Positive Feedback on the Research Ethics Service
Source: http://www.corec.org.uk/recs/docs/Positive_feedback.pdf

Version date:  18 August 2006

1.  Report of the Ad Hoc Advisory Group on the Operation of NHS RECs, Department of Health Web Site, 6 June 2005
Paragraphs: 2.5; 3.3; 3.6; 3.9; 4.4 from the report of the ad hoc advisory group on the operation of NHS Research Ethics Committees (often referred to as the Warner Report) acknowledge the improvements that the REC community has delivered to date and promise a further period of change:

2.5  Many of the criticisms reflect pent up frustration with the operation of the REC system over a number of years, and do not always take account of improvements that COREC has introduced more recently.

3.3  We do note, however, that changes such as the requirement for only a single application, the ability to book an agenda slot by telephone, the limiting to one set of supplementary questions, a common UK wide application form, standard operating procedures for all committees, and standard letters, have all substantially reduced the bureaucracy which existed even two years ago within the MREC/LREC system.

There were favourable comments about the Central Allocation System, which has helped speed up access to RECs for multicentre research.

3.6  The creation of a central support structure for NHS RECs, provided through COREC, made it possible to begin attending to the historic mismatch between capacity and need.

It has to be recognised that whilst the recently introduced changes in constitution and operational systems were essential, they have been far from comfortable for RECs themselves, whose members are volunteers. The administrators in particular have had an arduous task. We recognise and applaud the commitment and professionalism of all those involved in adapting to the changes.

3.9  The changes required were very considerable indeed, and it is to the credit of COREC that they have been achieved without even more disruption to the committees and their users. We noted from some user groups that the UK is well in advance of the European Community in adapting its previous operating systems to meet the requirements of European legislation.

4.4  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.

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2.  Regulation or Revolution:  The Impact of the European Directive
Clinical Research Focus June 2005, 16:5; 65-67

A report on a session held at the Institute of Clinical Research Spring meeting to review the status of the implementation of the EU Directive across the 25 member states.  The speaker, Pamela Charnley-Nickols reported that there is still variance about the structure of Independent Ethics Committees, and not all countries have implemented a single ethical opinion.  She referred to ‘impressive data’ coming out of the UK relating to timelines.  http://www.instituteofclinicalresearch.org/id10homepage.asp

3.  COREC and the way forward
Clinical Research Focus, June 2005, 16:5; 67-69

A report on a session held at the Institute of Clinical Research Spring meeting lead by Professor Terry Stacey, who at the time was the Director of COREC.   Terry Stacey reported on COREC’s recent achievements and outlined the future agenda for COREC.   The reporter of the session also acknowledged that COREC has done a great deal to improve the Ethics Committee process.
http://www.instituteofclinicalresearch.org/id10homepage.asp

4.  More Changes for UK Ethics System,
Andrew Smith, Clinical Research Focus, July 05,16:6; 4

An interpretation of the Ad Hoc Review which begins; The UK ethics review community must be pretty good at coping with change.  http://www.instituteofclinicalresearch.org/id10homepage.asp

5.  Research ethics committees in the UK – the pressure is now on research and development departments
Rustam  Al-Shahi , Journal of the Royal Society of Medicine. Oct 2005,  98:10; 444-447

An essay by a researcher who had previously experienced delays in obtaining ethical approval under the old MREC/LREC system.  The author provides a history of the research ethics committee system with 44 references, and states that “COREC has implemented laudable mechanisms to improve RECs’ speed of review, consistency, standards, training and appeals procedure.”  The author writes “You apply to an REC online. After clarifying questions about your application on just one occasion, you get a decision at no charge, within 60 days, and it is valid for the whole of your country.
While this scenario is a fantasy in countries such as the USA, Canada, and Australia, a recent Department of Health report celebrates this new era of REC operation in the UK.”
http://www.jrsm.org/

6.  Living with the European Clinical Trials Directive:  one year on
J Hall and C Diaz-Navarro, Anaesthesia, October 2005, 60 (10)  949-951

An editorial which states that  ‘unlike other groups, ethical approval is the most efficient part of the process, as LRECs must turn around projects in 60 days’.  
www.blackwell-synergy.com
 

7.  Research governance: where did it come from, what does it mean?
Sara Shaw, Petra M Boynton, and Trisha Greenhalgh, Journal of the Royal Society of Medicine, Nov 2005; 98: 496 - 502.

The authors acknowledge the 60 day ethics approval time, and “the move from an ethos of policing research to one of quality assurance and facilitation.”   http://www.jrsm.org/cgi/content/abstract/98/11/496

8.  U.K. Ethics Review and the R & D process – Too many Tiers?
Joan Perou, Clinical Discovery, December 2005

The author gives a brief background to the history of research ethics committees and sponsor companies in the UK, and states that many people feel the EU Directive has had a positive effect on the ethics review process.  She states that ‘sponsor companies have a new perceived enemy in their sights: the R&D departments!!’, and she describes problems with delays in obtaining R and D approval. 
The author also refers to the Warner Report and believes that although decisions still have to be made,  it seems likely that a one-step process will ‘provide salvation for ethics/R and D.’ http://www.clinicaldiscovery.com/readArticle.aspx?articleID=15

9.  Editorial: Using personal health information in medical research
Tom Walley BMJ.21 Jan 2006; 332: 130-131

The editorial acknowledges that ‘There are encouraging signs that some thought is going into containment of bureaucracy, better coordination of research ethics committees, and unified documentation for ethics applications and use of NHS data for other purposes.’
http://bmj.bmjjournals.com/cgi/content/full/332/7534/130

10.    We all need RECs 
G Michael Addison, 25 March BMJ, 332,  730  (in response to Masterton G. Two decades on an ethics committee. BMJ 11 March 2006;332: 615.bmj.com)

The Chair of a REC defends the REC  system  stating  that everyone, is working to improve and simplify the form.  He writes that longest form he has reviewed was 28 pages. http://bmj.bmjjournals.com/cgi/content/full/332/7543/730-a

11.  Ethics service plan secures BMA backing
BMA News Review (doctors’ edition), Sat 6 May pg 4

Plans to streamline and develop the NHS RECs have been broadly welcomed by the BMA. http://www.bma.org.uk

12.  Centralized and non-centralized ethics review: A five nation study  Fitzgerald, M. H., & Phillips, P. A.. Accountability in Research. 2006;13: 47-74.

This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralised review, to explore issues related to centralisation of the review process. The recently introduced system in the U.K. is still going through “teething pains.” As one key informant remarked, 2004 was probably the “best of times and the worst of times” to study the review process in the U.K. In terms of understanding the issues associated with centralized review, it was probably the best of times. Most of the problems identified seem to be resolvable (e.g., problems with the newly introduced electronic form and how local committees should deal with differences of opinion they might have with the central committee’s review) and many may cease to be problems as people become more familiar with the new system. http://taylorandfrancis.metapress.com;

13.  Ethical review of non-commercial clinical trials Peter A Heasman
J of Medical Ethics,  (electronic letters 4 Aug 2006 in response to Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK? L Sheard, C N E Tompkins, N M J Wright, and C E Adams J Med Ethics 2006; 32: 430-434 [PDF]

“The Central Office for Research Ethics Committees (COREC) continually strives to ensure that problems with the system are identified and resolved. “ http://jme.bmjjournals.com/cgi/eletters/32/7/430#579

14.   Research ethics committees in Europe: implementing the directive, respecting diversity
A Hedgecoe, F Carvalho, P Lobmayer, and F Raka, J Med Ethics 2006:32; 483-486
   
The authors compare RECs in Sweden, UK, Portugal and Hungary.  They  counter criticism of the changes to the REC systems as being necessary because  of the EU Directive.    ''We need to see RECs in their context, as parts of an international regulatory system  for pharmaceutical products, subject to pressures of different interest groups at different levels (EU, national and local)''
http://jme.bmjjournals.com/cgi/content/abstract/32/8/483?etoc

15.   Some Research Ethics Committees believe in facilitating ethical research, Michael S Pegg, BMJ electronic letters 6 Aug 2006 (in response to Confidentiality and consent in medical research: Overcoming barriers to recruitment in health research   Jenny Hewison, Andy Haines, BMJ, 5 Aug 2006, 2006; 333: 255-258  http://bmj.bmjjournals.com/cgi/content/full/333/7562/300)

Michael Pegg, a REC Chair writes that his REC invite researchers to meetings in order to discuss ''opt-in'' recruitment, and that there are RECs interested in facilitating research.
http://bmj.bmjjournals.com/cgi/eletters/333/7562/300#139099

16.        Pressures in the UK CR market are generating innovative trial approaches,  Graham Wylie, Pharma Marketletter, 7 Aug 06,  24-25

Most of the article is about a trial support organisation, especially for trials taking place in the community.  The positive feedback is:
• There are a multiple of pressures on UK clinical trial research but, overall things are looking up.

• The British research environment has woken up to the competition at last, with improvements in the COREC system, efforts to reduce bureaucracy across the board…..
http://www.marketletter.com/

17.       Response from the Central Office for Research Ethics Committees, Janet Wisely, Hugh Davies and John Lilleyman,  BMJ electronic letters 16 Aug 2006 (in response to Confidentiality and consent in medical research: Overcoming barriers to recruitment in health research   Jenny Hewison, Andy Haines, BMJ, 5 Aug 2006, 2006; 333: 255-258  http://bmj.bmjjournals.com/cgi/content/full/333/7562/300

A response to the issue of opt in, as well as clarifying the role of COREC in improving REC performance.
http://bmj.bmjjournals.com/cgi/eletters/333/7562/300

18.     NHS ethics committees do not hinder medical research, Paddy Stevenson Guardian, 18 Aug 06, pg 37

A letter in by the Vice-Chair of Newcastle and N Tyneside REC of what the research ethics service does, why and how it is done.   He emphasises that the changes have be made because of the EU Directive, discusses opt-in and gives figures about the usual size of an application form.  http://www.guardian.co.uk/comment/story/0,,1852612,00.html

19.         PIAG''s role in promoting good research
BMJ rapid response Joan M Higgins (14 August 2006)

The Chair of the Patient Information Advisory Group (PIAG) responds to recent criticism (Souhami,  BMJ 2006; 333: 315-316 ) that bodies involved in research governance are "highly restrictive", "unco-ordinated" and "sometimes contradictory" and they can result in "endless delays" for researchers. She writes that PIAG have been working closely with other organisations such as the Central Office for Research Ethics Committees, the Medical Research Council, the Department of Health and the Office of the Information Commissioner to ensure that the research approval process is streamlined and that there is consistency of advice.  http://bmj.bmjjournals.com/cgi/eletters/333/7563/315