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Obtaining ethics and governance approval for your research project is a mandatory step, one 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. 

More information is available via the Monash Health Research website using the links below.

Human Research Ethics Applications and Site Authorisation

Resources for Researchers - Forms Library


Ethics & Governance Training Sessions

How do I submit a Human Research Ethics Application? Which documents will I need to prepare?

Answer these questions and more by watching the recorded training sessions offered by Research Support Services. The sessions provide information on topics such as:

  • Guidelines, Legislation, Policies and Procedures
  • Human Research Ethics Applications
  • ERM – Ethical Review Manager
  • Ethics Documents – HREA – Protocol – VSM – IB – PICF – Radiation
  • Low Risk Projects
  • Quality Assurance Projects
  • Site Specific Assessment (Governance) Applications
  • Research Agreements

Click the link below to access the recordings and slides.

Training Repository - Ethics & Governance

National Statement on Ethical Conduct in Human Research

While completing a Human Research Ethics Applications (HREA), you will be asked to provide details about your research project and answer questions relating to ethical standards and guidelines from the National Statement on Ethical Conduct in Human Research.

The National Statement -- published by the National Health and Medical Research Council (NHMRC) -- outlines core values and principles of ethical conduct in human research. It also provides guidelines as to how these should be applied. The core values and principles are:

  • Research merit and integrity
  • Justice
  • Beneficence
  • Respect

In terms of their application, the National Statement discusses ethical considerations including: 

  • Risk and benefit
  • General requirements for consent
  • Ethical considerations specific to participants (e.g. people who are pregnant, children and young people)

National Statement on Ethical Conduct in Human Research (2023)


NHMRC standards & guidelines

Below are NHMRC guidelines on ethical conduct in human research apply to research conducted in Australia.

Additional ethics resources are available in the Library's Ethics & Law Resource Guide.

Ethics & Law Resource Guide

Patient Information and Consent Form (PICF)

Your research team will be required to submit a PICF as part of your application to a Human Research Ethics Committee (HREC). PICFs should be written in plain language to ensure potential participants' understanding and support informed consent.

A well-written PICF can assist with:

  • recruiting participants
  • establishing trust
  • managing risk

(RCH, 2020, The Value of a Well-Written PICF)

Visit the Forms Library on the Monash Health Research page for essential information about consent.

Resources for Researchers - Forms Library


Templates

The NHMRC offers downloadable PICF templates for various study types. These templates should be adapted to reflect your specific project -- for more details see the instructions on the first page of each template.

NHMRC - PICF templates

Templates are also available from the Coordinating Office for Trials and Clinical Research (select "Templates" from the left-hand menu). 


Resources & guidance

The Monash Health Patient Experience team provides a range of resources to assist with creating information for consumers, such as:

Patient Experience also offers an online workshop, Health Literacy 101, for Monash Health employees. Register via Latte.

Click the blue button below to view more resources on the Monash Health intranet. 

Developing Information for Patients (intranet link)

A plain language guide is available in the Forms Library maintained by the Monash Health Research team.

Resources for Researchers - Forms Library

Monash Health acknowledges the Traditional Custodians of the land, the Wurundjeri and Boonwurrung peoples, and we pay our respects to them, 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.