Research governance delays for a multicentre non-interventional study

Summary

Objectives

To evaluate the delay in research governance approval for a non-interventional, multicentre study in the United Kingdom.

Design

The times taken from application to the granting of research governance approval for an observational study of childhood stroke with ethical approval were prospectively recorded.

Setting

Ninety-two acute NHS Trusts in the United Kingdom.

Main outcome measures

Median delay (in working days) between application and research governance approval.

Results

The median delay between application and research governance approval was 43 working days (interquartile range 27–62, range 0–147). The reason for delay beyond 43 working days was inexplicable in 30 (70%) of 44 trusts.

Conclusions

There is considerable variation in the processes undertaken by research and development departments that can lead to significant delays in commencing an ethically approved study. Any improvements to the systems for gaining approval are welcome.

Introduction

Over the last 10 years the processes for obtaining ethical approval for conducting multicentre medical research in England have undergone large changes. A previously decentralized system of local research ethics committees (LRECs) posed particular problems for multicentre studies with the wide heterogeneity of responses being well documented.^1–3 In 1997 multicentre research ethics committees (MRECs) were created and in 2000 the MREC/LREC processes were further harmonized and coordinated by the Central Office for Research Ethics Committees (COREC). In 2007 COREC became incorporated into the new National Research Ethics Service (NRES) which operates in a standardized manner under a strict timetable for giving responses. However, even with ethical approval granted most studies must still seek research governance approval from individual NHS Trust research and development departments before beginning the study in the said trust.

The aim of this study was to prospectively assess the time taken to grant research and development department (RDD) approval for a non‐commercial, non‐interventional multicentre study.

Methods

The Study of Outcome of Childhood Stroke (SOCS) is a multicentre study recruiting participants from across 92 NHS trusts in the southern half of England. It is funded by a grant from the charity The Stroke Association. The aim of the study is to define the epidemiology of childhood stroke in children aged 1 month to under 16 years old and to assess children's outcome one year after stroke. Children are identified and recruited by collaborating paediatric neurologists at nine main centres (major centres) across the study area. It was predicted that the majority of potential participants would be seen in one of these centres as children with stroke are usually referred to a paediatric neurologist for management. In the other 83 centres (minor centres) collaborating paediatricians, radiologists and physiotherapists identify potential participants and send them a letter of invitation. Collaborators in the minor centres do not seek to recruit participants directly by obtaining consent from parents. This is done by a study researcher if the families respond to the letter of invitation by contacting the study.

The study will collect clinical and demographic data from participants' medical notes. Approximately 12 months after the stroke, participants will be visited at home by a study researcher to assess outcome in five main domains: motor function; cognitive function; behaviour; quality of life; and recurrence of the stroke. These domains will be assessed by neurological examination and a variety of validated assessment tools and questionnaires. Participation in the study has no bearing on the clinical care of the participants and the study proposes no intervention although blood is taken (usually at the time of venepuncture for clinical reasons) for DNA extraction and storage. As a major aspect of the study is to estimate the incidence of childhood stroke it was important to have a defined start date for prospective identification of cases that was the same for all centres. Hence, the study could not begin until research and development approval was granted in all centres.

MREC approval was granted for the study in January 2008. The study was granted site specific assessment exemption for the minor centres but did require LREC approval at the major centres. LREC approval was granted in all but one centre within the 25-day limit prescribed by NRES. In one centre LREC approval took 34 days due to staff illness. Applications for RDD approval began in January 2008 and were completed and sent by a single researcher. For all centres, the RDD was contacted by telephone prior to sending an application to ensure that the appropriate methods for applying were adhered to.

All application and approval dates were recorded. Approval dates were recorded as the date of writing the approval letter rather than the actual date of receipt of the letter by the researcher. All communication with the RDDs was also recorded. In some instances the RDDs requested clarification or further documentation after the initial application. If we did not reply the same day then this delay was recorded. Total time taken to grant approval was calculated as the difference in days between the application date and the approval date minus any delay in replying to clarifications. Only working days were counted.

Results

Total time to grant approval ranged from 0 days (approval letter issued on the same day as an electronic application was sent) to 147 working days ( Figure 1). The median time was 43 days and the interquartile range was 27–62 days.

Figure 1.

Time in working days from application to research and development department approval. Black bars are major centres (median = 43 working days)

Telephone enquiries were made to 59 trusts to investigate the reason for delay. These enquiries were made to all 44 centres with delays longer than the median of 43 days. Of these 44 centres, 30 (70%) stated that there was no specific problem and the study was reported to be progressing through the research governance processes as expected. In the other 13 (30%) centres the most common reasons to explain delays were lost applications (although four out of six lost applications were subsequently found by the RDDs), staff shortages, failure of the study to be passed on to replacement staff and omitting to get one aspect of research governance ‘signed off’.

Discussion

It is a stated goal of the government that it is ‘determined to make the UK the best place in the world for health research, development and innovation’.⁴ The Department of Health proposes that measures to ‘reduce bureaucracy’ are an important aspect of achieving this goal.⁵ Although, significant improvement has been made to the ethical approval processes, RDD approval is the weak link in the chain between obtaining research funding and starting to recruit participants. This study demonstrates enormous variability in the research governance processes undertaken by NHS research and development departments despite all departments working under the same government framework.⁶ Other studies have shown similar variability and delays for clinical trials.⁷ An analysis of times to approve four clinical trials found a median delay of 44 working days and an interquartile range of 23–80 working days.⁸ By their nature clinical trials are likely to require greater scrutiny and have greater resource implications than SOCS. Nevertheless, the data presented here show that the same delays that can befall clinical trials can still occur for simple, non‐interventional studies.

It is claimed that perceived difficulties in obtaining ethical approval in the United Kingdom have resulted in multinational studies not having a UK centre.⁹ If there are similar difficulties surrounding RDD approval then this may be contrary to the government's aim of promoting research in the UK. Also, delays are likely to have financial implications. For each month's delay SOCS has direct staff costs of £3600 that are funded from a charitable grant. Finally, delays in starting research that has already been peer‐reviewed to assess its scientific rigour as well as ethically approved may delay the dissemination of the study's results, potentially denying patients the benefits of the study's findings. Therefore, unnecessary RDD delay could be deemed unethical.

Measures to emulate the coordinated, single application point of NRES are planned for gaining permission to conduct research in the NHS and this study can act as a benchmark to gauge the effectiveness of these proposed changes. The National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) was due to be fully operational in April 2008.¹⁰ Although this was postponed the system finally launched in November 2008 for studies that are eligible for inclusion in the National Institute for Health Research Clinical Research Network Portfolio.¹¹ It is important to note that not all studies are adopted into this network portfolio and, therefore, are currently ineligible to use the NIHR CSP. However, if this system can work as planned then a major bottle‐neck impeding the start‐up of multicentre health research studies in the UK can be removed and keep the country at the forefront of health research.

Footnotes

DECLARATIONS —

Competing interests AAM is a researcher for SOCS. FJKO is the chief investigator for SOCS

Funding SOCS is funded by The Stroke Association. The funding source had no influence on the content of this paper and the views expressed are those of the authors alone

Ethical approval Not applicable

Guarantor FJKO

Contributorship AAM and FJKO initiated and designed the study. AAM conducted the study and did the data analysis. AAM and FJKO interpreted the results and wrote the paper