For ABMDR approved research projects, a progress / completion report must be submitted by the Chief Investigator in the following situations:
- Annual Reporting: Every year on the date of approval of the research proposal
- Project Closing: At completion of the research project
- Project Amendments: any modification is made to an approved research project including:
- extensions of ethics approval
- addition/ removal of investigators or other personnel
- new funding arrangements
- and changes to recruitment procedures, methodology, or documents (e.g. Participant Information and Consent Forms, and any other recruitment materials).
A letter explaining the changes and reasons for the project amendment including any ethical implications must be submitted with the progress/ completion report, before the amendments are implemented:
Withdrawal of Approval
The ABMDR can withdraw approval of the research proposal in the following cases:
- Not receiving progress reports in the anniversary of the approval or before the end of the approval period
- The reporting of any conduct or event that affect continued ethical acceptability of the research proposal
If these reporting requirements are not met, approval for the project will lapse and a new application will be required.