Applying for University ethical approval

Human participants

‘Human participants’ are defined as including

• living human beings
• human beings who have recently died (cadavers, human remains and body parts)
• embryos and foetuses
• human tissue and bodily fluids
• personal data and records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements)

Where researchers undertake research-aligned activities (i.e. consultancy, evaluation, impact, engagement, audit) to share knowledge, enhance understanding or improve services by collecting data from human participants in the form of surveys or other types of feedback, they do not normally require ethics review. However, if these activities are designed to generate robust data or evidence to be published, presented or otherwise made publicly available, then ethics review is necessary.

The Ethical Public Engagement Tool and Guidance helps researchers to determine if their activity involving members of the public incorporates research and therefore requires ethics review.

Non-human subjects

All research involving animals other than humans where the animal is the subject of the research, whether undertaken by the University's staff or students, must undergo an ethics review and a favourable opinion must be obtained before it commences. For the purposes of ethics review of research, the University uses the broadest definition of animal.

Projects involving the NHS

Projects involving the NHS may be classified by the University as research but may not be classified as such by the HRA, e.g. service evaluations and audits. In cases where the project involves human participants, but it has not been defined as research by the HRA, ethical approval will need to be sought through the University’s ethics review processes.

Read more on Projects involving the NHS, MOD, HMPPS, or health and social care services and ethical approval.

Ethical review is a process that helps researchers to fulfil their responsibilities as per the University’s Code of Good Research Practice.

Failure by a researcher to comply with the provisions of the Code will be grounds for action to be taken under the University’s Procedure for the Investigation of Allegations of Misconduct in Research or the Academic Offences Procedures for students, as appropriate.

Consult the guidance

• You should consult the Guidance on ethical issues in research with humans, their data or samples and the Guidance on ethical issues in research with animals for more on what to consider when planning your project and completing an ethics application.
• The Moodle course Research Involving Human Participants provides an overview of the responsibilities researchers have when conducting research involving human participants. It also outlines the ethical considerations of such research. Completion of this course is recommended before commencing an application for ethical approval for the first time.
• If your research involves the NHS you should read the guidance about Projects involving the NHS, MOD, HMPPS or health and social care services.

Log in to ERAMS

Applications for ethics approval are made via ERAMS (Ethics Review and Management System). 

• Log in to ERAMS

Complete and submit the ethical approval form

Remember,

• The form should name all researchers associated with the project so that ethical approval covers everyone involved.
• Student applications should be checked and authorised by their supervisor.
• Researchers should submit their application as far in advance of needing to start their project as possible to ensure it can be reviewed in time.
• The ERAMS will not permit researchers to enter a start date which is within two weeks of the date of the creation of an application.
• Make sure you include the Participant Information Sheet and Consent Forms.

Where appropriate you should include the following with your application form,

• Participant Information Sheets and Consent Forms must be submitted along with the application form.
• Where there are different participant groups, separate Participant Information Sheets and Consent Forms must be supplied.
• Any relevant research tools (e.g. surveys, interview schedule, etc) should be attached to the application form.
• If appropriate, a health and safety risk assessment for the study should be enclosed.
• Advertising materials such as posters, email texts and social media recruitment material should be included.

Applications with incomplete sections or submitted without the requisite supporting documents will be returned to applicants for modifications before being processed for further review.

On submission, ERAMS will route your application to your departmental Ethics Officer. They may contact you about your application if more information is required.

For students, ERAMS will route your application to your supervisor who is required to confirm that they have read and approved the quality of both the research proposal and the application.

You may need to revise and resubmit your ethics application to address ethical issues, to provide more information about the project or to comply with the University’s guidelines and policies.

The Recommended Guide for Research Ethics Reviewers lists issues an ethics reviewer may consider when reviewing an application.

You must wait for confirmation of a favourable opinion before you can start your project. This is issued in a formal letter.

Research must not commence until written approval has been received.

A favourable opinion is valid for duration of the project that is listed in your ethics application. Once you have received a favourable opinion, if your project changes and no longer reflects that which you described in your original application; or if your project needs to be extended, you must submit an amendment.