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Student Application for Ethical Approval Form

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Student Application for Ethical Approval Form
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    Research and Enterprise Office (smp) March 2013 Page: 1 of 7 Application for Ethical Approval of Research Involving Human Participants This application form should be completed for any research involving human participants conducted in or by the University by masters and undergraduate students. ‘Human participants’ are defined as including living human beings, human beings who have recently died (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids, and human data and records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements). Research should not commence until written approval has been received (from Departmental Research Director / Ethics Officer, Faculty Ethics Committee (FEC) or the University’s Ethics Committee ). This should be borne in mind when setting a start date for the project.  Applications should be made on this form, and submitted electronically, to your Departmental Research Director / Ethics Officer. A signed copy of the form should also be submitted. Applications will be assessed by the Research Director / Ethics Officer in the first instance, and may then passed to the FEC, and then to the University’s Ethics Committee.  A copy of your research proposal and any necessary supporting documentation (e.g. consent form, recruiting materials, etc) should also be attached to this form.  A full copy of the signed application will be retained by the department/school for 6 years following completion of the project. The signed application form cover sheet (two pages) will be sent to the Research Governance and Planning Manager in the REO as Secretary of the University’s Ethics Committee. 1. Title of project: 2. Principal Investigator (i.e. name of student) Name: Department: 3. Name of supervisor(s): Name: Department: 4. Proposed start date of research (note ethical approval cannot be granted retrospectively) : 5. Probable duration : 6. Will this project be externally funded? Yes / No If Yes, 7. What is the source of the funding?    Research and Enterprise Office (smp) March 2013 Page: 2 of 7 9. If external approval for this research has been given, then only this cover sheet needs to be submitted External ethics approval obtained (attach evidence of approval) Yes / No Declaration of Principal Investigator: The information contained in this application, including any accompanying information, is, to the best of my knowledge, complete and correct. I/we have read the University’s Guidelines for Ethical Approval of Research Involving Human Participants  and accept responsibility for the conduct of the procedures set out in this application in accordance with the guidelines, the University’s Statement on Safeguarding Good Scientific Practice   and any other conditions laid down by the University’s Ethics Committee. I/we have attempted to identify all risks related to the research that may arise in conducting this research and acknowledge my/our obligations and the rights of the participants. Signature(s): . ..................................................................................................………………………….…..  Name(s) in block capitals: ........................................................................... ...........………………………..   Date: ……………………………………………………………………………………………………….   Supervisor’s recommendation (Student Projects only):   I have read and approved both the research proposal and this application. Supervisor’s signature:  .. …………………………………………………………………………….…….   Outcome: The Departmental Director of Research (DoR) / Ethics Officer (EO) has reviewed this project and considers the methodological/technical aspects of the proposal to be appropriate to the tasks proposed. The DoR / EO considers that the investigator(s) has/have the necessary qualifications, experience and facilities to conduct the research set out in this application, and to deal with any emergencies and contingencies that may arise. This application falls under Annex B and is approved on behalf of the FEC This application is referred to the FEC because it does not fall under Annex B This application is referred to the FEC because it requires independent scrutiny Signature(s): .......................................................................................………………… .. …….…… . …….  Name(s) in block capitals: ..................................................................................…… .. ………….……….   Department: ……………………………………………………………………… .. ……………….……   Date: ……………………………………………………………………………………………………..  The application has been approved by the FEC The application has not been approved by the FEC The application is referred to the University Ethics Committee Signature(s): .......................................................................................…………………………………. . Name(s) in block capitals: … ............................. .....................................................…………………….  Faculty : ……………………….…………………………………...……………………………………   Date: …………………………….………………………………………………………………………      Research and Enterprise Office (smp) March 2013 Page: 3 of 7 Details of the Project 1. Brief outline of project  (This should include the purpose or objectives of the research, brief  justification, and a summary of methods but should not include theoretical details. From the information provided, the reviewer must be able to understand what participants will be asked to do. It should be approx. 150 words in everyday language that is free from jargon). Participant Details 2. Will the research involve human participants? (indicate as appropriate) Yes No Note: Under no circumstances should participants be contacted before ethical approval of this project has been granted. 3. Who are the participants? 4. How will they be recruited? (If any recruiting materials are to be used, e.g. advertisement or letter of invitation, please provide copies). 5. Will participants be paid or reimbursed? Yes / No If so, how will they be paid?    Research and Enterprise Office (smp) March 2013 Page: 4 of 7 6. Could participants be considered: (a) to be vulnerable (e.g. children, mentally-ill)? Yes / No (b) to feel obliged to take part in the research? Yes / No If the answer to either of these is yes, please explain how the participants could be considered vulnerable and why vulnerable participants are necessary for the research. Informed Consent 7. Will the participant’s consent be obtained for involvement in the research orally or in writing? ( If in writing, please attach an example of written consent for approval): Yes No If in writing, please tick to confirm that you have attached an example of written consent How will consent be obtained and recorded? If you are obtaining consent orally, explain why. If consent is not possible, explain why. Please note that, if you are using an on-line questionnaire, consent may be assumed on submission of the questionnaire but you need to inform participants that this is the case and provide them with information about the research and their rights before they start to complete the questionnaire. Please attach a participant information sheet where appropriate. Have you reviewed the information provided by the REO on participant information and consent? Yes / No
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