Which Type of Ethics Approval is Required?
Avenues for Ethical Approval
1. Division/School Review: Low Risk STUDENT projects only
A limited number of Divisions/Schools across the University have the ability to provide ethical review of low/medium risk student projects at Division/School level, providing they adhere to a specified set of criteria. As this criteria varies between Divisions/Schools it is imperative that you take the time to read the guidance notes below if you wish to apply for ethical review at Division/School level. Please also ensure you discuss this with your supervisor as mistakes can result in substantial delays to the ethical review process. If you do not see your Division/School listed below then it does not currently have this avenue available and you will need to apply for ethical review via Proportionate or full UREC.
Guidance Notes for Divisional/School Review
- Alliance Manchester Business School
- Arts, Languages and Cultures
- Computer Science
- Environment, Education and Development
- Mechanical, Aerospace and Civil Engineering
- Psychology Research (i.e. Division of Human Communication, Development & Hearing, Division of Neuroscience & Experimental Psychology and Division of Psychology & Mental Health)
- Social Sciences
2. Proportionate University Research Ethics Committee (UREC) Review: Low Risk staff or student projects
Proportionate UREC review is available to those researchers (staff and students) conducting low risk projects which are defined as adhering to the Proportionate UREC criteria outlined below.
**Denotes mandatory criteria that must be met in order to qualify for Proportionate UREC review. If your study does not meet these mandatory criteria you will need to apply for full UREC review, where appropriate.
If your research involves an activity falling within one of the conditional criteria beginning with ‘if’ then it must meet the requirements of that criterion or criteria to be considered for Proportionate UREC review.
Participants and Consent
- **Involves only participants who are non-vulnerable adults able to give informed consent or, if children/ young people are involved, they must be in an educational setting/accredited organisation and have the opportunity to assent with parental/guardian opt-in consent also provided.
Data Collection and Experimental Procedures
- **Does not involve physically invasive procedures (please note physically invasive refers to any test in which the skin of the participant is broken, or an implement is inserted into any opening of the human body, or involves the taking of body samples such as saliva, hair, urine, faeces, sputum, blood, skin, nails, or taking biopsies of any form for any purpose, or any form of scanning such as DEXTA scans, ultrasound scans, MRI, fMRI, CT or PET scanning). This excludes standard audiology tests such as collecting optoacoustic emissions, measuring acoustic reflex thresholds, performing otoscopy and tympanometry providing these are involving healthy adult volunteers (if involving other groups of participants such as children, full UREC review is required).
- **Does not involve activities that pose a significant risk of causing physical harm or more than mild discomfort.
- **Does not involve activities that pose a significant risk of causing psychological stress or anxiety.
- **Does not require participants to take part in activities that pose a significant risk of having an adverse effect on their personal well-being (e.g. physical and psychological health), social well-being (e.g. social standing, social connectedness) or economic well-being (e.g. employment, employability, professional standing).
Sensitivity of Topic or Data
- **Does not involve collecting or revealing data that enables individuals, groups or organisations to be identified in such a way that they could experience negative effects on their personal, social or economic well-being.
- **Does not require research participants to provide personal and sensitive information likely to lead to significant levels of distress (ie research must only involve topics that are either not contentious or sensitive at all, or where a reasonable person would agree the topic is of legitimate interest and may result in distress only in rare instances).
- If topics being researched are of a sensitive nature, they are not personal to the participants.
- If using video recording or other images captured by the researcher and/or research study participants, the researcher is able to guarantee controlled access to authorised viewing.
- If researching professional practice, participants are in professional roles and the research is conducted in their work setting. It would also be acceptable to conduct these interviews via telephone or Skype as long as the content of the interviews is focused on professional practice and non-sensitive topics. Please note that in this instance, participants will be responsible for ensuring appropriate privacy arrangements.
- If conducting observations, they will be on ordinary, non-sensitive behaviours.
Location of Data Collection
- **Will be conducted exclusively inside the EU or in one of the 3 non-EU EEA member countries.
- **Will be carried out within normal working hours or at a time convenient to participants.
- If conducting observations they will be located in a public space or the clearly public areas of a building (e.g. the high street, the University campus, the entrance hall of a town hall).
Human Tissue Specific Criteria (if applicable)
- Research involving relevant material, limited to the secondary use of anonymised tissue samples, previously collected with consent for use in research.
- Research involving the analysis of DNA (or RNA), or using the results of DNA analysis from bodily materials, including extraction of DNA (RNA) from acellular materials where the samples have been anonymised, previously collected and with specific consent for DNA (or RNA) analysis in research.
- Research involving the use of tissue samples that comprise existing holdings that were collected before September 2006.
If your study does not meet all the mandatory criteria as outlined above, you MUST apply for full UREC review.
If you have any queries regarding this process or your application, please email email@example.com and be sure to include the reference number and title of your submission.
3. Full University Research Ethics Committee (UREC) Review: High risk staff or student projects
4. Health Research Authority (HRA) Approval (including NHS REC)
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.
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 contact:
- Lynne MacRae for those in all Faculties (email: FBMHethics@manchester.ac.uk)
5. Both HRA and UREC approval
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.