The requirements for ethical review by Research Ethics Committees are set out in section 2.3 of the harmonised UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC), published by the UK Health Departments in May 2011.
- Requirements for ethical review of research under legislation applying to the UK as a whole or particular countries of the UK
- Requirements for ethical review under the policy of the UK Health Departments, where research relates to the services for which they are responsible
REC review is required for specific research projects involving:
- Research participants identified from, or because of their past or present use of, services for which the UK Health Departments are responsible (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls
- Research participants identified because of their status as relatives or carers of past or present users of these services
- Collection of tissue (i.e. any material consisting of or including cells) or information from any users of these services, including those who have died within the last 100 years
- Use of previously collected tissue or information from which the research team could identify individual past or present users of these services, either directly from that tissue or information, or from its combination with other tissue or information in or likely to come into their possession.
The relevant services are:
- NHS healthcare (UK-wide)
- Adult social care (England, Wales, NI)
- Children’s social care (Wales, NI)
REC review is also required for the following:
- Xenotransplantation (i.e. putting living cells, tissue or organs from animals into people)
- Health-related research involving prisoners in the custody of the National Offender Management Service, Scottish Prison Service and Northern Ireland Prison Service
- Social care research projects funded by the Department of Health.
Exceptions to the need for REC review
Subject to any overriding legal requirements, REC review is not required for the following types of research:
- Research limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection), provided that the patients or service users are not identifiable to the research team in carrying out the research
- Research limited to secondary use of tissue samples previously collected in the course of normal care with consent for research, provided that the patients or service users are not identifiable to the research team in carrying out the research
- Research limited to use of acellular material (e.g. plasma, serum, DNA,) extracted from tissue previously collected in the course of normal care, provided that the patients or service users are not identifiable to the research team in carrying out the research
- Research limited to the involvement of NHS or social care staff recruited as research participants by virtue of their professional role
- Research involving use of or access to a care organisation’s premises or facilities, but not otherwise involving patients or service users.
Activities that are not research do not require REC review. This includes healthcare market research conducted by professional market researchers in accordance with the Legal and Ethical Guidelines issued by the British Healthcare Business Intelligence Association (BHBIA).
Additionally, review by a REC within the UK Health Departments’ Research Ethics Service is not required for social care research projects which are reviewed by another REC operating in accordance with the Economic and Social Research Council’s Framework for Research Ethics (e.g. a university REC), unless:
- There is an overriding legal requirement for REC review;
- The research involves NHS patients / service users;
- The research involves withdrawing standard care from social care users; or
- The project is funded by the Department of Health in England.