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Does my study need ethical approval?

Does my study require ethical approval?

Decisions on the conduct of a study, including whether there is a need for ethical approval, is the responsibility of the Principal Investigator.  However, the University requires that:

Researchers are required to consider the ethical risk of any procedure within a research project which involves human participation or personal data, consulting the relevant Faculty, Department, School and University policies and personnel, before any work is undertaken. Advice must be sought in case of doubt.

Where more than minimal risk is identified, reasonable and proportionate independent ethical review must be carried out prior to research work commencing.

In practical terms studies that involve “more than minimal risk”, and therefore require ethical review, may include: studies where the intention is to submit findings for publication in journals, oral presentations, books, web-pages, and other media, or as part of coursework; studies involving the collection or analysis of data that could be used to identify participants (including email addresses or other contact details); physical contact with participants; any risk of discomfort or inconvenience to participants; any risk of psychological distress to participants or their families; participants recruited from vulnerable groups, in particular children and those whose capacity to consent to participation may be challengeable because they have a temporary, fluctuating, or permanent impairment in, or disturbance of the functioning of the mind or brain; data collection that will be undertaken overseas.  If the study contains any of these elements, then ethical approval should be sought from the appropriate Research Ethics Committee.

Studies with data collection using on-line resources, even those that do not collect or store identifiable data, may require ethical review to ensure that participants are giving informed consent (e.g. are adequately warned of sensitive questions or images), that there are adequate safeguards against children taking part where appropriate, and that data storage meets current Data Protection regulations.

Some studies that do not require ethical approval include those involving information freely available in the public domain (e.g. published biographies, newspaper accounts), and the analysis of datasets, either open source or obtained from other researchers, where the data are properly anonymised and informed consent was obtained at the time of original data collection.

Some studies require ethical review by the National Research Ethics Service and therefore fall outside the remit of the University’s Research Ethics Committees.  Information on which studies require ethical approval by the National Research Ethics Service can be found at the website: http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-arrangements-for-research-ethics-committees/.  A decision tool which may help researchers to judge whether their application must be submitted to NRES can be found at: http://www.hra-decisiontools.org.uk/ethics/index.html

Regardless of whether or not ethical approval is necessary, in the vast majority of cases research with human participants requires appropriate consent.

Submission checklist

It is recommended that you complete the following checklist prior to making your submission. Have you included the following documents in your submission?

  • Completed application form
  • Signatures of all applicants
  • Consent forms
  • Participant information sheets
  • Submitted grants
  • Recruitment flowchart
  • Recruitment letters, adverts, etc.
  • Questionnaires
  • Insurance letter