OxTREC Application Process
This page tells you how to apply to the Oxford Tropical Research Ethics Committee (OxTREC) for ethical review.
When writing your application, assume that you are the expert in your topic area and explain your project methods clearly and simply. This includes giving a clear idea of potential ethical issues and how you propose to address them. Remember that the ethics committee partially relies on your expertise as a researcher in your field, in order to be clear about the ethics of a project.
- Criteria for submission to OxTREC
- Do I need formal ethical consent?
- How to apply for minimal risk (expedited) review
- Minimal risk application process and timeframe
- How to apply for full committee review
- Full committee application process and timeframe
- Post-approval processes
- If approval is not given
Criteria for submission to OxTREC
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 (Type 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 NRES committee which has been registered with the Office for Human Research Protections (OHRP), even if performed within the EU
Do I need formal ethical consent?
A waiver of ethical approval will be considered for:
- Most research on educational methods
- Research on publically available anonymised data or samples
- Audits or service reviews (Definition of these terms (175kb); also see 'audit' in the Glossary)
- Laboratory services which are 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
How to apply for minimal risk (expedited) review
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 (90kb), together with the following supporting documents:
- Protocol (23kb)
- Participant information sheet (21kb) (if appropriate)
- Consent form (44kb) (if appropriate)
- Form for NIH funded studies (53kb) (only applicable if your study is funded by the US National Institutes of Health (NIH) or another US federal funding agency)
- Any other documents relevant to the study
N.B. 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.
Minimal risk application process and timeframe
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. Here is what the process looks like:
How to apply for full committee review
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, 10 February 2017||
Thursday 30 March 2017
|Friday, 7 April 2017||Thursday 18 May 2017|
|Friday, 2 June 2017||Thursday 13 July 2017|
|Friday, 18 August 2017||Thursday 28 September 2017|
|Friday, 13 October 2017||Thursday 23 November 2017|
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:
- Protocol (50kb)
- 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 (21kb) (PIS), if relevant
- Consent form (44kb) , 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.
Full committee application process and timeframe
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. Here is what the process looks like:
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 OxTREC Annual Review Form (42kb). 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.
If approval is not given
In extremely rare cases CUREC may not be able to provide ethical approval. An Appeal procedure (250kb) is available for appealing a decision to withhold, suspend or withdraw approval of research.