[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-228109-en":3,"doc-seo-228109-105":30,"detail-sidebar-cat-0-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":4,"is_deleted":4,"is_public":20,"is_downloadable":20,"audit_status":20,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":14,"update_tm":28,"read_time":29},228109,962085564549,"Aditya","https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45",7,"Healthcare","Louisa Haine - Amblyopia research protocol 5 - Protocol compliance declaration","This document sets out a research protocol for examining new visual acuity and crowding distance tests to improve detection of amblyopia. The protocol specifies the protocol version and administrative identifiers including the IRAS number and sponsor information, and provides a formal HRA protocol compliance declaration. It includes a signed confirmation from the sponsor and chief investigator agreeing to conduct the study according to the approved protocol and relevant regulatory principles, including data confidentiality and transparent dissemination of results.","Louisa Haine – Amblyopia research protocol 5.0 IRAS Number: 238449  \nHRA Protocol Compliance Declaration  \nThis protocol has regard for the HRA guidance and order of content  \nLouisa Haine – Amblyopia research protocol 5.0 IRAS Number: 238449  \nAN EXAMINATION OF NEW VISUAL ACUITY AND CROWDING DISTANCE TESTS,  \nFOR BETTER DETECTION OF AMBLYOPIA.  \nNew visual acuity and crowding tests for better detection of amblyopia.  \nPROTOCOL VERSION NUMBER: 5.0  \nDATE: 17/02/2021  \nIRAS Number: 238449  \nSponsor number: FST/FREP/17/739  \nLouisa Haine – Amblyopia research protocol 5.0 IRAS Number: 238449  \nSIGNATURE PAGE  \nThe undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory requirement.  \nI agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the investigation without the prior written consent of the Sponsor.  \nI also confirm that I will make the findings of the study publically available through publication or other dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the study will be given; and that any discrepancies from the study as planned in this protocol will be explained.  \nFor and on behalf of the Study Sponsor:  \nSignature:   Date:  /  /   Name (please print):  \nPosition:    \nChief Investigator:  \nSignature:   Date:  /  /   Name: (please print):  \n......................................................................................................  \nResearch Supervisor:  \nSignature:   Date:  /  /   Name: (please print):  \n......................................................................................................  \nLouisa Haine – Amblyopia research protocol 5.0 IRAS Number: 238449  \nLIST OF CONTENTS  \n\n| GENERAL INFORMATION | Page No. |\n| --- | --- |\n| HRA PROTOCOL COMPLIANCE DECLARATION | i |\n| TITLE PAGE | ii |\n| RESEARCH REFERENCE NUMBERS | ii |\n| SIGNATURE PAGE | iii |\n| LIST OF CONTENTS | iv |\n| KEY STUDY CONTACTS | v |\n| STUDY SUMMARY | vii |\n| FUNDING | ix |\n| ROLE OF SPONSOR AND FUNDER | xi |\n| ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS | xiii |\n| STUDY TIMELINE AND FLOW CHART | xviii |\n| SECTION |  |\n| 1. BACKGROUND | 1 |\n| 2. RATIONALE | 5 |\n| 3. THEORETICAL FRAMEWORK | 10 |\n| 4. RESEARCH QUESTION/AIM(S) | 11 |\n| 5. STUDY DESIGN/METHODS AND DATA ANALYSIS | 13 |\n| 6. STUDY SETTING | 25 |\n| 7. SAMPLE AND RECRUITMENT | 27 |\n| 8. ETHICAL AND REGULATORY COMPLIANCE (inc confidentiality and risk) | 32 |\n| 9. DISSEMINATION POLICY | 43 |\n| 10. REFERENCES | 45 |\n| 11. APPENDICES | 52 |\n\nLouisa Haine – Amblyopia research protocol 5.0 IRAS Number: 238449  \nKEY STUDY CONTACTS  \n\n| Principal Investigator | Louisa Haine – Postgraduate Researcher COS 407; Anglia Vision Research, Department of Vision and Hearing Sciences, Faculty of Science and Technology,\u003Cbr>Anglia Ruskin University,\u003Cbr>Cambridge\u003Cbr>CB1 1PT\u003Cbr>Phone: 01223 698584\u003Cbr>Email: [louisa.haine@aru.ac.uk](louisa.haine@aru.ac.uk) |\n| --- | --- |\n| Chief Investigator / Research Supervisor\u003Cbr>(Study Co-ordinator) | Dr Sarah Waugh – Reader in Vision Sciences Department of Optometry and Vision Sciences, University of Huddersfield\u003Cbr>HD1 3DH\u003Cbr>Phone: 01484 422288\u003Cbr>Email: [s.j.waugh@hud.ac.uk](s.j.waugh@hud.ac.uk) |\n| Sponsor | Anglia Ruskin University Contact on behalf of the Sponsor Professor Peter Bright\u003Cbr>Chair: FREP (Faculty of Science and Technology Research Ethics Panel)\u003Cbr>Department of Psychology, Faculty of Science and Technology, Anglia Ruskin University, Cambridge\u003Cbr>CB1 1PT\u003Cbr>Phone: 01223 698647\u003Cbr>[peter.bright@aru.ac.uk](peter.bright@aru.ac.uk) |\n| Joint-sponsor(s)/co-sponsor(s) | N/A |\n| Funder(s) | Contact on behalf of the Sponsor/funder","cbCaivDTXBtsaBVG","https://ap.wps.com/l/cbCaivDTXBtsaBVG","pdf",3699151,1,92,"English","en",105,"# HRA Protocol Compliance Declaration\n# Signature Page\n# List of Contents\n## General Information\n## Study Sections\n# Key Study Contacts","[{\"question\":\"What is the study’s main objective described in the protocol?\",\"answer\":\"The protocol aims to examine new visual acuity and crowding distance tests for better detection of amblyopia.\"},{\"question\":\"Which compliance and ethical principles are referenced for conducting the study?\",\"answer\":\"The signature page confirms adherence to the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory requirements, aligned with the approved protocol.\"},{\"question\":\"How does the protocol address confidentiality and dissemination of study findings?\",\"answer\":\"It requires that confidential information is used only for evaluation or conduct of the investigation without prior written consent. It also confirms findings will be made public through publication or other dissemination tools without unnecessary delay, with an honest, accurate, and transparent account.\"}]","Louisa Haine - Amblyopia research protocol 5 - Protocol compliance declaration | PDF",1789021095,232,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":13,"keywords":34,"description":14,"schema_data":35,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":28},"louisa-haine-amblyopia-research-protocol-5-protocol-compliance-declaration","",{"@graph":36,"@context":85},[37,54,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":20},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/document/","Document",2,{"item":49,"name":12,"@type":43,"position":50},"https://docshare.wps.com/document/healthcare/",3,{"item":52,"name":13,"@type":43,"position":53},"https://docshare.wps.com/document/louisa-haine-amblyopia-research-protocol-5-protocol-compliance-declaration/228109/",4,{"url":52,"name":13,"@type":55,"author":56,"headline":13,"publisher":58,"fileFormat":61,"inLanguage":23,"description":14,"dateModified":62,"datePublished":62,"encodingFormat":61,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/pdf","2026-09-10",true,{"@type":65,"interactionType":66,"userInteractionCount":4},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What is the study’s main objective described in the protocol?","Question",{"text":75,"@type":76},"The protocol aims to examine new visual acuity and crowding distance tests for better detection of amblyopia.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"Which compliance and ethical principles are referenced for conducting the study?",{"text":80,"@type":76},"The signature page confirms adherence to the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory requirements, aligned with the approved protocol.",{"name":82,"@type":73,"acceptedAnswer":83},"How does the protocol address confidentiality and dissemination of study findings?",{"text":84,"@type":76},"It requires that confidential information is used only for evaluation or conduct of the investigation without prior written consent. 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