Published on in Vol 22, No 10 (2020): October

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/19129, first published .
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Journals

  1. Ivanova D, Katsaounis P. Real-Time Dynamic Tiered e-Consent: A Novel Tool for Patients' Engagement and Common Ontology System for the Management of Medical Data. Innovations in Digital Health, Diagnostics, and Biomarkers 2021;1(2):45 View
  2. De Sutter E, Borry P, Geerts D, Huys I. Personalized and long-term electronic informed consent in clinical research: stakeholder views. BMC Medical Ethics 2021;22(1) View
  3. Tamuhla T, Tiffin N, Allie T. An e-consent framework for tiered informed consent for human genomic research in the global south, implemented as a REDCap template. BMC Medical Ethics 2022;23(1) View
  4. De Sutter E, Meszaros J, Borry P, Huys I. Digitizing the Informed Consent Process: A Review of the Regulatory Landscape in the European Union. Frontiers in Medicine 2022;9 View
  5. Bromberg J, Nimaja E, Kiragu A, Lawson K, Lee L, Nasr I, Pruitt C, Ruest S, Mello M. Developing and Implementing Electronic Consent Procedures in Response to Covid‐19 Restrictions. Ethics & Human Research 2022;44(4):39 View
  6. Nyholm Gaarskjær A, Crookshanks Duroux M, Hogreffe R. Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens. Contemporary Clinical Trials Communications 2022;28:100927 View
  7. Ludema C, Rosenberg M, Macy J, Kianersi S, Luetke M, Chen C, Golzarri-Arroyo L, Ables E, Maki K, Allison D, Rocha H. Does receiving a SARS-CoV-2 antibody test result change COVID-19 protective behaviors? Testing risk compensation in undergraduate students with a randomized controlled trial. PLOS ONE 2022;17(12):e0279347 View
  8. Kogetsu A, Kato K. Framework and Practical Guidance for the Ethical Use of Electronic Methods for Communication With Participants in Medical Research. Journal of Medical Internet Research 2022;24(4):e33167 View
  9. Ivanova D, Katsaounis P. Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations. Innovations in Digital Health, Diagnostics, and Biomarkers 2022;2(2022):16 View
  10. Butts B, Alford T, Brewster G, Carlson N, Coleman E, Davis E, Ferranti E, Kimble L, Narapareddy L, Wells J, Yang I. Adaptation of Metabolomics and Microbiomic Research Protocols During the COVID-19 Pandemic. Nursing Research 2022;71(2):128 View
  11. Mazzochi A, Dennis M, Chun H. Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials. Trials 2023;24(1) View
  12. De Sutter E, Verreydt S, Yskout K, Geerts D, Borry P, Outtier A, Ferrante M, Vandermeulen C, Vanmechelen N, Van der Schueren B, Huys I. Using provocative design to foster electronic informed consent innovation. BMC Medical Informatics and Decision Making 2022;22(1) View
  13. De Sutter E, Geerts D, Borry P, Coteur K, Bamps D, Marynissen H, Ampe E, Geenens E, Depré M, Huys I. Co-creation with research participants to inform the design of electronic informed consent. DIGITAL HEALTH 2022;8:205520762211090 View
  14. De Sutter E, Coopmans B, Vanendert F, Dooms M, Allegaert K, Borry P, Huys I. Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era. Frontiers in Pediatrics 2021;9 View
  15. Huh K, Jeong S, Moon S, Kim M, Yang W, Jeong M, Song I, Kwak Y, Lee S, Kim M. METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials. Frontiers in Medicine 2022;9 View
  16. De Sutter E, Lalova-Spinks T, Borry P, Valcke P, Kindt E, Negrouk A, Verhenneman G, Derèze J, Storme R, Huys I. Rethinking informed consent in the time of COVID-19: An exploratory survey. Frontiers in Medicine 2022;9 View
  17. Yusof M, Teo C, Ng C. Electronic informed consent criteria for research ethics review: a scoping review. BMC Medical Ethics 2022;23(1) View
  18. Lambert Y, Galindo M, Suárez-Mutis M, Mutricy L, Sanna A, Garancher L, Cairo H, Hiwat H, Bordalo Miller J, Gomes J, Marchesini P, Adenis A, Nacher M, Vreden S, Douine M. Tailoring Mobile Data Collection for Intervention Research in a Challenging Context: Development and Implementation in the Malakit Study. JMIR Formative Research 2022;6(6):e29856 View
  19. De Sutter E, Borry P, Huys I, Barbier L. Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study. BMC Health Services Research 2023;23(1) View
  20. Simon C, Wang K, Shinkunas L, Stein D, Meissner P, Smith M, Pentz R, Klein D. Communicating With Diverse Patients About Participating in a Biobank: A Randomized Multisite Study Comparing Electronic and Face-to-Face Informed Consent Processes. Journal of Empirical Research on Human Research Ethics 2022;17(1-2):144 View
  21. Hu Z, Ouyang C, Hahne J, Khoshnood K, Zhang J, Liu X, Wu Y, Wang X. Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study. Journal of Empirical Research on Human Research Ethics 2022;17(3):362 View
  22. de Man Y, Wieland-Jorna Y, Torensma B, de Wit K, Francke A, Oosterveld-Vlug M, Verheij R. Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review. Journal of Medical Internet Research 2023;25:e42131 View
  23. Budowle B, Sajantila A. Revisiting informed consent in forensic genomics in light of current technologies and the times. International Journal of Legal Medicine 2023;137(2):551 View
  24. Smales K, Lloyd A, Rayner S. Perry Starlight, Ali Orbit and Kim Cosmos' alien encounter: creating a picturebook as information for children and parents participating in research. Journal of Documentation 2023;79(5):1124 View
  25. Chatters R, Cooper C, O’Cathain A, Murphy C, Lane A, Sutherland K, Burton C, Cape A, Tunnicliffe L. Learning from COVID-19 related trial adaptations to inform efficient trial design—a sequential mixed methods study. BMC Medical Research Methodology 2022;22(1) View
  26. LeCroy M, Potter L, Bandeen-Roche K, Bianco M, Cappola A, Carter E, Dayan P, Eckstrom E, Edwards D, Farabi S, Fisher S, Giordano J, Hanson H, Jenkins E, Juhn Y, Kaskel F, Stake C, Reeds D, Schleiss M, Wafford Q, McColley S. Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic. Journal of Clinical and Translational Science 2023;7(1) View
  27. Simoens S, Abdallah K, Barbier L, Lacosta T, Blonda A, Car E, Claessens Z, Desmet T, De Sutter E, Govaerts L, Janssens R, Lalova T, Moorkens E, Saesen R, Schoefs E, Vandenplas Y, Van Overbeeke E, Verbaanderd C, Huys I. How to balance valuable innovation with affordable access to medicines in Belgium?. Frontiers in Pharmacology 2022;13 View
  28. Mitchell E, Appelbe D, Bravery A, Culliford L, Evans H, Farrin A, Gillies K, Hood K, Love S, Sydes M, Williamson P, Wakefield N. e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence. Trials 2023;24(1) View
  29. Muller S, van Thiel G, Mostert M, van Delden J. Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences. DIGITAL HEALTH 2023;9 View
  30. Heyrman B, Meers S, Van De Velde A, Anguille S. Combined Results of Two Cross-Sectional Surveys on the Participation in Clinical Trials and the e-Consent Procedure in the Landscape of Haematology. Clinics and Practice 2023;13(6):1520 View
  31. Ellis L, Barcroft J, St John E, Loughran D, Kyrgiou M, Phelps D. Digital consent in gynecology: an evaluation of patient experience. Archives of Gynecology and Obstetrics 2023;309(2):611 View
  32. De Sutter E, Geerts D, Yskout K, Verreydt S, Borry P, Barbier L, Huys I. Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study. Journal of Medical Internet Research 2023;25:e46306 View
  33. Chimonas S, Lipitz-Snyderman A, Matsoukas K, Kuperman G. Electronic consent in clinical care: an international scoping review. BMJ Health & Care Informatics Online 2023;30(1):e100726 View
  34. Corneli A, Starling S, Choi Y, Vosylius J, Madre L, Mackinnon A, Tenaerts P. Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study. Pilot and Feasibility Studies 2024;10(1) View
  35. De Sutter E, Barbier L, Borry P, Geerts D, Ioannidis J, Huys I. Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?. DIGITAL HEALTH 2024;10 View

Books/Policy Documents

  1. Gupta N. Perioperative Neuroscience. View
  2. Charles W, Magtanong R. Applied Ethics in a Digital World. View
  3. Charles W, Delgado B. Blockchain in Life Sciences. View