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:
- The research involves a medical, therapeutic, or pharmaceutical intervention of any kind.
- The participants are recruited by virtue of being under the care of a healthcare professional.
- The research may identify conditions which require the attention of a healthcare professional.
- The research involves an invasive procedure (class A in the CUREC glossary).
- The study is funded by the US National Institutes of Health or another US federal funding agency, and the study has not been or cannot be reviewed by an NHS ethics committee which has been registered with the Office for Human Research Protections (OHRP), even if performed within the EU.
How to apply
A waiver of ethical review will be considered for:
- most research on educational methods (NB: 'educational methods' are methods used for the instruction of students in a learning environment)
- research on publicly available anonymised data or samples
- audits or service reviews:
See also 'audit' in the glossary
- laboratory services provided to another organisation which is sponsoring a clinical research project and which has obtained ethics approval for the project and where samples being analysed are anonymised
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 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.
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:
- The risk and magnitude of possible harms associated with these studies must be no greater than those of daily living activities of the volunteers
- Includes most questionnaires or interviews which would not distress the volunteers and will remain confidential
- Does not include a drug or medical device
- May allow non-invasive or minimally invasive specimens or tests (eg urine/stool/saliva samples; nasal/throat/rectal/vaginal swabs in adults)
- May allow use of specimens collected for routine health purposes
- May include venous blood sampling from healthy adults up to a maximum volume of 1ml/kg in 8 weeks
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.
|Submission deadline||OxTREC meeting date|
|Friday 7 December 2018||Thursday 24 January 2019|
|Friday 8 February 2019||Thursday 21 March 2019|
|Friday 12 April 2019||Thursday 23 May 2019|
|Friday 7 June 2019||Thursday 18 July 2019|
|Friday 9 August 2019||Thursday 19 September 2019|
|Friday 11 October 2019||Thursday 28 November 2019|
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)
Any other documents relevant to the study
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.