Research is key to providing evidence for best practice in healthcare. The current system of approvals and permissions for conducting research in the NHS presents a number of practical challenges, most noticeably navigating the complexities of the system and overcoming the inconsistencies that can be encountered.
Few would argue with the need for some sort of ethical review of research in the NHS – protection of patients under NHS care is paramount. There is a clear duty of care that exists, particularly when research involves potentially vulnerable populations like children.
The system of obtaining approval to carry out research in the NHS is constantly evolving. Currently, studies classified as ‘research’, rather than service evaluation or audit, have to obtain approval from an NHS Research Ethics Committee and local-level NHS management permission – research and development (R&D) approval. By the end of 2015, both REC and R&D approval will be undertaken in one sitting by the NHS Health Research Authority (HRA).
Based on my experience with gaining research approval – even for studies broadly classified as 'low risk', like those involving consenting NHS staff – there is room for improvement. Single approval from the HRA seems like an important first step to help with consistency across the service.
An inconsistent process
Why is variability in the approval process such a problem? Let me give an example.
As part of an evaluation funded by the Cabinet Office, I am working with a team to evaluate locally run volunteer schemes in sites across England that aim to reduce hospital admissions and assist patient discharge.
One part of this evaluation requires interviews with NHS staff. Other parts of the evaluation fall outside the NHS remit, such as interviews with volunteers, stakeholders and paid project staff working for various charities.
According to current advice, it is not necessary to obtain NHS Research Ethics Committee or local level R&D approval for evaluation work. However, it is still necessary to contact local R&D departments to see if they have any specific requirements.
In this case, I approached two R&D departments with exactly the same information, describing the nature of the project – a service evaluation – and asking for details of their local process.
The first location did not require any formal local level approval for a service evaluation, and said that we were 'good to go'. We were free to speak to whomever we liked, as long as they gave individual consent.
But in location two, we were told we would need to obtain full R&D approval via the Integrated Research Application System (IRAS) as they would classify the project as research rather than evaluation.
Implications of ethical variance
These two very different interpretations of the same project had big consequences for how the work was carried out.
In location two, we felt that the timelines were too short to achieve approval. The IRAS R&D form is populated by much the same content used to complete a full application to a REC. It is a lengthy process which we did not feel could be justified for one or two interviews. As such, we identified interviewees from other sources outside the NHS to bypass the requirement for local-level approval.
Ultimately, research projects have funding and time constraints, which mean that research design needs to be pragmatic – and this may mean avoiding working within the NHS system if it jeopardises the deliverability of a study.
There are obvious implications for this. If the views of NHS staff and potentially patients are not represented, the extent to which findings can be used to improve practice will be limited.
Tips for researchers
The process as it stands is challenging to researchers, who need to have the time and knowledge to dedicate to the administration involved. I am in the fortunate position (or unfortunate, depending on your perspective) of having gone through the process a few times. I now know, more or less, what to expect. Based on these experiences I would offer the following advice:
- Allow a healthy period of time to navigate NHS research approval as well as other associated administration depending on the work being undertaken.
- Contact the R&D department local to where the work is being conducted to see what their specific requirements are but have a clear idea in your mind whether your work is research, audit or service evaluation.
A new era
Will a single approval from the Health Research Authority (HRA), which will incorporate both aspects of the current review system, help?
Having a streamlined process seems to be a step forward in terms of speeding up the time taken for research ethics approval. In the case of work falling under the research classification this will be extremely valuable.
I will watch with great interest as the next phase of changes to the NHS research approval process takes place. My hope is that the process removes some of the uncertainty as to how a project is dealt with at a local level so that the focus can be on quality research rather than administration. This is the best way to ensure patient protection.