medigraphic.com
Instituto Nacional de Salud Pública

2025, Number 3

<< Back Next >>

salud publica mex 2025; 67 (3)

Operational criteria related to biobank research practices: Mesoamerican Project

Basagoitia-Echalar A, Domínguez-Esponda R, López-Ridaura R, Ángeles-Llerenas A

Language: English
References: 35
Page: 239-247
PDF size: 250.80 Kb.


ABSTRACT

Objective. To investigate the implementation of international ethics guidelines in Research ethics committees (RECs) to address ethical considerations in biobank research in Mesoamerican countries, given the importance of biobank research and the role of RECs in its evaluation. Materials and methods. Based on a 2018 study that used an online survey to assess training needs of RECs in Colombia, Costa Rica, Guatemala, and Mexico, this paper describes information on RECs operating procedures related to biobank research reported by 55 participants. Results. More than 70% of participants reported frequently requesting key components of biobank research. Specifying the time and location of sample and data storage was the least reported. 43.6% used a specific consent form, while 41.8% identified gaps in knowledge regarding the inclusion of residual samples. Recontact policies varied across countries and were limited by sample anonymity. Conclusión. RECs in Mesoamerican countries lack clear policies on biobanks and have deficiencies in informed consent and governance. Regulatory advances and ongoing training are needed to protect participants’ rights.


REFERENCES

  1. Coppola L, Cianflone A, Grimaldi AM, Incoronato M, Bevilacqua P, MessinaF, et al. Biobanking in health care: evolution and future directions. JTransl Med. 2019;17(1):172. https://doi.org/10.1186/s12967-019-1922-3

  2. Malsagova K, Kopylov A, Stepanov A, Butkova T, Sinitsyna A, Izotov A, etal. Biobanks. A platform for scientific and biomedical research. Diagnostics.2020;10(7):485. https://doi.org/10.3390/diagnostics10070485

  3. Frascarelli C, Bonizzi G, Musico CR, Mane E, Cassi C, Guerini-Rocco E,et al. Revolutionizing cancer research: the impact of artificial intelligencein digital biobanking. J Pers Med. 2023;13(9):1390. https://doi.org/10.3390/jpm13091390

  4. Dabrock P, Taupitz J, Ried J. Trust in biobanking. Dealing with ethical,legal and social issues in an emerging field of biotechnolog y. New York:Springer, 2012.

  5. Gille F, Axler R, Blasimme A. Transparency about governance contributesto biobanks’ trustworthiness: call for action. Biopreserv Biobank.2021;19(1):83-5. https://doi.org/10.1089/bio.2020.0057

  6. Heeney C, Kerr SM. Balancing the local and the universal in maintainingethical access to a genomics biobank. BMC Med Ethics. 2017;18(1):80.https://doi.org/10.1186/s12910-017-0240-7

  7. Caenazzo L, Tozzo P, Borovecki A. Ethical governance in biobankslinked to electronic health records. Eur Rev Med Pharmacol Sci.2015;19(21):4182-6 [cited September 6, 2024]. Available from: https://www.researchgate.net/publication/290045432_Ethical_governance_in_biobanks_linked_to_electronic_health_records

  8. Kurihara C, Kerpel-Fronius S, Becker S, Chan A, Nagaty Y, Naseem S, etal. Declaration of Helsinki: ethical norm in pursuit of common global goals.Front Med. 2024;11:1360653. https://doi.org/10.3389/fmed.2024.1360653

  9. World Medical Association. WMA declaration of Taipei on ethicalconsiderations regarding health databases and biobanks. Secondary WMADeclaration of taipei on ethical considerations regarding health databasesand biobanks. France: WMA, 2016 [cited September 6, 2024]. Availablefrom: https://www.wma.net/policies-post/wma-declaration-of-taipei-onethical-considerations-regarding-health-databases-and-biobanks/

  10. Council for International Organizations of Medical Sciences. Internationalethical guidelines for health-related research involving humans. 4thed. Geneva: CIOMS, 2016 [cited September 6, 2024]. Available from: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

  11. Council for International Organizations of Medical Sciences. Internationalguidelines on good governance practice for research institutions.Geneva: CIOMS, 2023 [cited September 6 2024]. Available from: https://cioms.ch/publications/product/international-guidelines-on-good-governance-practice-for-research-institutions/

  12. Organisation for Economic Co-operation and Development. OECDguidelines on human biobanks and genetic research databases. Eur JHealth Law. 2010;17(2):191-204.

  13. Moodley K, Singh S. “It’s all about trust”: reflections of researcherson the complexity and controversy surrounding biobanking in SouthAfrica. BMC Med Ethics. 2016;17(1):57. https://doi.org/10.1186/s12910-016-0140-2

  14. Ángeles-Llerenas A, Thrasher JF, Domínguez-Esponda R, López-RidauraR, Macklin R. Operation of research ethics committees in Colombia,Costa Rica, Guatemala, and Mexico: Mesoamerican Project. Salud PublicaMex. 2022;64(1):66-75. https://doi.org/10.21149/12588

  15. African Bioethics Consortium. Research Ethics Committee AssessmentToolkit (RECAT). Baltimore: Johns Hopkins University, 2017 [cited September6, 2024]. Available from: https://bioethics.jhu.edu/recat/

  16. Ángeles-Llerenas A. Questionnaire research ethics committee members.Mexico: figshare, 2021 [cited September 6 2024]. Available from:https://doi.org/10.6084/m9.figshare.14082848.v1

  17. Wiertz S, Boldt J. Evaluating models of consent in changing health researchenvironments. Med Health Care Philos. 2022;25(2):269-80. https://doi.org/10.1007/s11019-022-10074-3

  18. Lazcano-Ponce EC, Oropeza-Abúndez C. Conversaciones de SaludPública. Mexico: INSP, 2023 [cited September 6, 2024]. Available from:https://spmediciones.mx/libro/conversaciones-de-salud-publica_150008/

  19. Remes-Lenicov F, Fink NE. Ethical issues in the use of leftover samplesand associated personal data obtained from diagnostic laboratories. ClinChim Acta. 2023;548:117442. https://doi.org/10.1016/j.cca.2023.117442

  20. Tamuhla T, Tiffin N, Allie T. An e-consent framework for tiered informedconsent for human genomic research in the global south, implementedas a REDCap template. BMC Medical Ethics. 2022;23(1):119. https://doi.org/10.1186/s12910-022-00860-2

  21. Budin-Ljøsne I, Teare HJA, Kaye J, Beck S, Bentzen HB, Caenazzo L, etal. Dynamic consent: a potential solution to some of the challenges ofmodern biomedical research. BMC Medical Ethics. 2017;18(1):4. https://doi.org/10.1186/s12910-016-0162-9

  22. Chalarca-Cañas D, Vargas-Tejada DA, Valencia-Ocampo OJ, Velásquez-Lopera MM. Biobanks: conservation of the humanity scientific heritage.Iatreia. 2022;35(3):310-20 [cited September 6, 2024]. Available from:http://www.scielo.org.co/pdf/iat/v35n3/0121-0793-iat-35-03-310.pdf

  23. El Congreso de Colombia. Ley 2287 de 2023 (enero 13). Por mediode la cual se crea el Sistema Nacional de Biobancos y se regula elfuncionamiento de los biobancos con fines de investigación biomédicabiotecnológica y epidemiológica y se dictan otras disposiciones. Colombia:Diario Oficial, 2023 [cited September 6 2024]. Available from: https://www.fao.org/faolex/results/details/en/c/LEX-FAOC220631/

  24. Centro de Desarrollo Estratégico e Información en Salud y SeguridadSocial. Reglamento de investigación biomédica. Costa Rica: Universidad deCosta Rica, 2021 [cited September 13 2024]. Available from: https://vinv.ucr.ac.cr/sites/default/files/documentos/reglamento_investigacion_biomedica_de_la_ccss.pdf

  25. Vega-Jiménez B. Biobancos en los servicios de anatomía patológicaen Costa Rica: un análisis bioético y biojurídico. Acta Med Costarric.2022;64(4):55-63. https://doi.org/10.51481/amc.v64i4.1245

  26. Mora-Vega SM. CCSS avanza en estudio de viabilidad para conformarBiobancos Humanos. Costa Rica: El Mundo, 2023 [cited September 6,2024]. Available from: https://elmundo.cr/costa-rica/ccss-avanza-en-estudio-de-viabilidad-para-conformar-biobancos-humanos/

  27. Canario JA. Comparative analysis of regulatory framework on biobankingto inform policymakers in Central America and the DominicanRepublic. Wellcome Open Res. 2021;6(95). https://doi.org/10.12688/wellcomeopenres.16547.1

  28. Ministerio de Salud Pública y Asistencia Social. Normativa para laregulación de ensayos clínicos en humanos. Guatemala: Ministerio deSalud Pública y Asistencia Social, 2019 [cited September 6, 2024]. Availablefrom: https://medicamentos.mspas.gob.gt/phocadownload/Acuerdo%20Ministerial%2082-2019.pdf

  29. Motta-Murguia L, Saruwatari-Zavala G. Mexican regulationof biobanks. J Law Med Ethics. 2016;44(1):58-67. https://doi.org/10.1177/1073110516644199

  30. Soto-Gómez L. Regulating Mexican biobanks for human biomedicalresearch: what can be learned from the european experience?Mex Law Rev. 2014;7(1):31-55 [cited September 6, 2024]. Availablefrom: https://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S1870-05782014000200002

  31. Comisión Nacional de Bioética. Guía nacional para la integración y elfuncionamiento de los Comités de Ética en Investigación. Mexico: Conbioética,2018 [cited September 6, 2024]. Available from: https://www.gob.mx/cms/uploads/attachment/file/414149/Guia_CEI_2018.pdf

  32. Secretaría de Gobernación. Ley general de protección de datos personalesen posesión de sujetos obligados. Mexico: Orden Jurídico, 2017[cited March 30 2025]. Available from: https://www.ordenjuridico.gob.mx/Documentos/Federal/pdf/wo119547.pdf

  33. Secretaría de Gobernación. Ley federal de protección de datospersonales en posesión de los particulares. Mexico: Orden Jurídico, 2010[cited March 30 2025]. Available from: http://www.ordenjuridico.gob.mx/Documentos/Federal/pdf/wo83178.pdf

  34. Instituto Mexicano del Seguro Social. Biobanco del IMSS conformaacervo de muestras y datos biológicos con potencial de evaluar campañasde vacunación y coadyuvar al desarrollo científico. Mexico: IMSS, 2023[cited May 8 2024 ]. Available from: https://www.imss.gob.mx/prensa/archivo/202303/133

  35. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.Biobanco Mexicano de Enfermedades Metabólicas. Mexico: INCMNSZ,2020 [cited Jun 27 2024]. Available from: https://www.incmnsz.mx/opencms/contenido/investigacion/uiem/biobanco.html




2020     |     www.medigraphic.com