"Medical research in the U.K. is being suffocated by excessive governance and ethical review".

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Candidate: 13027                Integrative Assignment 1

Community Health Sciences BMedSci                Medical Ethics Research Governance

Integrative Assignment 1

Candidate: 13027

Community Health Sciences BMedSci

Hand in Date: 09/01/2006

Word Count: 2,982

“Medical research in the U.K. is being suffocated by excessive governance and ethical review”

(Guidance for BMedSci Students, Tutors and Examiners Booklet 2005; 5)

Contents:                                                                                                     Page

  1. History of UK’s Research Ethics                                                    2
  2. The “Warner Report”                                                                    4
  3. Digestion of The “Warner Report”                                                    5
  4. What happens now?                                                                    6
  5. The Separation of Scientific Review                                                    9
  6. Community Considerations                                                           10
  7. Personal Conclusions                                                                   10

“Medical research in the U.K. is being suffocated by excessive governance and ethical review”

This report will explore and focus on the recent overhaul and complete reform of the face of research ethics in the UK (United Kingdom). Researchers and research ethic committees have been waiting for these changes for a considerable amount of time but will they increase quality of research or the quantity of it. This report also will try to examine whether the new changed aid in the safety and dignity of participants or hinder these in favour of interesting research protocols.

History of UK’s Research Ethics

The first signs of a “centralised” research governance system of ethics occurred in 1991. These were however set up as local branches known as LREC (Local Research Ethics Committees) and were involved in the regulation of research in their respective local NHS establishments.1, They are funded by local health authorities and made up by twelve members consisting of medical professionals to lay persons. There seemed to be no standardising of directives between each LREC and hence led to inconsistencies in approving research proposals, especially multicentre trials. 

This led to an uprising in researches complaining about the procedures in place which inevitably led to calls for a reform. The main concern was that for a multicentre approval the application was time consuming and was surrounding with “red tape” and bureaucracy which hindered the advance of research itself.,,  This called for one regulatory body in the UK to have the final approval, if granted this meant that the approved research protocol could take place across a number of European countries without further criticisms. Thus in 1997 the advent of MREC (multicentre research ethics committees) took place. This meant that multicentre applications instead of being scrutinised by many LRECs, will be considered by one MREC.2

However one aspect of research MRECs failed to consider are local issues. This resulted in a research protocol being submitted to LRECs for consideration on the impact of the research in their local communities. The chief medical officer introduced "pertinent local issues" as a bid to clarify and decrease time delays in determining community considerations.4, This brought some light to standardising approval methods, although other problems remained. It became necessary for multiple research applications to be submitted to each LREC and again the original problem of inconsistencies and bureaucracy hindering research began to emerge. In some cases LRECs reviewed not only the local issues but ethical ones also and if noticed it would write to a MREC which were often too busy to reply and hence the protocol would be rejected.

Research ethics committees have been accused of making researchers work increasingly arduous. Five different research groups recorded a range of problems with ethic committees including distorting designs, delaying research protocols and prohibitive scientific advances.,,,, Sometimes the paperwork involved in one aspect of ethics such as confidentiality resulted in production of long application forms which the lay public find difficult to digest and understand, hence resulting in lowered response rates.13

Researchers continued to argue against the increased work that was placed on them to deal with these multiple ethical reviews and felt that ethical committees not only delayed their research but prevented scientific advances in helping the population as a whole. This forced a major review in 2001 in which governance arrangements replaced directives of 1991 and 1997. Various legislative reforms continue to occur including the 2004 clinical trial regulations. 

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The “Warner Report”

In view of these continuing changes in policy and burdensome nature of research ethics committees, Lord Warner, in late 2004 a junior health minister arranged for an independent ad hoc advisory review of all NHS research ethics committees in health and social care. 

Group members examined aspects concerning remit, administration, operation, and workload of ethics committees in England. Their main tasks were to explore the presence of unnecessary regulations that hinder future research approvals.  Other objectives of this group were to find solutions to any limiting factors that are existed ...

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