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Research ethics at Monash Health

All research projects undertaken at Monash Health must be approved by the Monash Health Human Research Ethics Committee (HREC).

Monash Health HREC

The following information is directly from the Monash Health HREC page:

  • Prior to commencing a research project, researchers require ethics and governance approval. A Human Research Ethics Committee (HREC) provides ethics approval, whilst an institution provides Site Specific Authorisation for a study to be conducted at a particular site.
  • The Monash Health HREC are able to provide HREC Review for other institutions, however, Site Specific Authorisation to conduct the study at a site must still be obtained from each institution prior to the study commencing.
  • If a researcher already has obtained HREC Review from an Institution which is NHMRC Certified for multi-centre review for that category of research, Monash Health will not duplicate HREC Review and will require an application for Site-Specific Authorisation Only.
  • In the event, that the study requires review by the Monash Health HREC and Site-Specific Authorisation at Monash Health, researchers are asked to submit both an HREC application and an application for Site-Specific Authorisation.  It is requested that the application be submitted simultaneously, to allow concurrent review.

Learn more about research approval processes from Monash Health Research Support Services, including recordings of their Ethics and Governance Seminar Series. 

Research Support Services

Ethics and Governance Seminar Series

PROMPT Policies and Procedures

Monash Health policies and procedures relating to clinical and research ethics can be found in Monash Health's PROMPT system. Guidelines are available in relation to:

  • Monash Health ethics review
  • Data and records
  • Authorship
  • Informed consent
  • Quality assurance
  • Privacy and confidentiality

Accessing PROMPT

A desktop shortcut for PROMPT is provided on all Monash Health PCs. To access PROMPT from home, use Citrix or set up a remote login by following these procedures:

Only from your smartphone and/or device
     1.   Using Google Chrome, visit: app.prompt.org.au 
     2.   Enter your work email address ONLY
     3.   Click/tap ‘Send Access Token’
     4.  Click/tap on the URL that will be sent to your work email address

Monash Health policies and procedures relating to clinical and research ethics can be found in Monash Health's PROMPT system. A desktop shortcut is provided on all PCs. Policy and procedure queries should be directed to policiesandprocedures@monashhealth.org.

Overarching guidelines

The below guidelines from the National Health and Medical Research Council (NHMRC) apply to all research in Australia.

Clinical trials

The following guidance is aimed at the ethical conduct of clinical trials:

International documents & guidelines

  • The Nuremberg Code : adopted in 1947 after the Nuremberg trials considered experiments by Nazi doctors on concentration camp prisoners.
  • Declaration of Helsinki : following the adoption of the Nuremberg Code, the World Medical Association developed the Declaration of Helsinki in 1964 which was most recently revised in 2000. This cornerstone document provides a set of principles for human research ethics. 
  • Belmont Report : produced in 1979 by a panel of experts and published by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report establishes ethical principles and guidelines for research involving human subjects and participants. It responded to ethical failures such as the Tuskegee Syphilis Study.
  • CIOMS International guidelines for health related research involving humans : detailed guidelines from the Council for International Organizations and Medical Science originally published in 1993 and last updated in 2016. Historical versions are available on the CIOMS website.
  • U.S. Common Rule : provides a standard of ethics to which any government funded research in the United States is held. First published in 1991, this rule was significantly revised in 2018 and is also known as the Federal Policy for the Protection of Human Subjects.

Each funder of medical research will have applicable codes and standards (as listed in the ‘Research Guidelines’ tab in this guide) to ensure the research they fund is conducted according to appropriate ethical, legal and professional frameworks.

It is therefore essential that research projects adopt responsible research practices and researchers check the guidelines stipulated by their funding body.

Key funders of medical research in Australia are:

If you are looking for a research grant, view our list of grants and funding organisations in the Research & Grant Proposals Guide.

Research & Grant Proposals - Finding Grants

Open Access

Many funders will also require that research outputs from supported research are made openly accessible. It is essential that you check these policies before submitting work for publication.

If you need help identifying open access publications contact library@monashhealth.org.

For more information on publishing in open access journals, visit our Writing, Referencing & Publishing Guide.

Writing, Referencing & Publishing - Open Access

You can track new articles on research ethics by downloading the Read mobile app. To download the app, click the logo below:

     

Also see our video instructions on how to set up Read by QxMD. Further guidance on keeping up to date and tracking new research is available in our keeping up to date guide.

Australian:

International:

Research Ethics Books

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.