Ethics Committee

Frequently Asked Questions on Loughborough University’s Ethical Approval Policy and Procedure

These pages outline some of the frequently asked questions about how ethical approval is obtained at the University. The information on these pages has been approved by the Loughborough University Ethics Committee but is not a substitute for the full information available from the relevant Sub-Committee websites. For more information, please go to:

How are projects ethically reviewed?

How projects are ethically reviewed, and who reviews the projects, depends upon the nature of the work. The lead researcher (e.g. PI or supervisor) is responsible for deciding if ethical review is needed and which review procedure is applicable. At the very least, the Ethical Quick Test should be completed by the PI or supervisor.

How does Loughborough University’s ethical review procedure work?

The University Ethics Committee is responsible for overseeing all ethical review at Loughborough. It has ownership of the Ethical Policy Framework and the Quick Test. It delegates specific activity to two Sub-Committees. The Ethics Approvals (Human Participants) Sub-Committee (HPSC) reviews all activity involving human participants. The Ethics Approvals (Human Tissue) Sub-Committee (HTSC) ensures all policy and procedure around the University’s Human Tissue Act Licence are maintained.

How many people need to review projects under the University ethics review procedure?

This depends upon the ‘risk’ of the project:

  • Low risk projects will be assessed by the student and supervisor (in the case of student projects) and the member of staff (for staff projects). The appropriate forms may be signed by the Dean of School or their signatory, but they do not review the study in details.
  • Potentially high risk projects will be assessed by the Ethics Committee or relevant Sub-Committee. Depending on the nature of the risk, the project could be reviewed by up to seven people (in a full Ethics Approvals (Human Participants) Sub-Committee)

What constitutes a ‘potentially high risk’ project?

Work that is ‘potentially high risk’ will involve one of the following:

  • Particularly vulnerable participants (e.g. who may not be able to exercise informed consent – such as children)
  • Highly sensitive topics (e.g. religion, health, sexuality, violence)
  • Potentially sensitive research funders (e.g. cigarette producers, arms manufacturers)
  • Potentially sensitive donors to the University (e.g. persons who obtained their money unethically)

Researchers should reflect on the risk-level presented rather than viewing the process as a box-ticking exercise. The ethical approval process is to protect investigators as much as to protect any participants in research. The Ethics Committee and Sub-Committees provide the opportunity to prepare and manage the risks involved in a study more than preventing a higher-risk study from going forward.

Does research which is undertaken abroad require ethical review?

Yes. The researcher should determine if there is an appropriate ethics review procedure in the country where they wish to undertake the project. The researcher should then inform the Committee or Sub-Committee of the ethical review process to be undertaken and, if sufficiently robust, this can go ahead. If the review is not sufficient, the researcher should apply for University ethical review.

What documents are needed for ethical review?

This will depend on the type of work the researcher is undertaking. All investigators should complete an Ethical Quick Test to ensure no further approvals are required. For approval for studies involving human participants, the investigators should look at the Ethics Review Sub-Committee website to understand what application forms and supporting documentation are required.

Ethics Review Sub-Committee

What level of detail should be included in the ethics application form?

The application forms should include enough detail to enable a lay person unfamiliar with the work to understand the proposal. This then enables the Committee and Sub-Committee member to make an informed decision on whether the work should proceed, and provides sufficient information on the work if any complaints are made.

How is the outcome of ethical review recorded?

Ethical review decisions made by either the Ethics Committee or Sub-Committee are recorded within the Minutes of the meeting. Investigators are also informed separately of the ethical review decision.

For how long should ethics documentation be kept?

Where practical, ethics documentation should be kept for one year following the completion of undergraduate and postgraduate-taught student projects and for up to three years following the completion of staff and postgraduate research student projects. Documents can be kept in hard copy or electronically. If any student or staff has difficulty retaining documentation for this period of time, they should contact either the Ethics Committee Secretary or Ethics Review Sub-Committee Secretary for advice.

Where can I find out more about the University’s Ethical Approval Policy and Procedure?

The Ethical Policy Framework can be found on the Loughborough University Ethics Committee website. Further information on ethical approval for work involving human participants can be found on the Ethics Review Sub-Committee pages.