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 Tick Please fill out the following Sections: Desktop study only Section A - General Project Details No external participants, patients or Section B Rationale and Summary of Methods – employment data to be used Section E Project Declaration – Research Study with Participants Please fill out the following Sections: External Participants Initial Approval Required Workplace/Organisation Approval – Collection of new samples and use of Letter (if applicable) existing samples of Human Biological Section A - General Project Details Material (not cells) If based in a workplace/organisation, an Section B Rationale and Summary of Methods – approval letter from the company is also required Section C Participant Information – Involves self completed questionnaires Section D Human/Animal Cell/GMO Lab Work Information – Involves focus groups, observations or (if human biological material is being used) semi-structured interviews Section E Project Declaration – To contact the Middlesex University HTA Attachment 1 Participant Information Sheet & Consent Form Designated Individual - Lucy Ghali – Lab Based (Biological Tissues) Tick Please fill out the following Sections: Human Cell Samples Initial Approval Required – Genetically Modified Organisms (GMO) GM Committee Approval (if applicable) Samples Initial Approval Required Recognised UK Ethics Committee – Authority (UKECA) or NHS Research Ethics Committee To contact the Middlesex University GM Approval required for primary human cell lines (if applicable) Committee Secretary: Graham Shennan 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 Tick Please fill out the following Sections: Other Chemical or Biological Agents 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 Tick Please fill out the following Sections: Physical sampling, monitoring or external Section A - General Project Details data collection outside of university or trial of employment Section B Rationale and Summary of Methods – Data/Information gathering outside of normal workplace Section E Project Declaration – Attachment 3 Field based Risk Assessment –
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
Natural-Science-Reserach-Ethics-Application-Form-B.docx