During your research

Throughout your research, if you wish to make any changes you must submit an amendment request to the FMHS FREC.  You must also report any issues that have (or may have) an impact on the FMHS FREC's Favourable Ethical Opinion (FEO).

After a favourable ethical opinion has been given, any changes require submission of an amendment request before the change can be implemented. The request to amend the study must be given a favourable ethical opinion by the FMHS FREC prior to its implementation.

The types of changes that require further ethical review include (but are not limited to) anything that alters the:

  • Design of the study
  • Details in the original FMHS FREC application form
  • Protocol or other supporting documentation
  • Participant information leaflets or consent forms
  • Recruitment materials  

If you are unsure whether a change you propose to make to your research project requires ethical review, contact the FMHS FREC Administrator on health.ethics@keele.ac.uk.

If you wish to amend a Programme of Work, there are different documents to complete; follow the process outlined on the Programme of Work page and return here to submit your amendment. For all other amendment applications, to make an amendment:

  1. Amend the affected documents (using tracked changes or otherwise clearly identifying all changes)
  2. Complete the ‌FMHS FREC Amendment Request Form

Once the changes to affected documents are complete:

  1. Complete this FMHS FREC Google Submission Form.   Under “What type of submission is this?” select “Amendment.” (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).
  2. Upload all affected documents as directed by the Google Submission Form
  3. Submit the application.

Within 4 working days, the FMHS FREC Administrator will review your application to ensure that it has been submitted correctly. Any queries will usually be sent to you by email.

Decisions on amendments (see Outcome of REC Review) will usually be given within 14 working days of submission.

If the FMHS FREC requests further information, you should respond in the same way as for initial applications.

If you become aware of any issue that may have an impact on the ethical opinion of your research project (for example a participant’s safety / welfare has been put at risk), this must be reported to the FMHS FREC via email to health.ethics@keele.ac.uk along with supporting documents and evidence as applicable.

The FMHS FREC Administrator will acknowledge receipt of this information via return email and it will be provided to the Committee Chair (or a delegated member of the Committee) who will liaise with you as required.

If you are required to submit a periodic Progress Report, this will be detailed in your favourable ethical opinion letter.  If this is applicable, you will need to submit the report within 30 days of reaching the reporting date (e.g. for annual reporting, you will need to submit this within 30 days of the anniversary of the original favourable ethical opinion).

To complete a Progress Report:

  1. Download and complete the FMHS FREC Annual Progress Report Form
  2. Email the report to health.ethics@keele.ac.uk

The FMHS FREC Administrator will acknowledge receipt of the Report via return email.

The Progress Report will be reviewed by the Chair (or their delegate) and where necessary, they may provide you with feedback or request further information if required.

The FMHS FREC may request a progress report or more regular / additional progress reports  at any time, for example, as a result of a previous report or submission of an amendment request.