The Pharmaceutical Journal
Vol 272 No 7301 p675-676
29 May 2004

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New procedures for obtaining ethics committee approval for NHS research

In the past few months there has been a major overhaul of the procedures for obtaining ethics committee approval to carry out research within the NHS. In this article, Mary Tully reviews the main changes

Last year, Judy Cantrill and I wrote an article on the implications of the Research Governance Framework¹ for pharmacy practice research.² Since then, there has been a major overhaul of the operational procedures for obtaining ethics committee approval to do research within the NHS. As such, it is timely to revisit this issue.

One of the main impetuses for the recent system revisions has been EU Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use,³ which came into force in the UK on 1 May 2004. The requirements in this directive regarding ethical review only apply to clinical trials. However, the UK government has decided that it will have a single system for all research studies, regardless of the subject under investigation. At the moment, there are no special processes for student research but this situation is currently under discussion.

In the interests of brevity, I will only cover the main aspects of the review process that have changed in the past few months. These are the requirement for a sponsor, the application form, the application process, and the site-specific assessment. However, there are also many smaller changes that have taken place, which can be found on the website of the Central Office of Research Ethics Committees (COREC, www.corec.org.uk).

Research sponsor

The Research Governance Framework¹ requires all research to have a sponsor, ie, an organisation that has the responsibility for ensuring compliance with the published standards. For externally funded research, it will be the funding body. For research that is funded internally by a university, hospital department or community pharmacy organisation, the sponsor would be the chief investigator’s employer.

In the first instance, once your research protocol has been written, you should contact the research and development department of the NHS trust where you wish to carry out your research. There are no universal requirements as to when you are expected to do this, only that approval must be obtained before you start the research. However, it is probably best to contact the trust before the ethics committee process starts, particularly if you intend to do “own-account” research (ie, not externally funded), when the trust is expected to act as the research sponsor. Approval from the main research ethics committee (REC) does not mean that researchers have permission from the trust to carry out the study. Management approval still must be obtained from the relevant host organisations, using the current systems.

Application form

The COREC website has made available the standard NHS research ethics committee application form. This is a new, three-part form that must be used for all applications to all RECs throughout the UK. Parts A and B should be sent to the main REC (see glossary) and part C to each REC that will conduct a site-specific assessment (see below). Applications will no longer be accepted on the old wordprocessor-based forms. The new form can be completed in two ways, depending on your preference and your computer — using OfficeForms Filler or via a web-based version of the form.

OfficeForms Filler should be downloaded from the COREC website and installed on your computer, before downloading the empty form from the same site. When you wish to save a partially or fully completed application form, the programme will save only the data in the form, not the actual form itself (which will remain unchanged). Unfortunately, this software is only suitable for PCs and not for Apple Macs. For researchers with these computers, a web-based version is available via the COREC website. Prior registration is required and researchers set up an account, where they can save partially or fully completed forms.

Even if you have used the previous version of the standard application form (which was piloted for Multi-Centre Research Ethics Committees [MREC] applications over the past year), it is still important to read the documents available on the website, since there have been some changes. The document called “Question-specific advice”, in particular, is useful because it explains what the RECs are looking for in the answers to the individual questions. The form is self-populating (ie, answers are copied from earlier questions to later ones, as required) and contains a core set of questions for all applications. In addition, the answers to some of the questions force the form to display extra pages. For example, if you answer in the affirmative that it is a student research project, a page will appear for the supervisor to complete. If you answer that the study involves ionising radiation, a section will appear that contains further questions that are pertinent to that type of research.

Application process

When the application is almost ready, you must find out which committee will review your application. The name of that committee, and the booking number they will give you, must be included on the actual form. All clinical trials of medicinal products, no matter how small, and all studies taking place in more than one domain (see glossary) must be booked into the system via the central allocation system. All other studies that are going to be conducted in a single research site (see glossary) must be booked into the system via the Local Research Ethics Committees (LREC) for the area where the chief investigator (see glossary) is professionally based. With studies that are going to be conducted in several research sites within a single domain, there is a choice. They can be booked in either via the central allocation system, or via the LREC for the area where the chief investigator is professionally based.

The staff at the central allocation system or the LREC administrator will tell you which committee will be able to conduct the review at the earliest time. If you are applying via the central allocation system, you could potentially be told that the next available slot is somewhere else in the UK. This could be at an unacceptable distance or you may decide that speed is of the essence and that you are willing to travel. You are not required to accept a particular slot; if you prefer, you can chose to wait for a later slot with an MREC or LREC in a more convenient location. The choice is yours. Similarly, when applying to an LREC, the administrator may offer to transfer your application to another LREC within that domain, in order to get your review conducted as soon as possible.

Once the application has been booked in, parts A and B of the completed form should be sent electronically to the appropriate REC offices, either within four days or via a closing date agreed with the administrator. In addition, one paper copy, with all relevant signatures, should also be sent. Once the application has been checked and assessed as valid, a 60-day clock starts. Within that time, the REC must make a decision to accept or reject the application and can only write once to the chief investigator seeking clarification or asking for further information. The clock stops while the REC is waiting for a response. Chief investigators will be asked to attend the committee meeting (although attendance is not compulsory), in order to facilitate this process.

Site-specific assessment

A favourable decision by a main REC is valid throughout the whole of the UK. Local site assessors (usually the relevant LREC), however, must still make an assessment to advise the main REC on the suitability of the local investigators and support staff, and the appropriateness of the local research environment and facilities. This used to be called locality assessment and is now called site-specific assessment.

At the same time as parts A and B are submitted to the main REC, part C should be submitted to the relevant LREC or LRECs where the work is going to be carried out, along with a copy of each principal investigator’s curriculum vitae. For multisite studies, it would be expected that there would be one principal investigator at each site; it is his or her responsibility to seek the site-specific assessment. However, if it is a single site study, and the main REC is actually the LREC covering the research site, then parts A, B and C should be submitted together. If it is a single site study but the main REC is another LREC in the same domain, part C should be sent to the LREC for the research site. In both these circumstances, however, the chief investigator and the principal investigator are the same person.

When the site-specific assessment has been completed, the LREC administrator will inform the main REC of the findings. Thus, all correspondence to the chief investigator regarding the ethical approval will be from the main REC. The chief investigator could thus receive a series of letters from the main REC. The first one would give approval from the main REC to conduct the study, listing the sites that had, at that time, given approval for the study to be conducted in their area. As additional sites give approval for the study (if necessary), further letters would be issued, with an updated list of sites where the research can be done. If no sites give approval to the main REC for the research, the letter of approval usually cannot be issued. Therefore, it is in the researchers’ best interests to make sure the site-specific assessment process takes place at the same time as the review process by the main REC.

Conclusion

This new system is still in its early implementation stages and, in the short term, there will be some confusion as to exactly what is supposed to happen and in what order. I would suggest to any researchers who are confused, and who are about to embark on this process for the first time, that they should contact the administrator of their local LREC for advice. The administrators are knowledgeable and helpful and they recognise that it is in everyone’s best interests for this process to run smoothly. For multisite studies in particular, the new system should prove to be an improvement over the previous haphazard system, not least because all RECs will accept exactly the same documentation and all are required to give a speedy response to applications.

References

1. Department of Health. Research Governance Framework for Health and Social Care. London: Department of Health; 2001.
2. Tully MP, Cantrill JA. The research governance framework and its implications for pharmacy practice research. The Pharmaceutical Journal 2003; 271:51–4 (PDF 120K)
3. Harman R. The regulation of clinical trials in the United Kingdom. The Pharmaceutical Journal 2003;271:618–22 (PDF 120K)