Anglia Ruskin University ETHICS REVIEW CHECKLIST This checklist should be completed by the Principal Investigator / Supervisor / Student undertaking a research project which involves human participants. The checklist will identify whether a project requires an application for ethics approval, and whether it needs to be submitted directly to UREC or to the School Representative on UREC. Before completing this form, please refer to the University Code of Practice on ethical standards for research involving human participants and any School guidelines. As the Principal Investigator / Supervisor, you are responsible for exercising appropriate professional judgement in this review. If there is uncertainty in completing any sections of this document, please consult your School’s UREC representative. Section A If the research proposal is being submitted for approval to a properly constituted ethics committee external to the University (e.g. LREC, MREC or Research Governance Group), please notify UREC that you will be seeking ethics approval via this route, and lodge a copy of the ethics approval letter with the UREC secretary. In the case of projects in teacher education to be carried out in schools/colleges, if the project is approved by the appropriate school/college authorities or If the research is library based, or is confined to the analysis or scrutiny of publicly available documents, and does not involve the direct observation of, or involvement of human or animal participants, or If the research project started prior to October 1st 2002, and the ethics procedures in place at the time were adhered to, and where the protocols have not changes significantly since that time, then you do not need formal approval from UREC to conduct your research. Projects involving the use of animal subjects or material are outside the terms of reference of UREC. You should contact the Graduate School for advice in these cases. Section B If the research involves contact with, observation of, or collection and storage of confidential information about human participants then you may need ethics approval. Complete the following questionnaire, and then follow the accompanying flow-chart to help you decide. YES 1. Does the study involve participants who are unable to give informed consent? (eg children, people with learning disabilities, unconscious patients) 2. Are drugs, placebos or other substances (eg food substances, vitamins) to be administered to the study participants? 67 www.apu.ac.uk/research/gradsch/gshome.shtml – follow “ethics” NO 3. Will the procedures use human tissue, or include the penetration of a participant's skin or body orifices by any substance or device? 4. Will participants be presented with painful stimuli or high intensities of auditory, visual, electrical or other stimuli? 5. Could participants be required to undergo long periods of sleeplessness, confinement, sensory deprivation or any other form of stress? 6. Is there any foreseeable risk of physical, social or psychological harm to a participant arising from the procedure? 7. Will deception of participants be necessary during the study? 8. Will the study involve more than a minimal invasion of privacy, or accessing confidential information about people without their permission? 9. Will the study involve NHS patients or staff, or social services department service users or staff? If you have answered ‘Yes’ to any of questions 1-9, you must submit your proposal using the UREC application form to the University Research Ethics Committee Secretary, at the Graduate School. If you answered ‘Yes’ to question 10, an application must be submitted to the appropriate external LREC, MREC or Research Governance Group. 1 Please notify UREC in advance, and ensure that a copy of your ethics approval letter is lodged with the Committee Secretary. If you answered 'No' to all questions in Section B: and you are undertaking your research as part of an undergraduate or taught postgraduate qualification, then you need not submit your project for ethics approval. However it is still incumbent on you to observe the University's rules on ethics in the conduct of your research, and in particular to ensure that your research complies with the Data Protection Act by which you are legally bound.2 and you are either a member of staff or a postgraduate research student, you must still get formal ethics approval for your project. Send the completed UREC application form to the School UREC representative for processing. Please note that the School may still decide that the application must be approved by the full UREC. NOTE: When any doubt arises in relation to the above, always forward your proposal to the School UREC representative. All materials submitted to UREC will be treated confidentially. 1 Contact details of local committees can be found at www.corec.org.uk 2 Specific guidance on data protection can be found on the ethics website 68 www.apu.ac.uk/research/gradsch/gshome.shtml – follow “ethics”