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Research ethics involves the principles and guidelines that govern how research should be conducted to ensure the protection of participants, integrity of the research, and the welfare of society. It ensures that studies are designed and carried out in ways that are scientifically valid and morally sound.

Why is it important?

  • Ensures that participants' rights, safety, and well-being are safeguarded.
  • Promotes valid, reliable, and unbiased data collection and analysis.
  • Upholds the reputation of the scientific community and the public’s trust in research.
  • Prevents legal and regulatory breaches by adhering to ethical standards.

How to comply with research ethics in Australia

In Australia, compliance with research ethics is governed by national guidelines and laws, including the National Statement on Ethical Conduct in Human Research (2023), which provides ethical principles and standards for research involving humans. Key steps include:

  1. Obtain approval from the Human Research Ethics Committee (HREC) before conducting any study involving human participants. 
  2. Ensure participants give informed consent.
  3. Maintain the confidentiality and privacy of participant data.
  4. Assess and minimise potential risks or harms to participants.
  5. Ensure that the benefits and risks of the research are equitably distributed, and vulnerable populations are not exploited.
  6. Monitor the study to ensure it continues to meet ethical guidelines and to address any emerging issues.
  7. Report results accurately and without fabrication, falsification, or plagiarism. If unexpected adverse events occur, these must be reported to the HREC.

Recommended resources:

Ethics & Law Resource Guide


Stanford Center for Clinical Research. (2024). Good Clinical Practice and Ethics.



Obtaining ethics and governance approval for your research project is a mandatory step that must be completed prior to beginning your project. At Monash Health, ethics and governance approval is facilitated by the Monash Health Human Research Ethics Committees (HRECs) and the Research Support Services team. 

Recommended resources:

Human Research Ethics Applications and Site Authorisation

Resources for Researchers - Forms Library

Training Repository - Ethics & Governance

A Patient Information and Consent Form (PICF) is a document used in clinical research and other health studies to inform participants about the study and obtain their informed consent. It is an essential part of ethical research practices, ensuring participants understand what the study involves and their rights.

Why is it Important?

  • Ensures respect for the autonomy of participants by allowing them to make an informed decision.
  • A legal requirement in most jurisdictions to comply with human research ethics guidelines.
  • Builds trust with participants by providing all necessary information.
  • Serves as evidence that participants have given voluntary, informed consent.

How to create a PICF

  • Refer to local guidelines and templates, such as those provided by the NHMRC in Australia
  • Write at a reading level accessible to the average person and avoid jargon.
  • Structure the document clearly.
  • Consult with your HREC
  • Pilot with laypeople
Examples
ACT Government sample informed consent form for research participation.
South Eastern Sydney Local Health District sample patient information sheet.

Recommended resources:

Monash Health Research Support Services - Consent Forms

Monash Health Patient Experience Team

Monash Health acknowledges the Bunurong/Boonwurrung and Wurundjeri Woi-wurrung peoples, the Traditional Custodians and Owners of the lands where our healthcare facilities are located and programs operate. We pay our respects to their culture and their Elders past, present and future. 

We are committed to creating a safe and welcoming environment that embraces all backgrounds, cultures, sexualities, genders and abilities.