Applying to FMHS FREC

Only applications from the Faculty of Medicine and Health Sciences (that DO NOT meet the  Central REC Review Criteria (PDF, 452kb)) will be accepted by the FMHS FREC. If you apply to the FMHS FREC incorrectly, your application will usually be rejected and you will be redirected to re-apply to the correct REC.

Applications may be referred to the FMHS FREC by another University Research Ethics Committee.  Depending on the reason for this, your application may be re-directed by the FMHS FREC, or you may be asked to withdraw your application and re-apply to a different REC.

If you are preparing an amendment to an application that already has ethical approval, go to Making a change to your research (amendments).

If you are preparing an application for a Programme of work you should follow the process outlined on the Programmes of Work page before progressing your application further.  You will need to follow the processes outlined on that page and return here to submit your application to the FMHS FREC.

For an initial application to the FMHS FREC, you should prepare the following mandatory document(available):

  1. (U‌sually) FMHS FREC Application Form. If your research involves NHS staff and you are also applying through for HRA approval, the FMHS FREC will accept the completed (and authorised) IRAS form instead of the usual FMHS FREC Application form.
  2. The following (suggested templates are provided where available), as applicable to your research project:
  • A protocol or proposal of activity
  • Written information to be provided to participants / subjects (e.g. Participant Information Leaflet Template)
  • Consent Form (e.g. Consent Form Template)
  • Information on any substances to be administered
  • Available safety information
  • All other documents which are required to enable the REC to fulfil its responsibilities; including but not limited to example website text, questionnaires, interview schedules, guidance documents for participants

All finalised documents must be clearly identifiable by their filename and must be fully version controlled (including version number and date).

All final versions of documents must be converted to PDF format for submission.

Once you have finalised the documents you need for your project, you should:

  1. Where applicable, ensure that you have discussed the Application with your supervisor (you will be asked to confirm this at the time of submission)
  2. Complete the FMHS FREC Google Submission Form ‌(a copy of the questions to be answered on the FMHS FREC Google Submission Form are available for reference purposes under FMHS FREC Templates and Guidance; note that applications will ONLY be accepted through completion of the online Google Form accessed through the link to the Google Form itself above).
  3. Upload the finalised versions of your applicable documents as indicated by the Google Submission Form
  4. Submit the application

Submission of the application will start the review clock. If, following submission of the application you wish to withdraw or change it, please contact the FMHS FREC Administrator at health.ethics@keele.ac.uk.

The FMHS FREC Administrator will confirm receipt of the application within 4 working days of submission.  They will check that the application has been sent to the correct committee and that all required documents have been included; such applications will be deemed as "valid" and will progress to review.  If the application is incorrect or incomplete, you may be asked to provide further information or resubmit it.

If your application is identified (via the submission system) as meeting the criteria set out in the FMHS FREC Light Touch Review Checklist (PDF, 291kb), review will usually be conducted by 2 FMHS FREC Committee members.  Applications not meeting this criteria will usually be reviewed by 4 Committee members (a "full" committee). Each review will have a Lead Reviewer, responsible for leading the review and summarising feedback.  Applications may be escalated from light touch review to full review if the reviewers deem this necessary.

In all cases, initial decisions on valid applications will usually be given within 26 working days of submission. See Outcome of REC Review for information on the decisions that a REC can make.

Where applicable, correspondence from the REC will be copied to your supervisor(s) via the contact details that you provide on the Google Submission Form.

If the outcome of your review is a Further Information request, this means that the FMHS FREC either need further information to make their decision OR require you to make changes to your documents which they need to review before issuing their final decision. The FMHS FREC will usually specify a timeframe within which they expect a response to the further information request; if the outlined timeframe is not met, the FMHS FREC reserve the right to reject your application.

If you are asked for further information by the FMHS FREC, it is important that you address all points as comprehensively as possible.

To respond to a request for further information: 

  1. Amend any documents affected
  2. Address any comments that require a response
  3. Email your response with the subject <<[REC Reference]; Response to Further Information Request>>, including any amended and / or supporting documents to the HumSS FREC Administrator at health.ethics@keele.ac.uk

You will usually receive the outcome of the review of any further information from the FMHS FREC within 9 working days.

A maximum of 2 further information requests will be made by the FMHS FREC.  If following this, the information provided is still unsatisfactory, you will be required to make a full new application.

Where the FREC Favourable Ethical Opinion (FEO) includes conditions, this opinion only remains valid if you comply with these conditions.  Where you are not able to do this, you must contact the FMHS FREC Administrator at the earliest opportunity.

If you have received an Unfavourable Ethical Opinion (UFEO) from the FMHS FREC and you wish to appeal, follow the process outlined on the Appealing a REC Decision page.

You may begin your research once the FMHS FREC has confirmed that it is is satisfied with any further information you have provided (if applicable) and have issued you with a Favourable Ethical Opinion (FEO).