Methodology

Introduction

1. The Secretary of State for Health and Social Care, the Right Honourable Wes Streeting, published the terms of reference for the Independent Maternity and Neonatal Investigation (‘the Investigation’) on 15 September 2025. These terms of reference set out the aims of the Investigation, which are to:

• develop and publish one set of national recommendations to:
  • drive the improvements needed to ensure high-quality and safe maternity and neonatal care across England
  • reduce inequalities and promote health equity in the delivery of those services
  • help bereaved and harmed families to receive justice and accountability in the future
• ensure that the lived experiences of women, babies and families, including fathers and non-birthing partners, are fully heard and used to inform the development of the national recommendations
• conduct and publish 12 local investigations of maternity and neonatal services in NHS trusts and use these alongside other sources of data and evidence gathered by the Investigation to inform the development of the national recommendations

2. This paper sets out the methodology for the rapid investigation. The methodology will take a Families First approach. This is an approach which has been taken with other national reviews and investigations such as the Hillsborough Inquiry and East Kent Review of Maternity Services. It puts women, women, babies and families, including fathers and non-birthing partners, at the heart of the Investigation. To that end, a Family Engagement Strategy has been developed which will set out how the Investigation includes family perspectives on the work we do. The methodology should be read in conjunction with the Family Engagement Strategy.
   
   
3. The Independent Investigation is a systemic review of maternity and neonatal services in England. One aspect of this systemic review is the Chair listening to the experiences of women, babies and families, including fathers and non-birthing partners, using maternity and neonatal services to increase her understanding of the systemic issues that are present in maternity and neonatal services. However, the Investigation will not be undertaking individual reviews of the cases families share with the Chair and the Investigation team. This is a rapid investigation focused on system change.
   
   
4. A key aim of the Investigation is to understand the inequalities which persist in maternity and neonatal care and propose recommendations which promote health equity in the delivery of those services. This aim is included in the terms of reference. The Investigation methodology includes this aim under a separate workstream. However, inequalities will also be addressed across all workstreams.
   
   
5. The Independent Investigation will undertake an analysis of the quality, safety and experience of those using maternity and neonatal services. From prior consultation with women and families, including fathers and non-birthing partners, we heard about the importance of including accountability structures, the legal framework, professional philosophies governing pregnancy and labour, and how NHS organisations and national regulators respond when things go wrong. These areas have been included in the methodology.
   
   
6. The Secretary of State announced in June 2025 that reviews of 10 NHS Trusts would form part of the Investigation. The Chair of the Independent Investigation reviewed the data provided to her and considered that there were 11 NHS Trusts that she wanted to include in the review of local NHS Trusts. In addition to the 11 identified NHS Trusts, the Chair also decided that she wanted to include 3 further NHS Trusts in her investigation because they had previously been identified as Trusts with significant problems and had been subject to national reviews. The Chair was keen to understand what, if any, sustained changes had been made since the national reviews had been undertaken to provide her with evidence of the system’s ability to adapt and learn from mistakes. Consideration of these Trusts would also provide her with insights into the barriers to implementing recommendations which would be helpful in informing the development of her national recommendations.
   
   
7. On 24 October 2025, the Chair announced that 2 Trusts were being removed from the scope of the Investigation: Leeds Teaching Hospitals NHS Trust was removed following the Secretary of State’s announcement on 20 October 2025 that he would be commissioning an independent inquiry into the Trust’s maternity units; and Shrewsbury and Telford Hospital NHS Trust was removed following discussions with West Mercia Police about the detail and schedule of their ongoing criminal investigation. The methodology therefore refers to 12 local reviews.

Workstream 1: Local Reviews of Maternity and Neonatal Services in 12 NHS Trusts

8. The methodology set out below has been developed to understand the quality and safety of services, and experience of women and families using maternity and neonatal services in each of the local NHS Trusts that have been selected.
   
   
9. These Trusts were selected with a view to ensure a diverse mix of trusts, including variation in case mix, trust type, geographic and demographic coverage and views expressed by families. By taking this approach, the Investigation can capture learning from a wide range of provision and experiences, ensuring the findings are relevant across the system.
   
   
10. The Investigation will seek to understand:

• How culture impacts on the delivery of services and how healthcare professionals listen to women and families, including fathers and non-birthing partners, throughout the maternity and neonatal care pathway
• The experience of women, babies and families from Black and Asian backgrounds, those from deprived groups and those from other marginalised groups when receiving maternity and neonatal care
• How the leadership and oversight for maternity and neonatal services supports or detracts from each Trust providing services, that are of high quality, safe and support a positive experience for women and families
• The extent to which Trusts listen to women and families when things go wrong
• The ability of Trusts to learn when things go wrong and sustain that learning
• The ability of Trusts to identify and respond to known risks in maternity and neonatal services
• The extent to which Trust leadership listen to staff experience of working in maternity and neonatal services
• The extent to which Trusts are supported by local and regional leadership teams
• The extent to which the systems and processes of investigation and governance provide accountability when things go wrong in maternity and neonatal services
• The barriers Trusts face when responding to issues identified in existing investigation reports
• The barriers to the provision of consistent, holistic care

Methods

11. A variety of methods will be used to understand the quality, safety and women and families’ experience. These will include:

• Hearing the experience of women, babies and families, including fathers and non-birthing partners
• Hearing the experience of women, babies and families from Black and Asian backgrounds, those from deprived groups and those from other marginalised groups when receiving maternity and neonatal care
• Document review
• Trust questionnaire
• Interviews with senior team at local NHS Trusts
• Hearing the experience of staff delivering maternity and neonatal services
• Site visits
• Data packs containing performance and operational data

Women, Non-birthing Partners and Family Experience

12. The Investigation team will collect evidence to understand the experience of women and families using maternity and neonatal services at each Trust site. The Chair is particularly interested in hearing the experiences of women, non-birthing partners and families who have experienced harm, and who are from diverse ethnic minority groups. The Investigation will use information from a variety of different sources including:

• Family evidence panels held in the local areas
• Information held by the Trust on the experiences of women and families using these services such as patient experience surveys, complaints letters and any other information that can be identified
• Information on patient experience held by other organisations such as CQC

Document Review

13. The local investigations will review a range of documents to assist with understanding the local picture.

Publicly available documents

• Trust Board minutes – public
• CQC reports
• Prevention of Future Death Reports from local Coroners’ services

Documentation from the Trust or other NHS sources

14. A list of documents will be requested from each NHS Trust that includes relevant internal management, governance and executive committee and subcommittee papers including all maternity performance and service data that goes to the Trust Board. This will include the documents that are listed below and any other document that the Investigation identifies as helpful during the course of its work.

• Quality Committee (or equivalent) minutes
• Finance Committee minutes
• All maternity and neonatal performance and service data that goes to the Trust Board
• Any CQC warning notices or other formal or informal actions related to maternity and neonatal services
• Complaint documentation relating to maternity and neonatal services
• Any Freedom of Information requests received by Trusts in relation to maternity and neonatal services
• Patient Safety Incident Investigations Reports (PSII) related to maternity and neonatal services
• Patient Safety Incident Response Plan
• Maternity and Newborn Safety Investigation (MNSI) data
• Maternity Safety Support Programme (MSSP) documentation reports
• ICB performance reports
• NHS Resolution reports and activity
• Improvement strategies for Maternity and Neonatal Services
• Maternity and Neonatal risk register
• Staff disciplinary data
• Freedom to speak up occurrences
• Prevention of Future Death Reports
• Maternity and neonatal staff data

Interviews with senior team at local NHS Trusts

15. These interviews will be conducted remotely and will use an interview plan that has previously been agreed by the Chair. All those interviewing will be trained in interview techniques and trauma informed practices. Interviews will be held with:

• Chair of NHS Trust
• CEO
• Chair of Quality Committee or equivalent
• Chief Medical Officer
• Chief Nurse
• Senior Midwife for Trust
• Executive Director with responsibility for maternity (if not Chief Nurse)
• Senior manager responsible for maternity such as Divisional manager
• ICB representatives x 2 (to be identified by the Investigation)
• NHS England Regional representative (to be identified by the Investigation)
• Lead Maternity and Newborn Safety Investigations representative
• Clinical Director of Maternity
• Clinical Director of Neonatology
• Labour Ward Shift Co-ordinators
• Senior Neonatal Clinician/Nurse

16. The Investigation will also conduct interviews with key roles representing service user voices

• Maternity and neonatal independent senior advocates (MNISAs)
• Maternity and neonatal voices partnership leads (MNVPs)
• Maternity and Neonatal System (LMNS) Service User representatives

17. The Investigation may identify other individuals that it wishes to interview during the course of its investigation. This could include individuals that have previously held senior positions at one of the Trusts.

Staff experience

18. The Investigation will collect evidence to assist in understanding staff experience in each of the 12 sites. This will include an evidence panel.

Site visits

19. The Chair will undertake site visits to each of the 12 Trusts. The Chair will be supported by Expert Advisors and the investigation support team. The purpose of the site visits is for the Chair, Expert Advisors and investigation support team to see the maternity and neonatal facilities in which services are delivered, and to meet with families and staff. Meetings with families will be held off site. Each visit will take at least two days.

Data outcomes for each site

20. A data pack will be produced for each site comprising of data outcomes collected by NHS England.

Reporting arrangements

21. A report will be compiled for each NHS Trust and the themes arising from the review will be identified and summarised into one report. Both reports will be published in due course.

Workstream 2: System-wide review

22. The system-wide review is designed to:

• Hear the experiences of women and families who have used maternity and neonatal services, particularly those women and families who are from diverse ethnic minority groups and who are from marginalised and excluded communities and groups
• Understand accountability structures at a national level for improving the quality, safety and experience of women and families using maternity and neonatal services
• Understand barriers to improvement and why previous investigations and public inquiries have failed to deliver the promised improvements. This will include understanding the barriers that exist across the system to implementing recommendations and how these barriers can be overcome
• Understand the extent to which national leaders understand when local maternity and neonatal services are failing in a timely manner
• Understand the extent to which national leaders respond promptly when local Trusts are failing
• Understand the impact of specific professional beliefs and approaches around pregnancy and birth

Evidence sources

23. The system-wide review will include evidence collection from the following sources:

• Family evidence panels
• Expert evidence panels
• Community/stakeholder panels
• A call for evidence from the public
• A call for evidence/survey for NHS staff
• International comparison for outcomes and service design
• Interviews with national leaders from the healthcare system
• Review of recommendations from previous national investigations and public inquiries
• Investigating revenue and capital investment

24. In addition to the above methods of evidence collection, the system-wide review will also consider the findings from the 12 local investigations. The local investigations will produce individual reports for each site visit. It will also produce an overall thematic report that collates the findings from all investigation sites. The thematic report will contribute to the understanding of systemic failings to improve the quality, safety and experience of maternity and neonatal services for women and families.

Identification of national and international examples of good practice

25. This will comprise of the following:

• A desktop review of examples of national good practice
• Interviews with national leaders, local providers and clinical experts
• Panel of clinical and academic experts
• A review of 3 comparable countries and any other countries that are identified as having the potential to assist the Investigation
• Interviews with international experts in maternity and neonatal services

Interviews with national leaders and system stakeholders

26. A list of leaders for national organisations, including statutory, Arm’s Length Bodies and the voluntary and charitable sector will be developed. Leaders of these organisations will be invited to a formal interview with the Chair, Director of Investigation and a member of the Expert Panel. The list below gives examples of leaders to be interviewed. It will be added to as more individuals are identified. We may also request written evidence or supplementary documents as evidence to support the Investigation.

National bodies with formal accountability or regulatory roles

• Care Quality Commission (CQC) – Chair and CEO
• DHSC Chief Scientific Advisor
• DHSC – Chief Medical Officer
• General Medical Council (GMC)
• Healthcare Services Safety Investigation Body – Chair & CEO
• Maternity and Newborn Safety Investigations Programme (MNSI)
• NHS England – Chair, CEO, Chief Nursing Officer, Chief Midwife
• NHS England National Clinical Director for Maternity
• NHS England National Clinical Director for Neonatology
• NHS England National Clinical Director for Women’s Health
• NHS England National speciality advisors
• Nursing and Midwifery Council (NMC)
• Royal College of Midwives (RCM)
• Royal College of Obstetricians and Gynaecologists (RCOG)
• A selection of Higher Education Institutions

Key stakeholders including voluntary and community sector organisations

27. The list of stakeholder organisations is an evolving list and the methodology will be adapted as required.

The voice of staff working in maternity and neonatology

28. The Investigation recognises that to fully understand what is happening in maternity and neonatal services, it needs to hear the perspective of those staff who work in them. We will be conducting a survey to hear from staff at the same time that we are undertaking the call for evidence from women, non-birthing partners and families.

Review of recommendations from previous national investigations

29. As set out in the Terms of Reference, the Investigation will undertake a thematic review of previous recommendations that have been made by public inquiries and national investigations into maternity and neonatal care from 2015 to the present. This will include identifying how many of those recommendations have been implemented, understanding the impact of those recommendations that have been adopted and implemented, and identifying the reasons recommendations have not been implemented. It will also include identifying the opportunities for and barriers to making improvements and implementing previous recommendations in maternity and neonatal care, considering cultural and systematic factors. This will feed into workstream 5: development of one set of recommendations.

Workstream 3: Inequalities experienced by specific groups using maternity and neonatal services

30. The terms of reference specifically require the Investigation to understand the experience of Black, Asian and other seldom heard communities. The experiences of these different groups when using maternity and neonatal services will be viewed through the lens of inequalities in each of the workstreams. However, the issue of inequalities is considered so central to this Investigation that we have also included a separate workstream. The work in this workstream will include:

• Evidence panels with women and families, including fathers and non-birthing partners, from a range of communities
• Evidence panels with inequalities experts
• Desktop review of reports covering the experience of Black, Asian and other seldom heard communities.

Workstream 4: Legal framework for Coronial involvement in stillbirths and compensation arising from harms sustained from clinical negligence

31. When developing the terms of reference for the Independent Investigation, feedback from families identified concerns over the legal framework governing the investigation of stillbirths. In particular, some families expressed concern that the Coroner does not investigate if a baby is stillborn without taking a breath. This is perceived by families as unfair as it denies the family a coronial investigation into why their baby died.
    
    
32. In addition to the Coronial system, the Investigation also received feedback from families on the difficulties presented by the current compensation system for harm caused by clinical negligence. Families believe that the current compensation system encourages an adversarial approach to be taken by NHS Trusts as they seek to protect Trusts from the courts finding against them and the subsequent costs.
    
    
33. The Investigation is unable to undertake a full review of these issues in the time available to it. However, a high-level review of the issues in each of these areas will be undertaken to identify key issues, hear evidence on these matters and make findings and recommendations.

Coronial system

34. Desktop review of available evidence in relation to the Civil Partnerships, Marriages & Death (Registration) Act 2019
    
    
35. Interview with the following individuals:

• Family representatives
• Chief Coroner
• National Medical Examiner
• Ministry of Justice representative
• Academic legal expert

Legal framework for compensation following harm caused by clinical negligence

36. The Investigation will collect evidence from a range of different individuals who have knowledge of this work including, but not limited to:

• Family representatives
• NHS Resolution, including Maternity Voices Advisory Group representative
• Academic legal expert
• Interested organisations e.g. Society of Clinical Injury Lawyers (SCIL)

37. A report will be compiled and published for this workstream.

Workstream 5: The development of one set of recommendations

38. The evidence-based findings from workstreams 1-4 will be used to develop one set of national recommendations. This will be published as part of the final report.

Summary

39. This methodology has been developed to meet the aims of the Independent Investigation as set out in its terms of reference, published in September 2025. It places the experiences of women, babies and families, including fathers and non-birthing partners, at its heart. Although the methodology provides a framework for the work of the Independent Investigation, it will follow the evidence as it emerges. This may require additional investigation methods to be added. It is an iterative methodology and will be adapted in line with the evidence that emerges during the course of the Investigation.