Ethical Review

Ethical Review

Research which should be considered for ethical approval

General guidance is available in these pages, but in principle careful ethical consideration should be given to any piece of work at any level conducted within the University, or in partnership with it, that implicates the involvement of others (human or animal) or has the capacity to interfere with or make a difference to their lives. ‘Others’ commonly refers to participants in the research, but could also refer to others affected by it e.g. at risk of physical or mental harm. This is without reference to the length of the piece of work, or the level at which it is undertaken. Researchers in all cases will:

  • ensure that all research is subject to active and appropriate consideration of ethical issues;
  • comply with ethical, legal and professional frameworks, obligations and standards as required by statutory and regulatory authorities, and by employers, funders and other relevant stakeholders.

It is not possible to provide exhaustive checklists of criteria which determine whether or not a proposed research project concerned with human subjects must or need not receive prior independent ethical review. Table 1 below lists the types of research which prima facie should have an independent ethical review but, in general, any research project which has the potential to harm, upset or significantly inconvenience a participant, or seek confidential or sensitive personal information about a participant or where the relationship between the researcher and the participant is unequal, should be reviewed by the Ethics Committee

Likewise, research involving any animal, including invertebrates must be submitted for ethical approval. Note that research involving procedures on live vertebrates and cephalopods must comply with the Animals (Scientific Procedures) Act, 1986, which requires a Home Office Licence for individual researchers, the establishment(s), and the project involved. 

Table 1

Research Involving Human Subjects

In the following cases proposed research should always be referred to a Research Ethics Committee for approval. The list, however, is not exhaustive and in all cases of doubt, appropriate advice should always be sought:

  • Research involving the ingestion (by whatever means of delivery) of any substance by participants. This might be a drug but also food or drink if consumed for research purposes.
  • Research involving any invasive procedure, such as a biopsy.
  • Research involving the use of human tissue, including foetal and placental material (in compliance with the terms of the Human Tissue Act 2004).
  • Research involving the cadavers of or tissue from the deceased (in compliance with the terms of the Human Tissue Act 2004), other than bequeathed cadavers and tissue obtained in the normal course of necropsy;
  • Research involving anyanimal, including invertebrates. Note that research involving live vertebrates and cephalopods must comply with the Animals (Scientific Procedures) Act, 1986, which requires a Home Office Licence for individual researchers, the establishment(s), and the project involved.  More guidance can be found at:https://www.gov.uk/guidance/research-and-testing-using-animals;
  • Research involving privileged access to clinical or personal records, or access to potential participants on the basis of their being or having been patients, or the invitation to participants to divulge facts about themselves which they would not wish the investigator to allow to become known to other persons.
  • Research involving any form of risk or inconvenience to the participant; this might include but not be limited to interviews, observations and focus groups
  • Research involving any risk of psychological damage or distress to the participants or their family.
  • The use of novel techniques, technologies or devices even where apparently non-invasive, whose safety may be open to question
  • The collection of person-identifiable data requiring consent under the Data Protection Act.
  • The participation of vulnerable individuals
  • 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 of the 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 at http://www.hra.nhs.uk/resources/before-you-apply/non-nhs-recs/national-social-care-research-ethics-committee/.
  • 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 practising midwives

Research Involving Animals 

The government is committed to the replacement, reduction, and refinement of the use of animals in research - the ‘3Rs’. 

The use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work both in health and disease, and in the development of new medicines, treatments and technologies. Underpinning this research is a strong commitment to maintaining a rigorous regulatory system which ensures that animal research is carried out only where no practicable alternative exists and under controls which keep suffering to a minimum.  This is achieved through robustly applying the principles of the 3Rs to all research proposals involving the use of animals.

Implementing the 3Rs requires that, in every research proposal, animals are replaced with non-animal alternatives wherever possible; that the number of animals is reduced to the minimum needed to achieve the results sought; and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The government is committed to ensuring that any licence we grant under the Animals (Scientific Procedures) Act 1986 must rigorously and demonstrably apply the 3Rs principles.

In 2010, the coalition government made a commitment to work to reduce the use of animals in scientific research and a delivery plan has been published. The plan shows how alternative methods can deliver fast, high-quality research that also boosts economic growth. We have now published a delivery report which describes the progress made on actions set out in the delivery plan.

More guidance can be found at: https://www.gov.uk/guidance/research-and-testing-using-animals