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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:

  • Are your participants considered vulnerable? Yes
  • Do you need a Gatekeeper to access your participants? Yes
  • Will the audio recordings be used solely for the purposes of producing an anonymised transcript/summary and then deleted and will not be used in any outputs or made publicly available? No
  • Will your research involve the collection of photographic materials which will identify a participant? Yes
  • Will your research involve the collection of video materials? 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, procedues 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
  • 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? Yes
  • Will any identifiable participant data be transferred outside the European Economic Area? Yes