The Pharmaceutical Journal
Vol 274 No 7351 p650-651
28 May 2005

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Research governance and pharmacy practice research: a case-study

In this article Charles Morecroft, Darren Ashcroft and Peter Noyce argue that it is important that the research governance process is refined and applications processed expeditiously, otherwise the existing governance framework will become another barrier to future research

Research governance aims to improve the quality of research and protect the public while minimising bureaucratic processes.¹ In the UK, two forms of written approval are required under the research governance framework before a research study that involves NHS staff, premises or patients can proceed. The first is ethical approval from the relevant local or multicentre research ethics committee (LREC or MREC) to ensure that the quality, ethics and dissemination of the research is of acceptable standards.² The second form is research and development (R&D) approval from the relevant NHS trust(s) in which the study is planned to take place. NHS trusts have a responsibility to maintain records of all research being conducted in their trusts and to ensure that it meets the relevant standards. In addition to this approval, honorary contracts are required for each researcher.

A considerable amount of published literature exists about why there is a need for a framework for research governance and its implications for research.³ While some literature has been published about the experiences of applying for R&D approval,^4–9 none focuses on the implications for pharmacy practice research.

The case study

The focus of this article is to describe the process of obtaining R&D approval for a national evaluation of repeat dispensing by community pharmacists, commissioned by the Department of Health and undertaken by a research team from the University of Manchester. The evaluation was a multi-component design involving semi-structured interviews with primary care trust personnel, community pharmacists, general practitioners and practice staff, an audit of repeat dispensing prescriptions and non-participant observation of the dispensing process in selected community pharmacies. Participants for the evaluation were recruited from across the 80 PCT pathfinder sites for repeat dispensing. Although MREC approval had been obtained, the evaluation could not commence until R&D approval from 14 PCTs involved with repeat dispensing, had been received.

The application process

Although acquiring the contact details of the relevant PCTs (from the “NHS in England” website¹⁰) was fairly straightforward, establishing contact with the specific person(s) involved in research governance proved to be more difficult. First, a number of PCT employees only worked part-time, so further telephone calls had to be made at specific times when particular employees were at work because no other person shared responsibility. Second, the phrase “research governance” was not readily understood by the switchboard personnel and in a number of cases we were transferred to others who were not remotely involved in the process. Finally, an umbrella organisation, usually a care trust, had undertaken to oversee the process of R&D approval for a number of PCTs. Despite this, the name and contact details of the research governance facilitator was not always known by personnel in the PCT.

Once we were able to establish contact with the relevant facilitators, the necessary registration forms were forwarded as e-mail attachments. These registration documents varied from one to two pages to some containing up to 30 pages. In addition, the amount of supporting documentation that each PCT required also varied considerably. To simplify the process, a decision was made to forward to each PCT one set of documentation which satisfied the most stringent requirements. This set comprised both printed and electronic versions of the MREC application, the MREC approval letter, research protocol, consent forms, participant information leaflets, interview schedules, data collection forms (for all the component studies), signed summary curriculum vitae of both the principal investigator and researcher, and signed application forms for honorary contracts. The equivalent of approximately 50 double-sided pages of text was forwarded to each PCT. In addition, applications for each honorary contract required copies of criminal record bureau checks, references and occupational health declarations.

Populating the registration documents for each PCT was the most time-consuming element of the whole application process for a number of reasons. First, no two registration applications were the same, although most asked similar questions. Secondly, although the forms had been submitted by e-mail, only two of the 14 forms could be completed electronically. The remaining forms had to be completed by hand, because the formatting of the form fluctuated uncontrollably when computer text was added. Finally, each form required the signature of the chief investigator and, in some cases, the signature of the head of the school of pharmacy. Fourteen days after starting the task, the applications were posted using a next-day-delivery service. The R&D approvals began to arrive after three weeks; the last approval was received eight weeks after posting the application.

Obtaining honorary contracts from each PCT required a number of follow-up calls or e-mails. This took considerable time and inevitably influenced when and in which PCTs the evaluation could start. Even though Department of Health guidance suggests that trusts can accept each other’s honorary contracts, in this case only one PCT awarded an honorary contract on receipt of a copy of another trust’s honorary contract.¹¹ For a number of PCTs a different department within the PCT was responsible for issuing the honorary contracts. This fractionation of the process inevitably involved further time delays.

Reflections on the process

On reflection the process appeared to be inconsistent and excessively time consuming for research studies that straddle a number of PCTs. If one form had been acceptable by all PCTs, and capable of being populated using a cut-and-paste facility, that would have made the task less onerous. To this end, a new website has been recently developed by the NHS R&D Forum,¹² which promises to become a valuable resource for researchers in the future. Unfortunately, the existence of this website only became known after the above process had been completed. The forum is seeking to develop a national standard application form. It is to be hoped that this form, when developed, will be readily accepted by all PCTs. Although the website endeavours to list the contact details of all PCT research governance facilitators, which should save considerable time, regrettably not all the contact details are complete. Although these developments are welcome, they do not deter from the fact that documentation has been forwarded to 14 research governance facilitators for their approval. This process, while time consuming for the researcher, is likely to be more wasteful of the resources of the PCT personnel involved as each research governance facilitator will be undertaking similar tasks in order to determine if approval is to be granted.

Similarly, honorary contracts seem to demand comparable requirements regardless of the study context. Obtaining criminal record bureau checks and occupational declarations is understandable if the research participants are vulnerable (eg, children and elderly patients), if data involve clinical investigations, if the researcher comes into contact with hospital inpatients or people who may be possible carriers of particular diseases (eg, tuberculosis) or if access to clinical records is required. However, requiring this level of checks for research that does not involve any of these elements seems over-cautious.

Implications and future directions

Although there is a need for R&D approval to ensure that research has the standards and mechanisms to protect the needs, wellbeing and safety of research participants, it does have implications for both pharmacy practice and health services research.

It is important to ensure that these particular kinds of research studies are not deterred or stifled by the application process. Perhaps, for research that covers a number of PCTs, a multi-R&D approval application could be generated, similar to ethical approval applications. Once approval has been given by the multi-R&D, an outline of the research could be forwarded to other PCTs, not necessarily for approval, but for notification purposes. This would reduce the burden on PCTs and delays in commencing research studies minimised.

Similarly, applications for honorary contracts could be segmented to take account of the methodologies employed by the research study or evaluation. For example, those studies involving clinical investigations or vulnerable people would require a higher burden of proof regarding the credentials of the researchers than studies which do not involve direct contact with patients or clinical records. In addition, it may be prudent for research institutions to consider obtaining criminal record bureau checks for some or all of their research staff in order to expedite the honorary contract application process.

In conclusion, although the aims of research governance are laudable, it is important that the process as experienced is refined and applications processed expeditiously otherwise research governance will become another barrier to future research. This could result in fewer valuable and necessary research projects being undertaken.

References

1. Department of Health. Research governance in health and social care: NHS permission for R&D involving NHS patients. London: Department of Health; 2004.

2. Tully M. New procedures for obtaining ethics committee approval for NHS research. Pharmaceutical Journal 2004;272:675–6.

3. Tully M, Cantrill J. The research governance framework and its implications for pharmacy practice research. Pharmaceutical Journal 2003;271:51–4 (PDF 120K)

4. Salisbury C, Leese B, McManus R. Ensuring that research governance supports rather than stifles research. British Journal of General Practitoners 2005;55:4–5.

5. Jones A, Bamford B. The other face of research governance. BMJ 2005;329:280–1.

6. Boshier A, Shakir S, Telfer P, Behr E, Pakrashi T, Camm A.
The negative effect of red tape on research. Pharmacoepidemiology and Drug safety. In press.

7. Elwyn G, Seagrove A, Thorne K, Ceung W. Ethics and research governance in a multicentre study: add 150 days to your study protocol. BMJ 2005;330:847.

8. Hill J, Foster N, Hughes R, Hay E. Meeting the challenges of research governance. Rheumatology 2005;44:571–2.

9. Togerson D, Dumville J. Ethics review in research: research governance also delays research. BMJ 2005;328:710.

10. NHS in England

11. Department of Health Guidance notes on research governance and honorary contracts

12. NHS R&D Forum Research governance documentation and information guide for primary care trusts. Available at: www.rdforum.nhs.uk (accessed 4 April 2005).