When you receive human research ethics approval, it is on the basis of the research proposal described and documented in your application documents.
If you want to change your approved project in any way, you will need to seek approval by submitting a ‘request for amendment’.
Amendment of an existing project
When do you need to seek approval to amend your approved project?
During the course of conducting an approved research project, it is not uncommon for changes to be requested regarding research team composition, recruitment of participants, research methodology, data collection and processing, or a number of other aspects of the approved project.
Although the following list is not exhaustive, it provides key examples of project changes that cannot be implemented until they are approved by the HREO:
- Aims and objectives.
- Methodology and procedures.
- The type, range, and volume of data being collected.
- To data management arrangements.
- Changes to the number, or type, of participants to be recruited.
- Changes in the personnel on your research team.
- Any other change that results in the specification of your project deviating from the project that was originally reviewed and approved.
What you need to do
Approval must be obtained, in writing, through the Human Research Ethics Office before any change to an approved human research ethics project can be implemented.
If a proposed amendment requires modifications to an information sheet or consent form related to the project, the amended version of the forms should also be submitted together with the Amendment Application Form
. This requirement also applies to other documents that may need to be changed, for example, survey instruments.
Researchers must exercise judgement when completing an Amendment Application Form for an existing, approved project as each application will be assessed on its merits.
However, conditional upon individual circumstances, a request to amend an existing project should include:
- Clear, plain language explanation of the nature of all changes being requested.
- Reasons and justification for the changes being requested, including an explanation of the benefits that may accrue to the project.
- Identification of all relevant implications that may result if the amendment were to be approved.
- Clear consideration of all potential changes to risks to, and impositions on, research participants.
- Revised participant information and consent documents, where the amendment would require them.
- New, or revised, survey instruments or other relevant project instruments, where appropriate.
- Clear explanation and consideration of any other factor of relevance in assessing the request for amendment.
When would a new ethics application be required?
Should a request for an amendment propose a significant change to the procedures and ethical implications of a project, the applicant may be required to submit a new Human Research Ethics Application to the HREO.
In such cases, a new human research ethics project will be established with a new project reference number.
A new ethics application may also be required where multiple, previous amendments have resulted in a substantial evolution of the current research activity relative to the original project that was reviewed and approved by the Human Research Ethics Committee, or other ethics review body.
Requests for project amendments should be submitted to the Human Research Ethics Office (HREO) on the required Amendment Application form