[Methodological and ethical congruence in medical research protocols at a local hospital committee].

BACKGROUND

ethodological 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.

CONCLUSION

While most protocols were methodologically well-structured, significant shortcomings were found in ethical aspects. These findings highlight the need to strengthen training in clinical bioethics and to implement more rigorous evaluations to ensure ethically sound medical research.