Policy responses and statements

Name of organisation:: National Patient Safety Agency
Name of policy document:: Consultation on implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees
Deadline for response:: 21 April 2006

Background: Through its Central Office for Research Ethics Committees (COREC), the National Patient Safety Agency (NPSA) has launched its consultation on implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees, an independent report commissioned by the Department of Health.

COREC, now part of the NPSA, was tasked with drawing up a plan to address the report’s recommendations following its publication in June 2005.

The resulting consultation document, Implementing the recommendations of the Ad Hoc Advisory Group, has been developed to deliver the report’s recommendations in the most effective ways: making the system as efficient as is possible to assist researchers; and protecting the safety, dignity, rights and well being of research participants.

Development of the Plan has been informed by a high level Change Advisory Group, made up of a comprehensive range of research ethics stakeholders including: NHS Research and Development; strategic health authorities, patient groups, the pharmaceutical industry, the Medicines and Healthcare products Regulatory Agency (MHRA), higher education institutions, the UK Clinical Research Collaboration and research ethics committees themselves. Although the recommendations and Implementation Plan only apply in England, Northern Ireland, Scotland and Wales are represented on the Change Advisory Group.

Chair of the Change Advisory Group and NPSA Medical Director, Professor Sir John Lilleyman, said: “COREC has begun to make considerable improvements to the research ethics system in recent years and the recommendations contained in the Department of Health commissioned report have given it an important opportunity to build upon these improvements. Conceived in partnership with major stakeholders, the Implementation Plan is designed to deliver the best possible service to researchers and participants alike.”

One of the Implementation Plan’s key proposals is to reconfigure the research ethics committee system as a more agile research ethics service. This will include the establishment of a new independent group of National Research Ethics Advisers who will ensure that only appropriate proposals for studies are considered by full committees and who will also be able to take some straightforward decisions on their behalf. This will help to ensure that studies that are not regarded as research will be filtered out and that the level of review of those that are is proportional to the ethical dimensions of the study. The aim is to allow a more streamlined system without loss of fully independent scrutiny, and the proposals outlined were developed recognising the need to comply with the sentiments of the Declaration of Helsinki.

COMMENTS ON
NATIONAL PATIENT SAFETY AGENCY
CONSULTATION ON IMPLEMENTING THE RECOMMENDATIONS OF THE REPORT OF THE AD HOC ADVISORY GROUP ON THE OPERATION OF NHS RESEARCH ETHICS COMMITTEES

The Royal College of Physicians of Edinburgh is pleased to respond to the National Patient Safety Agency on Consultation on implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees.

The document provides a comprehensive and sensible implementation plan for the future of NHS Research Ethics Committee Services. Many of the recommendations are to be welcomed, specifically recommendation 2 in the implementation document is important as it acknowledges the need for ethics committees to review the quality of the science in order to reassure themselves that the study has the potential to deliver the benefits that justify the risks and that the design is appropriate.

Building a scientific screening mechanism into the preliminary triage process is therefore a significant advance. It will be important, however, to ensure that the appropriate core staff are recruited into the research ethics service and that they have the necessary competencies to assess such scientific issues.

The general principle of making ethical approval proportionate to the level of risk is very appropriate. However, implementation will need very careful monitoring since one or two bad decisions could have a catastrophic effect on the whole system.

The implementation report is, perhaps, a little optimistic about the load which will be taken away from the existing ethics committees. The RECs may to have to consider fewer submissions as the triage will only take away the straightforward submissions, but this will leave the ethics committee with just as many difficult submissions to review. However, the triage system should simplify procedures in many cases.

Over all these proposals for NHS Research Ethics Committees are to be welcomed.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[20 April 2006]

Policy responses and statements

COMMENTS ON NATIONAL PATIENT SAFETY AGENCY CONSULTATION ON IMPLEMENTING THE RECOMMENDATIONS OF THE REPORT OF THE AD HOC ADVISORY GROUP ON THE OPERATION OF NHS RESEARCH ETHICS COMMITTEES

COMMENTS ON
NATIONAL PATIENT SAFETY AGENCY
CONSULTATION ON IMPLEMENTING THE RECOMMENDATIONS OF THE REPORT OF THE AD HOC ADVISORY GROUP ON THE OPERATION OF NHS RESEARCH ETHICS COMMITTEES