Facilitating world-class research
If a research project involves human participants wholly outside the United Kingdom and the European Union it should be submitted to OxTREC for ethical review if it meets any of the following criteria:
Before starting any application to OxTREC, please refer to this guide:
Waiver of ethical review
A waiver of ethical review will be considered for:
See also 'audit' in the glossary
All other studies should be submitted for ethical review (see the sections on 'Applying for minimal risk review' and 'Applying for full committee review' below).
Studies involving Oxford investigators as collaborators
For any study on which an Oxford investigator is collaborating:
If the Oxford investigator has played/will play a major role in the design and/or conduct of the study, then it needs to be submitted to OxTREC for review.
NB: this list of examples is indicative, not exhaustive.
In general, research that involves only previously collected, fully anonymised, non-NHS data that cannot be traced back to an individual by the researcher or their collaborators, and involves no biological samples, does not require ethical review. Please see Where and how to apply for ethical review for further details.
However, some NIH data repositories (eg dbGaP, NIDDK Central Repository) require evidence of ethical approval from the researcher’s host institution before they will release previously collected, fully anonymised data from the repository. In such cases, please contact the OxTREC secretariat, providing all relevant details, for further advice.
Studies involving human tissue samples should be submitted to OxTREC for ethical review and approval in the usual way (see the sections on 'Applying for minimal risk review' and 'Applying for full committee review' below).
However, please note that where it is planned to import the samples into England, it is the responsibility of the PI to make arrangements before the samples are transferred to store them under the governance of a Human Tissue Authority (HTA) licence.
It is a legal requirement that any tissue or fluid made up of or containing human cells to be used for the purpose of research is stored on premises licensed by the HTA unless covered by an exemption. OxTREC approval is not a recognised exemption.
Further information may be found on the University’s Human tissue governance webpages. Any queries should be directed to the University’s Human Tissue Governance team.
Note: The activities listed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to participants.
1. Whether a study qualifies as minimal risk or not is a decision taken by OxTREC and not the applicant. OxTREC therefore reserves the right to request a full application at any time.
2. Indicative criteria for minimal risk studies are as follows:
3. For such studies please complete the OxTREC minimal risk application form:
Please also submit the following supporting documents:
Participant information sheet (if appropriate)
Consent form (if appropriate)
Form for NIH funded studies (only applicable if your study is funded by the US National Institutes of Health)
Any other documents relevant to the study
Please note that, for minimal risk studies only, it is no longer necessary to submit a protocol with your application.
All study documentation should have a version number and date on each page of the document (header or footer).
4. The application form and supporting documentation should be emailed to the OxTREC secretariat.
5. 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.
1. The OxTREC committee meets six times a year (see dates below). Applications received before the next submission deadline will be reviewed at the following meeting. You can expect to receive a response from the committee approximately two weeks after the meeting date.
2. Applications for full review should be submitted electronically via the OXTREAD online submission system.
3. The following supporting documents should be uploaded to OXTREAD along with the full application form:
Separate PI signatory page (available on OXTREAD; must be signed, scanned and uploaded with the rest of the full application)
A copy of the local ethical approval (must be submitted to OxTREC; the study can only commence once both local ethical approval and OxTREC approval have been given)
Participant information sheet (if relevant)
Consent form (if relevant)
4. 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 OXTREAD checklist. Please put the OxTREC application number on each document.
5. Important note: For clinical trials, please ensure that you complete fully the questions on trial registration in OXTREAD. Provision of this information is mandatory and trials cannot be granted ethical approval by OxTREC in the absence of a clinical trial registration number.
Minimal risk applications can take up to 30 days to review. Note the 30 day clock starts when your application is valid. It stops while we are waiting for revisions from you.
Full committee applications received before the next OxTREC submission deadline will be reviewed at the following committee meeting. You can expect to receive a response within two weeks of the meeting. Note that you may be asked for clarification/amendment before approval can be granted.
1. Any changes to your study post-approval must be submitted via email to the OxTREC secretariat as an amendment. This should include a letter giving the reasons for the proposed modifications and all modified documents with changes tracked.
2. On each anniversary of the date of approval, you must submit an annual report via email to the OxTREC secretariat using:
The annual report should include 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 also be entered in the annual review form.
3. Within 12 months of completion of your study, you should submit an end of study report via email to the OxTREC secretariat using:
In extremely rare cases CUREC may not be able to provide ethical approval. An appeals procedure is available for appealing a decision to withhold, suspend or withdraw approval of research.