What does ethics approval mean?

  • The ethics clerance you are given is valid for one year. This approval relates to the ethical content of the study only, and you are responsible to obtain any other relevant approval.
  • If your study is a clinical trial, it should be registered with the clinical trial registy prior to starting the study.

 Progress reports/ Final report

  • If the study is continued for a period beyond one year, you are required to furnish an annual progress report for the year and an application for the extension of approval by a further year.  The ERC will issue such extension after consideration of the progress report and any other information it may require from you for this purpose.
  • Progress reports and final reports should be submitted in the recommended template, which can be downloaded from the ERC web page of the Faculty of Medicine, University of Colombo website.
  • In similar manner, you are required to furnish a progress report and an application for the extension of approval for each subsequent year as long as the study is continued.  If no such application is made or extension of approval given, the ethics clearance lapses automatically once the current year of approval is finished.
  • If the progress report and/or the final report is/are delayed more than one month beyond the due date (which is the final date of ethics approval in force), approval for the study will lapse and you will be required to furnish a new application should you wish to resume or continue the study.
  • If a PI has three or more research proposals in which the progress reports and/or final reports have lapsed in this manner, no further applications for ethics review shall be entertained from such PI.

 Documents required at submission

       Amendments

  1. Cover letter with Justification and relevant page numbers
  2. Relevant documents with the amendments highlighted

       Extensions

  1. Cover letter with Justification and relevant page numbers
  2. Progress report - Annual/Final Report-Template or Clinical Trials-Annual/Final Report - Template