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.