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Published by Department of Health
This document outlines the Department of Health's 1991 guidelines for Local Research Ethics Committees (LRECs) in the United Kingdom. It establishes the committees' advisory role, expands their review scope to include epidemiological and questionnaire-based research, and details requirements for membership (including lay representation), informed consent, and compensation disclosure.
Key Takeaways
Replaced the 1975 circular (HSC(IS)153). Key transitions include: extending review oversight to all NHS body research (including trusts and FHSA); shifting the LREC role from direct executive gatekeeper to an advisory advisory role; increasing minimum lay members from one to two; establishing a mandatory vice-chairperson position; requiring lay leadership in at least one chairing role; expanding jurisdiction to epidemiological data and questionnaires; and introducing specific 'minimal risk' criteria for non-therapeutic trials on minors.
District Health Authorities are responsible for appointing Local Research Ethics Committees (LRECs) to review research on humans undertaken by any NHS body (including family health services authorities, special health authorities, or trusts, as well as NHS patients treated elsewhere).
Any NHS body asked to approve a research proposal must consult its local research ethics committee, which holds an independent, advisory role.
Committees must include two or more lay persons, alongside hospital medical staff, nursing staff, and general practitioners, with representation from both sexes and a wide range of age groups.
At least one of the two roles of chairperson and vice chairperson must be filled by a lay member.
Epidemiological research using existing records must be submitted to the committee for ethical approval. An 'opting out' form of consent should be used, excluding patients who have indicated they do not want their records utilized.
Proposals for research utilizing questionnaires must be submitted to and approved by the committee due to the risk of causing anxiety or distress.
Non-therapeutic research on children under 18 is permitted provided that all safeguards for therapeutic research apply, and the child is subject to no more than minimal risk.
Research subjects (volunteers and patients alike) must be told in advance of all known risks associated with the study.
All research subjects must be informed in advance of the arrangements for compensation in the event of injury resulting from participation, as well as potential legal difficulties in obtaining compensation.
Researchers must notify the local research ethics committee if there is a significant deviation from the original protocol, or if unusual or unexpected results arise that might raise questions about safety.
For studies planned to take place in more than one area, committees are encouraged to arrive at a voluntary arrangement where one LREC is nominated to consider the proposal on behalf of all participating committees.
LRECs are required to keep a register of all proposed research projects and must publish an annual report detailing their advisory activities.
Clinical Topic
Research ethics committees
Objectives
Protecting the public from harm and enhancing the conduct of good scientific research
Target Patient Population
NHS patients and human research subjects
Target Providers
Guideline Scope
Care Settings
Special Populations
Monitoring Guidance
Only if there is significant deviation from the original protocol, or unusual or unexpected results which might raise questions about the safety of research, is the researcher expected to notify the committee of what has happened.
Difficulty
intermediate
Exam Relevance
Learning Paths