• Introduction
• Policy statement
• Guidance on approval process
  • OXTREC
• FAQs
• Checklists and application form
• Glossary
• Guidance on documents for participants
• Protocols
• Guidelines
• Find out more
• Contact details
• Web changes

OXTREC

Applications to OXTREC must be submitted using OXTREAD, a web-based application system (with the exception of minimal risk student projects, for which there is a separate form - see 'Forms' below). OXTREAD was introduced in 2012 and applications made using the old forms will no longer be accepted.

OXTREAD

• OXTREAD application system: http://bcc.well.ox.ac.uk/oxtreidxp/
• OXTREAD Standard Operating Procedures as a PDF (385kb)

Deadlines for 2012/13

Forms

• OXTREC Minimal Risk Student Project Form as Word file (90kb) - please review the guidance on minimal risk studies if you wish to use this form
• OXTREC Annual Review Form as Word file (63kb)
• OXTREC End of Study Report as Word file (67kb)

Applications will be submitted to the OXTREC Administrator.

OxTREC Administrator
University of Oxford
Joint Research Office
Block 60 Churchill Hospital
Old Road
OxfordOX3 7LJ
tel. +44 (0) 1865 (5)72224
fax +44 (0) 1865 (5)72228
e-mail: OXTREC Administrator

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 OXTREC Application System, 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 trial 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.

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