College Ethical Approval Panel for Taught Programmes Ethical Approval Application Form for Taught Programme Students ETHICAL APPROVAL MUST BE OBTAINED BY ALL STUDENTS PRIOR TO STARTING RESEARCH WITH HUMAN SUBJECTS, ANIMALS OR HUMAN TISSUE. The completed Proportionate Review checklist and full Application form should be submitted to: Health-TaughtEthics@salford.ac.uk Applications will only be processed with approval of the supervisor. Proportionate Review Criteria All student research that collect primary data should consider the ethical issues involved in their project. It is acknowledged that student research should have educational and training benefits for the student through submission of research proposals to ethics committees. The Economic Social Research Council (ESRC) advises that student research should be treated in the same manner as all other research and subject to ethics review. In some cases, student research may receive a ‘light touch,’ or proportionate review, where such applications involve minimal risk. Minimal risk should be determined based on the guidance provided in appendix 2 Ethics panels therefore approach the review in a facilitative and proportionate way that recognises that limited experience of the student and guides what is expected of them. However, student projects that involve more than minimal risk must be subject to a full review. The College Ethical Approval Panel for Taught Programmes has developed a ‘proportionate review’ system to facilitate an appropriate appraisal of the ethical issues in student research. Supervisors are encouraged to work with their student and identify whether the student’s proposed project requires full or proportionate review. The guidance below and contained in the appendices has been developed to support the supervisor’s assessment of their student’s research proposal. Please select a response to the following questions. Projects that indicate that potential risk is involved will be subject to a full review by the ethics panel. Projects that select mainly ‘YES’ or NA will be subject to a proportionate review by an ethics panel member. Once approved, the applicants will receive feedback within ONE week of submission for proportionate review. Projects that are not subject to Proportionate Review will be sent to full ethical review, which normally takes 4-5 weeks. Each project should be carefully assessed with the supervisor according to the relevant professional regulatory guidelines for research ethics. All students should be encouraged by their dissertation supervisors to apply the relevant professional regulatory guidelines as a standard to underpin their research. All projects should ensure that the participant’s autonomy is paramount and that the benefits of undertaking the project are clearly assessed against the potential risks. Students and supervisors should consult the appropriate professional regulatory guidance and can contact the ethics team for further guidance if required. Links to professional regulatory ethical frameworks can be located on the College Ethics website for taught programmes at http://www.salford.ac.uk/chsc/research/taught-programme-ethics: All students should ensure that they submit the following documents: 1. Fully completed and signed ethics application form 2. Consent form (if required) 3. Data collection tools (for example interview schedules, questionnaires etc) 4. Risks assessment form 5. Checklist 6. Participant information sheet 7. Any organisational letters or correspondence. Office use only College Ethical Approval Panel for Taught Programmes Proportionate Review Criteria Ref No: Name of Applicant: Full Programme Title: Award: BA BSc MA MSc Name of Supervisor: Title of Study: All student research that collects primary data should consider the ethical issues involved in their project. It is acknowledged that student research should have educational and training benefits for the student through submission of research proposals to ethics committees. The Economic Social Research Council (ESRC) advises that student research should be treated in the same manner as all other research and subject to ethics review. In some cases, student research may receive a ‘light touch,’ or proportionate review, where such applications involve minimal risk. Minimal risk should be determined based on the guidance provided in appendix 2. Ethics panels therefore approach the review in a facilitative and proportionate way that recognises that limited experience of the student and guides what is expected of them. However, student projects that involve more than minimal risk must be subject to a full review. Please note that systematic and other forms of literature reviews do not need ethical approval. Please use the guidance in the Appendix to support your appraisal Evidence . (Ethical approval ref no/application page no etc) 1 2 3 4 5 6a 6b 6c 7 The project is part of a larger research study that already has ethical approval? The project proposes to collect secondary data only?* If ‘YES’ please ensure that the project meets the requirements for data protection The project uses validated Questionnaires that only include nonsensitive or low risk research areas or where accidental disclosure would NOT have serious consequences. (Please use the guidance in appendix to guide your selection.) The project is proposing to use interviews that only include nonsensitive or low risk research areas or where accidental disclosure would NOT have serious consequences The project includes minimally invasive basic science studies that have full supervisor support undertaken on healthy volunteers. The project includes the use of the PAR-Q to assess participant suitability. The project involves testing/protocols/equipment which has previously been used in an approved application. The project involves testing/protocols/equipment which has previously been used in an approved application, and involves the same population. The project’s recruitment strategies exclude the use of social media sites? Supervisor and Applicant Reviewer (please delete as appropriate) (please delete as appropriate) Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Yes/No/NA Signed by Student: Date: Signed by Supervisor: Date: Supervisor Recommendation: Proportionate Review/Full Review* *Please delete as appropriate Supporting information from Supervisor in support of decision: Reviewer Recommendation: *Please delete as appropriate Feedback from Reviewer in support of decision: Proportionate Review/Full Review* Appendix: College Guidance for Sensitive or High Risk Research Subjects The College Guidance for Sensitive or High Risk Research Subjects is predicated on the following range of professional regulatory ethics frameworks: British Psychological Society, Social Research Association, Economic Social Research Council, Social Policy Association (SPA), RESPECT Code of Practice for SocioEconomic Research & Royal College of Nursing Guidance on Ethics (2009). It is acknowledged that some research may pose risks to participants in a way that is legitimate in the context of that research and its outcomes. However, it is advised that the longer-term gains should outweigh the short-term immediate risks to participants. Students and supervisors need to provide a robust rationale for sensitive subjects and articulate what the longer term gains are and whether there are any potential benefits for the participants (BPA 2012). No generic formula or guidelines exist for assessing the likely benefit or risk of various types of social enquiry. Nonetheless, social researchers must be sensitive to the possible consequences of their work and should as far as possible, guard against predictably harmful effects (SRA). The following research (as per BPS/ESRC guidance) would normally be considered as involving more than minimal risk: Research involving potentially vulnerable groups (such as children aged 16 and under; those lacking capacity; or individuals in a dependent or unequal relationship, powerless individuals); Research involving those who lack capacity or who come during the research project to lack capacity must be approved by an appropriate ‘body’ (for example a flagged NREs Panel) that operates under the Mental Capacity Act (2005) Research involving sensitive topics (such as participants’ sexual behaviour; their legal, illegal or political behaviour; their experience of violence; their mental health gender or ethnic status); Research involving deceased persons, body parts or other human elements Research involving a significant element of deception; Research involving access to records of personal or confidential information (including genetic or other biological information); Research involving respondents through the internet – in particular where visual images are used and where sensitive issues are discussed. Research involving access to potentially sensitive data through third parties (such as employee data); Research that could induce psychological stress, anxiety or humiliation or cause more than minimal pain (e.g. repetitive or prolonged testing); Research involving invasive interventions (such as the administration of drugs or other substances or techniques such as hypnotherapy) that would not usually be encountered during everyday life; Research involving physical exercise protocols that would not usually be encountered; Research that may have an adverse impact on employment or social standing (e.g. discussion of an employer, discussion of commercially sensitive information); Research that may lead to ‘labelling’ either by the researcher (e.g. categorisation) or by the participant (e.g. ‘I am stupid’, ‘I am not normal’); Research that involves the collection of human tissue, blood or other biological samples. Office use only College Ethical Approval Panel for Taught Programmes Application Form Ref No: Ethical Approval Form for undergraduates and post graduates (taught programmes) Ethical approval must be obtained by all students prior to starting research with human subjects, animals or human tissue. The student must discuss the content of the form with their dissertation supervisor who will advise them about revisions. A final copy of the summary will then be agreed and the student and supervisor will ‘sign it off’. Please submit the application via your supervisor to (Health-TaughtEthics@salford.ac.uk) The form must be completed electronically; the sections can be expanded to the size required but not exceeding the word count specified. To assist you with the completion of this form there are ‘Guidance Notes for Completing the College Ethics Form’ on the website (http://www.salford.ac.uk/chsc/research/taught-programme-ethics) which indicate what is required for each section. Is this application a resubmission? (delete as appropriate) Yes No Is this an amended version of the original application? (Please Yes highlight any changes) (delete as appropriate) No If Yes, please indicate Ref No. (if known) Name of Student: Full Programme Title: Award: BA BSc MA MSc (delete as appropriate) Supervisor: Will this project use any NHS sites? (delete as appropriate) Yes No Will this project include children? (delete as appropriate) Yes No Will this project involve adults lacking the capacity to consent for Yes themselves? (delete as appropriate) No Will this project take place on University premises? Yes No (delete as appropriate) Is a DBS check required? (delete as appropriate) N/A Yes No Have you read the Lone Worker Policy?(delete as appropriate) N/A Yes No 1. Title of proposed research project (refer to guidelines section 1) 2. Project focus (refer to guidelines section 2) 3. Project objectives (refer to guidelines section 3) 4. What is the rationale which led to this project? (refer to guidelines section 4) 5. Is your project linked to any other projects? (refer to guidelines section 5) 6. Research Strategy. Please provide an indication of the project duration or project schedule in your research strategy or as an appendix. Please detail where the study will take place (setting), how data will be collected and how data will be analysed. (refer to guidelines section 6) 7. How many participants will be recruited and/or involved in the research study, and what is the rationale behind this number? (refer to guidelines section 7) 8. Please describe how you plan to obtain organisational agreement for your project. (refer to guidelines section 8) 9. Are you going to recruit individuals to be involved in your research? Please detail how, rather than who you will recruit. (refer to guidelines section 9) YES/ NO (delete as appropriate and if Yes explain clearly how participants will be recruited) 10. How will you ensure you gain informed consent from anyone involved in the study? Please also refer to the participant information sheet and consent procedure (refer to guidelines section 10) 11. Are there any data protection issues that you need to address? (refer to guidelines section 11) YES / NO (delete as appropriate and explain response) 12. Other ethical issues that need to be considered (refer to guidelines section 12) 13. References – provide full list of all references used NB. Projects that involve NHS patients, patients’ records or NHS staff, will require ethical approval by the appropriate NHS Research Ethics Committee (REC). The College Research Governance and Ethics Committee will require written confirmation that such approval has been granted. Where a project forms part of a larger, already approved, project, the approving REC should be informed about, and approve, the use of an additional co-researcher. NB: The ethical and efficient conduct of research by students is the direct responsibility of the supervisor. I certify that the above information is, to the best of my knowledge, accurate and correct. I understand the need to ensure I undertake my research in a manner that reflects good principles of ethical research practice. Signed by Student: …………………………………………………………. Date ……………………………………………. Please note that whilst the College indemnifies student research projects, the supervisor is signing that they are satisfied that the student has considered the ethical implications of their work and to confirm for the students project to proceed subject to approval by the ethics panel Signed by Supervisor:……………………………………………………… Date ………………………………………. Prior to submitting the application form: Please refer to the ‘Application Checklist’ and ensure appropriate supporting documentation is submitted with the application form Failure to complete the necessary documents will result in the application being returned to the applicant without being reviewed for re-submission thus delaying the approval process.