If your study is led from England and involves the NHS is England, you should now use HRA Approval.
NHS Research Ethics Committees consist of up to 18 members, 1/3rd of whom are lay (broadly, this means their main professional interest is not in a research area, nor are they a registered healthcare professional). They safeguard the rights, safety, dignity and well-being of research participants, independently of research sponsors.
They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. RECs are entirely independent of research sponsors (that is, the organisations which are responsible for the management and conduct of the research), funders and investigators. This enables them to put participants at the centre of their review.
Each year, RECs review around 6,000 research applications across the UK. On average, they give an opinion in less than 40 days: well within the maximum allowance of 60 days.
There are currently more than 80 RECs across the UK.
What do they cover?
RECs review a wide range of research, including research that falls into one or more of the following categories:
- clinical trials of investigational medicinal products (CTIMPs), apart from phase 1 CTIMPs in healthy volunteers. (Selected RECs can review Phase 1 trials in healthy volunteers; our Central Booking Service (CBS) can identify agenda slots at meetings of these NHS Type 1 RECs)
- research involving medical devices;
- research involving prisoners;
- research involving adults lacking capacity;
- establishment of research tissue banks;
- projects funded by the US Department of Health and Human Services (DHHS);
- establishment of research databases.
Research applicants include:
- pharmaceutical and medical device companies;
- healthcare professionals in the NHS;
- academic researchers, including students; and
- prison health researchers.
Researchers look at a wide range of issues in addition to clinical trials of investigational medicinal products (CTIMPs); for example, qualitative research, other clinical interventions, and research into the NHS itself. Some applicants to RECs wish to set up Research Databases for use in other projects, or to establish a tissue bank for research purposes.