Organisational Duty of Candour: non-statutory guidance - revised March 2025

1. Introduction

1.1 General – Legal

The duty of candour provisions of the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 (The Act)^[3] and The Duty of Candour Procedure (Scotland) Regulations 2018 (The 2018 Regulations)^[4] set out the obligations on and the procedure that those providing health services, care services and social work services in Scotland are required by law to follow when there has been an unintended or unexpected incident in providing those services that results in, or could result in, death or harm (or additional treatment is required to prevent injury that would result in death or harm). The duty of candour provisions apply to individuals and organisations, but in the majority of instances, it will be organisations. From here on in, we will use the term ‘organisation’ to cover health services, care services, and social work services.

Every organisation (and individual) covered by the duty of candour legislation is regarded as a ‘responsible person’ within the definition as set out in section 25 of The Act.

A ‘relevant person’ is a person who has been harmed during the incident, or where that person has died, or is, in the opinion of the responsible person, lacking in capacity or otherwise unable to make decisions about the service provided, a person acting on behalf of that person. This is set out in section 22(3) of The Act.

In this guidance, the word ‘must’ refers to actions that are a legal requirement as set out in The Act and The 2018 Regulations.

The legislation requires that organisations inform those affected (relevant person) that an unintended or unexpected incident has occurred, apologise that the relevant person experienced the incident, invite them to attend a meeting about the incident (incorporating elements outlined in Regulation 6(2) of The 2018 Regulations), offer an account of the incident, review what happened with a view to identifying areas for improvement, and learn (taking account of the views of the relevant person).

1.2 General – Overview

Alongside the legal requirements in following the organisational duty of candour procedure, this guidance outlines what organisations will want to consider at each point in the procedure, suggests best practice, and provides a checklist of the steps to be taken to fulfil the duty. The guidance also includes several ‘issues to consider’ sections that outline areas to think about in support of implementation of the organisational duty.

Links to other helpful resources are included throughout.

Where terms are used that do not have specific definitions outlined in the legislation (either The Act or The 2018 Regulations), the common language meaning applies.

Organisations may wish to develop local guidance and procedures to support notification, meetings, review, training, and support requirements in a manner that is tailored to the particular services they provide.

This guidance is to help organisations understand and operate the duty of candour. It is not intended to provide legal advice, which organisations should seek from their own legal advisers as required.

If organisations have questions for the Scottish Government about the organisational duty of candour, they can get in touch via email: dutyofcandour@gov.scot.

1.3 Duties of candour

The organisational duty of candour is a separate duty from the professional duty of candour, which exists for a range of regulated health and social care professionals.

1.4 Professional duty of candour

This is a moral and ethical duty, that every health and care professional must be open and honest with patients and people in their care when something goes wrong with their treatment or care causes, or has the potential to cause, harm or distress.

The professional duty of candour is overseen by the regulatory bodies in the UK, such as the Nursing and Midwifery Council^[5], General Medical Council^[6], and General Dental Council^[7], General Pharmaceutical Council^[8], and the Health and Care Professions Council^[9], amongst others.

1.5 Organisational duty of candour

This duty is provided for in The Act and The 2018 Regulations. Further information to help understand and implement the organisational duty of candour is outlined throughout this revised guidance.