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The University of Jendouba's Comprehensive Digital Framework for Research Ethics Management: An Integrated System with Real-Time Verification, Surprise Audits, and Public Access through QR Codes and DOIs.

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Title: The University of Jendouba's Comprehensive Digital Framework for Research Ethics Management: An Integrated System with Real-Time Verification, Surprise Audits, and Public Access through QR Codes and DOIs.
Authors: Dergaa I; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia; High Institute of Sport and Physical Education of Ksar Said, University of Manouba, Manouba, Tunisia., Dhahbi W; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia., Guelmemi N; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia., Ben Jebli M; Faculty of Legal, Economic and Management Sciences of Jendouba, University of Jendouba, Jendouba, Tunisia., Jridi M; Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia., Sebai H; Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia.
Source: La Tunisie medicale [Tunis Med] 2025 Nov 01; Vol. 103 (11), pp. 1555-1564. Date of Electronic Publication: 2025 Nov 01.
Publication Type: Journal Article
Language: English
Journal Info: Publisher: Societe Tunisienne Des Sciences Medicales Country of Publication: Tunisia NLM ID: 0413766 Publication Model: Electronic Cited Medium: Internet ISSN: 2724-7031 (Electronic) Linking ISSN: 00414131 NLM ISO Abbreviation: Tunis Med Subsets: MEDLINE
Imprint Name(s): Original Publication: Tunis : Societe Tunisienne Des Sciences Medicales
MeSH Terms: Ethics Committees, Research*/organization & administration , Ethics Committees, Research*/standards , Biomedical Research*/ethics , Biomedical Research*/organization & administration , Biomedical Research*/standards , Electronic Data Processing*/methods , Ethics, Research* , Access to Information*, Universities/organization & administration ; Humans
Abstract: The University of Jendouba is implementing a novel digital framework to transform how Institutional Review Board (IRB) approvals are managed, with phased deployment commenced on June 13th, 2025, tackling pressing global issues in research integrity and transparency. Built on international standards like the Declaration of Helsinki and Good Clinical Practice (GCP), this system employs advanced tools such as QR codes and Digital Object Identifiers (DOIs) to enable real-time verification and public access to approved protocols. Crucially, the system extends its oversight beyond IRB approvals, monitoring the entire research process to ensure ethical compliance from the initial protocol submission through to the final publication of results. This framework addresses critical challenges, including the falsification of IRB approvals, data manipulation, and undisclosed changes to research protocols. It features automated compliance checks, risk-based evaluations of protocols, and real-time tracking of research activities to ensure studies adhere to their approved plans. Additionally, surprise audits and continuous oversight mechanisms are in place to detect and prevent unethical practices at every stage of the research process. As the first system of its kind in North Africa, this platform aligns with both local and international research ethics guidelines, fostering collaboration and standardization across disciplines. It also integrates blockchain technology and connects with global ethics databases to enhance transparency and trust in research outcomes.
Contributed Indexing: Keywords: Authentication; clinical trials; compliance; cybersecurity; electronic data; monitoring systems; protocols; public health; research governance; transparency
Entry Date(s): Date Created: 20260408 Date Completed: 20260714 Latest Revision: 20260714
Update Code: 20260715
DOI: 10.62438/tunismed.v103i11.5812
PMID: 41949949
Database: MEDLINE
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  Data: The University of Jendouba's Comprehensive Digital Framework for Research Ethics Management: An Integrated System with Real-Time Verification, Surprise Audits, and Public Access through QR Codes and DOIs.
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  Data: <searchLink fieldCode="AU" term="%22Dergaa+I%22">Dergaa I</searchLink>; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia; High Institute of Sport and Physical Education of Ksar Said, University of Manouba, Manouba, Tunisia.<br /><searchLink fieldCode="AU" term="%22Dhahbi+W%22">Dhahbi W</searchLink>; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia.<br /><searchLink fieldCode="AU" term="%22Guelmemi+N%22">Guelmemi N</searchLink>; High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia.<br /><searchLink fieldCode="AU" term="%22Ben+Jebli+M%22">Ben Jebli M</searchLink>; Faculty of Legal, Economic and Management Sciences of Jendouba, University of Jendouba, Jendouba, Tunisia.<br /><searchLink fieldCode="AU" term="%22Jridi+M%22">Jridi M</searchLink>; Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia.<br /><searchLink fieldCode="AU" term="%22Sebai+H%22">Sebai H</searchLink>; Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia.
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  Data: <searchLink fieldCode="JN" term="%220413766%22">La Tunisie medicale</searchLink> [Tunis Med] 2025 Nov 01; Vol. 103 (11), pp. 1555-1564. <i>Date of Electronic Publication: </i>2025 Nov 01.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Societe+Tunisienne+Des+Sciences+Medicales%22">Societe Tunisienne Des Sciences Medicales </searchLink><i>Country of Publication: </i>Tunisia <i>NLM ID: </i>0413766 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2724-7031 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200414131%22">00414131 </searchLink><i>NLM ISO Abbreviation: </i>Tunis Med <i>Subsets: </i>MEDLINE
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  Data: <i>Original Publication</i>: Tunis : Societe Tunisienne Des Sciences Medicales
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  Data: <searchLink fieldCode="MM" term="%22Ethics+Committees%2C+Research%22">Ethics Committees, Research*</searchLink>/<searchLink fieldCode="MM" term="%22Ethics+Committees%2C+Research+organization+%26+administration%22">organization & administration</searchLink> <br /><searchLink fieldCode="MM" term="%22Ethics+Committees%2C+Research%22">Ethics Committees, Research*</searchLink>/<searchLink fieldCode="MM" term="%22Ethics+Committees%2C+Research+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Biomedical+Research%22">Biomedical Research*</searchLink>/<searchLink fieldCode="MM" term="%22Biomedical+Research+ethics%22">ethics</searchLink> <br /><searchLink fieldCode="MM" term="%22Biomedical+Research%22">Biomedical Research*</searchLink>/<searchLink fieldCode="MM" term="%22Biomedical+Research+organization+%26+administration%22">organization & administration</searchLink> <br /><searchLink fieldCode="MM" term="%22Biomedical+Research%22">Biomedical Research*</searchLink>/<searchLink fieldCode="MM" term="%22Biomedical+Research+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Electronic+Data+Processing%22">Electronic Data Processing*</searchLink>/<searchLink fieldCode="MM" term="%22Electronic+Data+Processing+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Ethics%2C+Research%22">Ethics, Research*</searchLink> <br /><searchLink fieldCode="MM" term="%22Access+to+Information%22">Access to Information*</searchLink><br /><searchLink fieldCode="MH" term="%22Universities%22">Universities</searchLink>/<searchLink fieldCode="MH" term="%22Universities+organization+%26+administration%22">organization & administration</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink>
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  Data: The University of Jendouba is implementing a novel digital framework to transform how Institutional Review Board (IRB) approvals are managed, with phased deployment commenced on June 13th, 2025, tackling pressing global issues in research integrity and transparency. Built on international standards like the Declaration of Helsinki and Good Clinical Practice (GCP), this system employs advanced tools such as QR codes and Digital Object Identifiers (DOIs) to enable real-time verification and public access to approved protocols. Crucially, the system extends its oversight beyond IRB approvals, monitoring the entire research process to ensure ethical compliance from the initial protocol submission through to the final publication of results. This framework addresses critical challenges, including the falsification of IRB approvals, data manipulation, and undisclosed changes to research protocols. It features automated compliance checks, risk-based evaluations of protocols, and real-time tracking of research activities to ensure studies adhere to their approved plans. Additionally, surprise audits and continuous oversight mechanisms are in place to detect and prevent unethical practices at every stage of the research process. As the first system of its kind in North Africa, this platform aligns with both local and international research ethics guidelines, fostering collaboration and standardization across disciplines. It also integrates blockchain technology and connects with global ethics databases to enhance transparency and trust in research outcomes.
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  Data: <i>Keywords: </i>Authentication; clinical trials; compliance; cybersecurity; electronic data; monitoring systems; protocols; public health; research governance; transparency
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