Narrativas digitales sobre consentimiento informado electrónico en investigaciones biomédicas en Latinoamérica
Palabras clave:
Bioética, Investigación biomédica, Protección de datos, Derecho a la privacidad, Digitalización
Resumen
El consentimiento informado electrónico (e-consent) es la representación de la transformación resultante de los cambios tecnológicos en los últimos años, al modificar los procesos tradicionales de autorización en la investigación biomédica. Este artículo analiza la percepción sobre el proceso del e-consent de los participantes de investigación, mediante narrativas digitales expuestas en plataformas abiertas. Se realizó un estudio exploratorio con muestreo intencional estratificado por tipo de plataforma y estudio. Se incluyeron 18 narrativas relacionadas con ensayos clínicos, estudios observacionales, salud digital y biobancos, con seis categorías emergentes: claridad y comprensión de la información, trato recibido, expectativas y motivaciones, privacidad de datos, dinámicas de decisión y contexto de participación. Las narrativas evidencian al e-consent como un texto muy extenso y de difícil comprensión terminológica, decisiones condicionadas por terceros, poca transparencia en el uso y resguardo de la información. En conclusión, el e-consent no desarrolla acompañamiento del proceso, ni transparencia, ni privacidad de la información. La recomendación es incorporar estrategias multimodales para conseguir un proceso dinámico y claro, con la retroalimentación post-investigación y para cumplir con la protección de datos. Se propone que los Comités de Ética en Investigación aporten al cumplimiento de estas expectativas antes de iniciar la investigación.
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Citas
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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
Publicado
2026-06-16
Cómo citar
Bustamante-Cabrera, G. I., Mondragón-Barrios, L., & Cachicatari-Vargas, E. (2026). Narrativas digitales sobre consentimiento informado electrónico en investigaciones biomédicas en Latinoamérica. Apuntes De Bioética, 9(1), AdB1433. https://doi.org/10.35383/apuntes.v9i1.1433
Sección
Bioética Clínica y Tecnociencia
Derechos de autor 2026 Gladys Inés Bustamante Cabrera, Liliana Mondragón-Barrios, Elena Cachicatari Vargas (Autor/a)
Esta obra está bajo licencia internacional Creative Commons Reconocimiento 4.0.
Los autores conservan los derechos de autor.
Esta obra está bajo una licencia internacional Creative Commons Attribution 4.0.
Los artículos publicados por la revista científica "Apuntes de Bioética" de la Universidad Católica Santo Toribio de Mogrovejo, Chiclayo, Perú están sujetos a una licencia internacional Creative Commons Attribution CC BY 4.0.
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