Research requiring ethical approval
For all research projects conducted by either staff or students involving humans, human data or animals, must undergo an ethics review by completing the relevant faculty forms:
In order to determine what level of approval a project may require the following breakdown will help you.
1. Research involving more than minimal risk
When conducting research with humans/human data consider these points:
- Research involving vulnerable groups - for example children, and young people, those with a learning disability or cognitive impairment, or individuals in a dependent or unequal relationship
- Research involving sensitive topics - for example participants' sexual behaviour, their illegal or political behaviour, their experience with violence, their abuse or exploitation, their mental health, or their gender or ethnic status
- Research involving groups where permissions of a gatekeeper is normally is normally required for initial access to members - for example ethnic or cultural groups, native peoples or indigneous communities
- Research involving deception or which is conducted without participants’ full and informed consent at the time the study is carried out
- Research involving access to records of personal or confidential information, including genetic or other biological information, concerning identifiable individuals
- Research which would induce psychological stress, anxiety or humiliation or cause more than minimal pain
- Research involving intrusive interventions – for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not encounter such interventions, which may cause them to reveal information which causes concern, in the course of their everyday life.
2. Research requiring review by an NHS Research Ethics Committee
The Research Governance Framework for Health and Social Care states that independent ethical review is undertaken of all health and social care research. Ethical approval must be obtained from an appropriate NHS Research Ethics Committee (REC) for any research proposal (including student projects) which involves:
- Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions
- Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above
- Access to data, organs or other bodily material of past and present NHS patients
- Fœtal material and IVF involving NHS patients
- The recently dead in NHS premises or facilities; and
- NHS staff – recruited as research participants by virtue of their professional role
For more information and the relevant forms see the Faculty of Health and Life Sciences Research Ethics page.
3. Animal Welfare
The development of drugs and medical technologies which help to reduce suffering among humans and animals is regulated according to the Animals (Scientific Procedures) Act 1986.
Our researchers demonstrate high ethical standards and adhere to strict legislation that safeguards animal welfare in the UK.
De Montfort University abides by current Home Office regulations. For more information on these please visit the Home Office's
website
4. Other areas where ethical issues could arise
- Where the research project presents a significant risk to the environment or society
- Where the research project raises any ethical issues that in the opinion of the Applicant/Supervisor require further ethical review