Methodological and ethical congruence in medical research protocols at a local hospital committee
Main Article Content
Keywords
Research Ethics, Meta-Research, Health Research Evaluation
Abstract
Abstract
Background: Methodological congruence and ethical congruence in medical research protocols is essential to ensure scientific validity and adherence to bioethical principles. Methodological congruence refers to the alignment between objectives, study design, and data analysis, while ethical congruence involves compliance with principles such as autonomy, beneficence, non-maleficence, and justice.
Objective: To evaluate methodological congruence and ethical congruence of medical research protocols submitted between 2022 and 2025 in a high-specialty medical unit in Mexico.
Material and methods: A total of 113 protocols were analyzed through an observational, descriptive, and cross-sectional study with an evaluation form based on the Mexican Official Standard NOM-012-SSA3-2012 and the General Law on Personal Data Protection. Twelve methodological items and 5 ethical items were assessed, and congruence was classified as high, medium, or low.
Results: 92% of the protocols demonstrated high methodological congruence, whereas only 38.9% showed high ethical congruence. Additionally, 20.4% had serious ethical deficiencies. Descriptive studies and specialties such as Anesthesiology and Critical Care were predominant.
References
1. Norma Oficial Mexicana NOM-012-SSA3-2012, Que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos. México: Diario Oficial de la Federación; 2012. Disponible en: https://www.imss.gob.mx/sites/all/statics/profesionalesSalud/investigacionSalud/normativaNac/4_NOM-012-SSA-3-2012.pdf
2. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA. 2013;310(20). doi: 10.1001/jama.2013.281053
3. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. J Korean Med Assoc. 2014;57(11). doi: 10.5124/jkma.2014.57.11.899
4. World Medical Association. Ethical principles for medical research involving human subjects. Eur J Emerg Med. 2001;8(3). doi: 10.1097/00063110-200109000-00010
5. Instituto Mexicano del Seguro Social. Guía para la elaboración del protocolo de investigación. México: IMSS; 2021.
6. Ortiz-García JM. Guía descriptiva para la elaboración de protocolos de investigación. Salud Tab. 2006;12(3).
7. Mbuagbaw L, Lawson DO, Puljak L, et al. A tutorial on methodological studies: the what, when, how and why. BMC Med Res Methodol. 2020;20(1). doi: 10.1186/s12874-020-01107-7
8. Mishra B. Research methodology for health professionals. J Community Health Manag. 2020;7(2). doi: 10.18231/j.jchm.2020.014
9. Li G, Abbade LPF, Nwosu I, et al. A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC Med Res Methodol. 2018;18(1). doi: 10.1186/s12874-017-0465-7
10. Vidali M. The reproducible science. Biochim Clin. 2020;44(4). doi: 10.19186/BC_2020.094
11. Baer DR, Gilmore IS. Responding to the growing issue of research reproducibility. J Vac Sci Technol A. 2018;36(6). doi: 10.1116/1.5049141
12. Kochalko D, Morris C, Rollins J. Applying blockchain solutions to address research reproducibility. Proc Int Conf Sci Technol Indic. 2018.
13. Gaglio B, Henton M, Barbeau A, et al. Methodological standards for qualitative and mixed methods patient centered outcomes research. BMJ. 2020;371. doi: 10.1136/bmj.m4435
14. Ley General de Protección de Datos Personales en Posesión de Sujetos Obligados. México: Cámara de diputados; 2017. Disponible en: https://www.diputados.gob.mx/LeyesBiblio/pdf/LGPDPPSO.pdf
15. Kiani AK, Naureen Z, Pheby D, et al. Methodology for clinical research. J Prev Med Hyg. 2022;63(2). doi: 10.15167/2421-4248/jpmh2022.63.2S3.2769
16. Garg R. Methodology for research I. Indian J Anaesth. 2016;60(9). doi: 10.4103/0019-5049.190619
17. Rogozinska E, Gargon E, Olmedo-Requena R, et al. Methods used to assess outcome consistency in clinical studies: a literature-based evaluation. PLoS One. 2020;15(7). doi: 10.1371/journal.pone.0235485
18. Zhao L, Shen C, Liu M, et al. Comparison of reporting and transparency in published protocols and publications in umbrella reviews: scoping review. J Med Internet Res. 2023;25. doi: 10.2196/43299
19. Zhou X, Li L, Lin L, et al. Methodological quality for systematic reviews of adverse events with surgical interventions: a cross-sectional survey. BMC Med Res Methodol. 2021;21(1). doi: 10.1186/s12874-021-01423-6
20. Kim HR, Choi CH, Jo E. A methodological quality assessment of meta-analysis studies in dance therapy using AMSTAR and AMSTAR 2. Healthcare (Basel). 2020;8(4). doi: 10.3390/healthcare8040446
21. Hutton B, Catalá-López F, Moher D. The PRISMA statement extension for systematic reviews incorporating network meta-analysis: PRISMA-NMA. Med Clin (Engl Ed). 2016;147(6):262-6. doi: 10.1016/j.medcle.2016.10.003
22. Reconde-Suárez D, Peña-Figueredo MA. Las regularidades teóricas de los protocolos de actuación de enfermería como resultado científico enfermero. Ene. 2019;13(2):1326. Disponible en: https://scielo.isciii.es/pdf/ene/v13n2/1988-348X-ene-13-02-e1326.pdf
23. Savitz DA, Wellenius GA. Can cross-sectional studies contribute to causal inference? It depends. Am J Epidemiol. 2023;192(4). doi: 10.1093/aje/kwac037
24. Johnson JL, Adkins D, Chauvin S. A review of the quality indicators of rigor in qualitative research. Am J Pharm Educ. 2020;84(1). doi: 10.5688/ajpe7120
25. Drolet MJ, Rose-Derouin E, Leblanc JC, et al. Ethical issues in research: perceptions of researchers, research ethics board members and research ethics experts. J Acad Ethics. 2023;21(2). doi: 10.1007/s10805-022-09455-3
26. Rizvi DS. Health education and global health: practices, applications, and future research. J Educ Health Promot. 2022;11(1). doi: 10.4103/jehp.jehp_218_22
27. Satalkar P, Shaw D. How do researchers acquire and develop notions of research integrity? A qualitative study among biomedical researchers in Switzerland. BMC Med Ethics. 2019;20(1). doi: 10.1186/s12910-019-0410-x
28. Sistema Nacional de Fiscalización. Informe 2023 al Comité Coordinador del Sistema Nacional Anticorrupción. México: SNF; 2023.
29. Comisión Nacional para la Protección. Informe Belmont: principios y guías éticos para la protección de los sujetos humanos de investigación. Bethesda, Maryland, EEUU: National Institutes of Health; 2003.
Article Sidebar
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Authors retain their copyright and grant the Revista Médica del IMSS the right of first publication. Articles are distributed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which allows sharing as long as the author and the original source are properly credited.