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

##plugins.themes.academic_pro.article.sidebar##

Published Jan 22, 2026
https://doi.org/10.62438/tunismed.v103i11.5812
Download
PDF
Vol. 103 No. 11 (2025): Tunis Med Nov 2025

##plugins.themes.academic_pro.article.main##

Ismail Dergaa
High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, High Institute of Sport and Physical Education of Ksar Said, University of Manouba, Manouba, Tunisia
https://orcid.org/0000-0001-8091-1856
Wissem Dhahbi
High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia
Noomen Guelmemi
High Institute of Sport and Physical Education of El Kef, University of Jendouba, El Kef, Tunisia
Mehdi Ben Jebli
Faculty of Legal, Economic and Management Sciences of Jendouba, University of Jendouba, Jendouba, Tunisia
Mourad Jridi
Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia
Hichem Sebai
Laboratory of Functional Physiology and Valorization of Bio-Resources, Higher Institute of Biotechnology of Beja, Beja, University of Jendouba, Tunisia

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.

Keywords:

Authentication, protocols, clinical trials, compliance, monitoring systems, cybersecurity, electronic data, public health, research governance, transparency

##plugins.themes.academic_pro.article.details##

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

References

  1. Université de Jendouba. Catalogue des formations [Internet]. Jendouba (TN): Université de Jendouba; [cited 2025 May 24]. Available from: https://www.uj.rnu.tn/fr/universite-de-jendouba/formations
  2. ShanghaiRanking Consultancy. ShanghaiRanking [Internet]. Shanghai (CN): ShanghaiRanking Consultancy; c2024 [cited 2025 May 24]. Available from: https://www.shanghairanking.com/index.html
  3. Van Noorden R: More than 10,000 research papers were retracted in 2023—a new record. Nature 2023, 624(7992):479-481.
  4. LeBlanc AG, Barnes JD, Saunders TJ, Tremblay MS, Chaput J-P: Scientific sinkhole: estimating the cost of peer review based on survey data with snowball sampling. Research Integrity and Peer Review 2023, 8(1):3.
  5. Dergaa I, Fekih-Romdhane F, Glenn JM, Fessi MS, Chamari K, Dhahbi W, Zghibi M, Bragazzi NL, Aissa MB, Guelmami N: Moving beyond the stigma: understanding and overcoming the resistance to the acceptance and adoption of artificial intelligence chatbots. New Asian Journal of Medicine 2023, 1(2):29-36.
  6. Schwan B: Sovereignty, authenticity and the patient preference predictor. Journal of Medical Ethics 2022, 48(5):311-312.
  7. Resnik DB: Standards of evidence for institutional review board decision-making. Account Res 2021, 28(7):428-455.
  8. Richtig G, Berger M, Lange-Asschenfeldt B, Aberer W, Richtig E: Problems and challenges of predatory journals. J Eur Acad Dermatol Venereol 2018, 32(9):1441-1449.
  9. Peterson M: Value Change, Energy Systems, and Rational Choice: The Expected Center of Gravity Principle. Science and Engineering Ethics 2023, 29(3):13.
  10. Hu Y, Qian Y: Gender, education expansion and intergenerational educational mobility around the world. Nature Human Behaviour 2023, 7(4):583-595.
  11. Sivasubramaniam S, Cosentino M, Ribeiro L, Marino F: Unethical practices within medical research and publication–An exploratory study. International Journal for Educational Integrity 2021, 17:1-13.
  12. Makhoul J, Chehab RF, Shaito Z, Sibai AM: A scoping review of reporting ‘Ethical Research Practices’ in research conducted among refugees and war-affected populations in the Arab world. BMC medical ethics 2018, 19:1-9.
  13. Núñez‐Núñez M, Maes‐Carballo M, Mignini LE, Chien PF, Khalaf Y, Fawzy M, Zamora J, Khan KS, Bueno‐Cavanillas A: Research integrity in randomized clinical trials: A scoping umbrella review. International Journal of Gynecology & Obstetrics 2023, 162(3):860-876.
  14. Shanks K, Paulson J: Ethical research landscapes in fragile and conflict-affected contexts: understanding the challenges. Research Ethics 2022, 18(3):169-192.
  15. Resnik DB: The ethics of research with human subjects: Protecting people, advancing science, promoting trust, vol. 74: Springer; 2018.
  16. Lewis NV, Kalichman B, Azeredo YN, Bacchus LJ, d'Oliveira AF: Ethical challenges in global research on health system responses to violence against women: a qualitative study of policy and professional perspectives. BMC Med Ethics 2024, 25(1):32.
  17. Kocyigit BF, Akyol A, Zhaksylyk A, Seiil B, Yessirkepov M: Analysis of Retracted Publications in Medical Literature Due to Ethical Violations. J Korean Med Sci 2023, 38(40):e324.
  18. Ben Ezzdine L, Dergaa I, Gaddas M, Ennouri E, Boussarsar M, Ben Saad H: QR codes and international databases: promoting transparency in IRB approvals for medical research. Libyan Journal of Medicine 2024, 19(1):2381311.
  19. Chaudhry I, Thurtle V, Foday E, Leather AJ, Samai M, Wurie H, Parmar D: Strengthening ethics committees for health-related research in sub-Saharan Africa: a scoping review. BMJ open 2022, 12(11):e062847.
  20. Serpico K: Defining institutional review board application quality: critical research gaps and future opportunities. Research Ethics 2023, 20(1):19-35.
  21. Guelmami N, Ben Ezzeddine L, Hatem G, Trabelsi O, Ben Saad H, Glenn JM, El Omri A, Chalghaf N, Taheri M, Bouassida A: The Ethical Compass: establishing ethical guidelines for research practices in sports medicine and exercise science. International Journal of Sport Studies for Health 2024, 7(2):31-46.
  22. World Medical Association. WMA - Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. Ferney-Voltaire: World Medical Association; 2013 [cited 2025 May 24]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/"
  23. Kushwaha P, Srivastava N, Kushwaha SP: Enhancing clinical drug trial monitoring with blockchain technology. Contemporary Clinical Trials 2024, 146:107684.
  24. Bhatt A: The revamped Good Clinical Practice E6 (R3) guideline: Profound changes in principles and practice!Perspectives in Clinical Research 2023, 14(4):167-171.
  25. Editors ICoMJ: Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals: International Committee of Medical Journal Editors; 2015.
  26. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F et al: Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Jama 2017, 317(24):2491-2492.
  27. Benchoufi M, Ravaud P: Blockchain technology for improving clinical research quality. Trials 2017, 18(1):335.
  28. Gopalakrishna G, Ter Riet G, Vink G, Stoop I, Wicherts JM, Bouter LM: Prevalence of questionable research practices, research misconduct and their potential explanatory factors: A survey among academic researchers in The Netherlands. PLoS One 2022, 17(2):e0263023.
  29. Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, Blomberg N, Boiten JW, da Silva Santos LB, Bourne PE et al: The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 2016, 3:160018.
  30. Liu J: Digital object identifier (DOI) and DOI services: An overview. Libri 2021, 71(4):349-360.
  31. Jackson B: The Changing Research Data Landscape and the Experiences of Ethics Review Board Chairs: Implications for Library Practice and Partnerships. The Journal of Academic Librarianship 2018, 44(5):603-612.
  32. Gazzarata R, Almeida J, Lindsköld L, Cangioli G, Gaeta E, Fico G, Chronaki CE: HL7 Fast healthcare interoperability resources (HL7 FHIR) in digital healthcare ecosystems for chronic disease Management: Scoping review. International Journal of Medical Informatics 2024:105507.
  33. Rubeis G: Ethical implications of blockchain technology in biomedical research. Ethik in der Medizin 2024, 36(4):493-506.
  34. Franke L, Liang H, Farzanehpour S, Brantly A, Davis JC, Brown C: An exploratory mixed-methods study on general data protection regulation (gdpr) compliance in open-source software. In: Proceedings of the 18th ACM/IEEE International Symposium on Empirical Software Engineering and Measurement: 2024; 2024: 325-336.
  35. Bouter L: What Research Institutions Can Do to Foster Research Integrity. Sci Eng Ethics 2020, 26(4):2363-2369.
  36. Food and Agriculture Organization of the United Nations. Ethics [Internet]. Rome: Food and Agriculture Organization of the United Nations; [cited 2025 May 24]. Available from: https://www.fao.org/ethics/en
  37. Mamak K: Rights for Robots: Artificial Intelligence, Animal and Environmental Law (2020) by Joshua Gellers. Science and Engineering Ethics 2021, 27(3):29.
  38. Organization WH: Laboratory biosecurity guidance: World Health Organization; 2024.
  39. Hoofnagle CJ, Van Der Sloot B, Borgesius FZ: The European Union general data protection regulation: what it is and what it means. Information & Communications Technology Law 2019, 28(1):65-98.
  40. Ashkar CE, Nakkash R, Matar A, Makhoul J: Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region. BMC Medical Ethics 2024, 25(1):86.
  41. Barchi F, Little MT: National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review. BMC Med Ethics 2016, 17(1):64.
  42. Standish K, McDaniel K, Ahmed S, Allen NH, Sircar S, Mira M, Khoshnood K: US trainees’ experiences of ethical challenges during research in low-and middle-income countries: A mixed methods study. Global Public Health 2022, 17(7):1433-1449.
  43. Ng LC, Hanlon C, Yimer G, Henderson DC, Fekadu A: Ethics in global health research: the need for balance. Lancet Glob Health 2015, 3(9):e516-517.
  44. Ivanova M: United Nations Environment Programme. In: Encyclopedia of Business and Professional Ethics. edn.: Springer; 2023: 1811-1818.
  45. Chaudhri S, Cordes K, Miller N: Humanitarian programming and monitoring in inaccessible conflict settings: A literature review. Journal of Management 2017, 7(8):81-104.
  46. Scheibner J, Ienca M, Kechagia S, Troncoso-Pastoriza JR, Raisaro JL, Hubaux JP, Fellay J, Vayena E: Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies. J Law Biosci 2020, 7(1):lsaa010.
  47. Mousa A, Flanagan M, Tay CT, Norman RJ, Costello M, Li W, Wang R, Teede H, Mol BW: Research Integrity in Guidelines and evIDence synthesis (RIGID): a framework for assessing research integrity in guideline development and evidence synthesis. eClinicalMedicine 2024, 74:102717.
  48. Shetty YC, Seetharaman R: Strengthening postapproval oversight in research ethics committees: Challenges and solutions. Perspect Clin Res 2023, 14(3):105-107.
  49. Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M: Ethics Committees: Structure, Roles, and Issues. J Korean Med Sci 2023, 38(25):e198.
  50. Bhatt A: The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!Perspect Clin Res 2023, 14(4):167-171.
  51. Van Rooyen M: Environmental and Biosafety Research Ethics Committees: Guidelines and Principles for Ethics Reviewers in the South African Context. Stellenbosch: Stellenbosch University; 2021.
  52. Resnik DB: Research ethics timeline (1932–present). blood 2018, 1939:45.
  53. Wallace M, Sheldon N: Business research ethics: Participant observer perspectives. Journal of Business Ethics 2015, 128:267-277.
  54. Burrell G, Hyman MR, Michaelson C, Nelson JA, Taylor S, West A: The ethics and politics of academic knowledge production: Thoughts on the future of business ethics. Journal of Business Ethics 2022, 180(3):917-940.
  55. Herath SK, Herath LM: Understanding the ethical and social consequences of data analytics for organizational management in the age of AI: accounting ethics perspective. In: AI and Data Analytics Applications in Organizational Management. edn.: IGI Global; 2024: 216-248.
  56. van den Hoonaard WC: Seeking a Research-Ethics Covenant in the Social Sciences: University of Alberta; 2023.
  57. Yadav SK: Ethics in Scientific Research. In: Research and Publication Ethics. edn. Cham: Springer International Publishing; 2023: 41-57.
  58. Alex H, Akram I, Diego V, Mickayla J, Lisa E, Annette R, Seema KS, Dorcas K: Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study. BMJ Global Health 2024, 9(8):e015233.
  59. Were E, Kiplagat J, Kaguiri E, Ayikukwei R, Naanyu V: Institutional capacity to prevent and manage research misconduct: perspectives from Kenyan research regulators. Research Integrity and Peer Review 2023, 8(1):8.
  60. Ferretti A, Ienca M, Sheehan M, Blasimme A, Dove ES, Farsides B, Friesen P, Kahn J, Karlen W, Kleist P et al: Ethics review of big data research: What should stay and what should be reformed?BMC Medical Ethics 2021, 22(1):51.
  61. Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK: Digital medicine: a primer on measurement. Digital biomarkers 2019, 3(2):31-71.
  62. Al-kfairy M, Mustafa D, Kshetri N, Insiew M, Alfandi O: Ethical Challenges and Solutions of Generative AI: An Interdisciplinary Perspective. Informatics 2024, 11(3):58.
  63. Harishbhai Tilala M, Kumar Chenchala P, Choppadandi A, Kaur J, Naguri S, Saoji R, Devaguptapu B: Ethical Considerations in the Use of Artificial Intelligence and Machine Learning in Health Care: A Comprehensive Review. Cureus 2024, 16(6):e62443.
  64. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama 2013, 310(20):2191-2194.
  65. Wandile P, Ghooi R: A role of ICH-GCP in clinical trial conduct. J Clin Res Bioeth 2017, 8(1):1-5.
  66. Stahl BC, Eke D: The ethics of ChatGPT – Exploring the ethical issues of an emerging technology. International Journal of Information Management 2024, 74:102700.
  67. Kiani AK, Naureen Z, Pheby D, Henehan G, Brown R, Sieving P, Sykora P, Marks R, Falsini B, Capodicasa N et al: Methodology for clinical research. J Prev Med Hyg 2022, 63(2 Suppl 3):E267-e278.
  68. Piantadosi S: Clinical trials: a methodologic perspective: John Wiley & Sons; 2024.
  69. May T, Perry B: Social research: Issues, methods and process: McGraw-Hill Education (UK); 2022.
  70. Chigbu UE, Atiku SO, Du Plessis CC: The science of literature reviews: Searching, identifying, selecting, and synthesising. Publications 2023, 11(1):2.
  71. Xiao Y, Watson M: Guidance on conducting a systematic literature review. Journal of planning education and research 2019, 39(1):93-112.
  72. Cox S, Solbakk JH, Luthardt Jr F, Bernabe RDLC: Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA. Current Medical Research and Opinion 2023, 39(3):341-350.
  73. Eren BA: QR code m-payment from a customer experience perspective. Journal of Financial Services Marketing 2024, 29(1):106-121.
  74. Ferraro MC, Moore RA, de C Williams AC, Fisher E, Stewart G, Ferguson MC, Eccleston C, O'Connell NE: Characteristics of retracted publications related to pain research: a systematic review. Pain 2022:10.1097.
  75. Zhaksylyk A, Zimba O, Yessirkepov M, Kocyigit BF: Research Integrity: Where We Are and Where We Are Heading. J Korean Med Sci 2023, 38(47):e405.