As your project progresses, there may be reasons to make changes (for example to principal investigator (PI), participant information, or procedures), known as amendments. These must be notified to the relevant IDREC or OxTREC for consideration and approval.
For amendments to projects previously reviewed by the SSH IDREC, please fill out an amendment form and submit this, the revised application form and any revised supporting document to email@example.com.
For amendment requests to OxTREC, please send an email to firstname.lastname@example.org giving the reasons for the proposed modifications and attaching all modified documents with changes tracked.
For amendment requests to the MS IDREC, please complete the amendment form below. 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 departmental review, revised documentation must first be sent to the department for continued approval. Approval of continued University sponsorship (where sought as part of the original application) will also be required before MS IDREC review.
You must not carry out your study with the changes applied until you receive confirmation from the relevant IDREC or OxTREC Secretariat. If the changes are significant and the project substantively altered, you may need to complete a new application.
The committee response will be:
- either an email confirming your amendment has been noted and filed
- or a formal letter of confirmation of the change and approval thereof
- or a notification that the amendment alters previous ethical consideration of your project requiring submission of a new application.
The IDREC/OxTREC use the following guidelines for classification of amendments:
(requiring, as a minimum, review by IDREC/OxTREC secretariat – note that some amendments are referred to committee for review)
- 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, or other requirements expected of, 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
(requiring check by IDREC/OxTREC secretariat and approval)
- 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