Which Type of Ethics Approval is Required?
There are two possible avenues for your research proposal to obtain ethics. It is important that you read the information below so that the relevant ethics committee is asked to consider all relevant material ethical issues:
1. University of Manchester Research Ethics Committees (UREC)
Your research proposal will have to be assessed by one of five URECs if you are proposing to work with participants who are:
- members of the general public
- members of certain non-NHS support groups/ charities
- individuals at your place of employment
and the type of research includes:
- focus groups
- case studies
- observational studies
- ethnographic research
- overseas research
- human tissue samples imported from outside the UK
- human tissue samples collected from Healthy Volunteers
- secondary use of tissue samples previously collected with consent for research and the patients or service users are not identifiable to the research team
- human tissue samples held under the HTA license
2. HRA Approval
In March 2016, the Health Research Authority (HRA) fully launched the HRA approval process. This streamlined process, which applies to research carried out in the NHS in England, brings together a new process of conducting governance and compliance checks on behalf of NHS organisations (HRA study-wide assessment) with independent NHS REC review (where required). HRA study-wide assessment is carried out by HRA assessors and replaces some of the checks that were previously carried out by individual Trusts as part of the old R&D approval process.
One of the benefits of the new system is that researchers only have to submit one application to the HRA. In most cases, this single application (which requires an IRAS form) will go through NHS REC review and HRA study-wide assessment in parallel. Once the REC approval is in place and all the HRA study-wide assessments have been completed, the study will be issued with HRA approval which means it can go ahead to within NHS sites in England (subject to local agreement).
However, there may be situations where studies only need to go through part of the process or bypass the HRA approval process completely:
Example 1- a study is taking place in a community setting with individuals who are not patients but who do lack capacity to consent. As this study does not involve the NHS, HRA approval is not required but, it does involve adults that lack capacity to consent so there is a legal requirement NHS REC review. The researcher would submit an application to the NHS REC only.
Example 2- a study was taking place in a hospital but the participants are members of staff recruited within their professional capacity. This would be exempt from REC review (based on the Governance Arrangements for RECs) but would need to have HRA approval (HRA study-wide assessment only). The researcher would submit an application for HRA approval indicating it is exempt from REC review.
- Example 3 – a study is taking place in the NHS and involves patients but is being carried out in Wales. The study would require NHS REC review because of patient involvement but, as it is being conducted outside of England, it would not require HRA approval. The researcher would submit an application to the NHS RECs and also to the R&D office for the NHS site.
How does HRA approval fit with UREC approval?
For the majority of research involving human beings, their tissue or data which is carried out on behalf of the University, the University expects it to have gone through a process of ethical review.
If your study has gone through NHS REC review as part of the HRA approval process or even outside of this process, you don’t need to apply for UREC review; the activities listed in the protocol and IRAS form will be covered by the NHS REC approval and this will satisfy the University’s requirements.
Where your study does not require NHS REC approval, it may need UREC approval to satisfy the University’s requirements. Unless the study was also exempt from UREC, you would need to make an application for UREC review.
If your study does require UREC review but also HRA approval i.e. it is being carried out in the NHS but exempt from NHS REC review, then you will need to the through both review processes. These review processes are independent and each requires a separate application form to be completed. The same core study documents (protocol, information sheets etc.) should be used for both review processes.
You will require HRA approval if:
- Your research involves the NHS in England
You will require NHS REC approval if your research will involve any of the following:
- NHS patients, their data or tissues
- NHS staff where the research is not limited to non-sensitive questions about their personal role
- Participants who are users of any services for which UK Health Departments are responsible. This includes adult social care in England under certain circumstances; a full list of circumstances that require approval by the National Social Care Research Ethics Committee can be found here
- Prisoners in the custody of the National Offender Management Service, the Scottish Prison Service or the Northern Ireland Prison Service, where the research is health-related
- Adult participants who, under the Mental Capacity Act, may lack the capacity to provide informed consent
- A non-CE marked medical device
- Exposure to ionising radiation
- Processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers without consent
- A clinical trial involving the participation of practicing midwives
- Participants who are being identified due to their past use of NHS services
Please visit their website for more information on the NHS REC or HRA review/approval process and the additional specific instances in which either NHS REC or HRA approval will be required.
If you are unsure as to whether your research will require approval via the NHS REC or the HRA, please use the HRA Decision Tool. The answer to this tool is definitive and it is strongly recommended that you save a copy of the result for your records.
If you have any additional queries about the specifics of your research project, please use the following contacts:
- Lynne Macrae for those in the Faculty of Biology, Medicine & Health (email: FBMHethics@manchester.ac.uk)
- Genevieve Pridham for those in the Faculties of Science & Engineering or Humanities (email:email@example.com)