoidance of doubt, this is likely to include, but is not limited to, the following:

• Mortuary staff in NHS Trusts;
• Local authority staff;
• Private and NHS ambulance staff;
• Funeral directors;
• Hospice directors;
• Senior leaders from medical schools and postgraduate medical training services;
• Senior leaders from regulators relevant to the Inquiry, for example, the Human Tissue Authority, the Care Quality Commission and the Independent Funeral Standards Organisation.

4.1 If other organisations and individuals with relevant information to Phase 2 are identified through the Inquiry’s investigations, they will also be asked to assist.

4.2 This evidence may be gathered in seminars, questionnaires and surveys and witness interviews, documentary reviews and site visits. The method of evidence gathering used will depend on the information required. All those contacted will be expected to assist the important work of the Inquiry. If an individual or organisation chooses not to assist the Inquiry will consider any further action it may be appropriate to take. This may include informing professional regulators and current employers. The Inquiry may consider including criticism in its report(s) of any individual or organisation that does not participate in or co-operate with its evidence gathering process.

4.3 Insofar as it will aid public understanding and it is appropriate to do so, some elements of the Inquiry’s evidence-gathering process may be recorded and shared on the Inquiry’s website. The Inquiry plans to publish recordings of the seminars undertaken with funeral directors, which took place in Autumn 2023.

Recommendations

5. In its Phase 2 report, the Inquiry will consider the need for recommendations to maintain the dignity and security of the deceased in both hospital and non-hospital settings.

Expert assistance

6. To conduct its work the Chair will be assisted by subject matter experts in the care and management of the deceased, pathology and mortuary services. Further details about the subject matter experts and the assistance they provide to the Chair will be set out in the Inquiry’s Phase 2 report and, as appropriate, on the Inquiry’s website.

The standard of proof

7. The standard of proof refers to the level of certainty required to prove an assertion or make a finding of fact. In contrast to its Phase 1 investigation which considered issues arising from the actions of David Fuller, the Inquiry’s Phase 2 investigation is less likely to need to investigate and make determinations on factual issues. Nonetheless, to the extent that this is necessary, the Inquiry will adopt a variable and flexible standard of proof when determining any factual issues.

7.1 A variable and flexible approach has been used in many other inquiries, considering the standards adopted in both the civil and criminal courts. Some findings may not be subject to a standard of proof, but judgements will be made by the Inquiry Chair on the basis of facts found during the Inquiry’s work.

Other relevant Inquiries

8. In conducting its work, the Inquiry will have due regard to the findings of other relevant statutory and non-statutory inquiries.

Fairness Process

9. As far as it is necessary to do so, the Inquiry will conduct a Fairness Process to ensure that identifiable individuals and organisations who may be the subject of criticism in its Phase 2 report are informed of this in advance of publication.

9.1 Individuals and organisations who face criticism in the Inquiry’s Phase 2 report will be provided with a summary of the proposed criticisms. This process will allow these individuals the opportunity to make written representations about the proposed criticisms before the Inquiry finalises the text of its report. Any representations made within the timeframe permitted by the Inquiry will be considered and taken into account before the report text is finalised.

9.2 The Fairness Process will be strictly confidential to ensure fairness to all individuals and organisations associated with the Inquiry.