MS IDREC application process

Before you start

** ADVANCE NOTICE: The MS IDREC office will be closed for the Christmas / New Year break from Friday 20th December 2024 to Friday 3rd January 2025 (inclusive).  Service will resume Monday 6th January 2025.**

 

The University requires the ethics review of research involving human participants, human tissue and/or personal data, as set out in its Research Ethics Policy.

In general, the MS IDREC reviews ethics applications for research involving human participants, human tissue (where the tissue is not relevant material under the Human Tissue Act) and/or personal data, from researchers based in (or linked to) a department in the Medical Sciences Division or Mathematical, Physical and Life Science Division. The exception to this is the department of Computer Science, which has its own Departmental Research Ethics Committee (DREC)).

The route you will need to follow in order to obtain ethics review and approval for your research will depend on a number of factors.

  1. Check the Where and how to apply flowchart to determine whether you will need to apply for ethics approval from an NHS research ethics committee instead of from the MS IDREC.
  2. If your application is eligible for review by the MS IDREC, apply through the online ethics application system  (Worktribe Ethics).  A custom form will be generated based on initial scope questions.

You may find it helpful to refer to our frequently asked questions, which cover topics such as:

  • Do I need ethics approval? 
  • Completing the application
  • Data management

If you have not received any ethics-related training before, you should complete our online research integrity course before you start completing your ethics application. The core module of the University’s research ethics and integrity training is compulsory for all new researchers and students, before commencing any research. Experienced researchers who have not completed any formal training in the past 3 years should complete our online refresher training module on research integrity.

Some departments require ethics applications to be reviewed internally before submission to the MS IDREC – check with your departmental administrator and see below. This is definitely the case if your study involves Magnetoencephalographic (MEG) recordings, Magnetic Resonance Imaging (MRI), Transcranial Magnetic Stimulation (TMS) or Transcranial Electrical Stimulation (TES or TCS), or if you are from the Department of Engineering or the Department of Women's & Reproductive Health.

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When writing the application, use language accessible to a non-expert audience, explaining your project methods clearly and simply. Include a clear description 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.

All departments should now be using the online ethics application system (Worktribe Ethics).  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.

Applications submitted to the MS IDREC will be categorised in the system as medium or high risk:

  • Medium risk applications (the equivalent of the previous CUREC 1 process) are reviewed on behalf of the committee by the MS IDREC 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.
  • High risk applications (the equivalent of the previous CUREC 2 or 3 process) are reviewed by the MS IDREC. Applicants should allow 60 working days for the review.

Contact worktribe-ethics@it.ox.ac.uk with any questions about the new system.
 

 

 

 

It is likely your application will need supporting documents, either for external (participant) or internal (researcher) use.

Documents for external use may include (but are not limited to):

  • recruitment adverts/invitation letters/emails
  • information sheet(s)
  • written consent and/or assent forms
  • surveys or questionnaires (paper or online)
  • debrief information

Please see our page on informed consent for more details and templates. If you intend to follow a CUREC approved procedure, please use the procedure-specific participant information sheets and consent forms as well as any other supporting documents associated with that procedure.

For studies involving administration of a drug licensed in the UK, you should use the template information sheet and consent form specifically for these higher risk studies.

Documents for internal use include researcher-completion surveys or questionnaires, semi-structured interview guides, detailed study procedures and risk-assessments.

Please note that submission of a protocol is not a requirement for research reviewed by the MS IDREC unless your study requires University Sponsorship and Health Research Authority (HRA) review in addition to our ethics approval.  All information should instead be on the application. If you do need a protocol, please use this template:

 

Applications are reviewed on a continuous basis, in the order of receipt of a valid (complete) application.  There are no deadlines for submission.

Please use the online ethics application system (Worktribe Ethics) to submit the application and upload all supporting documents to the 'documents' tab within the application.

Before an application can be reviewed, endorsement is needed from the PI, the student (if student research) and the head of department or delegated nominee. Applications will be routed to the supervisor if a student application.  Head of department or nominee endorsement will be requested by the committee on receipt of the application.

Applications are not valid until all endorsements and supporting documents have been provided to the MS IDREC.

The IDREC want to see final versions of all research documents in order to check compliance with the relevant University policy.
 

 

If the reviewer / ethics committee asks questions or for changes to be made, you will receive a notification by email that the application has been returned to you. Please wait to receive this email before you try to address comments. It is possible that multiple people may look at your application at different times and make comments, so waiting for the email ensures that review is complete.

Comments made on the application can be seen next to questions on each individual tab. You should respond to each point by making changes on the application itself. Do not delete or resolve the comments - leave them visible and open for the reviewers to refer to when the application is resubmitted

Once all documents have been updated and questions answered to the satisfaction of the MS IDREC, you will receive a decision letter. You may not start your study until you receive this letter.

The timeframe for review depends on the study risk, quality of the application and supporting documents, and committee workload. Note that the review clock starts when we have received all required documents for review. It stops while we are waiting for revisions from you.

  • Medium risk - Up to 30 working days
  • High risk - Usually within 60 days*

* High risk applications are considered by the full committee via correspondence. Should there be any ethical concerns raised, it may be necessary to refer such applications for review at the next MS IDREC termly meeting (held in January, May and October).

 

 

In extremely rare cases we may not be able to provide ethics approval. An appeals procedure is available for appealing a decision to withhold, suspend or withdraw approval of research:

Some departments have internal processes whereby all ethics applications must be reviewed within the department prior to submission to the MS IDREC. Please check with your departmental administrator for further details. If your application cites the CUREC approved procedures for Magnetoencephalographic (MEG) recordings, Magnetic Resonance Imaging (MRI), Transcranial Magnetic Stimulation (TMS) or Transcranial Electrical Stimulation (TES or TCS), or if you are from the departments of Engineering Science or Women's & Reproductive Health, your application must be reviewed internally.

Where your department/project requires an internal review/check prior to submission to the ethics committee, then you should do the following BEFORE submitting the application:
Enter the name of the person(s) who should review/check the study into the ‘other editors’ field on the 'details' tab within the ethics application (if you did not already do this when creating the application).
Go to the comments tab and tag that person (using @) in a comment, requesting their review.  They will then receive an email notification informing them.  The reviewer should tag you in another comment when the review is complete so that you receive email notification to address anything raised through internal review.  This will also indicate to the ethics committee that internal review was conducted.
 

Procedures requiring departmental review:
Procedure Contact Additional information
MRI Nancy Rawlings FMRIB/OHBA MRI ethics procedure
MRI with TCS or TMS Nancy Rawlings Reviews will be conducted by both Nancy and one of Charlotte Stagg, Jacinta O'Shea and Melanie Fleming, but should be submitted to Nancy.
TCS or TMS only Nancy Rawlings Reviews will be conducted by Charlotte Stagg, Jacinta O'Shea or Melanie Fleming, but should be submitted to Nancy.
MEG  Sven Braeutigam   
Engineering Science Tamara Lawson The applications will be checked in the first instance by the Research Office
Women's & Reproductive Health

Sharon Westcar

Lucy Kingham

 

 

 

As your project progresses, there may be reasons to make changes (for example to principal investigator (PI), participant-facing documents, or procedures), known as amendments. These must be notified to the MS IDREC for consideration and approval.  Amendments are to be submitted using the same system as the original ethics application; i.e., if the original ethics application was made using a Microsoft Word application form, the amendment needs to be submitted using the MS IDREC amendment form below.  Please complete the amendment form and email it to ethics@medsci.ox.ac.uk.  If the original application was submitted through Worktribe, the amendment will also need to be submitted through Worktribe.

You will also need to send any new or revised documentation, which must have changes highlighted, preferably using MS Office Word tracking so that deleted and revised text can both be seen. If your original application required departmental review, revised documentation must first be sent to the department for continued approval. Approval of continued University sponsorship, where sought as part of the original application, will also be required before MS IDREC review.

You must not carry out your study with the changes applied until you receive confirmation of continued ethics approval from the MS IDREC Secretariat. If the changes are significant and the project substantively altered, you may need to complete a new application form. See section E on our FAQs page for further details.

See the 'After approval' section of our FAQs for details.

 

 

The committee may ask to review your project, or for you to complete an annual progress report as part of routine monitoring exercises. Please always make sure you have the most up to date study procedures, supporting information and approval letters to hand, for ease of review.

Please note that researchers conducting studies designated as high risk (previously CUREC 2 or CUREC 3) that have a duration of more than one year, are required to submit annual progress reports.

 

In the event that a complaint is made about research approved by this research ethics committee, it should be referred to RGEA.complaints@admin.ox.ac.uk 

Where it becomes apparent that there has been a serious breach of the terms of the ethical approval, this will be communicated to the research ethics committee.

Any complaints about the committee itself should be made to CUREC: curec@admin.ox.ac.uk

If you have any questions about the application process or about addressing the ethical issues in your research contact us at ethics@medsci.ox.ac.uk