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European Respiratory SocietyResearch Ethics1992intermediate

Guidelines for local research ethics committees.

Published by Department of Health

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Summary

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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.

ethics committeelocal research ethics committeeinformed consentcompensationmulticentre studiesmonitoring

Key Takeaways

  • 1
    The 1991 guidelines represent the first definitive update on local research ethics committees in the UK in 14 years.
  • 2
    The role of the LREC is clarified as strictly advisory, leaving the final executive approval of research to the responsible NHS body.
  • 3
    Lay representation on committees is expanded to at least two members, and either the chair or vice-chair position must be held by a layperson.
  • 4
    The scope of LREC review is extended to cover epidemiological record-based research and research utilizing questionnaires.
  • 5
    Strict consent rules are established requiring researchers to fully disclose 'all known risks' and exact compensation arrangements to prospective subjects.

What's New in This Version

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.

Key Recommendations

Appointing authority and responsibility

  • LREC-01

    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).

    Administrative
  • LREC-02

    Any NHS body asked to approve a research proposal must consult its local research ethics committee, which holds an independent, advisory role.

    Administrative

Membership

  • LREC-03

    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.

    Administrative
  • LREC-04

    At least one of the two roles of chairperson and vice chairperson must be filled by a lay member.

    Administrative

Scope of research

  • LREC-05

    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.

    Ethical
  • LREC-06

    Proposals for research utilizing questionnaires must be submitted to and approved by the committee due to the risk of causing anxiety or distress.

    Ethical

Research subjects and informed consent

  • LREC-07

    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.

    Ethical
  • LREC-08

    Research subjects (volunteers and patients alike) must be told in advance of all known risks associated with the study.

    Ethical

Compensation

  • LREC-09

    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.

    Ethical

Monitoring research

  • LREC-10

    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.

    Administrative

Multicentre studies

  • LREC-11

    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.

    Administrative

Implementation

  • LREC-12

    LRECs are required to keep a register of all proposed research projects and must publish an annual report detailing their advisory activities.

    Administrative

Scope & Objectives

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

District Health AuthoritiesLocal Research Ethics CommitteesNational Health Service bodiesResearchers

Patient Criteria & Setting

Therapeutic Area

regional

Guideline Scope

AdministrativeEthical

Care Settings

HospitalPrimary CareCommunity

Special Populations

Children

Safety & Contraindications

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.

Guideline Features

MultidisciplinaryPatient involvement

Learning Context

Difficulty

intermediate

Exam Relevance

Research EthicsMedical LawHealth Policy

Learning Paths

Research EthicsNHS GovernanceMedical LawHistory of Clinical Research Regulation