Modifying an approved project/annual, final and incident reports

Modifying an approved project

It is the responsibility of the Chief Investigator to ensure the Ethics Office is contacted immediately regarding any proposed change.

If you need to make any changes to your project after approval, you will first need to submit an Amendment Request. Amendments may include:

  1. Request to extend the approval end date. Apply at least one month prior to the anticipated completion date for an extension to ensure ongoing approval is obtained, as retrospective approval will not be granted.
  2. Changes to project personnel.
  3. Changes to project detail including, but not limited to:
    1. recruitment methods
    2. data collection
    3. participants cohorts(s) or numbers
    4. location of interviews
    5. dissemination of results

To submit a request for amendments:

  1. Download and complete the Amendment request form
  2. Make the requested amendments to all relevant documents (e.g. PLIS, questionnaires etc)
  3. Send the completed Amendment request form along with any and all amended documentation to the Ethics Office at research.ethics@federation.edu.au

Notes:

  1. Amendment requests may be submitted at any time and will be reviewed outside of the meetings schedule.
  2. All amendments MUST be approved by the relevant Committee prior to being actioned.
  3. When requesting approval for amendments, researchers should read through the original approved application to ensure that the proposed amendments will not affect responses given in the original application.
  4. If possible, the amended documentation to support your request should be submitted as a single pdf in the following order:
    1. Recruitment material
    2. Plain Language Information Statement
    3. Consent form
    4. Data collection tools
    5. Other supporting documentation
  5. Changes to research personnel may require updates to recruitment or other participant materials to reflect changes in the research team.
  6. Documents which remain unchanged by the Amendment Request do not need to be resubmitted.

Annual, final and incident reports

Annual and final reports

It is a condication of approval that annual progress reports are submitted annually on the anniversary of the approval date. It is the responsibility of researchers to take note of the report dates on the approval notification, and submit as due. Failure to submit reports is a breach of compliance and project approval, which may result in ethics approval lapsing.

Amendment requestes will not be considered if annual reporting requirements are not met.

A final report must be submitted within one month of completion of the project. If the project does not proceed or is discontinued, for any reason, please advise the Committee by completing the final report form.

  1. Download and complete the Annual/Final Project Report Form (docx. 137kb)
  2. Send completed report to research.ethics@federation.edu.au

Notes:

  1. The HREC may conduct random audits and /or require additional reports concerning the research project as part of the requirements for monitoring, as set out in the National Statement on Ethical Conduct in Human Research.

Incident and adverse events

It is the responsibility of the Chief Investigator to ensure the Ethics Office is contacted immediately regarding any incident, serious or unexpected adverse event. This may include adverse effects of the research on participants or problems relating to the conduct of the project.  Failure to do so may result in discontinuation of approval and/or disciplinary action.

  1. Download and complete the Incident Report Form (docx 103kb)
  2. Send the completed report to research.ethics@federation.edu.au

Notes:

  1. You may be required to submit an amendment request alongside or shortly after your incident report.
  2. In most cases, recruitment and data collection should be paused while an incident report is under review.
  3. If you have any queries about whether or not you are required to submit and incident report, please contact the Ethics Team to discuss at research.ethics@federation.edu.au