3.2 Ethics approval procedures

Guidance on getting ethical approval for research
  1. You must ensure that ethical approval is acquired prior to an application for research funding where this is a requirement of the research funder, for example NHS research, and before research commences in other cases. In general, the PI is responsible for ensuring that ethical review and approval is in place if the research involves human participants, personal data or animal studies. Ethical approval may be required for projects funded by the University and those not receiving any funding at all, as well as for externally funded projects.
  2. You should seek advice on ethical approvals from the appropriate Departmental Ethics Officer or Ethics Sub-Committee member. Researchers may also seek advice from the Research Governance Manager, in particular around ethics review for research in the NHS. Students should also seek advice from their supervisor in the first instance.
  3. You must ensure that ethical approval is secured prior to the commencement of any research where this is required by:
    1. Statute or statutory instrument (such as the Clinical Trials Regulations or the Animals (Scientific Procedures) Act 1986);
    2. Government Policy (e.g. the Research governance framework for health and social care for NHS Health research);
    3. Regulatory authority, safety committee or professional body;
    4. Research funder (e.g. ESRC Framework for Research Ethics or Ministry of Justice); or
    5. the University's Research Ethics Code of Practice.
  4. In cases where ethical approvals are required and external research funding is available, Research Support Services will not release funds until it has received evidence that the necessary ethical approvals are in place. A temporary exemption may be granted for projects in which the development of the methodology forms part of the project such that prior approvals cannot be given.
  5. Where ethics approval is required, you must seek ethics review and approval from the appropriate sub-committee. Researchers are responsible for ensuring that the correct sub-committee is competent to reviews the research. You should contact your Departmental Ethics Officer or Ethics Sub-Committee member for advice on which Committee to approach.
  6. If your research involves the NHS it will need HRA  approval. Please contact the Research Governance Office who assist in this process. If HRA approval is required, the proposal does not need to be reviewed by the University Research Ethics Committee as well.
  7. Where the research needs to be reviewed by the University, you must submit an application online by using the University Ethics Review system. Policy and guidance on the University Ethics Review is regulated by the Research Ethics Code of Practice.
  8. You must seek a favourable opinion (equivalent to approval from other ethics committees) from the relevant NHS Research Ethics Committee designated by the Health Research Authority (HRA) for:
    1. Research involving NHS patients (including their tissue or data) or the relatives or carers of NHS patients identified because of this status;
    2. Health-related research involving prisoners;
    3. Social care research projects funded by the Department of Health; or
    4. Research where NRES review is required by law (e.g. within the remit of the Human Tissue Act 2004, the Mental Capacity Act 2005, or the Medicines for Human Use [Clinical Trials] Regulations 2004, with its amendments which came into force in August 2006, December 2006 and May 2008).
  9. If a study is using only NHS staff or premises it may not require an NHS ethics opinion but still require NHS R&D review and approval, as per the Governance arrangements for research ethics committees: a harmonised edition (Updated April 2012). In this case it may also require review through the University’s ethical review system. For advice in this area, you should contact the Research Governance Manager.
  10. Where research involves Ministry of Defence funded research, ethical approval must be sought from the relevant Ministry of Defence Research Ethics Committee (MODREC).
  11. Where the ethical requirements of an approving body conflict with the provisions of this Code, or where the requirements of multiple approving bodies conflict, researchers must seek guidance from the Chair of the University Research Ethics Committee.
  12. Research must be conducted in compliance with any conditions specified by an approving regulatory body, nominated reviewer, Ethics Sub-Committee, the University Research Ethics Committee or other relevant funder or approving body, and the University’s Research Ethics Code of Practice.

Share this page:

Who to contact

Research Support Services Contact details

Tel - (0116) 252 2437 or (0116) 229 7763

Fax - (0116) 252 2028

E mail - RED@le.ac.uk