Amendments

Any changes to a project which might affect its continued ethical acceptability will invalidate the project's ethical approval. In such cases an amended protocol must be submitted to the HREC for further approval. It is a condition of approval that it is immediately reported to the HREC Secretary anything which might warrant review of ethical approval. This includes:

• proposed changes in protocol/methodology
• serious or unexpected adverse effects on participants
• unforeseen events that might affect continued ethical acceptability of the project
• discontinuation of project before completion date

Approval of amendments must be obtained prior to work commencing.