OxTREC

The Oxford Tropical Research Ethics Committee was established to provide ethical review of clinical studies in the tropics conducted by University of Oxford researchers. OxTREC review does not replace the need for ethical review within the country where the research will take place.

Applications to OxTREC must be submitted by using OXTREAD (a web based application system). Follow the link below to access OXTREAD.  Please read the OXTREAD SOP below in order to familiarize yourself with how to use the system.

Deadlines for 2014

Submission Deadline OxTREC Meeting Date
Fri 28 February 2014 Thu 20 March 2014
Fri 18 April 2014 Thu 22 May 2014
Fri 13 June 2014 Thu 17 July 2014
Fri 22 Aug 2014 Thu 25 September 2014
Fri 24 October 2014 Thu 27 November 2014

Please note that the submission deadlines have been revised for the month of April 2014 onwards to the above and are now earlier by one week

OXTREAD Application System

We are in the process of radically revising the online application system.

PLEASE COMPLETE A REVISED APPLICATION FORM NOT SEEN ON OXTREAD

Temporarily we would ask for the APPLICATION FORM: Blank Template for Full Applications to be completed separately and emailed to Jacqueline Gerencser, the OxTREC administrator Jacqueline.gerencser@admin.ox.ac.uk. If your application relates to NIH funding please also complete the Additional template for NIH funded Studies.

NOTHING ELSE HAS CHANGED.

Please continue to upload relevant supporting study documents on OXTREAD (protocol, participant information sheet, consent form, peer reviews PI Signatory Page). The OxTrec reference will be assigned automatically on submission, and this must be put onto the application form before sending by e-mail.

Do not e-mail anything except the completed application form to Jacqueline.

We hope that the new form will be an improvement and apologise for any inconvenience caused.

http://bcc.well.ox.ac.uk/oxtread/

For any queries or help needed regarding OXTREAD, please see the OXTREAD SOP

Forms

Minimal Risk Project Form - please review the Central University Research Ethics Committee (CUREC) guidance on minimal risk studies if you wish to use this form

Annual Review Form

End of Study Report

Forms must be submitted to the OXTREC Administrator

OxTREC administrator
University of Oxford
Joint Research Office
Block 60 Churchill Hospital
Old Road
Oxford
OX3 7LJ
tel. +44 (0) 1865 (5)72346
fax +44 (0) 1865 (5)72228

e-mail Jacqueline.Gerencser@admin.ox.ac.uk

Guidance

The Oxford Tropical Research Ethics Committee, OXTREC, reviews medical research conducted in countries outside the European Union. Ethical approval is usually obtained through a formal application submitted electronically via the Oxford Tropical Research Ethics Application Database (OXTREAD). These applications are reviewed by the Committee at its meetings held six times a year. During the submission process, we will also check that train sponsorship and indemnity are in place for the study.

It is common for the Committee to ask for amendments and clarifications, which are usually resolved by correspondence within two months of the committee meeting, thus the time from first submission to final approval is typically less than three months. 

For studies that present no more than minimal risk to the participants, there is a fast track process for ethical approval:

  1. Standard applications that are identified as having no more than minimal risks may be reviewed by the OxTREC executive team (Chair, Vice-Chair and Administrator) which meets twice a month. Please send a covering letter or e-mail message with the application to say why the research has no more than minimal risks. The executive team may take Chairman's Action in approving the application as submitted, or ask for minor amendments and clarifications, or decide to review the application with the full Committee. A study with no more than minimal risks may be reviewed by the full committee if i) the research in question requires the expertise present on the full Committee, or ii) the study will set an important precedent, or iii) the studies raises important ethical issues that deserve careful discussion. When ethical approval can be granted by Chairman's Action, the time from submission to approval is approximately one month, depending on time taken to resolve amendments and clarifications.  Approvals by Chairman's Action are subject to confirmation at the next full Committee meeting.
  2. Supervised research conducted by students at the University of Oxford. There is a special application form for students in the Division of Medical Sciences who are planning research overseas. This application form is simpler than the standard form, and is designed for minimal risk research that will be supervised by an experienced member of the University.  These applications are reviewed by the OXTREC executive team, which meets twice a month. The executive team may take Chairman's Action in approving the application as submitted, or ask for minor amendments and clarifications, or decide to review the application with the full Committee. OXTREC's approval depends on the supervisor ensuring that ethical practice is part of the scientific quality of the research.  A covering letter explaining the arrangements for supervision overseas is helpful in obtaining approval. When ethical approval can be granted by Chairman's Action, the time from submission to approval may be approximately one month, depending on time taken to resolve amendments and clarifications.  Approvals by Chairman's Action are subject to confirmation at the next full committee meeting.

There is also a fast track option for exceptional circumstances as follows:

  1. If there is an exceptional case for an urgent ethical review (e.g. research on interventions to control an outbreak of an infectious disease), an application on the standard form will be reviewed as soon as it is received by the OxTREC executive team. If appropriate, approval will be given by Chairman's Action, subject to confirmation by the full Committee. In these exceptional circumstances, approval may be obtained within a few days.
  2. Several research groups in Oxford participate in international studies and are sent anonymised data or samples obtained with proper informed consent by collaborators with appropriate research ethics committee approval for the overarching study. Such research does not, normally, require additional ethical review by an Oxford ethics committee. There are, however, occasions when we are asked by a collaborator or funder to submit the Oxford part of the study for ethical review. In these cases, the Oxford researchers may write to the OXTREC Chairman explaining the study and requesting approval, which will usually be granted by Chairman's Action.

Social Science Studies

As the only University ethics committee empowered to review health-related studies that are conducted outside the European Union, OxTREC will review some research that includes social science methods. OxTREC is aware that its members' expertise is predominately in the medical sciences and it will co-opt one or more extra members from the social sciences as required. 

The Global Health Clinical Trials Website is being developed by a collaboration of researchers working in Africa, Asia and Latin America and is aiming to provide support, guidance, e-learning and career development for all researchers working on clinical trials in the field of global health. It is a source for templates, advice and explanation that can help you design and conduct your study. www.globalhealthtrials.org