ࡱ>  u=bjbj&& y DjDjd/>>7S""""""8"%" (....fg<Og _"og7cGf@ogogkk..x4':oooog0k.?"8.oogoo-!w"f.@t2h 4a<>(?i hffn"ԭ(ogogoogogogogog_nogogogogogogogogogogogogogogogog> :  APPLICATION FOR ETHICS APPROVAL No ethics-relevant action should be taken until this application has been approved. Please first read the HYPERLINK "/wp-content/uploads/sites/9/2023/07/20170602_Research_Ethics_Guidelines-09.05.2018.pdf"Guidelines to determine whether approval is required, fill out this form following the instructions in the HYPERLINK "/wp-content/uploads/sites/9/2023/07/20170602_Research_Ethics_Guidelines-09.05.2018.pdf"Guidelines, add any additional information in separate files, and send the complete application to  HYPERLINK "mailto:erp-submissions@uni.lu" erp-submissions@uni.lu. SECTION 1: PROJECT Title: SHAPE \* MERGEFORMAT Acronym: SHAPE \* MERGEFORMAT  Applicant(s): Researcher/StudentName: SHAPE \* MERGEFORMAT Position at UL: SHAPE \* MERGEFORMAT Faculty / IC: SHAPE \* MERGEFORMAT Research Unit: SHAPE \* MERGEFORMAT Telephone no: SHAPE \* MERGEFORMAT Email: SHAPE \* MERGEFORMAT  Principal Investigator Name: SHAPE \* MERGEFORMAT Position at UL: SHAPE \* MERGEFORMAT Faculty / IC: SHAPE \* MERGEFORMAT Research Unit: SHAPE \* MERGEFORMAT Telephone no: SHAPE \* MERGEFORMAT Email: SHAPE \* MERGEFORMAT Please specify in case you are not employed at UL. Please expand if more than 2 persons are involved. Funding: Source: SHAPE \* MERGEFORMAT Is ethical approval required before the funds can be obtained? FORMCHECKBOX  Yes FORMCHECKBOX  NoEthical approval is being requested for: Please note that enough detail needs to be provided for each study. FORMCHECKBOX  a single study FORMCHECKBOX  multiple studiesHas ethics approval already been obtained from another ethics committee for this project? FORMCHECKBOX  Yes  FORMCHECKBOX  NoHas ethics approval already been obtained from the ERP for a similar research design?  FORMCHECKBOX  Yes  FORMCHECKBOX  No In case ethics approval has already been obtained, please provide references. (see points below)  SHAPE \* MERGEFORMAT  Please list any research area-specific ethics guidelines (with a link to the relevant document) you have used in the planning of your research (e.g. from a professional society).  SHAPE \* MERGEFORMAT  SECTION 2: SHORT SUMMARY OF THE PROJECT (including research design and methodology)  SHAPE \* MERGEFORMAT  SECTION 3: PROPOSED START DATE AND DURATION OF ETHICS-RELEVANT ACTIVITY FOR EACH STUDY IN THE PROJECT Please see the HYPERLINK "/wp-content/uploads/sites/9/2023/07/20170602_Research_Ethics_Guidelines-09.05.2018.pdf"Guidelines for the definition of ethics-relevant activities. Study No.Study TitleStart DateDuration in Months1. 50 words max. 2. 50 words max. Please expand the rows in case of additional studies. SECTION 4: AIM OF EACH OF THE STUDIES Study No.Aim Study will involve: Please tick all appropriate boxes1. 100 words max.   FORMCHECKBOX  Human participants  FORMCHECKBOX  Vulnerable population   FORMCHECKBOX  Human biological material  FORMCHECKBOX  Pre-collected biological material  FORMCHECKBOX  Personal data  FORMCHECKBOX  Pre-collected personal data  FORMCHECKBOX  risks on the environment  FORMCHECKBOX  risks on the society2. 100 words max.   FORMCHECKBOX  Human participants  FORMCHECKBOX  Vulnerable population  FORMCHECKBOX  Human biological material  FORMCHECKBOX  Pre-collected biological material  FORMCHECKBOX  Personal data  FORMCHECKBOX  Pre-collected personal data  FORMCHECKBOX  risks on the environment  FORMCHECKBOX  risks on the societyPlease expand the rows in case of additional studies. SECTION 5: DETAILS OF EACH STUDY Please specify the ethically relevant issues for each of the studies. Study 1 Target sample size: (Please justify the target sample size, either statistically or by referring to existing literature)Key inclusion criteria:Key exclusion criteria:Age range of participants:Country/ies of recruitment:Expected duration of procedure :Data Collection: Audio / Video Methodology: Please explain concisely, 750 words max. Please expand the table in case of additional studies. SECTION 6: RISK ASSESSMENT AND RISK MINIMIZATION A risk assessment should be carried out for each study and it should be demonstrated that appropriate measures are taken to minimize any reasonably foreseeable risk, discomfort or disadvantages. 6.1- Health and safety risk(s) for the HUMAN PARTICIPANTS involved Potential risk(s)Extent of risk(s) and measures takenStudy 1 Human participants are involved in the study with potential risk related to  FORMCHECKBOX  Physical harm  FORMCHECKBOX  Psychological harm  FORMCHECKBOX  Invasion of privacy  FORMCHECKBOX  Social and economic harm  FORMCHECKBOX  Other Please explain concisely, 750 words max.  Are there any specific risks to the human participants involved, if any.  Please explain concisely. Please expand the table in case of additional studies. 6.2- Health and safety risk(s) for the RESEARCHER(S) Potential risk(s)Extent of risk(s) and measures takenStudy 1 Where does the research take place?  FORMCHECKBOX  Premises of UL  FORMCHECKBOX  Public area  FORMCHECKBOX  Study participants home  FORMCHECKBOX  Other location Please provide a copy of any authorisation / permission needed with regard to the research location. Please explain concisely, 750 words max.  Are there any specific risks to the researchers (which are not covered by the location)? Please explain concisely. Please expand the table in case of additional studies. 6.3- Changes to the ENVIRONMENT and SOCIETY Potential risk(s)Extent of risk(s) and measures takenStudy 1 Research activity includes  FORMCHECKBOX  Pollutants  FORMCHECKBOX  Chemical or biological waste  FORMCHECKBOX  Dual use research of concern (e.g. military research purpose(s))  FORMCHECKBOX  Other Please explain concisely, 750 words max. Are there any specific risks to the environment and/or society?  Please explain concisely. Please expand the table in case of additional studies. SECTION 7: PARTICIPANTS INFORMATION AND CONSENT Participants (or their legal representatives) have to be provided with information on the study, and participants have to give their consent. Consent form template and instructions can be found on the HYPERLINK "/en/about/organisation/administration/ethics-review-panel/"8xav internet site. Please indicate which information and consent form(s) you will use for your study/studies and attach a version of all information (in the language(s) used in the study) given to the participants (or their legal representatives) to this application:  FORMCHECKBOX  Participants information sheet(s) for study/studies Please tick as appropriate:  FORMCHECKBOX  Human participants  FORMCHECKBOX  Vulnerable population  FORMCHECKBOX  Participants consent for study/studies Please tick as appropriate:  FORMCHECKBOX  Human participants  FORMCHECKBOX  Vulnerable population Have you planned an additional oral debriefing? FORMCHECKBOX  Yes FORMCHECKBOX  NoHave you made explicitly clear that participants voluntarily take part in the study? FORMCHECKBOX  Yes  FORMCHECKBOX  NoHave you made clear that participants can withdraw from the study at any time without consequences? FORMCHECKBOX  Yes  FORMCHECKBOX  NoDo you plan to do audio/video recording? If you do audio/video recording, did you include this in the informed consent? FORMCHECKBOX  Yes  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  No Have you informed participants on the processing and management of personal data in the consent form? Do you have the intention to use the data for further research? Do you use the informed consent for a single study purpose? FORMCHECKBOX  Yes  FORMCHECKBOX  Yes  FORMCHECKBOX  Yes FORMCHECKBOX  No  FORMCHECKBOX  No  FORMCHECKBOX  NoHave you addressed how unexpected findings will be handled? Unexpected findings are those which may reveal situations that suggest the presence of a problem. If you have such eventuality, specify how you intend to handle the situation Have you mentioned to provide the study participant with a copy of the consent? FORMCHECKBOX  Yes  FORMCHECKBOX  Yes FORMCHECKBOX  No  FORMCHECKBOX  N/A  FORMCHECKBOX  No SECTION 8: DATA PROTECTION 8.1- Anonymity / Pseudonymity Please describe for each of the studies, how anonymity or pseudonymity is addressed.  SHAPE \* MERGEFORMAT  I am aware of and I comply with the 8xavs data protection regulations.  HYPERLINK "https://wwwen.uni.lu/university/data_protection/data_protection_policy_and_faq" https://wwwen.uni.lu/university/data_protection/data_protection_policy_and_faq. FORMCHECKBOX  Yes FORMCHECKBOX  NoArticle 38, related to the position of the DPO of the GDPR and the UL Data Protection Regulation set out the data protection policy of the 8xav. Further details can be found under: HYPERLINK "https://uniluxembourg.sharepoint.com/sites/dpo/SitePages/Data-Protection-Office.aspx"https://uniluxembourg.sharepoint.com/sites/dpo/SitePages/Data-Protection-Office.aspx In addition to the GDPR regulations, the ERP needs to be informed about pseudonymity anonymity, data storage and data access (see the following sections). 8.2- Data storage Please fill in the information in the following table on provisions for integrity and confidentiality. Raw data (incl. video or audio recordings)Processed data (anonymized, pseudonymized)Document(s) containing the names, contact information and personal details (the pseudonymisation key list)Other materialData carrier (digitalized or paper form)Number of copies e.g. 1 copy with researcher, 1 copy with supervisor Storage Location e.g. UL server, laptop Retention period e.g. 10 years  8.3- Data access How is access being controlled (physical access, security)?  SHAPE \* MERGEFORMAT  ADDITIONAL DOCUMENTS: The following document(s) has/ have been attached:  FORMCHECKBOX Previous ethics approvals for the study/studies (a copy of the approval letter, a description of any modifications made to the approved research design) FORMCHECKBOX A version of all material used to recruit participants (e.g. flyers, letters). FORMCHECKBOX A brief description of equipment used, if relevant. FORMCHECKBOX Information sheet(s) for participants, legal guardians and/or other involved parties FORMCHECKBOX Consent form(s) for participants, legal guardians and other involved parties FORMCHECKBOX A version of all study materials given to the participants (e.g. questionnaires, assignments) FORMCHECKBOX A copy of any other information given to the participants FORMCHECKBOX Any additional document(s), please specify . Please provide the documents in all languages used in the study. DECLARATION: We confirm to conduct the research in an ethically appropriate way in accordance with the 8xav of Luxembourg HYPERLINK "/wp-content/uploads/sites/9/2023/08/Politique-CER-ERP-Policy.pdf"Policy on Ethics in Research. ResearcherName: SHAPE \* MERGEFORMAT Signature: (hand-signed)  SHAPE \* MERGEFORMAT Date:  SHAPE \* MERGEFORMAT  Principal InvestigatorName: SHAPE \* MERGEFORMAT Signature: (hand-signed)  SHAPE \* MERGEFORMAT Date:  SHAPE \* MERGEFORMAT Please expand the rows in case of additional researcher(s) and/or PI(s).  if different from researcher; Supervisor if the researcher is a PhD student  Vulnerable populations include pregnant women, neonates, children and adolescents, individuals with cognitive impairment and/or mental disorders, people with anxieties, mentally-deficient persons, members of social minorities, the elderly, and detained persons. Please consult also page 36 of the Research Ethics Guidelines.  Please indicate the duration the data collection procedure (e.g. 30 min), not of the whole project  Pseudonymization is the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject. Data anonymization is the process of irreversible transformation of personal data.     8xav of Luxembourg Ethics Review Panel (ERP)  Form: 15.01.2026 Application ID (filled in by ERP): 20 characters max. doctoral candidate, post-doc, FSTC, FDEF, FLSHASE (+352) 46 66 44 xxxx name.surname@uni.lu professor, post-doc, FSTC, FDEF, FLSHASE. (+352) 46 66 44 xxxx name.surname@uni.lu FNR, ERC, UL, the reference number of the ERP. from another ethics committee, please join a copy of the approval letter. 300 words max. Please explain concisely, 750 words max. Please list the people who have access to the different types of data under 8.2 Data storage. Is cryptography used for managing data access?  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