Ethics Form Guidance Checklist Important Note – Your research project may consist of a range of research methods. Please refer to each type below to determine what sections are applicable to your ethics application and tick when completed accordingly. Desktop Research Desktop study only No external participants, patients or employment data to be used Please fill out the following Sections: Tick Section A - General Project Details Section B – Rationale and Summary of Methods Section E – Project Declaration Research Study with Participants External Participants Collection of new samples and use of existing samples of Human Biological Material (not cells) If based in a workplace/organisation, an approval letter from the company is also required Involves self completed questionnaires Involves focus groups, observations or semi-structured interviews To contact the Middlesex University HTA Designated Individual - Lucy Ghali Please fill out the following Sections: Initial Approval Required – Workplace/Organisation Approval Letter (if applicable) Section A - General Project Details Section B – Rationale and Summary of Methods Section C – Participant Information Section D – Human/Animal Cell/GMO Lab Work Information (if human biological material is being used) Section E – Project Declaration Attachment 1 – Participant Information Sheet & Consent Form Lab Based (Biological Tissues) Human Cell Samples Genetically Modified Organisms (GMO) Samples To contact the Middlesex University GM Committee Secretary: Graham Shennan Please fill out the following Sections: Tick Initial Approval Required – GM Committee Approval (if applicable) Initial Approval Required – Recognised UK Ethics Committee Authority (UKECA) or NHS Research Ethics Committee Approval required for primary human cell lines (if applicable) Section A - General Project Details Section B – Rationale and Summary of Methods Section D – Human/Animal Cell/GMO Lab Work Information Section E – Project Declaration Attachment 2 – LabRAT For the external collection and/or transport of samples: Attachment 3 – Field based Risk Assessment Lab Based (Other) Commercially available cell lines Other Chemical or Biological Agents Please fill out the following Sections: Tick Section A - General Project Details Section B – Rationale and Summary of Methods Section E – Project Declaration Attachment 2 – LabRAT For the external collection and/or transport of samples: Attachment 3 – Field based Risk Assessment Field Based Data collection Physical sampling, monitoring or external data collection outside of university or of employment Data/Information gathering outside of normal workplace Please fill out the following Sections: Tick Section A - General Project Details Section B – Rationale and Summary of Methods Section E – Project Declaration Attachment 3 – Field based Risk Assessment trial
Use of MU-owned vehicle (van) Does not require consideration here as there are specific processes in place. Employees students & public • Driven by appropriately licensed only • Nominated individual organizes use and maintenance of vehicle. Keeps copies of licences etc. • Should be considered as part of Fieldwork Risk assessment. Risk Calculation and Interpretation Severity Likelihood High – Death or major injury (as defined by RIDDOR) or illness causing long term disability High – where it is certain or near certain that harm will occur