Post approval - existing applications

Post approval - existing applications

Amendments or project modifications

It is the responsibility of the Chief Investigator to ensure HREC approval is obtained for all amendments prior to implementation. Failure to conduct research according to an approved protocol risks researchers' legal indemnity, right to publication and opportunity to seek future funding.  An amendment may include but is not limited to:

  • Changes to the protocol
  • Changes in recruitment strategies
  • Changes to Information Statements and Consent Forms
  • Changes to letters, advertisements, questionnaires or any other documents.
  • Changes to the research team

The Higher Degree Research Office requires students provide evidence of ethical approval to submit their theses for assessment.

Where modifications require changes to public document(s) such as Participant Information Statements, Consent Forms, advertisements and questionnaires, you should include amended documentation with your modification request. Please provide tracked and clean copies of any amended documentation.

Amendments must be submitted via the Human Research Ethics Management System. For more information about this system and the management of existing applications, please refer to the Human Research Ethics Management support page.

There are no submission deadlines for amendments.  Requests to change personnel only or change funding only are considered by the Ethics Secretariat and can be submitted at any time. Larger amendment requests are considered by the HREC or Executive, and should be submitted by the cut-off date for the next available meeting.

Adverse events

Adverse events should be reported to the HREC as soon as possible.

An adverse event is a harmful, unpleasant or undesirable response, reaction or outcome experienced by a research participant or researcher. Such incidents may include unanticipated harm to participants or harm to the reputation of the researchers and the University. They can also include instances of privacy breaches, loss of data and damage to property.

Adverse events must be submitted via the Human Research Ethics Management System. For more information about this system and the management of existing applications, please refer to the Human Research Ethics Management support page.

Complaints

Complaints from research participants

Patients or other research participants who have study-related queries should contact the Principal Investigator or other study contact as listed in the Participant Information Statement and Consent Form.  If patients or other research participants wish to speak to someone independent of the study or would like to make a formal complaint about any aspect of a research project, they should contact:

Dr Karolyn (Kandy) White
Director, Research Ethics and Integrity
Macquarie University

T: +61 (2) 9850 7854
E: ethics@mq.edu.au

Complaints from researchers

Researchers who wish to complain about any aspect of a research project, the way it is being conducted or about the review of a project by the HREC, they should contact:

Dr Karolyn (Kandy) White
Director, Research Ethics and Integrity
Macquarie University

T: +61 (2) 9850 7854
E: ethics@mq.edu.au

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