Study Amendments
Study amendments are changes made to a project after a favourable ethics opinion has been given. Amendments should be submitted if significant changes are made to the design or implementation of the project, but which are in line with and do not significantly deviate from the original favourable ethics opinion and are not expected to affect the risks of the project – please refer to the examples below. Study amendments must be detailed on the UREC notification of study amendment form with supporting documents appended. Once completed, the amendment form and all supporting documents must be submitted as one PDF document using the UREC Research Ethics and Governance Decision Tool. Any changes which are not in line with or significantly deviate from the original favourable ethics opinion or affect the risks of the project require a new ethics application - please refer to the examples below.
Please note:
Phased applications are different to amendments in that phased applications separate out different components of a single project, and seek separate ethical review for these sequentially. This is perhaps when the results of one stage will determine the design of a later one, or where methods of data collection will vary very substantially across different parts of the study. For each phase of the project, a new ethics application is required.
Any proposed changes should not be initiated without first having received a favourable ethics opinion by UREC. The only exception would be if urgent changes are necessary to address immediate hazards to investigators and/or participants; UREC must always be notified at the earliest possible opportunity in these instances.
Examples of changes that would constitute amendments would include:
- changes to the design, methodology or procedures undertaken by participants - but which are not expected to affect the level of risk
- changes to the number of participants or means by which they are to be recruited
- an extension to more or different groups of participants, but where the level of vulnerability does not change, for example not-vulnerable to not-vulnerable, or vulnerable for reason A to vulnerable for reason A
- inclusion of a new research location, which is not expected to affect the level of risk
- significant changes to study documentation, such as participant information sheets or consent forms
- appointment of a new principal investigator or student supervisor
- an extension to the end date or renewal of the original favourable ethics opinion
- changes in the arrangements for storing human tissue
- asking for additional data from existing participants
Changes that are too major to constitute amendments would include:
- a major redesign of the project and particularly the intended methods of data collection
- changes that amount to essentially a different project to that originally given a favourable ethics opinion
- changes that are likely to have an effect on the level of physical or mental risk on the participants and/or researcher(s), for example more stress, exertion, provision of different substances, different doses, a potentially more risky research location, etcetera
- an extension to more or different groups of participants, but where the level of vulnerability does change, for example not-vulnerable to vulnerable, or vulnerable for reason A to vulnerable for reason B
- a change to the indemnity/liability arrangements for the project
- a significant change to the terms of the UREC favourable ethics opinion
In these instances, a new ethics application would be required.
Changes that are too minor to constitute amendments would include:
- minor changes to the study documentation, for example correcting errors, updating contact points, minor clarifications
- changes to the investigators other than the PI or student supervisor
- changes in funding arrangements
- changes in the documentation used by the research team for recording study data
In these instances no additional ethical review is necessary and the project can continue uninterrupted.