1. Introduction

The national infection prevention and control manual (NIPCM) is an evidence-based practice guide for use in England. It contains standard infection control precautions (SICPs) and transmission-based precautions (TBPs), which when applied correctly can help reduce the risk of healthcare associated infection (HCAI) and ensure the safety of those being cared for, staff and visitors in the care environment.

The NIPCM aims to:

• make it easy for health and care staff to apply effective infection prevention and control (IPC) precautions
• reduce variation and optimise infection prevention and control practices throughout England
• help reduce the risk of HCAI
• help align practice, monitoring, quality improvement and scrutiny.

The NIPCM should be applied by all NHS staff involved in patient care. Furthermore, the principles in the NIPCM should be applied across all care settings (including acute, community and social care), complementing specific guidance produced for these settings. Several supporting tools (appendices) are available to complement the NIPCM.

The NIPCM is underpinned by scientific literature reviews, these are primarily aimed at infection control specialists and summarise the available evidence, highlight any research gaps.

Currently, the NIPCM for England uses the Scottish NIPCM literature reviews as its evidence base. NHS England will use these reviews for an interim period, during which we will develop the IPC evidence base for England. This guidance sets out the defined methodology that will be used to achieve this aim.

2. Guideline development group

It is fundamental to the integrity and applicability of the NIPCM that a wide group of stakeholders is involved in its development. Involving experts from all appropriate multidisciplinary groups during development of the NIPCM, its associated literature reviews and supporting tools ensures its recommendations are evidence-based, appropriate, practical and acceptable in all healthcare settings.

Two standing groups participate in developing the NIPCM: the NIPCM consensus group and the NIPCM clinical oversight group. In addition, topic-specific ‘review’ groups will be formed to support NIPCM literature reviews. Together, the NIPCM review, consensus and clinical oversight groups form the NIPCM guideline development group.

2.1 Membership

The membership of the NIPCM consensus group is intended to reflect IPC practitioners at the front line across a range of services (acute, community, mental health, etc). All members must be employed in a relevant position, ie related to HCAI and infection control.

The NIPCM consensus group membership is formed of frontline IPC specialists with responsibility for implementing IPC policy and guidance. The group has representation from across the seven geographical regions including acute, community, mental health and learning disability, and ambulance specialties. The full membership is available in the consensus group terms of reference.

The NIPCM clinical oversight group has a wider professional membership. The following organisations and specialties are represented (or included for engagement/consultation purposes) on the NIPCM consensus group:

• Healthcare Infection Society (HIS)
• Infection Prevention Society (IPS)
• Royal College of Nursing
• Academy of Medical Royal Colleges
• Occupational medicine
• NHS England regional IPC leads
• UK Health Security Agency (UKHSA)
• Health and Safety Executive (HSE)
• Chartered Physiotherapy Society
• Care Quality Commission (CQC)
• NHS England Primary care services (including dentistry)
• Department of Health and Social Care (DHSC).

NB This list is not exhaustive as membership is reviewed quarterly refer to Terms of Reference for current membership.

Lay representatives are also engaged for the NIPCM clinical oversight group. They will have an interest in the NHS and in reducing the incidence and impact of HCAI through applicable and accessible infection prevention and control guidance. The lay representatives are expected to attend all meetings and comment on recommendations from the perspective of a patient or visitor.

A specialist clinical ‘review’ group will also be formed for NIPCM literature reviews. The membership of these groups will vary but will comprise topic-specific (clinical and academic) experts and individuals with expertise in literature reviewing and guideline development. Members may also be drawn from the consensus and clinical oversight groups with relevant expertise.

A key role of the groups involved in the NIPCM development is to represent the views of all appropriate staff members/groups within and across the represented organisation/regions.

2.2 Roles and responsibilities

The roles and responsibilities of all members of the review, consensus and clinical oversight groups are laid out in full in the terms of reference corresponding to each group. Briefly, members must:

• contribute to the consultation process on the NIPCM (including literature reviews and any supporting documents/tools), feeding back the views of the professional groups/organisations they represent, such as barriers to implementation
• contribute to identifying evidence/research gaps in the literature pertaining to the NIPCM and support the development of research studies to enhance the evidence base.

Review group members will provide specialist input into the review process. NHS England scientists will lead on developing research questions, search strategies, identification of evidence, critical appraisal/data extraction, summarising evidence and final write-up. Review group members will provide expert input and critique/peer review at each of these stages. Review group members will provide additional clinical or scientific advice and input to the review by assessing:

• the technical or clinical validity and clarity of research questions
• the search strategies and identifying any omitted terms, acronyms or synonyms
• the appropriateness of the eligibility criteria developed
• the studies identified by NHS England for full text review to identify any additional studies not identified or erroneously excluded
• the final draft of the literature review as part of the defined stakeholder engagement process (peer review).

Review group members are not directly involved in the eligibility assessment, data extraction, appraisal, or in the drafting of the review.

2.3 Meetings

Meetings of both the consensus and clinical oversight groups are scheduled on a quarterly basis. For a meeting to be quorate at least 50% of members (including the chair or their deputy) must be present.

2.4 Competing interests

All members (including chairs) of the NIPCM review, consensus, and clinical oversight group are required to declare any competing interests (see Appendix 2).

3. Literature review designs

NHS England literature reviews that inform the NIPCM are produced using systematic (iterative) methods that are conducted in accordance with current best practice, eg Cochrane review methodologies.

The choice of literature review design is based on the topic, available resources and timescales required and must be agreed by the clinical oversight group and any review group formed for the purpose of conducting the review.

Overview of NHS England review methodologies

Scoping review

• Overview and intended use: Used when a systematic review is likely to be too restrictive to meet research objectives: for example, to clarify concepts or definitions, assess or map a body of evidence or identify knowledge gaps. Not typically intended for the development of evidence-based recommendations but this may be achievable with thoughtful design. Rigour of methodology is similar to a systematic review (ie an iterative and structured approach). Conducted in accordance with Joanna Briggs Institute methodology and reported in accordance with PRISMA extension for scoping reviews.

• No. of reviewers (NHS England scientists): 2

• Evidence sources: Purposefully broad, includes grey literature, policy and legislation, other guidance/ guidelines, and multiple biomedical databases are searched. May include hand searching and snowball searching.

• Screening of search results: Screening of literature search results is performed in full by two reviewers. 

• Critical appraisal and grading of evidence: Typically, no formal critical appraisal or grading of evidence is performed; data is extracted into evidence tables and checked (at least 30%) by the second reviewer.

• Evidence synthesis and reporting: A narrative synthesis is performed in accordance with SwIM and results are reported using the PRISMA extension for scoping reviews (PRISMA-ScR).

• Timescale: 4-6 months

Rapid review

Overview and intended use:

• Used to answer a research question that is extremely focused or to examine a topic where little is known/has been published or to examine a highly specialised and focused topic/specialty. Uses an explicit, systematic (iterative) and structured process to develop evidence-based recommendations. Similar to a systematic review but with a more restricted scope and typically shorter timeframe. Literature searches are restricted in number, and eligibility criteria are tighter/more focused than in a systematic review (eg, in terms of eligible date range). Conducted and reported in accordance with best practice (Cochrane and PRISMA).

• No. of reviewers (NHS England scientists): 2

• Evidence sources: Purposefully focused; omits grey literature unless identified as key evidence source by the review group; typically a single biomedical database is searched

• Screening of search results: Screening of literature search results is performed in full by a single reviewer; a second reviewer checks a minimum 20% sample during the first screen and 100% of excluded studies from the second screen.

• Critical appraisal and grading of evidence: Varies by timescale and topic and is agreed by the review group in advance.

• Evidence synthesis and reporting: Typically, a single evidence table without an evidence summary reported in accordance with PRISMA and SwIM.

• Timescale: At least 3 months

Systematic review (two reviewers)

Overview and intended use:

• Used to answer focused research question(s) on a specific topic to develop evidence-based recommendations. Uses an explicit, systematic (iterative) and structured process to identify, select and critically appraise evidence, typically from primary research. Conducted and reported in accordance with best practice (Cochrane, PRISMA, AGREE).

• No. of reviewers (NHS England scientists): 2

• Evidence sources: Multiple biomedical databases are searched. Includes grey literature, policy and legislation, other guidance/guidelines.

• Screening of search results: Two reviewers independently screen all search results against the eligibility criteria.

• Critical appraisal and grading of evidence: Critical appraisal and data extraction of all evidence as detailed in section 7 is performed by a single reviewer. A second reviewer performs a minimum 30% check.

• Evidence synthesis and reporting: Evidence tables and evidence summaries produced for each research question by a single reviewer. These are checked by the second reviewer and peer reviewed by the review group. Reported in accordance with PRISMA and SwIM.

• Timescale: 4-6 months

Systematic review (single reviewer)

Overview and intended use:

• Used to summarise and collate mandatory recommendations or directives from existing legislation or policy, nationally and internationally recognised evidence-based guidelines. This may be used in combination with the two person systematic review if some of the research objectives require searching biomedical databases and appraising peer-reviewed published scientific literature etc. Follows a similar process to a two-person systematic review but with a single reviewer identifying eligible evidence and performing data extraction. 

• No. of reviewers (NHS England scientists): 1

• Evidence sources: Focused on current national policy and legislation, and up to date (<1yr) evidence based guidelines. If literature searching is required, multiple biomedical databases will be searched; grey literature and other guidance/guidelines will be included (see two-person systematic review).

• Screening of search results: A single reviewer identifies relevant policy and legislation; this is checked by NHS England colleagues. If literature searching is required, the process for a two-person systematic review is followed.

• Critical appraisal and grading of evidence: Critical appraisal and data extraction of all evidence as detailed in section 7 is performed by a single reviewer. If a second reviewer is required for specific research questions, they will perform a minimum 30% check.

• Evidence synthesis and reporting: Evidence tables and evidence summaries produced for each research question by a single reviewer. These are checked by the second reviewer and peer reviewed by the review group. Reported in accordance with PRISMA and SwIM.

• Timescale: 3-5 months

4. Developing research questions

For each literature review a set of research objectives and research questions is initially drafted by NHS England scientists and clinicians (or review group if used) using the PICO framework. These are circulated to the consensus and clinical oversight group for input and agreement.

Additional research questions are considered when updating literature reviews as well as on an ad hoc basis in response to emerging infection control issues: eg in response to an outbreak or stakeholder enquiries/feedback. These are developed and agreed using the same process.

5. Identifying evidence

5.1 Developing search strategies

A search strategy for each literature review is undertaken using subject headings (controlled vocabulary) and free text (keywords) optimised for the different biomedical databases used (section 6.2). Grey literature searches are developed to identify relevant policy, guidance or guidelines from national and international organisations (section 6.2). Final search strategies are published as appendices to literature reviews.

5.2 Databases and other resources

When conducting systematic reviews, a minimum of three databases will be searched including Embase, Medline and/or Pubmed, CINAHL (Cumulative Index to Nursing and Allied Health Literature) and the Cochrane Library. Additional databases may be included for specialist topics or settings, eg MIDIRS for guidance aimed at maternity and neonatal settings.

The following online resources are also searched (as a minimum) to identify any relevant policy, guidance or guidelines or other significant grey literature:

1. UK Health Security Agency (UKHSA)
2. Department of Health and Social Care (DHSC)
3. World Health Organization
4. European Centre for Disease Prevention
5. Centers for Disease Control and Prevention
6. Society for Healthcare Epidemiology of America
7. Association for Professionals in Infection Control and Epidemiology.

5.3 Screening and retrieving articles

Titles and abstracts are initially reviewed for subject relevance by a single reviewer using a standardised abstract form. Subsequently an assessment of abstracts against the eligibility criteria is conducted. The same process is carried out for the full text screening assessment. If the review methodology includes a second reviewer, both reviewers will perform title and abstract screening independently, in full, except for rapid reviews.

When conducting rapid reviews both reviewers will screen a minimum 20% of the titles and abstracts to ensure consistency of approach. The remaining titles and abstracts are screened by a single reviewer. Full text screening is performed by a single reviewer and all excluded studies are checked by the second reviewer. Conflicts in assessment are resolved via consensus, if these cannot be resolved the opinion of the review group will be sought.

The reason for exclusion is recorded using the PICOS (Population; Intervention; Comparison; Outcome; Study design) criteria for later presentation in a PRISMA diagram.

5.4 Eligibility criteria

Inclusion and exclusion criteria for the review are developed in accordance with PICOS; these are presented for each literature review. A generic example is given below.

Eligibility criteria

Population: Defined population or setting the recommendations of the review will be applied to.

Exposure/Intervention: Defined exposure or intervention the recommendations will refer to.

Comparison: All appropriate comparators

Outcome: Defined outcome measure such as disease state, organism concentration/presence, infection rates etc.

Study design: Systematic reviews and meta-analysis, randomised controlled trials, cohort studies, before and after/interrupted time series, non-systematic reviews, non-epidemiological study designs (lab based etc), grey literature.

Exclusion criteria

• Relevant to TBPs rather than SICPs and vice versa.
• Focused on compliance/promotion/monitoring or effectiveness of training.Intervention(s) as part of a bundled approach.
• Predictive modelling studies or animal models of infection.Pre-print (not peer reviewed) studies.

Date range: 2010 and present (cut-off as per the latest database update or day search was run).

Language: English only.

Each review will specify excluded study designs within the methodology section. Generally, systematic reviews of systematic reviews (umbrella reviews), case series/reports, outbreak reports and letters to the editor are excluded, but this may vary depending on the research question/topic.

Articles may also be excluded following critical appraisal if quality of reporting, internal validity or applicability are sufficiently poor that the level of certainty is deemed extremely low.

However, it is anticipated that this would be a rare occurrence; the decision to exclude must involve a minimum of two reviewers and should be recorded within the critical appraisal form, data extraction table and PRISMA diagram.

5.5 Hand searching

Hand searching (including snowball searching) will be performed at the scoping stage and when optimising search strategies. It may also be appropriate when conducting scoping reviews, searching for historic texts that may not be held in the selected databases and when checking the provenance of recommendations.

The references of included systematic reviews will be checked for other articles identified by searches to avoid double counting in the evidence synthesis, otherwise hand searching will not routinely be performed on eligible studies unless pre-defined within the protocol of a scoping review.

6. Evidence appraisal and data extraction

6.1 Critical appraisal and data extraction

A single reviewer performs critical appraisal and data extraction on all included articles. If the review methodology includes a second reviewer, they will perform a minimum 30% check.

NHS England has developed a system of critical appraisal tools to support consistent and objective critical appraisal and data extraction. A scoring system (1-5) is applied to support the grading of evidence (low to high certainty) which is then translated into the overall strength of a recommendation incorporating clinical input (see Table 3). Critical appraisal and data extraction tools are available for the following study designs:

1. case control studies
2. case studies and case reports
3. cohort studies
4. guidance and guidelines
5. interrupted time series and before and after studies
6. non-epidemiological study designs
7. non-systematic reviews
8. outbreak reports
9. policy and legislation (data extraction only)
10. randomised controlled trials
11. systematic reviews and meta-analysis.

These tools are available to use on request (email england.improveipc@nhs.net).

6.2 Evidence tables

Following initial data extraction using critical appraisal and data extraction tools, data is further extracted to a standardised form within an evidence table using Microsoft Excel, which includes the main PICOS elements of the review in addition to quality assessment.

All critical appraisal and data extraction is subjected to a minimum 30% check by a second reviewer and is peer reviewed by the review group. These tables are published as supplements to the literature review.

7. Developing and grading recommendations

Following full data extraction, a summary evidence statement is produced to synthesise and grade draft recommendations. This is based on the volume, consistency, applicability, and quality of the available evidence. A template evidence statement is available in Appendix 1.

Following peer review and agreement by the review group, evidence statements are incorporated into the literature review before consultation and evidence summaries are published as supplements to the literature review.

Where it is not possible to make an evidence-based recommendation, a recommendation based on expert opinion will be developed by formal consensus (see section 9). Final recommendations are agreed by consultation (see section 11).

Table 3: Grading of evidence

8. Developing consensus recommendations

Where NHS England (and any review group) considers a recommendation to be sufficiently supported by evidence (as per the evidence summary, Appendix 1) the associated literature review will proceed directly to consultation (see section 11).

Where evidence is lacking (no direct evidence, very low certainty or contradictory evidence) to inform a recommendation, NHS England (and any review group) will draft a suggested recommendation by informal consensus.

Options for recommendations will not be submitted to a vote; if differing opinion prevents agreement on a single recommendation, multiple options can be developed. The opposing rationales should be recorded and published as an annexe to the final literature review. The suggested recommendation will then be agreed by formal consensus with the clinical oversight and consensus groups before circulating a final version of the literature review for consultation.

To reach consensus, clinical oversight and consensus group members will be asked to rank options for recommendations (where multiple options are presented), score each recommendation using a Likert scale and provide comment on any modifications required to the proposed recommendation(s).

This process will be carried out electronically (email). A nine-point Likert scale will be used, where:

• 1 represents ‘strongly disagree’
• 5 represents ‘neither agree nor disagree’
• 9 represents ‘strongly agree’.

A minimum of 80% of the membership of both the clinical oversight and consensus group members must respond before proceeding to the next stage. Scores will be grouped into three categories:

• 1 to 3 (disagree)
• 4 to 6 (neither agree nor disagree)
• 7 to 9 (agree).

The overall percentage agreement for each recommendation will then be calculated. Recommendations with 80% or greater agreement will be considered agreed and will proceed to consultation; recommendations with less than 80% agreement will be redrafted based on the comments received and the process repeated.

If, following two rounds of scoring, consensus agreement cannot be reached for any recommendation then ‘No recommendation’ will be made.

9. Presentation of literature reviews and recommendations

9.1 Reporting results

NIPCM literature reviews adhere to the report standards as defined by PRISMA and SwIM (synthesis without meta-analysis) guidelines.

All literature reviews are presented in a standardised format, the contents are limited to:

• Title page
• Document control sheets
• Contents
  • Objectives
  • Methodology (type of review, databases and resources used, eligibility criteria)
  • Results
  • Discussion
    • implications for practice
    • implications for research
    • Recommendations
  • References
• Appendix 1: Search strategies
• Appendix 2: PRISMA diagram(s)
• Appendix 3: Evidence tables

All draft versions of literature reviews and supporting tools are proofread for style and accuracy by a senior IPC healthcare scientist to ensure version control and consistency of presentation before approval by the clinical workstream lead.

9.2 Document control

Document control sheets are standardised, present, and up-to-date on all literature reviews and the NIPCM. Document control sheets include:

• current version number
• publication date of current and previous versions
• any changes made to the document if a previous version exists
• purpose and description of the document
• approvals (by consensus and clinical oversight group)
• target audience
• target clinical areas and any clinical areas to which the recommendations are not applicable
• a cross-reference section linking to this document and any related literature reviews or guidance documents.

The date of the next review and owner/author will be printed on the title page of the document. Similarly, all supporting tools should state the publication date, current version, and have appropriate NHS England branding.

9.3 Language, clarity and ease of understanding

The NIPCM summarises the literature review recommendations into practice recommendations. The individual recommendations including their grading are presented in the associated literature reviews, to ensure staff nearest to patients can quickly access the necessary information via the NIPCM; while the literature reviews provide a professional resource aimed at infection control specialists.

To prevent misinterpretation of recommendations by stakeholders and staff nearest to patients, the literature review evaluation tool (Appendix 3) specifically asks ‘are recommendations clear?’ Abbreviations are avoided where possible; only those that are commonly and frequently used in most care settings, such as alcohol based hand rub (ABHR) are used.

In addition, the NIPCM includes an up-to-date glossary of terms. When a literature review is updated the responsible scientist and clinical workstream lead determine whether any new terminology has been used that should be added to the glossary. New terms may also be added to the glossary at the request of stakeholders: for example, via the NIPCM consensus or clinical oversight groups.

9.4 Editorial independence

The process for developing the NIPCM (including its literature reviews and recommendations) does not involve any employee or department of NHS England or any other organisation with decision-making power over funding or publishing of the NIPCM.

10. Stakeholder engagement/consultation

All literature reviews undergo a process of stakeholder engagement to ensure recommendations are unbiased and appropriate for all care settings. Literature reviews are disseminated via the consensus and clinical oversight groups to their respective organisations accompanied by a literature review evaluation pro forma (Appendix 3).

Each member of the NIPCM clinical oversight or consensus group is expected to collate and return the comments of the professional body/organisation they represent. NHS England IPCT will collate and respond to all feedback, keeping a record of decisions made, and inform the NIPCM clinical oversight and consensus group members of all outcomes. Feedback will be anonymised and all documentation will be available on request.

Stakeholder engagement exercises will also be promoted to members of the Infection Prevention Society, the Healthcare Infection Society and the Royal College of Nursing with prior agreement. Promotion on social media platforms such as Twitter by consensus and clinical oversight group members will be encouraged; however, a formal social media communications strategy has not yet been developed.

11. Publication and communication

An accessible version of the NIPCM is currently published along with a PDF version. 

Updates to the NIPCM will be cascaded through multiple communications channels, including via the NIPCM consensus and clinical oversight groups, regional IPC leads and using the NHS England IPC team overarching communications strategy which includes:

• systems and organisations commissioning and delivering NHS services in England
• staff delivering NHS-commissioned services in England
• professional bodies.

11.1 Implementation

Tools and resources to assist and monitor implementation of the NIPCM are currently under development.

11.2 Feedback and enquiries

It is intended that the standalone website for the NIPCM will include a function for submitting feedback. In the interim, comments and feedback can be emailed directly to england.improveipc@nhs.net.

12. Maintaining and updating the NIPCM

The NIPCM is a ‘live’ document; the NHS England IPC team will continually monitor the evidence based informing the NIPCM recommendations using alerts (biomedical database auto-alerts, email subscriptions, etc), RSS feeds, and journal subscriptions.

All NHS England literature reviews that inform the NIPCM will be subject to formal updates every three years. NIPCM literature reviews will be ‘living’ reviews and the evidence base informing these will be monitored using scheduled monthly auto-alerts.

Quarterly reports detailing identified evidence will be submitted to the NIPCM consensus and clinical oversight groups for information. Evidence that supports NIPCM recommendations will be recorded for inclusion at the next formal update; evidence that may necessitate a change in NIPCM recommendations is immediately appraised and presented to the NIPCM consensus and clinical oversight groups to consider whether an immediate update of the associated literature review(s) and amendment(s) to the NIPCM are required.

Appendix 1: Evidence statement template

View the evidence statement template example.

Appendix 2: Competing interests policy

What are competing interests?

In this document a ‘conflict of interest’ is defined as:

“A set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”

Definitions

Material interest: A material interest is one which a reasonable person would take into account when making a decision regarding the use of taxpayer’s money because the interest has relevance to that decision. Interests fall into the following categories:

• Financial interests
  • Where an individual may get direct financial benefit (a benefit may arise from the making of gain or avoidance of loss) from the consequences of a decision they are involved in making. Example – the individual is a shareholder of an organisation which is doing or is likely to do business with an organisation in receipt of NHS funding.
    [Note – there is no need to declare shares or securities held in collective investment or pension funds or units of authorised unit trusts]
• Non-financial professional interests
  • Where an individual may obtain a non-financial professional benefit* from the consequences of a decision they are involved in making, such as increasing their professional reputation or promoting their professional career. Example – the individual is an advocate for a particular group of patients.
• Non-financial personal interests
  • Where an individual may benefit* personally in ways not directly linked to their professional career and do not give rise to a direct financial benefit, because of decisions they are involved in making in their professional career. Example – the individual is a member of a lobbying or pressure group with an interest in health and care.
• Indirect interests
  • Where an individual has a close association (these associations may arise through relationships with close family members and relatives, close friends and associates, and business partners) with another individual who has a financial interest, a non-financial professional interest or a non-financial personal interest who would stand to benefit* from a decision they are involved in making. Example – the individual has a close family member who would stand to benefit from a decision that the individual was involved in making.

A conflict of interest may be:

• Actual: there is a material conflict between one or more interests.
• Potential: there is the possibility of a material conflict between one or more interests in the future.

Examples of competing interests may include:

• A role or association with any commercial healthcare organisation or supplier, including:
  • holding shares
  • a prospect of future employment
  • partnership or other forms of business, for example consultancy
  • receiving products directly from a commercial organisation without charge or at a reduced rate for any purpose. This does not include unsolicited trial products, small promotional materials or any product purchased at a reduced rate negotiated by the NHS.
• Where a family member or close personal relationship exists with an external body or somewhere where you may be in a position to award services to.
• Patent applications (pending or actual) including individual applications or those belonging to the organisation to which the individual is affiliated and from which the individual be benefit.
• Being in receipt of, or in the application stage for research grants that have actual or potential overlap with the objectives of the NIPCM or NIPCM literature reviews.
• An author or someone associated personally or professionally with an author of any published study or guideline that is being discussed as part of the development of the NIPCM, NIPCM literature reviews or associated tools.

Note: this is likely to apply to NIPCM review group members who are invited because of their academic or clinical expertise in specific topics. If the member has been invited specially because of their expertise in a particular topic (including their publication history) this should not preclude participation but must be declared, managed at the discretion of the group chair(s) with input from other members and recorded appropriately.

A note on shares: holding shares or other ownership interests can be a common way to seek a return on investment. However, conflicts of interest can arise when individuals personally benefit from this investment because of their role with an organisation. For instance, if individuals involved in the procurement of products or services which are offered by a company they have shares in, then this could give rise to a conflict of interest.

Colleagues should declare, as a minimum, any shareholdings and other ownership interests in any publicly listed, private or not-for-profit company, business, partnership or consultancy which is doing, or might be reasonably expected to do, business with the NHS.

There is no need to declare shares or securities held in collective investment or pension funds or units of authorised unit trusts.

Why do we need to declare interests?

A formal process for declaring interests strengthens the integrity of the NIPCM development process to ensure recommendations produced are unbiased, evidence-based and not subject to any undue outside influence or commercial interests.

Who does this apply to?

All persons involved in the development of the NIPCM and its associated literature reviews and supporting tools are required to declare competing interests. This includes all members of the NIPCM review, consensus and clinical oversight groups (including chairs) and any invited experts from outside these groups.

NHS England staff members submit declarations of interest via Corestream as an organisational requirement. Should a competing interest arise that could affect their ability to objectively participate in the development of the NIPCM, they should alert the chair of the relevant group (steering or consensus) using the process outlined here in addition to following their organisational policy.

How will this process be applied?

An ‘opt out’ system for declaring interests will apply to all standing members of NIPCM consensus and clinical oversight groups: that is, members will have read this policy and will be assumed to have no competing interests unless they are declared. All temporary, invited experts to NIPCM review groups will be asked to complete a declaration of interests form before engaging in review group activities.

All members will be asked to declare any new competing interests before each group meeting commences. Outside of meetings (and following any declaration made at a meeting), declarations should be made to the relevant chair by email, copying in the NHS England IPC mailbox (england.improveipc@nhs.net). All correspondence will be saved by NHS England IPCT in accordance with our records management policy.

How will declared competing interests be managed?

Individuals with competing interests are not eligible to chair the NIPCM review, consensus or clinical oversight group. Declared competing interests will be considered by the chair in the first instance; if the potential impact of the declared interest is unclear, this will be discussed by the other members of the review, consensus or clinical oversight group and taken to a vote.

If declared interests are likely to impact on a significant number of topics the member may be asked to withdraw completely from the review, consensus or clinical oversight group. Members who have declared a topic-specific competing interest should withdraw from commenting or contributing to the development of any guidance to which their competing interest applies. An appointed deputy may take their place.

Appendix 3: Literature review evaluation pro forma

View the literature review evaluation pro forma example.

Publication reference: C1692