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

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 in the governance process, to submit recommendations in reducing the time required for protocol processing while still adhering to the rights, dignity and safety of research participants. Also aims of strengthening the system, structures and ensuring efficient processing of information and the adequate training of users and committee members needed to be achieved. 

The main conclusion reached by the group, which were published in June 2005 was that NHS research needed to be more efficient and punctual. It was stated that in order to achieve these vital factors the committees must be focused on ethical issues and that the scientific responsibilities of protocols must be placed on different governance body.  This meant that patient surveys, the suitability of staff involved and the adequacy of research sites can be resolved outside research ethics committees. The Central Office for Research Ethics Committees which is involved in the training of members, support and management was said to require further administrative support. The most vital result argued that the whole process of ethical approval was surrounded by the constraints of bureaucracy. The review brought to light the importance of standardization across all of Europe and within the UK which must include a simplified research governance framework. The examination further described the presence of too many committees and hence led to the inconsistencies experienced by multicentre trials. The solution was said to reduce committee numbers but to increase the frequency of meetings and to pay members and chairs of the committees for a better service. 18,

Digestion of the “Warner Report”

No doubt all the alterations suggested are very welcomed by the research community on the whole but whether they actually work remains to be seen. The recommendations for change may lead to some flaws not anticipated by the report.

Perhaps the increased number of committees does result in further inconsistencies in protocol approval. However the intended alterations would mean professionalising committee members. No evidence is given to suggest that increased frequency of meetings and paying the members would reduce cost, increase consistency and effectively increase efficiency. It remains to be seen that the members already in committees would accept these changes. Indeed it may result in a loss of the members that cannot spare longer hours or greater work loads or who have been serving out of public dedication and not for financial gain.4

The report seemed to have not resolved the distinction between the scientific review and the ethics behind a protocol. Its’ bid to separate science from ethics could be hindered by the laws that bind the two eternally. The aspect of ethical review after scientific independent peer review could be flawed as increased alteration in ethics of a protocol may inadvertently alter the scientific aspects of it also. Another factor is that independent peer review could be biased to the point where it is done by individuals who have done research themselves and who obviously the favour the advent of interesting research., 

The report in the whole is in good nature and it does follow the trend of concluding that more reform is needed again. The time allocated for the report and the narrow references used in it may have affected the ability to thoroughly review UK’s ethical legislations.21 However the reform seems to be in deregulation rather than the previous increased legislations and maybe just another bandage for a gun shot wound.

What happens now?

Continuing reforms of NHS brought with it the research governance strategy for England published by the Department of health in 2000.1 This new Research Governance Framework together with the changes in research ethics committees has been the largest reconstruction of research governance since post war 1960s.

The reform means from April 2004, research undertaken in care organisations must have a sponsor, this signifies how commercial interests have molded the way research ethics is viewed.

This is a bid to take advantage of the talents of researchers and their potential research material to encourage commercial gain and possible improvements of the NHS. The increased legal issues of using human subjects or human materials for research means that this vast commercial potential in the NHS goes unused. New Human Tissue Bill, Human Rights Act 1998 and Data Protection Act 1998 all promote strict restrictions in research that contain humans. 

Therefore, the main idea behind the sponsor apart from financial gain is that the NHS remains a care organisation. This means it must ensure that all research on it’s patients, staff, their private data any other materials that could be traced is carried out according to the framework stated. Having a sponsor would further achieve the goal of adhering to governance protocols, especially if the trust itself is its’ own sponsor. In all cases it is important to carry out an independent scientific review, which means all research has to be approved by the relevant governing body of the site. Conflicts of interest could arise when the trust is conducting internal research on its’ own patients, hence a system of internal independent review must be in place. 24 

The new European Union clinical directive introduced from May 2004 will mean that ethics committees will need to have better communication and a more centralized structure overseen by an organisation known as the Central Office for Research Ethics Committees. After May 2004, sole responsibility of all UK Ethics Committees will be with the Central Office. 

Scientific quality, consent process and above all the safety of research participants have been the dominant aspect of research ethics committees in the past. The fact that the new scheme would be the review of scientific aspects of the protocol by a sponsor or care organisations means the new breed of ethics committees will discuss safety and very vaguely defined ethics only. 24 

The main aim since the birth of the Declaration of Helsinki has primarily being the safety of the research participants above all else.

“In medical research on human subjects, considerations related to the wellbeing of the human subject should take precedence over the interests of science and society”.

The factors found addressed in the “Warner Report” such as delayed approval times and inconsistencies of decisions made are all acceptable if the fundamental above rule is adhered to. The new governance arrangements have aimed to target committee members which sometimes lacked guidance, funding, communication between committees and poor training. The independent ethics committee should be better guided and at the same time reduction of bureaucracy to hinder ethical research must be prevented, though not enough for flaws of ethical judgment to leak through to an extent of affecting research participant safety. It is finding the balance between these factors that is most important and the most difficult aspect of research ethics.,

The introduction of the European directive is a bid to stop the competition between ethical aspects and good clinical practice and instead seek to bind the two. The “good clinical practice” guidelines produced by the International Conference of Harmonisation were also based upon good ethical practice and the Declaration of Helsinki. The identification of the need to decrease legislation was also apparent in the article which was equally concerned with facilitating research and the ethics of projects concerned.

The aim on the whole is to ensure that Europe remains an attractive location for interesting and financially motivated research. Sponsored and multicentre clinical trials will be of most benefited by the new directives.4  

“It requires each member state to make one single opinion with regard to multicentre research, even if that research is limited to one member state.”

The governance of the research ethics committees will no doubt build on the above directives and it is hoped that it will produce better consistency. It is interesting to see however that this directive is an internal medical professional orientated bid and no lay or public input has gone into the formation of it. The public reluctance of scientific research is perhaps the stimulant of this nature of ethics committees that has decided to conduct private meetings., Also, no requirements or directives are in place about informing research subjects on decisions made in these meetings.24    

  “Paragraph 1.3 of the governance arrangements states that the dignity, rights, safety, and wellbeing of participants must be the primary consideration in a research study. Later, in paragraph 2.3, more concession is made to article 5 of the Helsinki Declaration. It states that the goals of research are secondary to the interests of participants. However, the fact that paragraph 1.3 does not state that participants’ interests are the primary consideration of the ethics committee and that the arrangements do not put primary consideration on the principle by placing it numerically before and expressly above paragraph 1.1, is worrying.” 4

If read between the lines this may suggest the subtle way of stepping away from considering safety to the research participant as the major factor in approving a protocol. Rather, it seems to dictate that ethics committees should balance this with the importance of the advances in medical science. This together with many new governance provisions increasingly inhibits the following the fundamentals of the Declaration of Helsinki stated above. Inevitably the placing of research participant’s safety as the dominant concern of research ethics committees is well and truly under attack.4,21 

The Separation of Scientific Review

The original guidance to LREC representatives dictated that committees should judge protocols in three different approaches.1

“Patient welfare involved a duty-based approach, patient dignity a rights-based approach, and scientific validity a goal-based approach.”4

The new framework would mean the much of the latter will be lost. The clinical trials directive has focused the committees into validating the clinical trial and the trial design only. This has been a new step backed by the “Warner Report” in reassuring the lay members of the committee that thorough independent review has already been passed on the protocol before being subjected to ethical review.19 Essentially, this suggests that the study design, control criteria, monitoring, withdrawal and inclusion criteria, benefits and risks, review of the research site and the arrangements to report the research will all be recorded and presented before ethical review takes place. However if the ethics committee are not satisfied with the prior review then they can ask for a resubmission but cannot conduct a scientific review themselves.

"All proposals for health and social care research must be subjected to review by experts in the relevant fields able to offer independent advice on its quality".4

Here in lies a fundamental difference in the new framework and does not stem from the European directive nor does it come from the research governance framework.  This means the review process would be more difficult as sometimes ethical and scientific reviews are hard to separate for reasons mentioned earlier in this article, hence decisions made by committees could become more controversial than ever before.

Community Considerations

In the past much conflict resulted in the presence of differing view between MRECs and LRECs, especially when it came to community considerations. The new directives state that multicentre research ethics will review protocol if more than five sites are involved. Furthermore local research committees at each site will be asked to review the protocol further, using strictly defined locality issues. Good communication between the MRECs and LRECs is a vital element for this scheme to work as they each must know what changed the other has made.4

The introduction of time limits in the UK protocol review has hastened the review process and although this would mean more cases are dealt with sooner, it may affect the safety of participants if matters are rushed. It also means that local issues require meetings in short notice, hence sometimes only few members can be present in short notice. This may decrease the diversity of views and could be seen as being unethical practice. 

Personal Conclusions

On the whole the latest revisions in guidance for the research ethics committees have been long awaited by researches. It was expected to stop the down regulation of research and encourage researchers to continue to produce work. The good that has come out of it has certainly been comprehensive and will benefit researchers and ethics committees in many ways mentioned above. Also the objectives of the latter is much better defined and regulated.

Conversely has this bid to increase research in a bid to improve scientific advance affected the public safety? Not only have some flaws regarding the safety of research participants identified in this report but also potential flaws regarding the design and quality of research that is being approved. The fact remains that it is highly ironic that the public view as a whole is not considered in forming these new directives. In fact the public view has never being considered in this aspect of research ethics which is in place to protect those who do not know its rules, regulations or its governance protocols. The recent vogue of public involvement in every aspect of medicine makes this self governance of research ethics by medical professionals is even stranger.

To answer the question stated at the start of this report, this recent change in ethical directives is a step away from the principles announced in the Declaration of Helsinki and it is addressing the issue of quantity of research not the quality of it. It is important to understand in the future that more change is needed and it will continue to happen. However as the new tide of directives continue to come it’s time to recognise that ethics remain at most a human response to conflicting social opinions. It is impossible to form a directive to every foreseeable ethical circumstance, so at the end it is up to the people to decide their own fate and increased governance will not have the final say.