Research Ethics Framework Ethical Approval: Policy, Principles and Process September 2015 Contents 1. Introduction 2. Definitions 3. Ethical Policy 4. Ethical Principles 5. Process of Ethical Approval 6. Ethical Approval Mechanism Student Projects/Dissertations Staff Research Appendices Appendix 1 Ethical Approval Application and Administration Forms. Student REC1, Checklist and REC1D Form. Staff REC1, Checklist and REC1D Form. Appendix 2 Ethical Approval Flowchart for UHI Undergraduate and Masters/ Taught Postgraduate Student Research Projects. Appendix 3 Ethical Approval Flowchart for UHI Staff, PHD/ Postgraduate Student Research Projects. 1 Introduction This document sets out the policy, principles and processes which govern ethical approval of all research studies undertaken by staff or students of the University of the Highlands and Islands and the UHI Academic Partnership. The UHI Research Ethics Framework has been designed to support a fair balance between a researcher’s right to unrestricted academic enquiry whilst ensuring adherence to appropriate and robust ethical standards to ensure the protection of all those participating in research studies. 2 Definitions The UHI Ethics Framework employs the following definitions: ‘Research’ is defined in the broadest sense as any gathering of data or facts to facilitate a contribution to the body of knowledge; ‘Student’ is used as the umbrella term for all UHI Undergraduate, Taught Postgraduate and Research Students registered on UHI programmes; ‘Staff’ is used as the umbrella term for all staff members listed on the UHI Register of Academic Staff; ‘Participant’ is used to describe any person who, either as an individual or as a member of a sample group, is involved in a research study for the purposes of quantitative or qualitative data collection. 3 Ethical Policy UHI requires all research undertaken by students and staff to be carried out to a high ethical standard. The Research Ethics Framework applies equally to all research projects led or undertaken by UHI staff or students, as well as all research projects involving staff or students as a sample group. This includes activity which: is internally or externally funded or unfunded; involves paid or voluntary participants; is undertaken on UHI/Academic Partner property or at any other location; is undertaken in a laboratory or in the field; involves data collection undertaken in person or by any other means; involves research which is basic or applied, descriptive or experimental. The UHI Ethical Policy is intended to ensure adherence to the Nolan Principles, and the Ethical Standards in Public Life etc. (Scotland) Act 2000 and should be read in the context of UHI’s Data Protection Policy, Freedom of Information Policy and Financial Guidelines. It may also require to be read with other Professional Codes of Practice for research involving human participants, human data or material, in particular: Health-related research involving the National Health Service which will need to comply with NHS Research Ethics Guidelines; i. any research involving children under the age of 18, which will need to refer to the Protection of Children (Scotland) Act 2003 and all other relevant applicable legislation. This Framework is developed in keeping with accepted norms and practices of research in other higher education institutions and professional bodies in the UK and abroad, including: consideration of the research risks - 'does not harm'; the need for informed and voluntary consent of participants; the need to respect confidentiality and the anonymity of participants. It is the responsibility of all researchers to consider ethical issues from the outset of a research study and at all subsequent stages, from the design and execution of a research project through to dissemination of the research findings. It is the responsibility of all researchers to be aware of the UHI Research Ethics Review mechanism. 4 Ethical Principles These principles are intended to ensure that all research is designed and undertaken with integrity: I. All researchers and participants must be fully informed of the nature of the research being undertaken. In particular, participants must be informed of what their participation entails and of any risks that may be incurred. II. Participants must give their consent voluntarily, free from any coercion. III. Any data and information gathered must be treated confidentially and the anonymity of participants respected. IV. Harm to participants must be avoided. V. Research must be carried out transparently and impartially and any potential conflicts of interest declared. VI. Researchers should give cognisance to any cultural, religious, gender or other variances in a research population. 5 Process of Ethical Approval The UHI Research Ethics Framework supports a robust process for ethical approval of all research that a UHI staff member or student proposes to undertake. No research may be allowed to go ahead without ethical approval having been first gained as part of this process. The UHI Research Ethics Committee (REC) and Faculty Research Ethics Committee (FREC) are actively involved in ensuring that appropriate decisions regarding ethical approval are taken. The processes for ethical approval of research studies proposed by both staff and students are very similar and employ the same stages, differing only in the requisite forms that need to be completed. A summary of the appropriate processes is given below and samples of the forms to be used at each stage of the process are given in Appendix A. Individual forms can be downloaded at UHI Research Ethics. All enquiries regarding the ethical approval process should be directed to either the UHI Research Ethics Officer (for administrative issues related to Staff and PHD/ Postgraduate applications), The Faculty Research Ethics Officer for administrative issues related to Undergraduate or Taught Postgraduate applications) or the Chair of the REC (for governance and policy issues). 6 Ethical Approval Mechanism Student Projects/Dissertations Ethical approval for student research lies initially with the Student’s lead Project Supervisor, who is responsible for exercising appropriate professional judgement in the ethical review. A Student will discuss the proposed research project with his/her Supervisor, covering such areas as topic understanding, research questions, data requirements, existing sources and possible new sources of information. The Student and the Project Supervisor should then complete Form REC1 Student (Application for Ethical Approval – Research Projects – UHI Students) and, if required, Form REC1-D Student (Detailed Application for Ethical Approval - Research Projects – UHI Student) and supporting documentation. (This will include a project outline/methodology, Participant Information Sheet, Questionnaires and Consent Forms as appropriate.) If completion of Form REC1-D is not required, and the Project Supervisor is satisfied that a) the research proposal complies with the ethical principles contained in the Ethics Framework, or b) that NHS ethical approval is to be sought ahead of project commencement, the Project Supervisor will endorse and sign Form REC1 accordingly. The completed form should then be passed to; The Faculty Research Ethics Officer for Undergraduate and Masters/ Taught Postgraduate Student Research Projects, OR the UHI Research Ethics Officer for PHD/ Postgraduate Student Research Projects. A copy should be retained by the researcher for inclusion in his/her research report or dissertation. If completion of form REC1-D and supporting documentation is required, the application will be submitted to the Chair of the relevant Research Ethics Committee for review and approval. Students seeking ethical approval for Undergraduate and Taught Postgraduate Research Projects will have their applications passed to the Chair of the Faculty Research Ethics Committee (FREC) by the Faculty Research Ethics Officer for review. More complex applications may be referred for full Faculty Research Ethics Committee (FREC) review or escalated for full UHI Research Ethics Committee (REC) review. PHD/ Postgraduate Students seeking ethical approval will have their applications passed to the Chair of the UHI Research Ethics Committee (REC) by the UHI Research Ethics Officer for review, with more complex applications referred for full Research Ethics Committee (REC) review and approval. Submitted REC1D applications complete with all supporting documentation are normally passed back to the UHI Research Ethics Officer/ Faculty Research Ethics Officer within 10 working days. An email is then sent to the researcher and their supervisor informing them of the decision. Notes: A Project Supervisor may request that the Research Ethics Committee review an application for ethical approval or may consult members of the Committee at any time during the ethical approval process should this be deemed helpful. Any subsequent significant1 change in the question, design or conduct of the research throughout the duration of the research activity should be notified to the Project Supervisor and may require the submission of a new application for ethical approval. Following approval the timeframe for completion of research projects will be one year and pro rata for part-time courses. If the research project has not commenced during this time then a new application for ethical approval should be lodged. Receipt of NHS ethical approval automatically satisfies the UHI Research Ethics Approval process. Internet Mediated Research (IMR) If your research project/ methodology involves use of online surveys, questionnaires, use of social media e.g. Facebook, or on-line support groups, chat rooms, Skype either for the recruitment of participants or the gathering of data then in addition to completing your REC1/ REC1D you should read the UHI IMR Guidance, complete an IMR checklist in consultation with your supervisor and submit this with your application for ethical approval. A change is considered to be ‘significant’ if it results in what had been a ‘No’ response to any of the questions in Form REC1 becoming a ‘Yes’ response. 1 Complex IMR projects may be referred to UHI’s Information Security Officer for consultation and advice. Staff Research Staff proposing to undertake research should complete Form REC1 Staff (Application for Ethical Approval), along with Form REC1-D Staff (Detailed Application for Ethical Approval - Research Projects – UHI Staff) if appropriate, at as early a stage as possible, and should pass the form(s) and supporting documentation (This will include a project outline/methodology, Participant Information Sheet, Questionnaires and Consent Forms as appropriate.) to their Senior Line Manager. If completion of Form REC1-D is not required, and the Senior Line Manager is satisfied that a) the research proposal complies with the ethical principles contained in the Ethics Framework, or b) that NHS ethical approval is to be sought ahead of project commencement the Senior Line Manager will endorse and sign Form REC1 accordingly. The completed form should then be passed to the UHI Research Ethics Officer and a copy retained by the staff member for inclusion in his/her research report. If completion of form REC1-D is required, the UHI Research Ethics Officer will inform the Chair of the Research Ethics Committee (REC). Staff seeking ethical approval will have their applications passed to the Chair of the UHI Research Ethics Committee (REC) by the UHI Research Ethics Officer for review, with more complex applications referred for full Research Ethics Committee (REC) review and approval. Submitted REC1D applications complete with all supporting documentation are normally passed back to the UHI Research Ethics Officer within 10 working days. An email is then sent to the researcher and their supervisor or Line Manager informing them of the decision. Notes: If the research project depends upon the successful submission of a grant application to an external funding body, ethical approval need not have been secured at the time of application, however the ethical approval process should be initiated immediately following the submission. A Senior Line Manager may request that the Research Ethics Committee review an application for ethical approval or may consult members of the Committee at any time during the ethical approval process should this be deemed helpful. Any subsequent significant2 change in the question, design or conduct of the research throughout the duration of the research activity should be notified to the Senior Line Manager and may require the submission of a new application for ethical approval. Following approval the timeframe for completion of research projects will be one year and pro rata for part-time courses. If the research project has not commenced during this time then a new application for ethical approval should be lodged. Receipt of NHS ethical approval automatically satisfies the UHI Research Ethics Approval process. Internet Mediated Research (IMR) If your research project/ methodology involves use of online surveys, questionnaires, use of social media e.g. Facebook, or on-line support groups, chat rooms, Skype either for the recruitment of participants or the gathering of data then in addition to completing your REC1/ REC1D you should read the UHI IMR Guidelines, complete an IMR checklist in consultation with your Line Manager and submit this with your application for ethical approval. Complex IMR projects may be referred to UHI’s Information Security Officer for consultation and advice. A change is considered to be ‘significant’ if it results in what had been a ‘No’ response to any of the questions in Form REC1 becoming a ‘Yes’ response. 2 Appendix 1 Ethical Approval Application and Administration Forms Research Projects - UHI Students REC1 All Undergraduate, Taught Postgraduate/Masters and Postgraduate Research/PHD Students registered on any UHI programme undertaking a research project must seek ethical endorsement via their Project Supervisor prior to undertaking any form of fieldwork or data collection exercise. It is essential that you read the UHI Research Ethics Framework before completing this form, signing and submitting it to your Project Supervisor for their endorsement and signature. Please pay close attention to the guidance notes, as it may be necessary for you to complete another form REC1D as part of this exercise. Further information on UHI’s Research Ethics Policy and the ethical approval process can be found at UHI ETHICS Guidance and Forms. Forename : Status: (Please tick the appropriate box) Surname: *Undergraduate Student *Taught Postgraduate/Masters Student *Postgraduate Researcher/PHD Student Student/ UHI Email: @uhi.ac.uk Tel. No: Contact address: Project Title: Module Title: Module Code: Name of Supervisor: Programme Leader: Module Leader Institution/ AP Faculty (Please tick the appropriate box) *Arts Humanities and Business *Science, Health and Engineering Proposed Start Date Proposed End Date Please complete as appropriate Yes 1 No Will the study involve recruitment of patients or staff through the NHS? If the answer to the above question is “Yes”, compliance with NHS Guidelines will be required (See NHS Ethics or your local NHS authority for guidance) and you will need to complete an NHS IRAS online application. (See IRAS Online ) *We recommend that before completing an IRAS application online you work through the IRAS Training Module. If you have answered “Yes” to Qu1 there is no need for you to answer the remaining questions on this REC1 form. Please complete and sign the declaration at the end of this form and submit it to your Supervisor. If the answer is “No”, please continue to Question 2. Yes No 2 Will the study involve human participants? If the answer to the above question (2) is “Yes”, please answer the remaining questions. If the answer is “No”, please complete and sign the declaration at the end of this form and submit it to your Supervisor. If your answer to question 2 was “yes”, your study will involve human participants, please complete all questions 3-19. 3 Will the study involve participants who are particularly vulnerable and may be unable to give informed consent (e.g. children under 18, persons with disabilities, people in dependent relationships e.g. university students, prisoners, asylum seekers etc. people in insecure employment, people who feel that participation in the research will result in access to better support or treatment for them etc.)? 4 Will any of the interviews or questioning of participants be conducted in a language other than the respondents’ first language? 5 Will the research require the co-operation of a gatekeeper for initial access to the groups or individuals to be recruited? (e.g. school students, members of selfhelp group, residents of nursing home, employers) or research in communities (in the UK or overseas) where access to research participants is not possible without the permission of another adult, such as another family member (e.g. the parent or husband of the participant) or a community leader. 6 Will the research involve Internet Mediated Research (IMR); respondents to the internet, e.g. use of survey monkey, recruiting participants via social networking sites e.g. Facebook, college/ group email addresses via a project website (Please consult UHI Ethics Guidelines for IMR projects) or involve visual/ vocal methods of recording where respondents may be identified? (For IMR projects please consult UHI IMR Guidelines and complete /submit an IMR_Checklist with your REC1/REC1D.) 7 Will it be necessary for participants to take part in the study without their knowledge/consent at the time? (e.g. covert observation of people in non-public places) 8 Will the study involve discussion of topics which the participants may find sensitive (e.g. sexual activity, own drug use, mental health, gender or ethnic status, political behaviour)? 9 Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study participants? 10 Will the study involve intrusive interventions or data collection methods- for example vigorous physical exercise beyond the participant’s everyday activity? 11 Will blood or tissue samples be obtained from participants? 12 Is physical pain or more than mild discomfort likely to result from the study? 13 Could the study induce psychological stress or anxiety, or cause harm or negative consequences beyond the risks encountered in everyday life? 14 Will the study involve prolonged or repetitive testing? 15 Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants? 16 Will the research involve administrative or secure data that requires permission from the appropriate authorities before its use? 17 Is there a possibility that the safety of the researcher may be in question? E.g. working in the field or remotely. 18 Will the research take place outside the UK? Yes No 19 Will research involve the sharing of data or confidential information beyond the initial consent given? If you have answered “No” in each case to Questions 3-19, please complete the Declaration and pass this form to your Project Supervisor for approval. If you have answered “Yes” to any of the questions, please complete Form REC1-D Student and submit it with your supporting documentation to your Project Supervisor along with this form. STUDENT DECLARATION Yes I confirm that I have read and understood the UHI Research Ethics Framework Yes I confirm that NHS Ethics Approval is being/has been* sought and that the UHI Research Ethics Committee will be notified that such approval is in place *please delete as appropriate Signed: Date: Print Name: PROJECT SUPERVISOR AUTHORISATION I confirm that: Yes The topic merits further research The researcher has the skills to carry out the research The Methodology, Participant Information Sheet, Questionnaires and Consent Forms for research participants are appropriate The procedures for recruitment and obtaining informed consent from participants and / or gatekeepers are appropriate Comments - ‘Endorsed’ or ‘Not Endorsed’: Signed: Date: Print Name: Email: No N/A N/A Student Application for Ethical Approval Check List. PLEASE SUBMIT THIS CHECKLIST WITH YOUR ETHICS APPLICATION Name: Student No: Project Title: Date: 1. You should have completed every section of the REC1 Application for Ethical Approval and REC1D form if applicable. 2. The Signature Section must be completed in hard copy by the Principal Researcher and their Supervisor. 3. Ethical approval must be obtained before any research involving human subjects is undertaken. Please indicate if the following documents have been enclosed by ticking the applicable option. REC1 Application Form for Ethical Approval (one electronic and one paper copy signed by the researcher and their Supervisor/ Line Manager). Yes REC1D Application Form for Ethical Approval (one electronic and one paper copy). Yes Have you ensured that you have listed your University of the Highlands and Islands e-mail address? Yes Research Outline/Proposal or Methodology. Yes Participant Information Sheet. No Not Applicable Yes No Not Applicable Written Information for Subjects (e.g. Questionnaires, Interview Schedules, etc) Yes No Not Applicable Consent Form(s). Yes No Not Applicable Gate Keeper Information/Consent. Yes No Not Applicable Internet Mediated Research (IMR) Checklist. Yes No Not Applicable Undergraduate and Taught Post Graduate /Masters Students: Please submit this form in hard copy with your full application for ethical approval to your Faculty Research Ethics Officer: Fiona Ryan, Faculty Research Ethics Officer, University of the Highlands and Islands, 12b Ness Walk, Inverness, IV3 5SQ, faculty.research.ethics@uhi.ac.uk PHD, Postgraduate Student Researchers, Please submit this form in hard copy with your full application for ethical approval to the UHI Research Ethics Officer: University of the Highlands and Islands, 12b Ness Walk, Inverness, IV3 5SQ. research.ethics@uhi.ac.uk PDF versions of completed forms may be emailed to UHI Ethics Officer or Faculty Research Ethics Officer ahead of hard copies, however original signed forms (typed names are not acceptable) must be received within 10 days of submission of the electronic version in order to process applications. REC1D Research Projects – UHI Student Please complete this form if you have answered “Yes” to any of the Questions 3 – 19 in Form REC1 Student. Name: Project Title: Please explain the ethical issues identified, estimate the risks and highlight any mitigating actions to be taken for only those questions to which there was a “Yes” response: Question No. 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 In addition to completing this form, please provide a copy of the Project’s Methodology, Participant Information Sheet, relevant Consent Forms for Participants and/ or Gatekeepers, Questionnaires or any other documentation which may inform the Ethical Approval process. Please submit Form REC1 Student, this form and any supporting documentation to your Project Supervisor. Thank you Research Projects - UHI Staff All staff listed on the UHI Academic Register undertaking a research project must seek ethical approval via their Senior Line Manager prior to undertaking any form of fieldwork or data collection exercise. Please read the UHI Research Ethics Framework before completing this form, signing and submitting it to your Senior Line Manager for their endorsement and signature. Please pay close attention to the guidance notes, as it may be necessary for you to complete another form REC1D as part of this exercise. Further information on UHI’s Research Ethics Policy and the ethical approval process can be found at UHI ETHICS Guidance and Forms. Chief Investigator: Co-Investigators: (If Applicable) UHI Faculty (please tick appropriate box): Science, Health and Engineering Arts Humanities and Business Institution/ AP UHI Email: Tel. No.: Contact address: Project Title: Outline Description Proposed Start Date Proposed End date Research Ethics Checklist Please complete as appropriate Yes 1 No Will the study involve recruitment of patients or staff through the NHS? If the answer to the above question is “Yes”, compliance with NHS Guidelines will be required (See NHS Ethics or your local NHS authority for guidance) and you will need to complete an NHS IRAS online application. (See IRAS Online ) If you have answered “Yes” to Qu1 there is no need for you to answer the remaining questions on this REC1 form. Please complete and sign the declaration at the end of this form and submit it to your Senior Line Manager. If the answer is “No”, please continue to Question 2. Yes 2 No Will the study involve human participants? If the answer to the above question (2) is “Yes”, please answer the remaining questions. If the answer is “No”, please complete and sign the declaration at the end of this form and submit it to your Senior Line Manager. If your answer to question 2 was “yes”, your study will involve human participants, please complete all questions 3-19. 3 Will the study involve participants who are particularly vulnerable and may be unable to give informed consent (e.g. children under 18, persons with disabilities, people in dependent relationships e.g. university students, prisoners, asylum seekers etc. people in insecure employment, people who feel that participation in the research will result in access to better support or treatment for them etc.)? 4 Will any of the interviews or questioning of participants be conducted in a language other than the respondents’ first language? 5 Will the research require the co-operation of a gatekeeper for initial access to the groups or individuals to be recruited? (e.g. school students, members of selfhelp group, residents of nursing home, employers) or research in communities (in the UK or overseas) where access to research participants is not possible without the permission of another adult, such as another family member (e.g. the parent or husband of the participant) or a community leader. 6 Will the research involve Internet Mediated Research (IMR); respondents to the internet, e.g. use of survey monkey, recruiting participants via social networking sites e.g. Facebook, college/ group email addresses via a project website (Please consult UHI Ethics Guidelines for IMR projects) or involve visual/ vocal methods of recording where respondents may be identified? (For IMR projects please consult UHI IMR Guidelines and complete /submit an IMR_Checklist with your REC1/REC1D.) 7 Will it be necessary for participants to take part in the study without their knowledge/consent at the time? (e.g. covert observation of people in non-public places) 8 Will the study involve discussion of topics which the participants may find sensitive (e.g. sexual activity, own drug use, mental health, gender or ethnic status, political behaviour)? 9 Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study participants? 10 Will the study involve intrusive interventions or data collection methods- for example vigorous physical exercise beyond the participant’s everyday activity? 11 Will blood or tissue samples be obtained from participants? 12 Is physical pain or more than mild discomfort likely to result from the study? 13 Could the study induce psychological stress or anxiety, or cause harm or negative consequences beyond the risks encountered in everyday life? 14 Will the study involve prolonged or repetitive testing? 15 Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants? 16 Will the research involve administrative or secure data that requires permission from the appropriate authorities before its use? 17 Is there a possibility that the safety of the researcher may be in question? E.g. working in the field or remotely. 18 Will the research take place outside the UK? Yes No 19 Will research involve the sharing of data or confidential information beyond the initial consent given? If you have answered “No” in each case to Questions 3-19, please complete the Declaration and pass this form to your Senior Line Manager for approval. If you have answered “Yes” to any of the questions, please complete Form REC1-D Staff and submit it to your Senior Line Manager along with this form and any supporting documentation. RESEARCHER DECLARATION Yes I confirm that I have read and understood the UHI Research Ethics Framework Yes N/A I confirm that NHS Ethics Approval is being/has been* sought and that the UHI Research Ethics Committee will be notified that such approval is in place *please delete as appropriate Signed: Date: Print Name: SENIOR LINE MANAGER AUTHORISATION I confirm that: Yes The topic merits further research The researcher has the skills to carry out the research The Methodology, Participant Information Sheet, Questionnaires and Consent Forms for research participants are appropriate The procedures for recruitment and obtaining informed consent from participants and / or gatekeepers are appropriate Comments - ‘Endorsed’ or ‘Not Endorsed’: Signed: Date: Print Name: Email: No N/A Staff Application for Ethical Approval Check List PLEASE SUBMIT THIS CHECKLIST WITH YOUR ETHICS APPLICATION Name: Project Title: Date: 4. You should have completed every section of the REC1 Application for Ethical Approval and REC1D form if applicable. 5. The Signature Section must be completed in hard copy by the Principal Researcher and their Senior Line Manager. 6. Ethical approval must be obtained before any research involving human subjects is undertaken. Please indicate if the following documents have been enclosed by ticking the applicable option. REC1 Application Form for Ethical Approval (one electronic and one paper copy signed by the researcher and their Supervisor/ Line Manager). Yes REC1D Application Form for Ethical Approval (one electronic and one paper copy). Yes Have you ensured that you have listed your University of the Highlands and Islands e-mail address? Yes Research Outline/Proposal or Methodology. Yes Participant Information Sheet. No Not Applicable Yes No Not Applicable Written Information for Subjects (e.g. Questionnaires, Interview Schedules, etc) Yes No Not Applicable Consent Form(s). Yes No Not Applicable Gate Keeper Information/Consent Yes No Not Applicable Internet Mediated Research (IMR) Checklist. Yes No Not Applicable Please submit this form in hard copy with your full application for ethical approval to the; UHI Research Ethics Officer: University of the Highlands and Islands, 12b Ness Walk, Inverness, IV3 5SQ. research.ethics@uhi.ac.uk PDF versions of completed forms may be emailed to UHI Ethics Officer ahead of hard copies, however original signed forms (typed names are not acceptable) must be received within 10 days of submission of the electronic version in order to process applications. REC1D Research Projects – UHI Staff Please complete this form if you have answered “Yes” to any of the Questions 3 – 19 in Form REC1 Staff. Name: Project Title: Please explain the ethical issues identified, estimate the risks and highlight any mitigating actions to be taken for only those questions to which there was a “Yes” response: Question No. 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 In addition to completing this form, please provide a copy of the Project’s Methodology, Participant Information Sheet, relevant Consent Forms for Participants and/or Gatekeepers, Questionnaires or any other documentation which may inform the Ethical Approval process. Please submit Form REC1 Staff, this form and any supporting documentation to your Senior Line Manager. Thank you. Appendix 2 -Ethical Approval Flowchart for UHI Undergraduate and Masters/ Taught Postgraduate Student Research Projects. Student Research Project Involving Human Participants APPROVED If NO answered to all 19 questions on REC1 Student Form. Student emailed confirmation of approval from Faculty Research Ethics Officer Student undertakes supervised research project Student work submitted with copy of REC1 Student Form and Approval. APPROVED Student & Project Supervisor notified by email. APPROVED Student & Project Supervisor notified by email. Student & Project Supervisor submit signed REC1Student Form to Faculty Research Ethics Officer. FURTHER REVIEW REQUIRED (Form REC1D) If YES answered to any of questions 3-19 on REC1 Student Form Student & Project Supervisor submit signed REC1 Student Form and REC1D Student Form & Supporting Docs to Faculty Research Ethics Officer Faculty Research Ethics Officer submits to FREC Chair for Review. REFERAL by Chair of FREC to Full Faculty Research Ethics Committee Review OR Full UHI Research Ethics Committee Review. NOT APPROVED Student & Project Supervisor notified by email. NHS APPROVAL MUST BE SOUGHT If YES answered to question 1 on REC1 Student form. Student & Project Supervisor notify Faculty Research Ethics Officer that NHS Approval is being sought and complete NHS IRAS online application. Level of NHS approval required determined by IRAS. Student sends copy of NHS approval to Faculty Research Ethics Officer and receives confirmation of UHI Ethical Approval. Student work submitted with copy of REC1 Student Form and NHS/ UHI Approvals. NOT APPROVED Student & Project Supervisor notified by email. Appendix 3. Ethical Approval Flowchart for UHI Staff, PHD / Postgraduate Student Research Projects. UHI Staff or PHD Student Research Project Involving Human Participants. APPROVED If NO answered to all 19 questions on REC1 Form. Researcher emailed confirmation of approval from UHI Research Ethics Officer Researcher undertakes supervised research project. Researcher work submitted with copy of REC1 Form and Approval. APPROVED Researcher & Project Supervisor notified by email. APPROVED Researcher & Project Supervisor notified by email. Researcher & Project Supervisor submit signed REC1 Student Form (OR REC1Staff Form) to UHI Research Ethics Officer. FURTHER REVIEW REQUIRED (Form REC1D) If YES answered to any of questions 3-19 on REC1 Form. Researcher & Project Supervisor submit signed REC1 and REC1D Forms & Supporting Docs to UHI Research Ethics Officer. UHI Research Ethics Officer submits to Research EC Chair for Review. REFERAL by Chair of REC to Full UHI Research Ethics Committee Review. NOT APPROVED Student & Project Supervisor notified by email. NHS APPROVAL MUST BE SOUGHT If YES answered to question 1 on REC1 Student form. Researcher & Project Supervisor notify UHI Research Ethics Officer that NHS Approval is being sought and complete NHS IRAS online application. Level of NHS approval required determined by IRAS. Researcher sends copy of NHS approval to UHI Research Ethics Officer and receives confirmation of UHI Ethical Approval. Researcher work submitted with copy of REC1 Form and copy of NHS/ UHI Approvals. NOT APPROVED Researcher & Project Supervisor notified by email.