OxTREC application process

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:

  • 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 research involves human tissue samples

Or if:

  • 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 UK or the EU.

Before starting any application to OxTREC, please refer to this guide:

Clinical research sponsorship

If you wish the University to sponsor a clinical trial or clinical research study that will be reviewed at an OxTREC full committee meeting, you should make contact with the Insurance Team (research.insurance@admin.ox.ac.uk) as early as possible, preferably at the time of the funding application and with the RGEA sponsorship group (rgea.overseas@admin.ox.ac.uk) at least 3 weeks before the OxTREC submission deadline. This will ensure that any sponsorship issues can be addressed. It will also enable determination of whether insurance cover can be arranged and, if so, any potential cost. A letter confirming sponsorship will then be issued prior to submission to OxTREC. 

 

 

How to apply

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Requirements for ethical review

Ethical review by OxTREC will not normally be required 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
  • audits or service reviews:
  • laboratory services provided to another organisation that is sponsoring a clinical research project and that has ethics approval. 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 that fits the criteria for review by OxTREC (above) 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.

For example:

  • the Oxford investigator has played a significant role in developing the protocol and/or participant recruitment process for the study, or
  • the Oxford investigator will have direct contact with participants, eg taking consent; conducting medical or qualitative procedures, or
  • the Oxford investigator will make decisions about participants' care, or
  • the Oxford investigator will play a significant role in analysing the results from the study.

NB: this list of examples is indicative, not exhaustive.

 

 

Some studies involving NIH data repositories (eg dbGaP, NIDDK Central Repository) that are not otherwise being reviewed by OxTREC may require evidence of ethical approval from the researcher's host institution before they will release previously collected, anonymised data from the repository. In such cases, please contact the OxTREC secretariat, providing all relevant details, for further advice.

 

Studies involving collection of human tissue samples should be submitted to OxTREC for ethical review and approval in the usual way.  If the samples have already been collected, please complete the form specifically for these studies:

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. Please get in touch with the Human Tissue Governance Team hta_help@admin.ox.ac.uk to discuss options for sample storage.

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 is available on the Human tissue governance pages. Any queries should be directed to hta_help@admin.ox.ac.uk.

 

 

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: 

All OxTREC documents are subject to ongoing review. Please always refer to this page for the current version of the minimal risk application form (rather than using locally stored versions).

 

Please also submit the following supporting documents:

Documents to submit
Document Template

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 not 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 are reviewed on a rolling basis. Once a study has been approved, it can be started.

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.

Submission deadlines
Submission deadline OxTREC meeting date 
Friday 15 December 2023 Thursday 25 January 2024
Friday 16 February 2024 Thursday 21 March 2024
Friday 26 April 2024 Thursday 23 May 2024
Friday 21 June 2024 Thursday 25 July 2024
Friday 23 August 2024 Thursday 26 September 2024
Friday 01 November 2024 Thursday 28 November 2024

 

2. Applications for full review should first be submitted to the RGEA sponsorship team (rgea.overseas@admin.ox.ac.uk) at least 3 weeks before the deadline above. The documentation and completed OxTREC application form should then be submitted electronically via email to the OxTREC Secretariat oxtrec@admin.ox.ac.uk by the deadline date above.

3. The following supporting documents, and any other relevant to the study, should be submitted along with the full application form:

Supporting documents
Document Template

 

Separate PI signatory page (must be signed, scanned and submitted with the rest of the full application)

 

A copy of the local ethical approval if available

 

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), and this must be stated on the OxTREC application form 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 the application form. Provision of this information is mandatory and trials cannot be granted ethical approval by OxTREC in the absence of a clinical trial registration number.

 

Application timeframe

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Minimal risk applications can take up to 30 days to review. Note the 30 day clock starts when all required documents have been received. It stops while revisions are being made.

1. Submit minimal risk form and supporting documents by email
2. Application checked by OxTREC administrator
3. Receive acknowledgement by email that all required documents are received

4. OxTREC secretariat will lead on reviewing your study

5. Receive a study review by email, which may ask for clarification or amendments

6. Respond by email and await further possible review - multiple emails may be involved

7. Respond satisfactorily to all emails sent by OxTREC.

8. Receive an approval letter by email as a PDF attachment.
 

 

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. Submit application form and supporting documents to the OxTREC Secretariat oxtrec@admin.ox.ac.uk
2. Application checked by OxTREC administrator
3. Receive acknowledgement by email that all required documents are received
4. Study reviewed at OxTREC meeting

5. Receive a study review by e-mail, which may ask for clarification or amendments

6. Respond by email and await further possible review - - multiple emails may be involved

 

7. Respond satisfactorily to all emails sent by OxTREC.

8. Receive an approval letter by email as a PDF attachment.

After you apply

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1. Any changes to your study post-approval must be submitted via email to the OxTREC secretariat as an amendment and copied to RGEA. 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 and copied to RGEA using:

3. Within 12 months of completion of your study, you must submit an end of study report via email to the OxTREC secretariat and copied to RGEA using:

Complaints process

In the event that a complaint is made either about research approved by this committee or about the committee itself, the complaints process will be followed:

 

In extremely rare cases OxTREC 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.