Authorization Processes for Access to Hospital Clinical Records: The Case of a Multicenter Study

Authors

  • Rafael Rocha Hospital de São João. Unidade Local de Saúde de São João. Porto. Portugal; Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal; Global Health and Tropical Medicine (GHTM, LA-REAL). Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal. https://orcid.org/0000-0001-7451-9137
  • Carla Maia Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal; Global Health and Tropical Medicine (GHTM, LA-REAL). Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal. https://orcid.org/0000-0002-2545-7686
  • Luzia Gonçalves Centro de Estatística e Aplicações da Universidade de Lisboa (CEAUL). Faculdade de Ciências. Universidade de Lisboa. Lisboa. Portugal; Z-Stat4life. Espaço Cowork Baldaya. Lisboa. Portugal. https://orcid.org/0000-0002-9710-1945
  • Cláudia Conceição Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal; Global Health and Tropical Medicine (GHTM, LA-REAL). Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal. https://orcid.org/0000-0001-7004-0268

DOI:

https://doi.org/10.20344/amp.22816

Keywords:

Biomedical Research, Confidentiality, Data Anonymization, Electronic Health Records, Ethics Committees, Research, Health Records, Personal, Portugal

Abstract

Clinical practice generates a wealth of data daily, collected for the purpose of providing healthcare. However, this data holds the potential to contribute to the generation of knowledge. The aim of this study was to describe the process of submitting requests for access to clinical records for research and the heterogeneity in the evaluation of a national research project by the boards of directors and ethics committees of hospitals, hospital centers, and local health units within the Portuguese national health service. The procedures and waiting times are described. The results of this study highlight considerable variability in the process of submitting requests for access to clinical data and the evaluation of research protocols. They also reveal lengthy waiting times for obtaining authorizations. This study underscores the urgent need to continue the discussion on the ethical and legal issues involved in studies requiring access to clinical records or other health data.

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References

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Published

2025-05-26

How to Cite

1.
Rocha R, Maia C, Gonçalves L, Conceição C. Authorization Processes for Access to Hospital Clinical Records: The Case of a Multicenter Study. Acta Med Port [Internet]. 2025 May 26 [cited 2025 Dec. 5];38(8):480-3. Available from: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/22816

Issue

Section

Short Reports