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:
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 a Participant Information Form or Participant Consent Form related to the project, the amended version of the forms should also be included when submitting the amendment on ROAP. 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:
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) via ROAP.