MS IDREC application process

Before you start

The Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) accepts applications for ethical review of studies:

  • where the research does not require ethical review by OxTREC or the NHS.
  • from researchers within the Medical Sciences Division
  • from other departments where a medical intervention is included

 

Before completing an application form, researchers will need to determine whether a CUREC approved procedure can be applied to the research.

Applications involving NHS staff, facilities, premises or data, and all CUREC 3 applications must be first sent to the Clinical Trials and Research Governance (CTRG) team for research sponsorship. This is to enable CTRG to ascertain that appropriate insurance cover can be provided for the study.

Note that some departments require your application to be reviewed internally (see below) prior to submission to the MS IDREC Secretariat – check with your departmental administrator. 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 received any ethics-related training before, we recommend taking either our online research integrity course or one of the face-to-face ethics courses before you start your research.

Expand All

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.

Always start by completion of sections A-E of the CUREC 1 checklist form. Once these sections are completed, instructions on the form will direct you to complete the rest of the CUREC 1 form, or else switch to a full CUREC 2 or CUREC 3 application. You do not need to complete sections F onwards of CUREC 1 if directed to complete another form, but you must send the checklist (sections A-E) from CUREC 1 with your CUREC 2 or CUREC 3 application.

A CUREC 2 form is only to be completed:

  • if you know your project has complex or higher risk ethical issues or cites more than one approved procedure
  • if you complete Sections D and E of the CUREC 1 checklist and it directs you to complete a full CUREC 2 application

A CUREC 3 combined protocol/application form is required where any licensed drug or other (non-drug) substance, eg a food supplement, is to be administered to healthy volunteers for the purposes of research. 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) and detailed study procedures (such as a protocol).

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, duration, or procedures). Please complete the amendment form and email it to the MS IDREC Secretariat.

You will also need to send any new or revised documentation, which must have changes highlighted, preferably using MS Office Word tracking. 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 from the MS IDREC. 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.

The MS IDREC uses the following guidelines for classification of amendments:

Major amendments (requiring, as a minimum, review by IDREC Secretariat and issue of a formal approval letter)
  • changes to the design or methodology of the study, or to background information affecting its academic value (including addition of participants)
  • changes to the procedures undertaken by participants (including any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study)
  • significant changes to study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers
  • appointment of a new chief/principal investigator
  • change of territory for international studies
  • a change to the insurance or indemnity arrangements for the study
  • temporary halt of a study to protect participants from harm (or resulting from a concern or complaint made), and the planned restart of a study following a temporary halt
  • any other significant change to the terms of the REC application
Minor amendments (requiring check by IDREC Secretariat and acknowledgement via email)
  • minor changes to the application form or other study documentation, eg correcting errors, updating contact points, minor clarifications
  • changes to the research team, subject to confirmation of additional researchers having undertaken appropriate training in research ethics (OxTREC only)
  • changes in funding arrangements
  • changes in the logistical arrangements for storing or transporting samples
  • inclusion of new sites or locations for the research (but note the need for a major amendment (above) in the case of a change of territory for international studies)
  • extension of the study beyond the period specified in the application form
  • changes to contact details for the chief/principal investigator or other study staff

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.

List of site pages