Research ethics breaches

A research ethics breach occurs when a researcher does not comply with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007), and/or the conditions of their ethical approval from the HREC.

This may include:

  • Undertaking research activities without HREC approval, where this approval is required;
  • Implementing modifications to a research protocol without further approval from the HREC;
  • Non-compliance with conditions of ethical approval from the HREC.

Breaches can be reported to the Ethics Office by any concerned individual or organisation, discovered by the Ethics Office, or self-reported by a researcher.

If you would like to report a potential research ethics breach, please contact the Manager of Ethics Administration at the University.

The University of Sydney has standard procedures for receiving, handling and reviewing research complaints in accordance with the National Statement.

This process involves the following steps:

  1. The Manager, Ethics Administration (“The Manager”) receives the complaint.
  2. The Manager or a delegated representative from the Ethics Office (“The Delegate”) gathers information regarding the complaint which may include:
    a. Formal response from the researcher addressing the concerns raised;
    b. Advice from a relevant internal (University of Sydney) or external expert or agency;
    c. Documents pertinent to the complaint such as ethics applications, research tools, information statements and correspondence.
  3. The Manager or Delegate presents this information to the HREC Executive committee, who make a recommendation on the appropriate course of action or escalate the breach to the HREC for consideration if necessary.
  4. The HREC Executive may determine that the breach is not substantiated, in which case no further action is required. If the breach is substantiated, action may include:
    a. A requirement for amendments to the project, including increased monitoring by the HREC;
    b. Suspension of ethical approval for the project;
    c. Termination of ethical approval for the project;
    d. Notification of the breach and recommendations to the Faculty;
    e. Referral to Research Integrity for an initial inquiry into research misconduct;
    f. Other action to resolve the breach.
  5. The researchers are informed, in writing, of the outcome and any necessary action by the Manager or Delegate.

If you are not happy with the outcome of a research ethics breach notification after it has been reviewed by the HREC, you have the right to dispute this decision.