Retrospective observational studies: Lights and shadows for medical writers

Retrospective observational studies: Lights and shadows for medical writers


  • Vincenzo De Sanctis Quisisana Hospital, Ferrara
  • Ashraf T Soliman Pediatrics and Endocrinology Department of Pediatrics, Hamad Medical Center, Doha, Qatar and Department of Pediatrics, University of Alexandria, Alexandria, Egypt
  • Shahina Daar Department of Haematology, College of Medicine and Health Sciences, Sultan Qaboos University, Sultanate of Oman and Stellenbosch Institute for Advanced Study (STIAS), Wallenberg Research Centre at Stellenbosch University, Stellenbosch, South Africa
  • Ploutarchos Tzoulis Consultant Endocrinologist and Diabetologist, Whittington Hospital- UCL Medical School, London, UK
  • Bernadette Fiscina Department of Pediatrics, NYU School of Medicine, New York, NY, USA
  • Christos Kattamis First Department of Paediatrics, National Kapodistrian University of Athens, Athens, Greece
  • International Network of Clinicians for Endocrinopathies in Thalassemia and Adolescence Medicine (ICET-A)


Retrospective studies, Ethical Committee, low-risk research, exemption, international variation, human, ICET-A survey.


A retrospective study (by definition non-interventional) is a purely observational review and/or reassessment of database records with the aim of analyzing previous events of interest. The ethical and scientific standards for conducting biomedical research with humans have been established in international guidelines. Nevertheless, the reporting of ethical considerations in human research is not yet agreed upon globally, although some progress has been made in recent years. If a study has been granted exemption from ethics approval, this should be indicated in the manuscript (including the reasons for the exemption) and, if formal review by an ethics committee is not available, a statement should be included indicating that the research was conducted according to the principles of the Declaration of Helsinki. Editors play an important role in adherence to these ethical requirements for all submitted and published research papers in their journals. This short review paper focuses on the main lights and shadows of ethical aspects for conducting retrospective observational studies in humans and implications for medical writers.

Author Biography

International Network of Clinicians for Endocrinopathies in Thalassemia and Adolescence Medicine (ICET-A)

Atanas Banchev (Sofia, Bulgaria), Denka Stoyanova  (Sofia, Bulgaria), Michael Angastiniotis (Nicosia, Cyprus), Soteroula Christou  (Nicosia, Cyprus), Heba  Elsedfy (Cairo,Egypt), Mohamed El Kholy (Cairo, Egypt), Doaa Khater (Alexandria, Egypt), Antonis Kattamis (Athens, Greece), Polyxeni Delaporta  (Athens, Greece), Haleh Bozorgi (Shiraz, Islamic Republic of Iran), Mehran Karimi (Shiraz, Islamic Republic of Iran), Saveria Campisi  (Siracusa, Italy), Salvatore Di Maio (Naples, Italy), Carmelo Fortugno (Catanzaro Italy), Maria Concetta Galati (Catanzaro, Italy), Giuseppe Raiola (Catanzaro, Italy), Soad K Al Jaouni  (Jeddah, Kingdom of Saudi Arabia), Yasser Wali (Muscat, Oman), Mohamed A Yassin  (Doha, Qatar), Joan Lluis Vives Corrons (Barcelona, Catalonia, Spain), Dulani Kottahachchi  (Ragama, Sri Lanka), Duran Canatan (Antalya, Turkey)


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How to Cite

De Sanctis V, Soliman AT, Daar S, Tzoulis P, Fiscina B, Kattamis C, et al. Retrospective observational studies: Lights and shadows for medical writers. Acta Biomed [Internet]. 2022 Oct. 26 [cited 2024 Jul. 24];93(5):e2022319. Available from: