JRSM >
Volume 100, Number 5 >
Pp. 234-238
1 Research Assistant, Division of Community Health Sciences: GP Section,
University of Edinburgh, 20 West Richmond St, Edinburgh, EH8 9DX, UK
2 Senior Researcher, Division of Community Health Sciences: GP Section,
University of Edinburgh, 20 West Richmond St, Edinburgh, EH8 9DX, UK
3 Research Secretary, Division of Community Health Sciences: GP Section,
University of Edinburgh, 20 West Richmond St, Edinburgh, EH8 9DX, UK
4 Programme Lead for Maximising Recovery from Acute Illness & Trauma, Centre
for Integrated Healthcare Research, School of Health in Social Science,
University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK
5 Professor of Primary Care Research & Development, Division of Community
Health Sciences: GP Section, University of Edinburgh, 20 West Richmond St,
Edinburgh, EH8 9DX, UK
6 Clinical Research Fellow, Division of Community Health Sciences: GP Section,
University of Edinburgh, 20 West Richmond St, Edinburgh, EH8 9DX, UK
Correspondence to: Tara Kielmann E-mail: tara.kielmann{at}ed.ac.uk
 | SUMMARY |
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 TOP SUMMARY INTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Design We sent applications (n=316), by email to each PCO, or consortium of PCOs, attaching a completed standard application form, the 15 required documents, and the approval we had been granted by the lead NHS organization. We maintained detailed records of the responses to our application, subsequent correspondence, additional paperwork requested, and time spent on the approval process.
Setting The UK Research Governance Framework, which regulates all research conducted in health and social care settings.
Participants All PCOs in England and Wales.
Interventions None.
Main outcome measures Time taken to obtain approval to undertake a telephone interview with a health service manager.
Results We were unable to establish contact with 13 (4%) PCOs. Six months after submitting our application we had received approval from 259/316 (82%) PCOs and were still awaiting a verdict from 41 (13%). The median time to approval was 56 days (IQR 42-72). Overall, an estimated 318 staff-hours were spent completing supplementary forms, providing additional information and chasing up dormant applications.
Conclusions Recent initiatives to ‘streamline’ research governance approval have failed to address the problems that face researchers undertaking multi-centre studies. There is an urgent need to develop a simpler process that allows low risk research to take place without threatening staff morale and endangering the quality of the research outputs. In the meantime, we advise researchers to allow far greater time than might reasonably be envisioned to obtain research governance approval.
| INTRODUCTION |
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TOPSUMMARYINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Recent literature on the R&D approval process has reflected on the rationale behind research governance procedures,1 explored how the governance process judges the risk of harm within research6 and described the underlying ethical principles,7,9 whilst arguing for flexibility in the application of these principles to health care research.6,7,10 While the justification for governance (‘to ensure that the public can have confidence in, and benefit from, quality research in health and social care’2) is clear, several researchers have publicly expressed frustration and demoralization resulting from stringent and lengthy research governance procedures that impede the onset, progress, quality and outcomes of research.11-16 In response to these concerns, a standard R&D application form (Form D) has recently been introduced to streamline applications for multi-centre research which ‘all NHS organizations are strongly recommended to accept.’17
This paper is the first to describe the experience of using the new ‘streamlined’ system to apply to all PCOs in England and Wales for R&D approval for the initial phase of an ethnographic study exploring respiratory workforce dynamics in PCOs in England and Wales.18 This first phase involved conducting a single telephone interview (maximum duration 45 minutes) with a health service manager in a sample of PCOs with a range of demographic profiles and offering diverse approaches to the delivery of respiratory services. Our project schedule required us to complete these interviews over three months, in preparation for subsequent in-depth case studies of the development of respiratory care in selected PCOs. Since approval was sought simultaneously from all PCOs in England and Wales, our experience provides a national snapshot of the current state of obtaining governance approval for low-risk, multi-centre research.
| METHODS |
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TOPSUMMARYINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Approval from the 316 remaining PCOs in England and Wales
During the week beginning 24 January 2006, we sent out applications by
email to 76 R&D leads covering 310 of the remaining 316 PCOs in
consortiums or individually, as listed on the R&D Forum website for
England and Wales. No contact details were available for the R&D leads in
the other six PCOs. We attached a completed standard R&D application form
(Form D) and the 15 required documents
(Table 1). In addition, we
appended the approval we had been granted by the lead NHS organization.
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Record of progress
The study researchers and secretary maintained detailed records of the
responses to our applications, subsequent correspondence, and additional
paperwork requested. Time spent on the approval process was noted at the end
of each working day.
| RESULTS |
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TOPSUMMARYINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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PCO approval granted
The median time to gaining approval was 56 days (IQR 42-72); three PCOs
(1%) declined approval. By the end of July 2006 (i.e. six months after
submitting our application) we had received approvals from 259/316 PCOs (82%)
across England and Wales, although approval for 16 Welsh PCOs was conditional
on translating the information sheet and consent form into Welsh. Time
constraints have prevented us from complying with this requirement and we have
thus lost the opportunity to gain potentially valuable insights into
respiratory service development in many of the Welsh PCOs. We had been unable
to contact 13 PCOs (4%) (six without contact details, and seven because the
details provided were incorrect) and were still awaiting a verdict from 41
(13%) after six months, by which time we had no choice but to move on with
subsequent phases of the study.
Time implications and opportunity costs
Overall, an estimated 318 staff-hours were spent achieving R&D
approval. This occupied all our secretarial time, a substantial proportion of
the senior researcher's time and considerable time input from the principal
investigator over about 10 weeks, as we were required to complete
supplementary forms, reformulate letters and chase up dormant applications,
rendering the study about two months behind schedule
(Figure 1). The on-going
requests for progress reports from the R&D offices, despite our sending a
standard report to all R&D offices from whom we had had approval at six
months, is currently further delaying the project.
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| DISCUSSION |
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TOPSUMMARYINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Limitations and strengths of this work
The minimal intervention for which we sought approval represented no
foreseeable risk to participants, so our findings may not be representative of
the delays imposed by the process on complicated intervention studies, and
particularly those involving patients. Also, our data only relate to
governance approval in England and Wales, and these experiences may thus not
be generalizable to Scotland or Northern Ireland. The study's main strength
lies in the fact that we attempted to approach all PCOs in England and Wales
either individually or through their R&D consortium. Importantly, it is
the first study to describe the experience of using the
‘streamlined’ system.
Interpretation of findings in relation to the published literature
Little appears to have changed since the introduction of a standard R&D
application form in March 2005 designed to ‘streamline the R&D
approval process’ and ‘minimise unnecessary bureaucracy for
researchers.’17,20
The process still feels impossibly cumbersome, taking a median of 56 days for
82% of PCOs to approve a short interview with a health care manager. Our
experience is very similar to that reported before the introduction of the
standard process. In 2003/04, only 80% of English PCOs had granted approval
for a questionnaire survey of health care professionals after four
months.13 Another
study involving patient questionnaires reported taking 103 days to achieve
approval in all the 20 NHS trusts to which they
applied.14 A key
factor is the devolution of research governance to individual trusts and a
lack of central guidance, which has resulted in diverse local interpretation
and a plethora of different forms and
procedures.5
Although the standard application form is ‘strongly recommended’
by the R&D Forum, it is not mandatory, and supplementary forms and
procedures abound. Six months after the introduction of the
‘streamlined’ procedures, a survey of PCO R&D officers found
that although they preferred their own local documentation, they stated that
they would accept the standard application
form.20 Our study,
in which a third of organizations requested additional forms or information,
suggests that this may not be the case.
Discussion papers have called for flexibility in estimating risk and applying research governance procedures.6,7,10 Our study, in which the nature of the research was harmless enough to show the absurdity of stringent governance requirements, illustrates this need. While it is clear that staff involved in health research owe full accountability to their study participants, governance procedures that have developed in response to investigational medicinal products cannot be appropriately applied to all applications for R&D approval.
The NHS R&D Forum have just released a common form for both local ethical and R&D approval which will hopefully reduce the burden of form filling.21 However, this does not address the key underlying problem of each trust enforcing regulations according to their own particular interpretation of the responsibilities. A system in which the lead R&D department (or a ‘Multicentre R&D committee’) classified research as being of high, medium or low risk according to agreed criteria, so that local trusts would then apply uniform regulations appropriate to the research, would seem sensible. Timescales, such as apply to ethics applications, should be mandatory.
| CONCLUSIONS |
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TOPSUMMARYINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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| Footnotes |
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Funding NHS Service Delivery and Organization R&D Programme (SDO/99/2005).
Ethical approval South-East Multi-centre Research Ethics Committee (05/MRE01/109).
Guarantors Hilary Pinnock and Aziz Sheikh are study guarantors.
Contributorship Hilary Pinnock, with the help of Guro Huby and Aziz Sheikh, led the development of the protocol, securing of funding, study administration, data analysis, interpretation of results and writing of the paper. Alison Tierney, Rosemary Porteous and Tara Kielmann undertook data collection and analysis, and led the writing of the paper. All authors reviewed the final manuscript.
Acknowledgments We thank the members of the Independent Steering Committee, Bonnie Sibbald, John Taylor and Donna Covey for their oversight and support of the project. We are also grateful to David Selling for his invaluable advice as the R&D manager for the lead NHS organization, and for his helpful comments on the paper.
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