MS IDREC application process


The Ethics Team Offices will be closed from 21 December 2019 to 1 January 2020, inclusive.
Any ethics applications requiring approval to commence research before 6 January 2020, should be submitted to the relevant IDREC/OXTREC team before 1 December 2019.

 

Before you start

In general, the MS IDREC reviews ethics applications for research involving human participants 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)).

However, the route you will need to follow in order to obtain ethical 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 ethical approval from an NHS research ethics committee.
  2. If you do not need to apply for NHS ethics approval, please work through our application decision tool to determine how to apply for ethical review and approval of your research.

Some departments require ethics applications to be reviewed internally prior to 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 Current Stimulation (TCS), or if you are from the Department of Women's & Reproductive Health.

If you have not previously undertaken ethics-related training, we recommend taking either our online research integrity course or one of the face-to-face ethics courses before you start your research.

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***All CUREC documents are subject to ongoing review. Please always refer to this page (rather than locally stored versions) for the current versions of application forms.***

Handwritten forms will not be accepted. 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.

Please follow the instructions in Before you start above to determine which form to complete. A CUREC 1 form is used for lower-risk research.

A CUREC 2 form is usually required where:

  • you know your project has complex or higher risk ethical issues or cites more than one approved procedure (and those procedures do not state they can be used together)
  • completion of the MS IDREC online application decision tool directs you to complete a full CUREC 2 application

The CUREC 3 ethical review process should be followed where any licensed drug or other (non-drug) substance is to be administered to healthy volunteers for the purposes of research. This may include food supplements or herbal remedies. It may also be required for research involving certain medical devices.

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

Documents for external use include:

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

Please see our page on informed consent for more details and templates. If you 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 CUREC 3 applications, you should use the template information sheet and consent form specifically for these higher risk studies.

 

Documents for internal use include sample research instruments (researcher-completion surveys or questionnaires, semi-structured interview guides) detailed study procedures (such as a protocol) and risk-assessments.

All CUREC 1 and 2 applications that require University sponsorship via CTRG must be accompanied by a detailed study protocol – please use this template:

Your full application (including all supporting documents) should be sent by email to the MS IDREC Secretariat (ethics@medsci.ox.ac.uk).

Applications are not valid until all signatures 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.
 

The MS IDREC Secretariat will acknowledge receipt of your application (please allow five working days for this) and initiate the review process. Once reviewed, you will receive feedback via email, which may request changes or further information. Once all documents have been updated and questions answered to the satisfaction of the MS IDREC, you will receive an approval letter. You may not start your study until you receive this letter.

The timeframe for review depends upon the study risk and quality of the application/supporting documents. Note that the review clock starts when your valid application is acknowledged. It stops while we are waiting for revisions from you.

CUREC 1 Up to 30 days
CUREC 2 Up to 60 days*
CUREC 3 Usually within 60 days*

* CUREC 2 and CUREC 3 applications are considered by the full committee via correspondence. Should there be any ethical concerns raised, it may be necessary to refer CUREC 3 applications for review at the next MS IDREC termly meeting.

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:

 

Some departments have internal processes whereby all study 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 Current Stimulation (TCS), ,or if you are from the Department of Women's & Reproductive Health, your application must be reviewed as follows:

Procedure Contact Additional information
MRI Nancy Rawlings FMRIB/OHBA MRI ethics procedure
MRI with TCS or TMS Nancy Rawlings  
TCS or TMS only Nancy Rawlings

Reviews will be conducted by Charlotte Stagg, but should be submitted to Nancy

MEG  Sven Braeutigam   
Women's & Reproductive Health Fiona Goddard
Lydia Brook
Applications for OxTREC ethics approval must also be reviewed by Fiona before submission

 

As your project progresses, there may be reasons to make changes (eg to principal investigator (PI), duration, or procedures), known as amendments. These must be notified to the MS IDREC for consideration and approval. Please complete the amendment form and email it to the ethics@medsci.ox.ac.uk.

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 either departmental or CTRG review, revised documentation must first be sent to the department and/or CTRG for continued approval.

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 CUREC application. See section E on our FAQs page for further details and guidelines on amendment classification.

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 CUREC 2 and CUREC 3 studies that have a duration of more than one year, are required to submit annual progress reports.

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