As researchers we accept that obtaining approvals and permissions to undertake studies is part of our working lives. The Health Research Authority (HRA) was set up in 2015 to “make the UK a great place to do health research, to build confidence and participation in health research, and so improve the nation’s health”. It brings together the assessment of legal compliance and ethical review of research in health and social care in England, and they work closely with the other countries in the UK to provide a UK-wide system. They provide guidance and tools to support decision-making.

We wonder if our recent experience over obtaining permissions for the BEEM trial will resonate with others. A few years ago the Maternity Theme for NIHR CLAHRC West Midlands worked with local community midwives to standardise the quality and content of their discussions with healthy, low-risk women about their place of birth options. We used COM-B theory [1] to underpin intervention development and showed an improvement in community midwives’ knowledge and confidence with a package that consisted of a face-to-face update session and ongoing support from a fellow member of the community midwifery team.[2] We have since gone on to develop an e-Learning for Health session with the Royal College of Midwives, which is accessible by all midwives (e-lfh.org.uk/programmes/place-ofbirth/).

In February 2019 we were approached by the Black Country Local Maternity System (LMS), who wanted to mandate this session for all of their community midwives. The LMS consists of four maternity hospitals, with nearly 20,000 births each year, and employing approximately 200 community midwives, thus it gave us an opportunity to more robustly evaluate the package.

After discussion with the Heads of Midwifery we agreed to undertake a cluster randomised controlled trial, incorporating a modified Solomon design. This would explore whether a Place of Birth lead midwife, in addition to a mandated e-learning session, further improves the fact-based knowledge of community midwives on place of birth options for healthy, low-risk women. Knowledge is being assessed by a questionnaire consisting of eight questions. The unit of randomisation will be the community midwifery team within each of the four participating NHS Trusts, stratifying within each to ensure that each Trust has the opportunity to have a Place of Birth lead midwife within a randomised number of teams, as these vary in number and size. The table below shows the study design.

We know that using a questionnaire before and after training is, in itself, likely to improve participants’ knowledge, so we have used a research design to account for this ‘pre-test sensitisation’.[3] In a ‘pure’ Solomon design some community midwives would have been excluded from completing the e-learning session, so the Solomon design has been modified to allow all teams to complete the session.[4]

Undertaking research with NHS staff does not require approval from the NHS Research Ethics Committee, as defined by the HRA decision tool for that purpose, but we do require peer review of the study as part of approval by the University of Birmingham (UoB) Ethical committee. This usually takes about eight weeks. As the study design was randomised we are required to have HRA approval, as well as approvals in each of the maternity units to undertake this work.

We co-designed the trial with community matrons from each maternity unit during the summer of 2019; developed a peer-reviewed protocol; and had University of Birmingham ethical permission in place by the middle of October 2019. Since then we have been battling with the HRA and the Research and Development Departments of local maternity units, with final permissions still not in place as of March 2020.

We began with the HRA process in the autumn by completing the electronic application form – we are not alone in finding the guidance on the HRA website confusing.[5] There were numerous iterations of the application between research governance at UoB and the research team, and it was submitted following UoB ethical approval in early November 2019. While some elements of research permissions processes have set timelines, once a project is submitted to HRA there is no specified time-frame for researchers to be made aware of the outcome and so we sat and waited. Early in 2020 the HRA were contacted and an apology received, followed eventually by a favourable outcome on 16th January – some ten weeks after submission.

Then begun our final hurdle, which required HRA approval to already be in place, and that is to obtain approval from each of the Research and Development departments of the participating hospitals. Initial exploration on the Trust websites as to who to contact in order to find out what documentation was required was only correct for two of the four Trusts. All of the contacts were sent a standard set of documents and all responded asking for different additional information. Once again there is no time-frame for us to expect permissions to be in place. Some eight weeks after HRA approval, local permissions are now almost in place. However, the trial has been halted in consultation with clinicians due to the impact of COVID-19. The total time taken for these permissions to be obtained has been 18 weeks to date.

Others have found that this process to be time-consuming, frustrating and a cause of delays. [5] The excessive bureaucracy has created a new industry of people supporting the process and the delays have increased the costs. Petrova and Barclay recently described a ‘low key’ study that involved 89 professionals in order to approve it![6] It seems to us that our desire to undertake this study using a randomised and more robust design (thus deeming it research) has caused this five month delay for what is, essentially, an evaluation of a mandated 15-20 minute e-learning session and completion of a short questionnaire to assess knowledge of community midwives. Luckily the heads of midwifery have been very patient and understanding, but that might not have been the case.

While we have not explicitly collected how long this has taken, considerable time and resources have been spent in this process. Some would say it is disproportionate for relatively low-risk trials of staff training to require the same level of detail and review as drug trials involving changes to clinical care and potential risk to participants. The HRA have acknowledged this, and additional templates are now available, but they don’t account for this type of study design. In the instance of our BEEM trial our question is: is this proportionate review? Have the delays we have encountered protected the participants?

Solutions are complex in order to expedite change to simplify research approval processes. These might include the development of a broad range of templates so researchers are not forced to use unsuitable ones or duplicate effort; time-frames for the approvals process; systems of more proportionate review; improved information and training for researchers; and ideally more evidence of the cost to researchers (both in terms of time and money) of the current process. Others may have additional ideas. Comments please to S.Kenyon@bham.ac.uk.

Sara Kenyon, Professor in Evidence-Based Maternity Care

References:

1. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011; 6: 42.
2. Henshall C, Taylor B, Goodwin L, Farre A, Jones ME, Kenyon S. Improving the quality and content of midwives’ discussions with low-risk women about their options for place of birth: co-production and evaluation of an intervention package. Midwifery. 2018; 59: 118-26.
3. McCambridge J. From question-behaviour effects in trials to the social psychology of research participation. Psychol Health. 2014; 30(1): 72-84.
4. Plowright A, Taylor C, Davies D, Sartori J, Hundt GL, Lilford RJ. Formative evaluation of a training intervention for community health workers in South Africa: a before and after study. PLoS One. 2018; 13(9): e0202817.
5. Ranieri V, Stynes H, Kennedy E. Navigating multisite research set-up and approvals: helping researchers on the ground—a commentary. Research Ethics. 2019; 15(3-4): 1–5.
6. Petrova M & Barclay S. Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better. BMC Med Ethics. 2019; 20:7.