OxTREC application process

Please note that the OxTREC office will be closed from 4pm on Thursday 15th December 2022 to 9am on Tuesday 3rd January 2023.  Due to current workloads, any applications submitted after 30th November 2022 may not get reviewed until the New Year.

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).

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 by OxTREC, 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. This will enable the Insurance Team to determine whether insurance cover can be arranged and, if so, any potential cost. A letter confirming sponsorship will then be issued at a later stage, as part of the ethics approval process.

 

 

How to apply

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Waiver of ethical review

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:
  • 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 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.

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.

 

 

In general, research that involves only previously collected, 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, 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.  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.

    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 9 December 2022 Thursday 26 January 2023
    Friday 10 February 2023 Thursday 23 March 2023
    Wednesday 14 April 2023 Thursday 25 May 2023
    Friday 16 June 2023 Thursday 27 July 2023
    Friday 11 August 2023 Thursday 21 September 2023
    Friday 13 October 2023 Thursday 23 November 2023

     

    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:

    Supporting documents
    Document Template

    Protocol

     

    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), and this 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.

     

    Application timeframe

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    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.

    1. Validation stage
      Submit minimal risk form and supporting documents by email
      Application checked by OxTREC administrator
      Receive acknowledgement by email that your application is valid
      The review process can start – this is not approval of your study
    2. Review stage
      OxTREC secretariat will lead on reviewing your study
      Receive a study review by email, which may ask for clarification or amendments
      Respond by email and await further possible review – multiple emails may be involved
    3. Approval stage
      Respond satisfactorily to all emails sent by OxTREC
      Receive an approval letter by email as a PDF attachment
      Start your study

     

    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. Validation stage
      Submit application form and supporting documents on the OXTREAD submission system
      Application checked by OxTREC administrator
      Receive acknowledgement by email that your application is valid – this is not approval of your study 
      Your study is ready to be reviewed at the next OxTREC meeting
    2. Review stage
      Study reviewed at OxTREC meeting
      Receive a study review by email, which may ask for clarification or amendments
      Respond by email and await further possible review – multiple emails may be involved
    3. Approval stage
      Respond satisfactorily to all emails sent by OxTREC
      Receive an approval letter by email as a PDF attachment
      Start your study

    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. 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:

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

    4. Any serious adverse events that are judged related to the study intervention should be copied via email to OxTREC within seven working days.

    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 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.