Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.
Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.
Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.
- Approx. 89 individuals were involved in the study approvals;
- 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
- 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
- 491 exhanges took place with the 89 individuals, generating 193 pages of text.
Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.
You can read the HRA’s response here, which signposts the reader to further resources.
Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.