of the Principal Researcher following Approval
Following approval the Principal Researcher MUST:
- report any PROPOSED CHANGES in previously approved research or apply for an EXTENSION to current ethics approval to the committee through completion and submission of the 'Amendment Approval Request Form'. The changes may not be initiated without prior review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
- report promptly any ADVERSE EVENTS involving risk to participants or others to the committee in the form of a full written report that should include any amendments to the participant information sheet and study protocol. Both non-serious and serious adverse events must be reported.
- if required report PROGRESS ON AN ANNUAL BASIS (or more frequently as deemed necessary by the ethics committee) through completion and submission of the 'Continuing Review Approval Form'.