Synopsis
Classify health and social-care projects correctly, protect participants through proportionate consent and oversight, and deliver approved research with reliable data, safety reporting and nation-specific capacity law under the UK framework current in September 2026.
- Classify the activity before recruitment: research, audit, service evaluation and quality improvement have different purposes and governance routes. Publication intent alone does not decide classification.
- A favourable research ethics opinion is not the same as all approvals. Confirm sponsor, regulatory, HRA or devolved-nation permissions, local capacity and capability, contracts and data arrangements before starting.
- Valid consent is an ongoing process: give understandable relevant information, support questions and voluntariness, assess capacity for the decision, document consent and respect withdrawal within explained data limits.
Reasoning priorities
Determine whether the activity is research and which governance office should lead.
Apply purpose and design, document the decision and seek formal advice when borderline. Labels chosen for speed do not remove research obligations.
Worked reasoning
An adult participant in England develops delirium before a research-only follow-up procedure. The original consent form is signed and a relative says to continue.
- Pause the research-only procedure and treat or assess the delirium clinically. Determine whether delay changes safety and whether the participant currently has capacity for this specific procedure; do not treat the old signature as irrevocable authority.
- Check the approved protocol, participant information and England-and-Wales provisions for adults lacking capacity. Contact the principal investigator or sponsor and research team; clarify whether the study lawfully includes this situation and whether a consultee process is approved.
- Seek the participant’s present wishes and signs of objection, involve the relative in the proper advisory role rather than assuming proxy consent, and use the least burdensome lawful option. Clinical care continues regardless of research participation.
- Final action: proceed only if the approved study and applicable legal framework authorise it and participation remains consistent with the person’s interests or presumed wishes; otherwise defer or withdraw from the procedure and notify the sponsor as required.
- Verification: document capacity, consultation, version and decision, confirm any deviation or safety report, reassess if capacity returns and provide the participant with updated information.