title: Failure of plastic surgical clinical trials to document compliance with international ethical guidelines: a systematic review.
abstract: BACKGROUND
  The Declaration of Helsinki (DOH) mandates that clinical trials must follow specific ethical standards including independent ethical review and registration in a public database to protect the rights and safety of human subjects and promote public trust. The purpose of this study was to perform a systematic review to identify whether independent ethical review and trial registration had been documented in all prospective clinical studies published in the journals Plastic and Reconstructive Surgery, Annals of Plastic Surgery and the Journal of Plastic Reconstructive and Aesthetic Surgery from 7/2007 to 7/2011 and if there was any difference in documentation between journals and between types of studies.
  
  
  METHODS
  The PubMed database was selected to search through the medical literature with specific inclusion criteria to disqualify irrelevant articles from the study. Appropriate articles were extracted, and all investigators assessed their quality and validity to maximize reproducibility. Each investigator systematically reviewed every article to determine whether independent ethical review and trial registration had been reported. Each investigator staged every study using the 2011 Oxford Centre for Evidence Based Medicine criteria. The data were then synthesized and analyzed for documentation of independent ethical review and trial registration.
  
  
  RESULTS
  Of the 235 studies retrieved, 155 met our inclusion criteria as prospective studies, 102 reported independent ethical review. Eight studies reported trial registration in a public database, two additional studies were registered at clinicaltrials.gov, but the publications did not document their registration. Seven of the reported studies did not comply with the DOH as they had been registered retroactively; thus only one study out of 155 (<1%) documented compliance with the DOH. Using Fisher's exact test, the only statistically significant difference between the groups was better documentation in PRS level 2 studies than in PRS level 3 studies (p = 0.007).
  
  
  CONCLUSIONS
  Plastic surgery clinical trials' documentation of compliance with international ethical guidelines must improve.
authors.affiliation: Voluntary Professor of Surgery, University of Miami School of Medicine, 9100 S. Dadeland Blvd. Suite 502, Miami, FL 33156-7815, USA. mfelix.freshwater@gmail.com
authors.forename: M Felix
authors.initials: MF
authors.lastname: Freshwater
authors.forename: D E
authors.initials: DE
authors.lastname: Garcia-Zalisnak
authors.forename: N E
authors.initials: NE
authors.lastname: González-Ortiz
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D004282:Documentation / Q000592:standards*; D026724:Ethical Review; D019983:Guideline Adherence; D006381:Helsinki Declaration; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards; D017410:Practice Guidelines as Topic; D013518:Surgery, Plastic