If a research project involves human participants wholly outside the European Union it should be submitted to OxTREC for ethical review if it meets any of the following criteria:
A waiver of ethical approval will be considered for:
Whether a study qualifies as minimal risk or not is a decision taken by the executive committee and not the applicant. The executive committee therefore reserves the right to request a full application at any time.
Indicative criteria for minimal risk:
For such studies please complete the minimal risk application form, together with a protocol and other documents if appropriate; see list for full applications below. The application form and supporting documentation should be emailed to the OxTREC secretariat: firstname.lastname@example.org. Minimal risk applications can be approved at any time and the study can then be started. The full committee will be informed at the following meeting.
A FULL APPLICATION is required for all other studies
|Submission Deadline||OxTREC Meeting Date|
|Friday 21 August 2015||Thursday 24 September 2015|
|Friday 23 October 2015||Thursday 26 November 2015|
|Friday 4 December 2015||Thursday 28 January 2016|
|Friday 5 February 2016||Thursday 17 March 2016|
|Friday 8 April 2016||Thursday 19 May 2016|
|Friday 3 June 2016||Thursday 14 July 2016|
|Friday 19 August 2016||Thursday 29 September 2016|
|Friday 14 October 2016||Thursday 24 November 2016|
2. Documents to be uploaded with the full application form, if appropriate are:
3. All study documentation should have a version number and date on each page of the document (header or footer) which must be stated on the checklist. Please put the OxTREC application number on each document.
4. Once the committee has reviewed your application you can expect a reply within 2 weeks of the meeting date.
Final approval will only be given once the committee is satisfied that the applicant has fulfilled all requirements.
To submit a project for full ethical review, please do so via the OXTREAD system.
1. Any subsequent changes to the application must be submitted to the committee as an Amendment. This should include a letter to give the reasons for the proposed modifications and all modified documents with changes tracked.
2. Annual Reports (due on the anniversary of the date of approval) are required for all approved studies, including drug safety issues and news of any publications arising from the research. Minor changes requesting extension of a study end date, or the addition of a new researcher can be entered in the annual review form.
3. An end of study report should be submitted after completion.
NB: all amendments, annual reports and end of study reports should be sent via email to the OxTREC secretariat: email@example.com.