Navigating Ethics for Service Evaluation in the NHS: A Practical Guide

Why This Topic Matters

Clinical audit, service evaluation, and research are distinct activities, each governed by different regulatory and ethical frameworks. While all are vital for improving patient care, they differ in their primary purpose, methodology, and the level of governance oversight required. Historically, there has been some confusion, leading to projects being categorised incorrectly or, conversely, over-burdening ethics committees with projects that do not require their review.

Incorrect classification can have several ramifications:

• Delay to project implementation: Unnecessary ethics applications can add months to a project timeline.
• Governance breaches: Failing to seek ethics review for a project that does require it can have serious consequences for patient safety, data protection, and organisational reputation.
• Wasted resources: Ethics committees, audit departments, and research offices spend valuable time reviewing projects that fall outside their remit.
• Impact on publication: Many journals require evidence of appropriate ethical approval or exemption for published work.

Understanding these distinctions from the outset is crucial for efficient, safe, and compliant quality improvement within the NHS.

Practical Explanation: Audit, Service Evaluation, and Research

The fundamental difference lies in the intent and design of the project.

Clinical Audit

Purpose: To measure the quality of care against explicitly defined standards. It asks, 'Are we doing what we should be doing?' and 'Are we meeting best practice guidelines?'

Key Characteristics:

• Compares current practice against pre-existing standards (e.g., NICE guidelines, local protocols).
• Aimed at demonstrating compliance or identifying areas for improvement within current services.
• Data collection is typically of anonymous or de-identified routine clinical data.
• No deviation from normal practice or intervention beyond routine care.

Ethics Review: Clinical audit rarely requires formal ethics committee review, as it falls under routine clinical governance. Local audit departments provide necessary oversight.

Service Evaluation

Purpose: To assess an existing service or a newly implemented service to judge its effectiveness, efficiency, or experience. It asks, 'How well is this new (or existing) service working?', 'What impact is it having?', or 'Are we meeting the needs of our patient population?'

Key Characteristics:

• Examines how a service is delivered and what it achieves.
• Often involves collecting data directly from patients or staff through surveys, interviews, or focus groups, about their experiences or opinions.
• May involve collecting new data that isn't routinely collected, but still within the scope of assessing the service itself.
• No randomisation or experimental intervention. Any change implemented is part of a planned service delivery initiative, not solely for research purposes.

Ethics Review: This is where the most ambiguity often lies. While many service evaluations do not require full ethics committee review, some specific scenarios do. This guide will focus on these nuances.

Research

Purpose: To generate new knowledge, test a hypothesis, or determine the effects of new interventions. It asks, 'What happens if we do X?' or 'Does intervention Y cause Z?'

Key Characteristics:

• Designed to answer a specific research question.
• Often involves randomisation, control groups, or novel interventions.
• May involve procedures beyond routine clinical care.
• Recruitment of participants specifically for the study.
• Results are intended to be generalisable to broader populations.

Ethics Review: Research, particularly clinical trials involving patients, always requires review by an NHS Research Ethics Committee (REC). This is a legal and ethical requirement.

When Does Service Evaluation Need Ethics Advice?

While the Health Research Authority (HRA) and the NHS REC system primarily focus on research, there are specific circumstances where a service evaluation might necessitate review by a REC, or at least advice from a local ethics committee, audit department, or research office. The key is to assess the level of risk and departure from routine practice.

Consider seeking ethics advice (from your local R&D office, audit department, or ethics committee) if your service evaluation involves any of the following:

1. More than minimal risk or burden to participants:

   • Collecting data through invasive procedures (e.g., additional blood tests for the evaluation, not for clinical care).
   • Requiring participants to undergo procedures solely for the purpose of the evaluation that are not part of their standard clinical care.
   • Inquiring about highly sensitive personal information that could cause distress or psychological harm (e.g., detailed trauma history without appropriate support pathways).

2. Involving vulnerable groups where additional safeguards are needed:

   • Children (under 16).
   • Adults lacking capacity.
   • Patients with severe mental health conditions.
   • Individuals in coercive situations (e.g., prisoners, those in dependent relationships).
   • Note: Involvement of these groups doesn't automatically mean your project is research, but it signals a higher ethical consideration for service evaluation.

3. Significant deviation from standard practice:

   • If the 'service' being evaluated introduces a completely novel intervention that has not been rigorously tested or doesn't have an established evidence base, it may stray into research territory.
   • The HRA guidance suggests that if the 'intervention' is primarily to find out if it works rather than to provide care, it's likely research.

4. Novel or complex data collection methods that raise privacy concerns:

   • Using novel digital tools or AI for data collection or analysis that aren't yet validated or understood for their privacy implications.
   • Collecting data that is routinely anonymous, but for the purpose of the evaluation, is linked back to identifiable individuals without robust justification and consent.

5. Perceived as research by patients or staff:

   • If the way the project is explained or conducted could reasonably lead patients or staff to believe they are participating in a research study, it's safer to seek advice.

6. Intention to publish in a high-impact journal that requires formal ethics review:

   • Some journals have strict requirements for documentation of ethical oversight, even for service evaluation, particularly if it involves patient data or interviews.

Step-by-Step Approach

1. Define your primary purpose: Be clear from the outset what you want to achieve. Is it to measure against standards (audit), assess an existing or new service (service evaluation), or test a hypothesis/generate new knowledge (research)?

2. Consult local guidance: Your Trust's R&D department, audit department, or QI lead will have local policies and flowcharts to help you categorise your project. This is often the most important first step.

3. Use the HRA decision tool: The Health Research Authority (HRA) provides an online tool to help distinguish between research, audit, and service evaluation. This is an excellent national resource.

4. Assess risk and burden: Objectively consider if your project places any additional burden or risk on participants beyond what they would encounter in routine care. Think about physical, psychological, and social risks.

5. Consider vulnerable groups: If your project involves children, adults lacking capacity, or other vulnerable individuals, seek advice early.

6. Data handling: How will you collect, store, and use patient data? Will it be anonymised or identifiable? Ensure compliance with GDPR and local information governance policies. Always involve your Information Governance team if there are any doubts about data handling.

7. Document your decision: Regardless of the outcome, document how you categorised your project and the rationale, along with any advice received (e.g., email from audit department). This is crucial for transparency and accountability.

8. If in doubt, seek advice: It is always better to ask than to proceed without appropriate oversight. Consult your local R&D office, local ethics committee, audit department, or clinical effectiveness team. They are there to help.

Common Pitfalls

• 'Research creep': Starting a service evaluation and then broadening the scope to include elements that make it research (e.g., adding a control group, testing a new intervention for efficacy).
• Assuming 'QI' means no ethics review: While many QI projects are service evaluations or audits, some significant QI initiatives that involve novel interventions or high-risk populations may require ethical oversight.
• Ignoring data sensitivity: Underestimating the ethical implications of collecting or sharing sensitive patient data, even if anonymised.
• 'I'm just a junior doctor/trainee, so I don't need to know this': All clinicians, regardless of seniority, have an ethical responsibility to understand and adhere to governance frameworks for any project they undertake.
• Over-reliance on personal opinion: Relying on personal interpretation instead of consulting formal guidance and local experts.

Example in Clinical Practice

Scenario 1: Clearly a Service Evaluation, no REC review likely needed. A team introduces a new digital pre-operative assessment questionnaire to streamline patient flow. They want to evaluate patient satisfaction with the new digital tool and clinic staff's perception of efficiency. They plan to collect satisfaction scores and anonymised staff feedback. This is evaluating an implemented change to an existing service.

Scenario 2: Service Evaluation, but ethics advice strongly advised (potentially REC review). A hospital implements a new pathway for patients presenting with suspected sepsis in A&E, involving a new rapid diagnostic test. To evaluate the pathway's effectiveness, the team plans to interview patients (including some who are unwell, but have capacity) about their experience, and collect detailed, identifiable data on patient outcomes (e.g., length of stay, readmission rates) by linking to their medical records. While evaluating a service, the collection of detailed identifiable patient feedback, the potential vulnerability of patients, and accessing linked identifiable data for evaluation purposes elevates the ethical consideration. Local R&D and IG advice is paramount.

Scenario 3: Likely Research, requiring REC review. A pharmaceutical company funds a study to compare the efficacy of a new drug with an existing treatment for a specific condition. Patients are randomised into two groups, and blinded outcomes are measured. This is clearly a comparative interventional study designed to generate new knowledge about treatment efficacy.

How Lazomis Can Help

Lazomis provides structured frameworks and tools that can assist clinicians in the planning and execution phases of their projects, helping to clarify their nature from the outset. Our QI Project Setup module guides users through defining project aims, objectives, and methodologies, prompting consideration of data collection and participant involvement. This process naturally aids in identifying whether a project leans towards audit, service evaluation, or research.

For service evaluations, our Data Collection and Analysis Tools can be configured to help collect information safely and compliantly, ensuring that sensitive data is handled appropriately according to pre-defined governance rules. While Lazomis does not provide ethics approval or classify projects, it helps you document your project design, making it easier to present to local audit, R&D, or ethics committees for their review and advice. Our templates encourage consideration of information governance and patient involvement from the start.

Key Takeaways