Research Ethics Committee (REC) Application for Ethical Approval Please note: this application form has been created for electronic completion and therefore contains check-boxes and drop-down lists for your responses. All items on this form require a response in order to allow the REC to fully scrutinise the research. Researcher Details Lead Researcher First Name: Surname: FAS: Primary dept. / area (please FoE: select from drop-down lists): FHSC: Please select from the drop down list Please select from the drop down list Please select from the drop down list Other: Staff / Doctoral Student? Please select from the drop down list (if student, supervisors should be included in the next field) Names & affiliations of research team / supervisory team Please note that any ethical approval granted on the basis of this application covers only the original study for which ethical approval was sought (unless advised otherwise by the relevant ethics committee at the time of approval). If a study is extended or changed and / or further use of samples or data from a study already completed is required, it advisable to contact the Research & Enterprise Support Office and the ethics committee from which your original approval was granted. Research & Enterprise Support Office Project Details Title: Start date of project: End date of project: Source of funding for the project: Research Method: Please select from the drop down list Detail of other / mixed methods: Risk Assessment Has a risk assessment been carried out? YES NO Please detail the reasons below Details if no risk assessment has been carried out (max 500 characters): If no risk assessment has been carried out, by which date do you intend to conduct one? Do your data collection and research methods include any of the following? Please tick all that apply. Administering drugs or other substances (please specify below) Deception (excluding blind research design) (please specify below) Blood sample (via needle insertion) Use of distressing images, video or other media (please specify below) Blood sample (not via needle insertion) Other physically or psychologically invasive method (please specify below) Collection of other bodily tissues, secretions or excretions (please specify below) Non-invasive Please provide details of the invasive method(s), as requested above (max 500 characters): Research Subjects: Please select from the drop down list Other: Are research subjects EHU Staff / Student? Document1 Please select from the drop down list Page 2 of 10 Research & Enterprise Support Office Location of project: Please select from the drop down list Other: Could the location present any risks to either the researcher(s) or to third parties (e.g. the general public, research subjects, etc.)? YES NO If yes, please provide details (max 500 characters): Document1 Page 3 of 10 Research & Enterprise Support Office Ethical Approval Information Has this proposal been through external or parallel ethical approval processes? YES NO Details (max 500 characters or attach separate sheet): Is this proposal an extension of a project that has previously undergone ethical approval procedures? YES NO Details (max 500 characters or attach separate sheet): Does this proposal require a specific ethical approval action (e.g. letter, facility) to be produced to support the project? YES NO Details (max 500 characters or attach separate sheet): Document1 Page 4 of 10 Research & Enterprise Support Office Outline of the Project & Ethical Issues Please attach your research proposal. Proposals should include details under the categories listed below. They can be presented in a submission written specifically for this document or consist of other written documents that outline the project (e.g. to external funders), as long as a cover sheet clearly specifies upon where each of the categories listed are elaborated. Submissions should include such detail as to allow readers to gain a clear understanding of the applicants’ attention to ethical issues and problems. Categories: Title of project / aims and objective of the project Outline of the project Methodology and outline of methods and analysis Identification of research participants Timescales and staging of the project Budget and logistics / sources of funding Specific ethical considerations / risk assessment Relevant supporting documents (e.g. consent forms, information sheets, invitation letters) Confirmation that EHU policies & procedures have been followed (e.g. risk assessment, health & safety protocol) Processes by which ethical review will be in place throughout the project Details of research staff Document1 Page 5 of 10 Research & Enterprise Support Office Document1 Page 6 of 10 Research & Enterprise Support Office Research Ethics Committee (REC) Approval Form Applicant’s Signature (lead researcher if more than one applicant) Date Comments from Head of Department / Area or Research Degree Supervisor (max 600 characters) HoD / Research Degree Supervisor Name HoD / Research Degree Supervisor Signature Date The completed, signed form should be returned to: FAS: Your Departmental Research Ethics Committee (DREC) Secretary FHSC: Victoria Kelly FoE: Julie Kirby Document1 Page 7 of 10 Research & Enterprise Support Office Comments from Departmental and / or Faculty REC Chair (max 600 characters) Departmental / Faculty REC Chair Name Departmental / Faculty REC Chair Signature Date Approved by DREC / FREC? Is the below decision that of DREC or FREC: Please select from the drop-down list YES NO: Re-submit to DREC / FREC NO: Re-submit for Chair’s Approval NO: Refer to FREC (DRECs only) NO: Refer to UREC NO: Rejected Please note: if rejected, the applicant has the right to lodge an appeal with UREC as per the Framework for Research Ethics. Document1 Page 8 of 10 Research & Enterprise Support Office Only if referred to UREC from Faculty REC: Comments from UREC Chair (max 600 characters) UREC Chair Name UREC Chair Signature Date Approved by UREC? YES NO Administration Committee / Sub-Committee Date Minute Reference Approval Date Further action, where needed (max 600 characters) Document1 Page 9 of 10 Research & Enterprise Support Office Document updated September 2013 Document1 Page 10 of 10