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Dear Colleague
REVIEW OF NHS RESEARCH ETHICS COMMITTEE SYSTEM
Mike Stevens' letter of 13 May provided an update on the status of the Ad Hoc Advisory Group's Review of NHS Research Ethics Committees in England commissioned by Lord Warner, and indicated that you would be kept informed of developments on how we propose handling this matter in Scotland.
The Scottish Ethics Advisory Group ( SEAG) referred to in that letter has now been established and held its first meeting on 20 June. We attach for your information the membership (Annex A) and remit (Annex B) of that group. A key decision from that first meeting was that comments should be invited on the report as soon as possible, so as to inform the thinking of the group at an early stage. The report can be accessed on the English Department of Health website at www.dh.gov.uk/assetRoot/04/11/24/66/04112466.pdf.
In order to facilitate the analysis and summarising of views, it would be useful if you could structure your comments on the report's conclusions and recommendations, and on other major issues specific to the Scottish ethics structure which you believe SEAG should consider. We would be grateful if you could do what you can to draw this letter and enclosures to the attention of research ethic committee members and Chief Investigators and other research colleagues to allow them the opportunity to provide comments on the findings of the report should they wish to do so.
Comments should be emailed to ethicsreview@scotland.gsi.gov.uk. Written responses should be sent to us at the above address, Room GE.14, St Andrew's House. It is our aim to provide a first stage analysis of comments to SEAG at their meeting on 29 August, so could we therefore invite any contributions you would wish to see included in that document by 12 August 2005. Comments submitted after that date will be passed on to SEAG. The final date for any comments is Friday 30 September 2005.
We would be grateful if you could clearly indicate in your response which conclusions or recommendations or parts of the review report you are responding to as this will aid our analysis of the responses received. A summary of the recommendations and conclusions from the review report is provided at Annex C which you may find helpful. If you have any queries, please contact us either by email or in writing. Our contact details are provided above.
This consultation, and all other Scottish Executive consultation exercises, can be viewed online on the consultation web pages of the Scottish Executive website at http://www.scotland.gov.uk/consultations. You can telephone Freephone 0800 77 1234 to find out where your nearest public internet access point is. Further information about the Scottish Executive Consultation System can be found at Annex D. A list of organisations involved in this consultation exercise can be found at Annex E.
The Scottish Executive now has an email alert system for consultations ( SEconsult: http://www.scotland.gov.uk/consultations/seconsult.aspx). This system allows stakeholder individuals and organisations to register and receive a weekly email containing details of all new consultations (including web links). SEconsult complements, but in no way replaces Scottish Executive distribution lists, and is designed to allow stakeholders to keep up to date with all Scottish Executive consultation activity, and therefore be alerted at the earliest opportunity to those of most interest. We would encourage you to register.
Handling Your Response
We need to know how you wish your response to be handled and, in particular, whether you are happy for your response to be made public. Please complete and return the Respondent Information Form at Annex F as this will ensure that we treat your response appropriately. If you ask for your response not to be published we will regard it as confidential, and we will treat it accordingly.
All respondents should be aware that the Scottish Executive are subject to the provisions of the Freedom of Information (Scotland) Act 2002 and would therefore have to consider any request made to it under the Act for information relating to responses made to this consultation exercise.
Next Steps In The Process
Where respondents have given permission for their response to be made public (see the attached Respondent Information Form), these will be made available to the public in the Scottish Executive Library by 20 October 2005. We will check all responses where agreement to publish has been given for any potentially defamatory material before logging them in the library. You can make arrangements to view responses by contacting the SE Library on 0131 244 4565. Responses can be copied and sent to you, but a charge may be made for this service.
Following the closing date, all responses will be analysed and considered along with any other available evidence to help us reach a view on the areas covered in Annex B. We aim to issue a report on this consultation process by Autumn 2005.
Comments and complaints
If you have any comments about how this consultation exercise has been conducted, please send them to us at the above address.
Yours sincerely
Mrs Moira Nolan/Dr Alison Hinds
Acting OREC Managers for Scotland
ANNEX A MEMBERSHIP OF THE SCOTTISH ETHICS ADVISORY GROUPChair
Professor Roland Jung, Chief Scientist
Directors of Public Health
Dr Harry Burns - NHS Greater Glasgow
Dr Lesley Macdonald - NHS Fife
Administrators
Mr Peter Reith - NHS Lothian
Ms Jan McCulloch - NHS Dumfries and Galloway
Multi Research Ethics Committee ( MREC) Scotland
Professor Kennedy Lees - Chairman MREC Committee A
Research & Development Director
Dr Heather Cubie - NHS Lothian Universities Hospital Division
Research Ethics Committee ( REC) Chairs
Mrs Margaret Thomson - NHS Highland
Dr Melvin Morrison - NHS Grampian
Medical Advisor
Mr Gus MacConnachie - NHS Tayside
Association of Research Ethics Committees ( AREC)
Dr Kate McGarva - NHS Fife
Chief Scientist Office ( CSO)
Mr Mike Stevens
Lay Representative
Mrs Joan Munro
Central Office of Research Ethics Committees ( COREC)
Mrs Moira Nolan
Dr Alison Hinds
ANNEX B SCOTTISH ETHICS ADVISORY GROUP - REMIT
The Scottish Ethics Advisory Group ( SEAG) will
- assess the extent to which the findings and recommendations in the report of the Review of NHS Research Ethics Committees in England are applicable in Scotland, taking into account the views expressed by the wider research community in consultation
- consider the implications of implementing those recommendations in Scotland
- specifically investigate the feasibility, resource implications and impact on committee members and administrators of a range of potential solutions to deliver the review's recommendation concerning the number of RECs
- consider any other changes necessary or desirable to the operation of the research ethics system in Scotland, including the impact of the Medicines For Human Use (Clinical Trials) Regulations 2004 on the operation of the Adults with Incapacity (Scotland) Act 2000
ANNEX C REPORT OF THE AD HOC ADVISORY GROUP ON THE OPERATION OF NHE RESEARCH ETHICS COMMITTEES: SUMMARY OF CONCLUSIONS AND RECOMMENDATIONS
Conclusion 1: Report references 3.1, 4 (no. 1)
It should remain the role of research ethical review to safeguard the rights, dignity, safety and welfare of potential human research participants by providing an independent opinion on the ethical implications of a research proposal. Vigilance must be applied at all stages to preserve the independence of the RECs' decisions from political, research or management interests.
Recommendation 1: Report reference 5 (no. 1)
The remit of NHSRECs should not include surveys or other non-research activity if they present no material ethical issues for human participants. COREC should develop guidelines to aid researchers and committees in deciding what is appropriate or inappropriate for submission to RECs.
Conclusion 2: Report reference 4 (no 2)
Research of relevance and good quality is essential to underpin further developments in health and social care. This gives Research Ethics Committees a secondary role - to facilitate ethical research.
Conclusion 3: Report references 3.1, 4 (no 3)
In addition to research in the NHS and Social Care, there is now a need also to provide for the requirements for ethical review set out by the new statutory and regulatory environments, such as for human tissue and mental capacity.
Conclusion 4: Report references 3.9, 4 (no 4)
There has been a major improvement in the efficiency of the process of ethical review in the very recent past that has not yet been fully appreciated. COREC and the RECs are to be warmly congratulated, but some problems still remain.
Conclusion 5: Report references 3.2, 4 (no 5)
RECs should deal with ethical rather than scientific review.
Recommendation 2: Report reference 5 (no 2)
RECs should not reach decisions based on scientific review. In the unusual situation of a REC having reservations about the quality of the science proposed, they should be able to refer to COREC for scientific guidance.
Recommendation 9: Report references 5 (no 9), Annex 3
We propose the creation of "Scientific Officers" in COREC to support the work of committees. They might undertake much of the preliminary assessment required, and review reports. Chairs, for whom it is a major burden, currently undertake this work.
Conclusion 6: Report references 3.1, 4 (no 6)
Much research, such as surveys, service evaluation and research on NHS staff, does not require ethical review.
Recommendation 1: Report reference 5 (no 1)
The remit of NHSRECs should not include surveys or other non-research activity if they present no material ethical issues for human participants. COREC should develop guidelines to aid researchers and committees in deciding what is appropriate or inappropriate for submission to RECs.
Conclusion 7: Report references 3.3, 4 (no 7)
The REC operating system is perceived to be bureaucratic and should be better described and presented. The procedure for site-specific assessment ( SSA) is cumbersome.
Recommendation 3: Report references 5 (no 3), Annex 3
The recently introduced managed operating system has been well received. Its use of IT points the way to further efficiency and quality improvements. We believe that responsibility for site-specific assessment should be transferred to NHS hosts as soon as acceptable mechanisms for quality assurance are in place.
Conclusion 8: Report references 3.3, 4 (no 8)
The IT system that underpins the operating system is generally successful, and the recently introduced combined approach with R&D is to be welcomed. Further opportunities for linkage of information supply amongst ethics committees, R&D departments and other regulatory bodies should be kept under constant review.
Conclusion 9: Report references 3.4, 4 (no 9)
The application form attracts frequent criticism. Much of it is related to earlier electronic versions or because of the use of paper versions of what is designed as an on-line form. Nevertheless, the form could be more intuitive and a more easily usable paper version developed.
Recommendation 4: Report references 5 (no 4)
The application form and application process call for improvement. The form should take more explicit account of differences between types of research and should also give more space and attention to ethical issues.
Conclusion 10: Report reference 4 (no 10)
The current operating system, requiring as it does comprehensive information to be supplied "up front" for the RECs, has exposed a very variable level of understanding of ethical issues within the research community. We feel this is at the heart of some of the criticisms of the form itself. It reveals a need for researchers and health professionals to have access to information, support and training. This may aid the ability of researchers to identify and consider the ethical issues arising out of their proposed research. Consequently, they might be better able to describe, in their submissions to RECs, the ethical arguments in favour of their proposed research project (whilst acknowledging potential harms and how they propose to minimise the risks involved).
Conclusion 11: Report references 3.6, 4 (no 11),
There is over-capacity in current NHSRECs. It is timely to rationalise further the number of RECs, with more intense operation for the smaller number resulting.
Recommendation 6: Report references 5 (no 6), Annex 3
We believe that a smaller number of RECs - perhaps one for each Strategic Health Authority, with a limited number of exceptions - would be more appropriate. Their operations would be more intense than at present, with a greater use of electronic communications. The time commitment required of members and support staff for training should be more formally recognised, as should the time taken in committee hearings and preparation. This implies paying REC members appropriately, either directly or through compensating their employers.
Conclusion 12: Report references 3.7, 4 (no 12)
We believe that the totally voluntary system of RECs may not be sustainable and, indeed, may no longer be appropriate. It is likely that it inhibits application for membership by sections of society that should be better represented.
Recommendation 7: Report reference 5 (no 7)
Research Ethics Committees must represent the public interest as well as patient perspectives on research. This means that membership needs to be drawn from a wider mix of society and that all members need to be supported by appropriate training. We believe that our recommendation that we move towards a system of fewer, paid RECs will support this objective.
Conclusion 13: Report references 3.8, 4 (no 13)
There appears to be some inconsistency amongst committees that cannot be explained by the necessary judgemental aspect of ethical review.
Recommendation 8: Report reference 5 (no 8)
The issue of excessive inconsistency amongst committees should be addressed by concentrating on the provision of appropriate training, and on capturing and sharing good practice where issues and arguments have been already explored. The newly introduced system of quality assurance by peer review amongst committees and their members should assist this process and should be further developed.
Conclusion 14: Report references 3.9, 4 (no 14)
The scale of the changes in operation that have recently been required of RECs should be acknowledged. The Chairs, members and support staff have responded magnificently.
Conclusion 15: Report references 3.10, 4 (no 15)
DH officials and colleagues in the other UK countries should look imaginatively at pursuing more harmonisation of governance arrangements, given that there are moves for harmonisation across Europe.
ANNEX D THE SCOTTISH EXECUTIVE CONSULTATION PROCESS
Consultation is an essential and important aspect of Scottish Executive working methods. Given the wide-ranging areas of work of the Scottish Executive, there are many varied types of consultation. However, in general, Scottish Executive consultation exercises aim to provide opportunities for all those who wish to express their opinions on a proposed area of work to do so in ways which will inform and enhance that work.
The Scottish Executive encourages consultation that is thorough, effective and appropriate to the issue under consideration and the nature of the target audience. Consultation exercises take account of a wide range of factors, and no two exercises are likely to be the same.
Typically Scottish Executive consultations involve a written paper inviting answers to specific questions or more general views about the material presented. Written papers are distributed to organisations and individuals with an interest in the issue, and they are also placed on the Scottish Executive web site enabling a wider audience to access the paper and submit their responses. Consultation exercises may also involve seeking views in a number of different ways, such as through public meetings, focus groups or questionnaire exercises. Copies of all the written responses received to a consultation exercise (except those where the individual or organisation requested confidentiality) are placed in the Scottish Executive library at Saughton House, Edinburgh (K Spur, Saughton House, Broomhouse Drive, Edinburgh, EH11 3XD, telephone 0131 244 4565).
All Scottish Executive consultation papers and related publications (eg, analysis of response reports) can be accessed at: Scottish Executive consultations ( http://www.scotland.gov.uk/consultations)
The views and suggestions detailed in consultation responses are analysed and used as part of the decision making process, along with a range of other available information and evidence. Depending on the nature of the consultation exercise the responses received may:
- indicate the need for policy development or review
- inform the development of a particular policy
- help decisions to be made between alternative policy proposals
- be used to finalise legislation before it is implemented
Final decisions on the issues under consideration will also take account of a range of other factors, including other available information and research evidence.
While details of particular circumstances described in a response to a consultation exercise may usefully inform the policy process, consultation exercises cannot address individual concerns and comments, which should be directed to the relevant public body.
ANNEX E REVIEW OF RESEARCH ETHICS COMMITTEE SYSTEM: CONSULTATION EXERCISE - LIST OF ORGANISATIONS CONTACTEDNHS Argyll and Clyde
NHS Ayrshire and Arran
NHS Borders
NHS Dumfries and Galloway
NHS Fife
NHS Forth Valley
NHS Grampian
NHS Greater Glasgow
NHS Highland
NHS Lanarkshire
NHS Lothian
NHS Orkney
NHS Shetland
NHS Tayside
NHS Western Isles
ANNEX F RESPONDENT INFORMATION FORM: REVIEW OF RESEARCH ETHICS COMMITTEE SYSTEM