Depending on who your participants are and the setting of your research project, you may need to apply for ethics approval from an external research ethics committee. Below is some information about instances when City research ethics committees are unable to review your study.
External research ethics committee approval
If your research project does require external approval you will still need to ensure that your study is covered by City’s insurance policy.
Although you will not need to get ethical approval from City of such projects, you are required to register your project using the external approval form. Unless you are a member of staff or a student in the School of Health Sciences, this form must be submitted to email@example.com.
Note that only authorised signatories are able to sign off applications to external research ethics committees. Students should note that, in most instances, this does not include their supervisor.
The following are authorised to sign off applications on behalf of City:
- Heads of Departments
- Associate Deans for Research
- Deans of Schools
You will also need to include a letter from the Sponsor (City) with your application that confirms that City is willing to accept the responsibility of the study. This letter should be written by the authorised signatory, unless that person is the same as the Principle Investigator.
There may be some local variations on the processes outlined above. Please contact your local REC for further information.
If the study will recruit patients and/or relatives or carers through the NHS, or access their medical records or personal details, approval from the Health Research Authority (HRA) will be required. Guidance on how to make an application can be found online, the application form here, and information about the HRA assessment here.
You can use the HRA decision tool to establish if you require HRA REC approval.
If the research study involves participants (16 years old & over) who fall under the Mental Capacity Act (2005) who are unable to give informed consent, for example, but not limited to, people who may have a degree of learning disability or mental health problems, which means that they are unable to make an informed decision on their own behalf; then an application to an authorised HRA committee must be made, regardless of whether or not they are NHS patients.
Guidance on capacity in adults can be found online here.
If the project is with Prisons or Probation Trusts an application to Her Majesty's Prison and Probation Service will be required. Please refer to HMPPS website for more information.
Note that the NOMS approval process extends to research in Community Rehabilitation Companies (CRCs) and their subcontractors, Young Offenders’ Institutions (YOIs), but excludes research in Secure Training Centres, Secure Children’s Homes or with Youth Offending Teams – applications to conduct research in these areas should be directed to the Youth Justice Board.
The ethical review of research funded by or sponsored by the Ministry of Defence, or research carried out by third parties on UK Armed Forces Staff is carried out by MoDREC.
City does not have a Human Tissue Licence.
A HTA licence is for storage of relevant material for use in research, not for the use itself.
Under the Human Tissue Act 2004, storage of ‘relevant material’ (material from a human body consisting of or including cells) for scheduled purposes in England, Wales or Northern Ireland requires a licence from the Human Tissue Authority (HTA). The scheduled purposes include research in connection with disorders or the functioning of the human body.
The HTA does not approve individual projects or license research activity itself but the organisations that store human tissue for research, including the following activities:
- Removal of relevant material from the deceased for the scheduled purpose of research.
- Storage of relevant material (from both the living and the deceased) for the scheduled purpose of research.
- A licence is not required for storage in connection with a specific research project with approval from a REC. This exemption does not apply to tissue banks storing relevant material for use in future research. Where voluntary application is made to a REC for ethical review of a research tissue bank, a copy of the licence will be required by the REC as a condition of a favourable opinion.
For further information is available on the HRA website.