Abstract
Introduction According to the Declaration of Helsinki, medical research and new therapeutic interventions
involving human subjects require prior informed consent and ethical approval. In 2010,
46% of pediatric surgical publications lacked documentation of ethical approval and
84% lacked documentation of informed parental consent with lowest rates of ethical
adherence found in articles concerning novel methods. The aim of this study was to
investigate whether adherence to ethical standards has improved in pediatric surgical
publications.
Materials and Methods All 3,093 consecutive articles published in Journal of Pediatric Surgery, European Journal of Pediatric Surgery, and Pediatric Surgery International over the last 5 years were systematically reviewed for publications describing novel
surgical methods. Novel methods were defined as surgical methods not published before
or not considered common practice. The publications were reviewed as to whether ethical
approval and informed consent to participate was documented.
Results In total, 105 articles describing novel surgical methods were identified (61 Journal of Pediatric Surgery, 16 European Journal of Pediatric Surgery, and 28 Pediatric Surgery International). Authors reported on new operative techniques (62%), modified techniques (31%),
or use of new materials (7%). Ethical approval was documented in 52% of the articles
with almost half reporting approval for retrospective data analysis only but not the
application of the novel method. Informed consent was documented in 21% of publications.
Complications were reported in 48% of the studies, including recurrences and reinterventions
for the unsuccessful novel methods. Two authors reported mortalities due to underlying
disease, one of which failed to report prior ethical approval or informed consent.
Conclusion Adherence to ethical publication principles in pediatric surgery has improved over
the last years but is still lacking in many publications. When implementing new methods,
prior ethical approval and informed consent and their documentation are mandatory,
specifically in the light of potential hazard to patients.
Keywords
pediatric surgical research - publication ethics - novel surgical methods - ethical
approval - informed consent
