Monitoring

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.