What constitutes high risk?

• Does your study involve the use of human tissue?  Yes
• Does your study involve experimentation on any of the following: animals, animal tissue, genetically modified organisms?  Yes

Participants Section

• Do your participants include minors (under 16)? Yes
• Are your participants considered adults who are competent to give consent but considered vulnerable? Yes

​Recruitment Section

• Do you need a Gatekeeper to access your participants? Yes

​Data Collection Activity Section

• 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

​Consent Section

• Do your participants include adults who lack/may lack capacity to give consent (at any point in the study)? Yes
• Will it be necessary for participants to take part in your study without their knowledge and consent? Yes

Participant Compensation Section

• Will financial or other inducements be offered to participants? Yes

Research Data Section

• 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

​Storage, Access & Disposal of Research Data Section

• Will any identifiable participant data be transferred outside the European Economic Area? Yes

​Will your research study take place outside the UK and/or specifically target a country outside the UK? (Additional Details)

• Not all questions are automatically high risk identifiers as risk is assigned by a combination of answers to the questions.  For example if you answer YES to "Are you currently a resident of the country named above?" and YES to "Do you intend to remain in or visit the country named above to undertake the research?" but then NO to "Do you intend to recruit participants from the country named above?"  the risk will be identified as high.
• However, some questions in this section are automatic high risk identifiers, such as "By participating in this research, are there any potential risks to participants?"  Yes