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What constitutes ‘high risk’

The ethics review and approval process provides a number of routes for approval of checklists, dependent on the level of risk presented.

Risk is identified by the answers provided to certain questions in Section 2 (filter questions) and Section 3 (my Research).

Section 2 Filter Questions which identify as ‘above minimal’ risk:

  • Does your study involve the use of human tissue?
  • Does your study involve experimentation on any of the following: animals, animal tissue, genetically modified organisms?
  • Research study taking place outside the UK and/or specifically targeting a country outside the UK

Section 3 ‘My Research’ – Questions which identify as ‘above minimal’ risk:

  • Do your participants include minors (under 16)? Yes
  • Are your participants considered adults who are competent to give consent but considered vulnerable? Yes
  • Do you need a Gatekeeper to access your participants? Yes
  • Will any photographs, video recordings or film identify an individual? Yes
  • Will any audio recordings, photographs, video recordings or film be used in any outputs or otherwise made publicly available? Yes
  • Will the study involve discussions of sensitive topics? Yes
  • Will any drugs, placebos or other substances be administered to the participants? Yes
  • Will the study involve invasive, intrusive or potential harmful, procedures of any kind? Yes
  • Could you research induce psychological stress or anxiety, cause harm or have negative consequences for the participants or research? Yes
  • Will your research involve prolonged or repetitive testing? Yes
  • Do your participants include adults who lack/may lack capacity to give consent (at any point in the study)?
  • Will it be necessary for participants to take part in your study without their knowledge and consent? Yes
  • Will financial or other inducements be offered to participants? Yes
  • Will the personal data collected include any special category data, or any information about actual or alleged criminal activity or criminal convictions which are not already in the public domain? Yes
  • Will research outputs include any identifiable personal information i.e. data at an individualised level in a form which identifies or could enable identification of the individual? Yes
  • Will any identifiable participant data be transferred outside the European Economic Area? Yes

The system will list the risk identifed (see ‘my Dashboard’ – column ‘risk’).  If you don’t think your checklist should be high risk, please refer back to the filter questions you have selected in Section 2 and the questions you’ve answered in Section 3.  For example if you have selected the filter question “Research study taking place outside the UK and/or specifically targeting a country outside the UK” but the research is taking place within the UK, don’t select this filter question as it is NOT relevant to your research.