OxTREC application process

Requirements for ethics review

Ethics 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:
  
  • Definition of terms
  • See also 'audit' in the glossary
• 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 ethics 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 ethics 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 ethics review and approval in the usual way. 

Please note that where it is planned to import the samples into England, it is the responsibility of the PI to make arrangements to store them under the governance of a Human Tissue Authority (HTA) licence before the samples are transferred. 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.

All applicants should now be using the online ethics application system (Worktribe Ethics) using their University Single Sign-on (SSO). The Microsoft Word application forms have been replaced by one online form. The form is dynamic, so the questions applicants are asked to answer will depend on answers to questions in the initial scope tab.

Please refer to the guidance within the Worktribe ethics applicant user guide.

Within the scope questions, you will be asked whether you believe your application presents minimal risk.  If you respond 'yes', your application will be categorised in the system as medium risk:

• Medium risk applications (the equivalent of the previous minimal risk process) are reviewed on behalf of the committee by the OxTREC Secretariat. Applicants should allow 30 working days for review from the time when a complete application (including all required supporting documents) has been received through Worktribe.

1. Whether a study qualifies as medium risk 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 answer ‘yes’ to the Worktribe scope question ‘Do you believe your research to present minimal risk?’

Please also submit the following supporting documents:

All study documentation should have a version number and date on each page of the document (header or footer).
 

4. The application and supporting documentation should be submitted through the online ethics application system (Worktribe Ethics)

5. Medium risk applications are reviewed on a rolling basis.

A full application is required for all other studies, and will be reviewed by committee.

All applicants should now be using the online ethics application system (Worktribe Ethics) using their University Single Sign-on (SSO). The Microsoft Word application forms have been replaced by one online form. The form is dynamic, so the questions applicants are asked to answer will depend on answers to questions in the initial scope tab.

Please refer to the guidance within the Worktribe ethics applicant user guide.

Within the scope questions, you will be asked whether you believe your application presents minimal risk.  If you respond 'no' (which is correct for full commitee review), your application will be categorised in the system as high risk:

• High risk applications (the equivalent of the previous full application process) are reviewed by committee at their next meeting (see meeting deadlines below).

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 that require University of Oxford Sponsorship should first be submitted to the RGEA sponsorship team (rgea.overseas@admin.ox.ac.uk) at least 3 weeks before the deadline above. The Sponsorship approval letter must be uploaded to the documents tab in the online ethics application system (Worktribe Ethics) prior to submission for ethics review.

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

4. All study documentation should have a version number and date on each page of the document (header or footer). 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. Provision of this information is mandatory and trials cannot be granted ethics approval by OxTREC in the absence of a clinical trial registration number.