In this situation, the researcher must consider whether the proposed amendment constitutes a significant change that could have a potential impact on the welfare, dignity and rights of the participants.
A `significant change´ refers to a new research approach or method that, had it been planned at the time, would have been mentioned on the original research ethics approval application.
Examples of this include:
This list is indicative, rather than exhaustive. In such cases, or if there is any other doubt about whether a proposed change is significant, the researcher should contact the Ethics Administrator who will then provide the details to one of the ethics reviewers who originally reviewed the project (ideally the lead reviewer, where relevant). The reviewer should then consider the changes and liaise with the Ethics Administrator to advise the researcher on the appropriate course of action. This could involve re-applying for full ethics approval, if the changes are particularly significant; alternatively, the reviewer may be happy to approve the changes immediately (it is left to the discretion of academic departments to decide departmental procedure in this regard). The Ethics Administrator should keep a record of the proposed changes and the actions that were undertaken as a result.
The requirements of this section do not apply to the routine, everyday adjustments to data gathering plans and activities that researchers must often make in response to the contingencies of research. Nor does it apply to minor corrections in the written information given to participants, such as remedying spelling errors or typos. Discretion, responsibility and common sense are necessary in interpreting this section: researchers are required to reflect upon what they are doing, its relationship to their original ethics approval application, and whether any ongoing adjustments are significant, in the terms outlined above.