Health Research Registration

All clinical trials should be registered in a public trials registry at or before the time of first patient enrollment as a CONDITION for publication in the Philippine Journal of Otolaryngology Head and Neck Surgery. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health- related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

We accept registration in the Philippine Health Research Registry (PHRR) http://registry.healthresearch.ph, a publicly-available database of newly-approved health researches from 2012 onwards, or in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) (http:// www.who.int/ictrp/network/en/), or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP. Registration should be made immediately after Institutional Review Board or Ethics Review Board approval is obtained.