University Research Ethics Application Form for Staff in Student Services This form has been approved by the University Research Ethics Committee (UREC) Date: Name of applicant: Research project title: This form should be completed by any member of Student Services staff who intends to undertake a project that involves human participants, personal data or human tissue. The form consists of 4 parts: PART A: Basic details form: requests key identifying information about you and the project. PART B: Pre-ethics review form: it is recommended that this part is completed to assist you in deciding whether your project constitutes research and needs to be ethically reviewed. PART C: Ethics review form: this part MUST be completed if your project constitutes research and requires ethical review. PART D: Risk assessment checklist: it is recommended that this part is completed to assist you in identifying whether your research project needs to be ethically reviewed via the LOW RISK or HIGH RISK ethics review procedure. How do I arrange for my project to be ethically reviewed? If your project DOES constitute research and needs to be submitted for ethical review, arrange for the project to be ethically reviewed according to either the LOW RISK or HIGH RISK procedures outlined below. The form should be accompanied by any information sheets/covering letters/written scripts which you propose to use to inform the prospective participants about the proposed research, and/or by a consent form where you need to use one; for guidance on the informed consent process, refer to Research Ethics Policy Note No.2: www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/consent. If your project is classed as ‘LOW RISK’ it will be reviewed by the nominated person within your Section: Email the completed form, together with other documents where applicable, to the nominated person within your Section; and Sign and date Annex 1 of this form and provide a paper copy to the nominated person. Important note for the nominated person: Following the ethics review the nominated person who has reviewed the application must provide the Student Services’ Ethics Administrator with a copy of the this research ethics application that s/he reviewed, a copy of the ethics reviewers comments form which s/he completed in relation to it and confirmation of the final ethics decision. The Ethics Administrator reserves the right to consult the Chair of the Student Services Ethics Review Panel (or equivalent) if s/he has concerns that projects classed as low risk should in fact have been classed as potentially high risk. If your project is classed as potentially ‘HIGH RISK’ it will be reviewed by three reviewers from the Students Services Ethics Review Panel: Email the completed form, together with any supporting documents where applicable to the Student Services Ethics Administrator; and Sign and date Annex 1 of this form and provide a paper copy of it to the Student Services’ Ethics Administrator. ADDITIONAL NOTE FOR PROJECTS THAT WILL BE REPEATED ON A REGULAR BASIS: If you intend to run the same project on a regular basis (e.g. annually), then a single ethics approval will be necessary; please tick the box on the right-hand side of this page to indicate if this is the case. However, please note that if significant changes are made to the project in future, then re-approval may be required. Applicants should refer to section 3.1.8 of the ‘Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue’ for further guidance: www.shef.ac.uk/ris/other/govethics/ethicspolicy/approval-procedure/review-procedure/changes-made-after-approval 2 Part A - Basic Details Form A1. Title of Research Project: A2. Project leader: Title: Post: Email: A2.1. A3. Name: Department: Telephone: Other key investigators/co-applicants (within/outside University), where applicable. Please list all (add more if necessary): Title: Post: Email: Name: Department: Telephone: Title: Post: Email: Name: Department: Telephone: Proposed Project Duration: Start date: A4. End date: Briefly summarise: i. The project’s aims and objectives: (this must be in language comprehensible to a lay person) ii. The project’s methodology: (this must be in language comprehensible to a lay person) 3 4 Part B - Pre-Ethics Review Form This part of the form, whilst not part of the University Ethics Review Procedure itself, has been recommended by Student Services and the UREC in order to assist staff in identifying whether their project constitutes research and therefore requires ethical approval. B5. Project classification Please read each of the following definitions and select the relevant definition for your project. [Definition of research taken from the University of Sheffield ‘Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue’. Definitions of audit and service evaluation from King’s College London.] Type of project Research Definition Tick if applies to your project ‘Research’ includes all investigation undertaken in order to acquire knowledge and understanding, across the full range of academic disciplines, from the arts and humanities to the natural sciences (whether funded or not), and also encompassing administrative research undertaken within, or on behalf of, professional services departments. Research which involves human participants, personal data or human tissue requires ethical approval. Audit Service evaluation Audit is defined as assessing the level of service being provided against a set of predetermined standards. This generally involves analysing existing data with results usually being used/distributed locally in order to effect change to improve/change the level of service currently being provided. Audit does not require ethical approval. Service evaluation is undertaken to benefit those who use a particular service and is designed and conducted solely to define or judge current service. Your participants will normally be those who use the service or deliver it. It involves an intervention where there is no change to the standard service being delivered (e.g. no randomisation of service users into different groups). Service evaluation does not require ethical approval. Note regarding projects classed as audit or service evaluation: Such projects do not require ethical approval. However, these projects may still present ethical issues which should be considered. Particular attention should be paid to projects which will involve particularly vulnerable participants – whether directly, or in terms of personal data about them – and/or which address highly sensitive topics (for further guidance refer to section 3.1.4 of the Ethics Policy:www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/reviewprocedure/assessing-risk Note regarding projects that cannot clearly be classed as research: Some projects may fall into a grey area which cannot be classed as service evaluation or audit, but for which it is not clear whether they should be classed as research either – for 5 such projects, the default position is that they should be treated as research for the purposes of ethical review, UNLESS you can provide a clear justification for why the project should not be classed as research. If you are providing a justification for why this project should not be classed as research, please do so in the space below: What should I do now? If the project is classed as research – Ethical review is required; please complete Parts C and D of this form, and the declaration at Annex 1. Submit the form for ethical review according to the LOW RISK ethics review procedure (within the Section) or the HIGH RISK ethics review procedure (by Panel) (see guidance on the cover page of this application form). If the project is classed as service evaluation or audit, or if you have provided a justification for why the project should not be classed as research – Ethical review is not required. Please complete the declaration at Annex 1 (you are not required to complete Parts C and D of this form). Email the form and provide a signed, hard copy of ‘Annex 1’ to the Student Services Ethics Administrator. You should also keep a record of this form. 6 Part C - Ethics Review Form Please complete this part of the form if your project is classed as research and requires ethical review. It is recommended that you familiarise yourself with the University’s Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue before completing the following questions. Please note that if you provide sufficient information about the research (what you intend to do, how it will be carried out and how you intend to minimise any risks), this will help the ethics reviewers to make an informed judgement quickly without having to ask for further details. I confirm that I have read the current version of the University of Sheffield ‘Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue’, as shown on the University’s research ethics website at: www.shef.ac.uk/ris/other/govethics/ethicspolicy C6. What is the potential for physical and/or psychological harm/distress to participants? C7. Does your research raise any issues of personal safety for you or other researchers involved in the project? (especially if taking place outside working hours or off University premises) If yes, explain how these issues will be managed. 7 C8. How will the potential participants in the project be: i. Identified? ii. Approached? iii. Recruited? C9. Will informed consent be obtained from the participants? Yes No If informed consent or consent is NOT to be obtained please explain why. Further guidance is at: www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/consent 8 C9.1. This question is only applicable if you are planning to obtain informed consent: How do you plan to obtain informed consent? (i.e. the proposed process?): Remember to attach your consent form and information sheet (where appropriate) C10. What measures will be put in place to ensure confidentiality of personal data, where appropriate? C11. Will financial/in kind payments (other than reasonable expenses and compensation for time) be offered to participants? (Indicate how much and on what basis this has been decided) C12. Will the research involve the production of recorded media such as audio and/or video recordings? YES NO 9 C12.1. This question is only applicable if you are planning to produce recorded media: How will you ensure that there is a clear agreement with participants as to how these recorded media may be stored, used and (if appropriate) destroyed? Guidance on a range of ethical issues, including safety and well-being, consent and anonymity, confidentiality and data protection are available at: www.shef.ac.uk/ris/other/govethics/ethicspolicy/policy-notes 10 Part D - Risk Assessment Checklist It is recommended that you complete this part of the form to assist you in identifying whether your research project needs to be ethically reviewed via the LOW RISK ethics review procedure (within the Section) or the HIGH RISK ethics review procedure (by Panel). The risk assessment checklist should be considered as a guide to aspects of a project which may be risky, but should not be considered a complete list. If you are in any doubt about the level of risk posed by the project, you should consult the nominated person within your Section to agree an appropriate level of risk. Mark ‘X’ in one or more of the following boxes if your research involves: People whose competence to exercise informed consent is in doubt, such as: infants and children under 18 years of age; people who lack mental capacity; people who suffer from psychiatric or personality disorders, including those conditions in which capacity to consent may fluctuate; and people who may have only a basic or elementary knowledge of the language in which the research is conducted. People who may socially not be in a position to exercise unfettered informed consent, such as: people who depend on the protection of, or are controlled and influenced by, research gatekeepers (e.g. school pupils, children and young people in care, members of the armed forces, young offenders, prisoners, asylum seekers, organisational employees); family members of the researcher(s); and in general, people who appear to feel they have no real choice on whether or not to participate. People whose circumstances may unduly influence their decisions to consent, such as: people with disabilities; people who are frail or in poor health; relatives and friends of participants considered to be vulnerable; people who feel that participation will result in access to better treatment and/or support for them or others; people who anticipate any other perceived benefits of participation; and people who, by participating in research, can obtain perceived and/or real benefits to which they otherwise would not have access. Potentially highly sensitive topics; these may include: 'race' or ethnicity; political opinion; religious, spiritual or other beliefs; physical or mental health conditions; sexuality; abuse (child, adult); nudity and the body; criminal activities; political asylum; conflict situations; and personal violence. If a box has been ticked against any of the above statements, or if you feel that the project should be classed as potentially high risk for any other reason, you should now follow the ethical review procedure for HIGH RISK research. The project will be reviewed by three ethics reviewers from the Student Services Ethics Review Panel (see guidance on the cover page of this application form). If no boxes have been ticked against any of the above statements then the project can be classed as low risk and should now follow the ethical review procedure for LOW RISK research. The project will be reviewed by the nominated person within your Section (see guidance on the cover page of this application form). 11 Annex 1 - The Signed Declaration Title of Research Project: I confirm my responsibility to deliver the research project in accordance with the University of Sheffield’s policies and procedures, which include the University’s ‘Financial Regulations’, ‘Good Research Practice Standards’ and the ‘Ethics Policy Governing Research Involving Human Participants, Personal Data and Human Tissue’ (Ethics Policy) and, where externally funded, with the terms and conditions of the research funder. In signing this research ethics application form I am also confirming that: The form is accurate to the best of my knowledge and belief. The project will abide by the University’s Ethics Policy, where necessary. There is no potential material interest that may, or may appear to, impair the independence and objectivity of researchers conducting this project. Subject to the research being approved where required, I undertake to adhere to the project protocol without unagreed deviation and to comply with any conditions set out in the letter from the University ethics reviewers notifying me of this. I undertake to inform the ethics reviewers of significant changes to the protocol, should ethics approval be required (by contacting the Student Services Ethics Administrator in the first instance). I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines relating to security and confidentiality of personal data, including the need to register when necessary with the appropriate Data Protection Officer (within the University the Data Protection Officer is based in CiCS). I understand that the project, including research records and data, may be subject to inspection for audit purposes, if required in future. I understand that personal data about me as a researcher in this form will be held by those involved in the University Ethics Review Procedure (e.g. the Ethics Administrator and/or ethics reviewers) and that this will be managed according to Data Protection Act principles. Name of the project leader: Signature of the project leader: Date: What should I do now? Submit the application form for ethical review according to the LOW RISK ethics review procedure (within the Section) or the HIGH RISK ethics review procedure (by Panel) (see guidance on the cover page of this application form). 12