Digital narratives on electronic informed consent in biomedical research in Latin America
Keywords:
Bioethics, Biomedical research, Data protection, Right to privacy, Digitalization
Abstract
Electronic informed consent (e-consent) represents the transformation resulting from technological changes in recent years, modifying traditional authorization processes in biomedical research. This article analyzes research participants' perceptions of the e-consent process through digital narratives posted on open platforms. An exploratory study was conducted with intentional sampling stratified by platform type and study. Eighteen narratives related to clinical trials, observational studies, digital health, and biobanks were included, with six emerging categories: clarity and understanding of information, treatment received, expectations and motivations, data privacy, decision dynamics, and context of participation. The narratives show e-consent to be a very long text with difficult-to-understand terminology, decisions conditioned by third parties, and little transparency in the use and safeguarding of information. In conclusion, e-consent does not provide support for the process, transparency, or privacy of information. The recommendation is to incorporate multimodal strategies to achieve a dynamic and clear process, with post-research feedback and to comply with data protection. It is proposed that Research Ethics Committees contribute to the fulfillment of these expectations before initiating research.
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References
Abernethy, E. R., Campbell, G. P., Hianik, R. S., Thomson, M. C., Blee, S. M., Sibold, H. C., Dixon, M. D., Switchenko, J. M., Pentz, R. D. (2021). Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting. Cancer, 127(20), 3794-3800. https://doi.org/10.1002/cncr.33746
Appelbaum, P. S., Anatchkova, M., Albert, K., Dunn, L. B., Lidz, C. W. (2012). Therapeutic Misconception in Research Subjects: Development and Validation of a Measure. Clinical trials (London, England), 9(6), 748-761. https://doi.org/10.1177/1740774512456455
Chau, M., Rahman, M. G., Debnath, T. (2025). From black box to clarity: Strategies for effective AI informed consent in healthcare. Artificial Intelligence in Medicine, 167, 103169. https://doi.org/10.1016/j.artmed.2025.103169
Chaux, A. (2025). La importancia crítica del consentimiento informado en la práctica médica y la investigación biomédica contemporánea. Revista UniNorte de Medicina y Ciencias de la Salud, 13(2), 56–69. https://doi.org/10.5281/zenodo.15755107
CIOMS. (2017). Pautas éticas internacionales para la investigación relacionada con la salud con seres humanos (4ta ed.). OPS/OMS
Corneli, A., Starling, S., Choi, Y., Vosylius, J., Madre, L., Mackinnon, A., Tenaerts, P. (2024). Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: An innovative qualitative pilot study. Pilot and Feasibility Studies, 10(1), 10. https://doi.org/10.1186/s40814-023-01432-w
Declaración de Helsinki (2024). Principios éticos para las investigaciones médicas con participantes humanos. 1964 última enmienda octubre 2024. Asociación Médica Mundial. https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principios-eticos-para-las-investigaciones-medicas-en-seres-humanos/
De Sutter, E., Berbier,L., Borry,P., Geerts, D., Ioannidis,J.P.A. Huys, I. (2024). Personalized and longitudinal electronic informed consent in clinical trial: How to move the needle? Digital Health, 10, 1-8 https://doi.org/10.1177/20552076231222361
De Sutter, E., Zaçe, D., Boccia,S., Di Pietro, M.L., Geerts, D., Borry, P., Huys ,I (2020) Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review. Med. Internet Res., 22(10), 1-13. https://www.jmir.org/2020/10/e19129/
Ecarnot, F., Quenot, J.-P., Besch, G., Piton, G. (2017). Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit. Annals of Translational Medicine, 5(Suppl 4), S41 :1-9 https://doi.org/10.21037/atm.2017.04.42
Enworo, O. C. (2023). Application of Guba and Lincoln’s parallel criteria to assess trustworthiness of qualitative research on indigenous social protection systems | Request PDF. Qualitative Research Journal, 23(4), 372-384. https://doi.org/10.1108/QRJ-08-2022-0116
Gesualdo, F., Daverio, M., Palazzani, L., Dimitriou, D., Diez-Domingo, J., Fons-Martinez, J., Jackson, S., Vignally, P., Rizzo, C., Tozzi, A. E. (2021). Digital tools in the informed consent process: A systematic review. BMC Medical Ethics, 22(1), 1-10. https://doi.org/10.1186/s12910-021-00585-8
Hernández Navas, J. A., Ochoa Castellanos, V., Dulcey, L., Therán León, J. S. (2025). El consentimiento informado, desafíos y oportunidades en la era digital. Revista Cubana de Medicina, 64, 1-4. https://www.researchgate.net/publication/395206155_El_consentimiento_informado_desafios_y_oportunidades_en_la_era_digital
Lajonchere, C., Naeim, A., Dry, S., Wenger, N., Elashoff, D., Vangala, S., Petruse, A., Ariannejad, M., Magyar, C., Johansen, L., Werre, G., Kroloff, M., Geschwind, D. (2021). An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study. Journal of Medical Internet Research 2021;23(12): e31121. https://doi.org/10.2196/31121
Mazzochi, A. T., Dennis, M., Chun, H.Y. Y. (2023). Electronic informed consent: Effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials. Trials, 24(1), 1-19. https://doi.org/10.1186/s13063-022-06959-6
McGrath, E., Kirby, N., Shiely, F. (2025). Use of participant data and biological samples is insufficiently described in participant information leaflets. Jorunal Clinica Epidemiology, 177, 111590. https://doi.org/doi: 10.1016/j.jclinepi.2024.111590
Mohd Yusof, M. Y. P., Hai Teo, C., Jenn Ng, C. (2022). Electronic informed consent criteria for research ethics review: A scoping review. BMC Medical Ethics, 23(1), 117. https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-022-00849-x
Mondragón-Barrios, L. (2009). Consentimiento informado: Una praxis dialógica para la investigación. Revista de investigación clínica, 61(1), 73-82. https://www.medigraphic.com/pdfs/revinvcli/nn-2009/nn091i.pdf
National Research Commitees. (2019). A Guide to Internet Research Ethics. Forskningsetikk. https://www.forskningsetikk.no/en/guidelines/social-sciences-and-humanities/a-guide-to-internet-research-ethics/
O’ Sullivan, L., Feeney, L., Crowley, R. K., Sukumar, P., McAuliffe, E., Doran, P. (2021). An evaluation of the process of informed consent: Views from research participants and staff. Trials, 22(1), 1-15. https://doi.org/10.1186/s13063-021-05493-1
Pietrzykowski, T., y Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension—systematic review. Trials, 22(1), 22-57. https://doi.org/10.1186/s13063-020-04969-w
Remes Lenicov, F., Y Fink, N. E. (2023). Ethical issues in the use of leftover samples and associated personal data obtained from diagnostic laboratories. Clinica Chimica Acta; International Journal of Clinical Chemistry, 548; 117442. https://doi.org/10.1016/j.cca.2023.117442
Sahan, K., Wijesurendra, R., Preiss, D., Mafham, M., & Sheehan, M. (2024). Towards an understanding of the ethics of electronic consent in clinical trials. Trials, 25(1), 545. https://doi.org/10.1186/s13063-024-08330-3
Skelton, E., Drey, N., Rutherford, M., Ayers, S., Malamateniou, C. (2020). Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. International Journal of Medical Informatics, 143, 104271. https://doi.org/10.1016/j.ijmedinf.2020.104271
Sunil George, M. S., Gaitonde, R., Davey, R., Mohanty, I., y Upton, P. (2023). Engaging participants with research findings: A rights-informed approach. Health Expectations, 26(2), 765-773. https://doi.org/10.1111/hex.13701
Thanh Tam, N., Tien Huy, Bich Thoa, L. T., Phuoc Long, N., Huyen Trang, N. T., Hirayama, K., Karbwang, J. (2015). Participants’ understanding of informed consent in clinical trials over three decades: Systematic review and meta-analysis. Bull World Heatlh Organization, 93, 186-198. https://doi.org/10.2471/BLT.14.141390
Wu, Y., Liu, X., Ge, X., Tan, X., Yu, W., & Wang, X. (2025). Exploring knowledge and attitudes toward electronic informed consent among clinical trial participants in China: A cross-sectional study. BMC Medical Ethics, 26, 67:1-9. https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-025-01222-4
Appelbaum, P. S., Anatchkova, M., Albert, K., Dunn, L. B., Lidz, C. W. (2012). Therapeutic Misconception in Research Subjects: Development and Validation of a Measure. Clinical trials (London, England), 9(6), 748-761. https://doi.org/10.1177/1740774512456455
Chau, M., Rahman, M. G., Debnath, T. (2025). From black box to clarity: Strategies for effective AI informed consent in healthcare. Artificial Intelligence in Medicine, 167, 103169. https://doi.org/10.1016/j.artmed.2025.103169
Chaux, A. (2025). La importancia crítica del consentimiento informado en la práctica médica y la investigación biomédica contemporánea. Revista UniNorte de Medicina y Ciencias de la Salud, 13(2), 56–69. https://doi.org/10.5281/zenodo.15755107
CIOMS. (2017). Pautas éticas internacionales para la investigación relacionada con la salud con seres humanos (4ta ed.). OPS/OMS
Corneli, A., Starling, S., Choi, Y., Vosylius, J., Madre, L., Mackinnon, A., Tenaerts, P. (2024). Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: An innovative qualitative pilot study. Pilot and Feasibility Studies, 10(1), 10. https://doi.org/10.1186/s40814-023-01432-w
Declaración de Helsinki (2024). Principios éticos para las investigaciones médicas con participantes humanos. 1964 última enmienda octubre 2024. Asociación Médica Mundial. https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principios-eticos-para-las-investigaciones-medicas-en-seres-humanos/
De Sutter, E., Berbier,L., Borry,P., Geerts, D., Ioannidis,J.P.A. Huys, I. (2024). Personalized and longitudinal electronic informed consent in clinical trial: How to move the needle? Digital Health, 10, 1-8 https://doi.org/10.1177/20552076231222361
De Sutter, E., Zaçe, D., Boccia,S., Di Pietro, M.L., Geerts, D., Borry, P., Huys ,I (2020) Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review. Med. Internet Res., 22(10), 1-13. https://www.jmir.org/2020/10/e19129/
Ecarnot, F., Quenot, J.-P., Besch, G., Piton, G. (2017). Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit. Annals of Translational Medicine, 5(Suppl 4), S41 :1-9 https://doi.org/10.21037/atm.2017.04.42
Enworo, O. C. (2023). Application of Guba and Lincoln’s parallel criteria to assess trustworthiness of qualitative research on indigenous social protection systems | Request PDF. Qualitative Research Journal, 23(4), 372-384. https://doi.org/10.1108/QRJ-08-2022-0116
Gesualdo, F., Daverio, M., Palazzani, L., Dimitriou, D., Diez-Domingo, J., Fons-Martinez, J., Jackson, S., Vignally, P., Rizzo, C., Tozzi, A. E. (2021). Digital tools in the informed consent process: A systematic review. BMC Medical Ethics, 22(1), 1-10. https://doi.org/10.1186/s12910-021-00585-8
Hernández Navas, J. A., Ochoa Castellanos, V., Dulcey, L., Therán León, J. S. (2025). El consentimiento informado, desafíos y oportunidades en la era digital. Revista Cubana de Medicina, 64, 1-4. https://www.researchgate.net/publication/395206155_El_consentimiento_informado_desafios_y_oportunidades_en_la_era_digital
Lajonchere, C., Naeim, A., Dry, S., Wenger, N., Elashoff, D., Vangala, S., Petruse, A., Ariannejad, M., Magyar, C., Johansen, L., Werre, G., Kroloff, M., Geschwind, D. (2021). An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study. Journal of Medical Internet Research 2021;23(12): e31121. https://doi.org/10.2196/31121
Mazzochi, A. T., Dennis, M., Chun, H.Y. Y. (2023). Electronic informed consent: Effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials. Trials, 24(1), 1-19. https://doi.org/10.1186/s13063-022-06959-6
McGrath, E., Kirby, N., Shiely, F. (2025). Use of participant data and biological samples is insufficiently described in participant information leaflets. Jorunal Clinica Epidemiology, 177, 111590. https://doi.org/doi: 10.1016/j.jclinepi.2024.111590
Mohd Yusof, M. Y. P., Hai Teo, C., Jenn Ng, C. (2022). Electronic informed consent criteria for research ethics review: A scoping review. BMC Medical Ethics, 23(1), 117. https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-022-00849-x
Mondragón-Barrios, L. (2009). Consentimiento informado: Una praxis dialógica para la investigación. Revista de investigación clínica, 61(1), 73-82. https://www.medigraphic.com/pdfs/revinvcli/nn-2009/nn091i.pdf
National Research Commitees. (2019). A Guide to Internet Research Ethics. Forskningsetikk. https://www.forskningsetikk.no/en/guidelines/social-sciences-and-humanities/a-guide-to-internet-research-ethics/
O’ Sullivan, L., Feeney, L., Crowley, R. K., Sukumar, P., McAuliffe, E., Doran, P. (2021). An evaluation of the process of informed consent: Views from research participants and staff. Trials, 22(1), 1-15. https://doi.org/10.1186/s13063-021-05493-1
Pietrzykowski, T., y Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension—systematic review. Trials, 22(1), 22-57. https://doi.org/10.1186/s13063-020-04969-w
Remes Lenicov, F., Y Fink, N. E. (2023). Ethical issues in the use of leftover samples and associated personal data obtained from diagnostic laboratories. Clinica Chimica Acta; International Journal of Clinical Chemistry, 548; 117442. https://doi.org/10.1016/j.cca.2023.117442
Sahan, K., Wijesurendra, R., Preiss, D., Mafham, M., & Sheehan, M. (2024). Towards an understanding of the ethics of electronic consent in clinical trials. Trials, 25(1), 545. https://doi.org/10.1186/s13063-024-08330-3
Skelton, E., Drey, N., Rutherford, M., Ayers, S., Malamateniou, C. (2020). Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting. International Journal of Medical Informatics, 143, 104271. https://doi.org/10.1016/j.ijmedinf.2020.104271
Sunil George, M. S., Gaitonde, R., Davey, R., Mohanty, I., y Upton, P. (2023). Engaging participants with research findings: A rights-informed approach. Health Expectations, 26(2), 765-773. https://doi.org/10.1111/hex.13701
Thanh Tam, N., Tien Huy, Bich Thoa, L. T., Phuoc Long, N., Huyen Trang, N. T., Hirayama, K., Karbwang, J. (2015). Participants’ understanding of informed consent in clinical trials over three decades: Systematic review and meta-analysis. Bull World Heatlh Organization, 93, 186-198. https://doi.org/10.2471/BLT.14.141390
Wu, Y., Liu, X., Ge, X., Tan, X., Yu, W., & Wang, X. (2025). Exploring knowledge and attitudes toward electronic informed consent among clinical trial participants in China: A cross-sectional study. BMC Medical Ethics, 26, 67:1-9. https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-025-01222-4
Published
2026-06-16
How to Cite
Bustamante-Cabrera, G. I., Mondragón-Barrios, L., & Cachicatari-Vargas, E. (2026). Digital narratives on electronic informed consent in biomedical research in Latin America. Apuntes De Bioética, 9(1), AdB1433. https://doi.org/10.35383/apuntes.v9i1.1433
Section
Clinical Bioethics and Technoscience
Copyright (c) 2026 Gladys Inés Bustamante Cabrera, Liliana Mondragón-Barrios, Elena Cachicatari Vargas (Autor/a)
This work is licensed under a Creative Commons Attribution 4.0 International License.
The authors retain copyright.
This work is under international license Creative Commons Attribution 4.0.
The articles published by the scientific journal "Notes on Bioethics" of the Universidad Catolica Santo Toribio de Mogrovejo, Chiclayo Peru, can be shared through the international public license Creative Commons Attribution CC BY 4.0
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