A new system has launched for Ethical approval applications related to Clinical Studies based outside of the European Union.

The University of Oxford has a formal requirement that all research involving human participants should be subject to ethical review, with approval obtained from a Research Ethics Committee before commencing the study. The reasons for this seek to protect the dignity, rights and welfare of all those involved in research, whether they are participants, researchers, or third parties, and to promote high ethical standards of research. This principle of ethical standards is highlighted in the Helsinki Declaration and reinforced in subsequent principles, such as Good Clinical Practice.

Whilst most Clinical Studies associated with the University of Oxford go through CUREC (the Central University Research Ethics Committee), all Clinical Studies requiring ethical approval which take place outside of the EU are required to submit applications to the Oxford Tropical Research Ethics Committee (OxTREC). As of today, 25th May 2012, the system for applying to OxTREC is changing. Previously, Researchers completed a Microsoft Word application form and submitted this via email to the OxTREC Administrator. The system has now been streamlined, with the implementation of a new web-based application system.

The Oxford Tropical Research Ethics Application Database (OXTREAD) is easily accessed from anywhere around the world and allows Researchers to complete and submit the application form in a far more straightforward and time efficient way. Having registered as a user of OXTREAD, the user can create a new application and work on it for as long as they require before submitting to OxTREC for review. Feedback and suggested amendments are recorded on the database, allowing OxTREC Administrators to easily search all applications via different criteria.

Although the new system will go live on Friday 25th May 2012, OxTREC are sympathetic to the fact that some Researchers may have already begun their applications using the old forms for the 15th June 2012 deadline. Therefore, applications for this deadline will be accepted using the old forms. However, for the 31st August 2012 deadline, it is expected that everyone will have made the transition and any applications using the old system will not be accepted and will be returned with a request to resubmit via OXTREAD.

You can access OXTREAD from the OxTREC website: www.tropicalmedicine.ox.ac.uk/oxtrec.

A Standard Operating Procedure (SOP) is available on the OxTREC website, answering any queries you might have regarding the system. Please read the SOP to familiarize yourself with OXTREAD, and should you have any further problems, please address them to the OxTREC Administrator, Jacqueline.Gerencser@admin.ox.ac.uk.