the national statement on ethical conduct in human research australia

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The ARC is committed to the highest standards of integrity in all aspects of research it supports. This includes ensuring that ARC-funded research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards; as well as the development and support of a research environment that is underpinned by a culture of integrity. To encourage responsible research practices, all Proposals and ARC-funded research Projects are either recommended or required to conform to the principles outlined in the following and their successor documents, as stipulated within the scheme-specific funding rules:

• The Australian Code for the Responsible Conduct of Research (2018) 

Supplementary Guides supporting implementation of the Code

Arc research integrity policy, national principles of intellectual property management for publicly funded research, the national statement on ethical conduct in human research (2007)—updated 2018, the national statement on ethical conduct in human research (2023)—effective 1 january 2024, ethical conduct in research with aboriginal and torres strait islander peoples and communities: guidelines for researchers and stakeholders.

• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (the AIATSIS Code)

The Australia Council for the Arts, Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (2007)

• The Australian Code For The Care And Use Of Animals For Scientific Purposes 8th edition ( 2013)

Other guidelines relating to the use of animals for scientific purposes, as promulgated by the NHMRC

The australian code for the responsible conduct of research (2018)  .

In June 2018, the ARC, National Health and Medical Research Council (NHMRC) and Universities Australia (the co-authors) issued the  Australian Code for the Responsible Conduct of Research 2018  (the Code) and the  Guide to Managing and Investigating Potential Breaches of the Code  (the Investigation Guide).

• Message from the co-authors about the release of the revised Australian Code for the Responsible Conduct of Research 

The Code articulates the broad principles that characterise an honest, ethical and conscientious research culture. It outlines the expectations for the conduct of research in Australia or research conducted under the auspices of Australian institutions. The new Investigation Guide will assist institutions to manage, investigate and resolve complaints about potential breaches of the Code.

The 2018 Code and Investigation Guide replace the 2007 version of the Code. NHMRC, ARC and Universities Australia expect institutions to meet the requirements of the 2018 Code and Investigation Guide by no later than 1 July 2019.

• Further information relevant to the implementation of the 2018 Code and Investigation Guide is available on the NHMRC website.  

The ARC, NHMRC and Universities Australia are developing a series of supplementary guides designed to support institutions and researchers to implement and comply with the Australian Code for the Responsible Conduct of Research (the Code).

The following guides have been released and can be downloaded from the  NHMRC’s website :

• Authorship 
• Management of Data and Information in Research 
• Peer Review 
• Disclosure of Interests and Management of Conflicts of Interest
• Research Supervision
• Collaborative Research
• Publication and Dissemination of Research
• Research Integrity Advisors

The policy outlines requirements for institutions, and individuals engaged in ARC business, to report to the ARC research integrity matters, and the action the ARC may take in response to reported breaches of the Code. It also describes how the ARC can refer concerns or complaints to research institutions, who, in accordance with the Code, are responsible for managing and investigating potential breaches of the Code.  

The National Principles of Intellectual Property (IP) Management for Publicly Funded Research (the National Principles) were developed by a working party of the Australian Government’s Coordinating Committee on Innovation .

The National Principles were developed to assist researchers, research managers and research institutions develop best practice in identifying, protecting and managing IP, thus ensuring appropriate commercial outcomes from publicly funded research.

The intention of the National Principles is simply to improve the commercial outcomes from publicly funded research where a commercial outcome is appropriate. The National Health and Medical Research Council (NHMRC) publicly announced the adoption of these National Principles in April 2013.  

Jointly developed by the ARC, the NHMRC and UA, the  National Statement on Ethical Conduct in Human Research  consists of a series of guidelines on ethical conduct in human research and is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants.  

The National Statement on Ethical Conduct in Human Research 2023 was issued on 29 June 2023. The 2023 National Statement will take effect, and replace, the 2007 National Statement from 1 January 2024. Co-authored by NHMRC, the Australian Research Council (ARC) and Universities Australia (UA), the National Statement is Australia’s principal human research guideline setting out the requirements for the ethical design, review and conduct of human research in Australia.

The 2023 National Statement and a summary of amendments can be found on NHMRC's website. The major changes in this update are to Chapter 2.1 and Section 5.  

Developed by NHMRC, Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders provides a set of principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islanders people and communities.  

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

The  Guidelines for Ethical Research in Australian Indigenous Studies  embody the best standards of ethical research and human rights. It is essential that Indigenous people are full participants in research projects that concern them, share an understanding of the aims and methods of the research, and share the results of this work. At every stage, research with and about Indigenous peoples must be founded on a process of meaningful engagement and reciprocity between the researcher and Indigenous people.  

• Music: Protocols for Producing Indigenous Australian Music
• Writing: Protocols for Producing Indigenous Australian Writing
• Visual Arts: Protocols for producing Indigenous Australian Visual Arts
• Media Arts: Protocols for Producing Indigenous Australian Media Arts  
• Performing Arts: Protocols for Producing Indigenous Australian Performing Arts

The ARC recognises that the Protocols may also have much broader application, and, as applicable, advises that any researchers accessing, using or reproducing music, literature, arts, images or ceremonies of Indigenous peoples, or Indigenous cultural materials conduct their research in accordance with these protocols.  

The Australian Code For The Care And Use Of Animals For Scientific Purposes 8 th edition ( 2013)

Endorsed by the NHMRC, the ARC, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and UA the purpose of the  Australian code for the care and use of animals for scientific purposes  is to promote the ethical, humane and responsible care and use of animals used for scientific purposes. The ethical framework and governing principles set out in the Code provide guidance for investigators, teachers, institutions, animal ethics committees and all people involved in the care and use of animals for scientific purposes. The Code encompasses all aspects of the care and use of animals for scientific purposes where the aim is to acquire, develop or demonstrate knowledge or techniques in any area of science.  

NHMRC provides additional guidelines and information for Animal Ethics Committees and researchers, relating to particular fields of research or types of animals. These guidelines should be read in conjunction with the  Australian code for the care and use of animals for scientific purposes  8th edition (2013) . They are available on NHMRC’s website and include, but are not limited to:

• Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008) ; and
• A Guide to the care and use of Australian native mammals in research and teaching (2014) . 

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Submission—National Statement on Ethical Conduct in Human Research

On 14 September 2023, the Australian Academy of Science made a submission to the National Health and Medical Research Council on the proposed amendments to Section 4 of the National Statement on Ethical Conduct in Human Research.

Download submission (PDF, 160KB)

© 2024 Australian Academy of Science

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National statement on ethical conduct in human research 2023

9780648464433 (ISBN)

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National Health and Medical Research Council (Australia) author & Australian Research Council author & Universities Australia, author. (2023). National statement on ethical conduct in human research 2023 Retrieved April 19, 2024, from http://nla.gov.au/nla.obj-3260080025

National Health and Medical Research Council (Australia) author, Australian Research Council author and Universities Australia, author. National statement on ethical conduct in human research 2023 Canberra: National Health and Medical Research Council, 2023. Web. 19 April 2024 < http://nla.gov.au/nla.obj-3260080025 >

National Health and Medical Research Council (Australia) author & Australian Research Council author & Universities Australia, author. 2023, National statement on ethical conduct in human research 2023 National Health and Medical Research Council, Canberra viewed 19 April 2024 http://nla.gov.au/nla.obj-3260080025

{{Citation   | author1=National Health and Medical Research Council (Australia) author.   | author2=Australian Research Council author.   | author3=Universities Australia, author.   | title= National statement on ethical conduct in human research 2023   | year=2023   | section=1 online resource (111 pages)   | isbn=9780648464433   | location=Canberra   | publisher=National Health and Medical Research Council   | url= http://nla.gov.au/nla.obj-3260080025   | id= nla.obj-3260080025   | access-date=19 April 2024   | via=Trove }}

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Informed consent and plain language

In this section

PICF and plain language resources

We have a number of templates and resources  to help you write your PICF and other participant-facing materials in plain language.  

Informed consent

The National Statement on Ethical Conduct in Human Research says that if you want people to take part in your research project, you need to get their informed consent. They should: 

• voluntarily agree to take part in your project and
• understand what your project involves. 

To help people understand your project, you should give them information in plain language . 

You also need to record the fact that each person has consented to take part in your project. You can record consent in a number of ways, depending on the:

• nature, complexity and level of risk of your project and
• personal and cultural circumstances of the person.

Some common ways of recording consent are: 

• written – for example, the person signs a Participant Information and Consent Form
• verbal – for example, you ask the person whether they agree to take part in your project and record their response in writing or on an audio device
• implied – for example, the person gives consent by filling out and returning a survey.

Children and young people

Research with children and young people under 18 years of age raises particular issues around informed consent. Usually, you need to get consent from:

• the child or young person and
• the parent or guardian.

When you are seeking consent from a child or young person, you need to think about:

• their capacity to understand what the research involves and
• the complexity of the research, and its potential risks and benefit.

You should respect the developing capacity of children and young people to be involved in decisions about their participation in research - see Chapter 4.2 of the  National Statement . In some cases, parental consent may not be necessary. For example, a 17 year-old with good literacy skills may be able to consent to low-risk research.

If the child cannot consent, you should still involve them in appropriate discussions about the research. A Child Information Sheet could help you do this. See our resources  for guidance.

Think about your participant's needs

You may be seeking informed consent from an individual whose needs do not suit the templates on our website, for example, the parent of a deceased child. If this is the case, please contact our office for advice. We will help you make sure that your written materials, and your recruitment processes, are appropriate for that individual. 

Opt out approach

The National Statement  says that you should respect people's capacity to make their own decisions. This normally means that people should give express consent to take part in your project. Sometimes it may be justifiable to use an alternative approach. This might be appropriate if you are running a large scale, low risk project and it is not feasible to get express consent from each person.

Using an opt out approach means that participants are included in the research unless they give their express decision to be excluded. Their decision must be informed. Therefore, you still need to give them information about your project. Once you have done this, you can assume that they are willing to take part in your project unless they say they do not want to. 

If you want to use an opt out approach, you must get permission from a Human Research Ethics Committee. You need to make a strong argument that:

• your project poses little or no risk to participants and
• the risk of not seeking express consent is outweighed by the public benefit or interest of the research.

This is only appropriate if people can make an informed choice about participation. This requires that:

• you give people written information about the project
• people receive this information, and are able to read and understand it
• people are able to act on the information to decline participation.

It may be appropriate for you to use different types of consent for different parts of your project. For example, you might seek explicit written consent for participation in clinical research. You might then use an opt out approach if you are seeking to use people’s information as part of a registry.

The opt out approach is unlikely to constitute consent if you are applying Commonwealth privacy legislation to the handling of sensitive information, including health information. In some cases, it may not be feasible for you to get a participant’s explicit consent to use their information, but you cannot achieve the purpose of your research by using non-identifiable information. In these cases, you must comply with the guidelines under section 95 or section 95a of the Privacy Act 1988. If you are seeking to use an opt out approach to which sections 95 or 95a apply, only a HREC can grant this approval.

For more information about an opt out approach, see Chapter 2.3, 2.3.5 - 2.3.6 of the National Statement.

Waiver of consent

In some cases, you may be able to use tissue or data without getting express consent from the individuals involved. In order to do so you will need to seek a waiver of consent. The National Statement on Ethical Conduct in Human Research states that a waiver of consent can only be granted by a fully constituted Human Research Ethics Committee (HREC). The HREC can only grant a waiver if sufficient justification is provided, and the necessary criteria are met. For more information about this, see Chapter 2.3 of the National Statement .

You can access the  list of projects  that the RCH HREC has granted a waiver of consent for.

Withdrawing from research

You should make your withdrawal processes as simple as possible. When designing your research, consider how your participants prefer to communicate. For example, they may like to communicate verbally or by text message. If so, your withdrawal processes should reflect this.

At the time of consent, you should tell people about the consequences of withdrawing from the research. You should also outline this in your Participant Information and Consent Form (PICF). See sections 2.2.6(g) and 2.2.20 of the National Statement .

If a participant does want to withdraw from the research project, engage them in a conversation so they understand the implications of withdrawal. This should be in line with your consent discussion and PICF. You can clarify exactly what they are withdrawing from. For example:

Are they willing for you to you continue using their already collected data or do they wish for it to be securely destroyed if possible?

Do they want to know what the study found? 

Would they mind being contacted about future research projects?

If they were on an investigational product, do they understand it may be in their best interests to be followed for safety?

In some cases, it may be appropriate to explore the reasons they want to withdraw. While they  are not obliged to give you this information (see section 2.2.19 of the National Statement) if they are willing to share then it may help improve the current project or help you design future research projects.

Make sure you record the participant’s withdrawal. If they withdraw verbally, keep a file note of your conversation including the date and the people involved in the discussion, in addition to the information above.

Final letter - communicating your research results 

The National Statement advises that you should communicate your research results to participants in a timely manner, and in clear and accessible language: see section 3.1.72 . The RCH HREC expects that in most cases you should do this by sending participants a final letter.

You should use our resources to help you draft your final letter:

• Example final letter  - with study results
• Example final letter,  study stopped early  - with no study results

When you've drafted your final letter, email it to  [email protected] . Please:

• include your study number in the subject heading of the email
• let us know whether your study is single site or multi-site . If your study is multi-site, clearly list the full names of all the sites in the email
• make sure you send a clean copy of the letter in Word format . We cannot provide advice on PDF letters.

Our Plain Language Adviser will give you feedback on your letter. When the letter is suitable for participants, the Plain Language Adviser will issue you with an approval certificate. 

Please do not submit the final letter on ERM. 

For more information, refer to the Final letter guidelines . 

Plain Language Adviser

If you need help extra help writing in plain language, you can contact the Plain Language Adviser (PLA), who is based in Research Ethics and Governance. The PLA will be of particular assistance to new researchers. However, experienced researchers may also wish to seek assistance from the PLA. 

The PLA can review documents for participants, including PICFs, newsletters and letters, and provide advice on how to make them clearer. Before you arrange for your documents to be reviewed, please:

• review the resources on our website, particularly the Example PICF
• proofread your documents
• obtain an ERM number , and quote this in the subject-line of your emails to us
• make sure your documents are clean copies in Word - please, no PDFs or track changes
• provide the PLA the protocol for your project - the PLA will use this for background information. They will not provide feedback on your protocol.

Please contact our office to request or arrange a review or make a time to discuss the resources and education materials available: [email protected]

When should I get consent from the parent/guardian?

In general, you should get consent from the parent/guardian if the young person is under 18 years of age. Sometimes you should seek the young person’s consent as well. See the next question.

Can a young person consent to taking part in research?

The young person’s capacity to provide informed consent will depend on:

• the nature and complexity of the research project, and
• the young person themselves. The capacity to understand and consent to taking part in research varies from young person to young person. You should assess this on a case-by-case basis. Remember that a young person’s capacity can change over time.

You should offer young people over 12 years of age the opportunity to consent if they are capable and mature enough to do so. This is in addition to their parent/guardian’s consent.

In some cases, you can get consent solely from a young person who is a mature minor, and not their parent/guardian. If you are seeking to do this, you need to provide the ethics committee with justification in line with sections 4.2.8 and 4.2.9 of the National Statement .

If a young person does not have capacity to consent, you should still involve them in discussions about the project. You may also wish to give them an information sheet about the project.

Can I use an assent form?

The term 'assent' has no legal standing in Australia and is not recognised in the National Statement . The Australian Paediatric Research Ethics and Governance Network (APREG) guidelines on consent reiterate that assent forms are not appropriate. For this reason the RCH HREC will not approve an assent form.

Welcome to the Human Research Ethics Application (HREA)

Hrea has been updated to reflect the revise d national statement on ethical conduct in human research (2023) ..

Submissions of applications for ethics review from public hospital Human Research Ethics Committees may need to be made using ERM , REGIS or Research GEMS (external links). For further information, please see NHMRC's website .

For FAQs , a How-to Guide and technical assistance on the HREA system, please consult the HREA resources page .

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Human research ethics in Australia: Ethical regulation and public policy

• Published: 22 May 2014
• Volume 19 , pages S4–S21, ( 2000 )

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• Susan Dodds 1  

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This paper critically assesses the National Statement on Ethical Conduct in Research Involving Humans as a piece of public policy concerning the regulation of research ethics. Two of the stated purposes of the National Statement are the provision of a “national reference point for ethical consideration relevant to all research involving humans” and the “protection of the welfare and rights of participants in research”. The process of Human Research Ethics Committee review of research proposals is evaluated in light of these two purposes. I argue that the approach taken in the National Statement has the potential to meet these purposes, but that, in its current form the statement does not provide sufficient guidance to HRECs to properly fulfil either purpose. For the National Statement to meet its promise, it needs to provide greater direction to HRECs which is properly informed by understanding of the full array of research involving human participants.

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Dodds, S. Human research ethics in Australia: Ethical regulation and public policy. Monash Bioethics Review 19 , S4–S21 (2000). https://doi.org/10.1007/BF03351236

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Published : 22 May 2014

Issue Date : April 2000

DOI : https://doi.org/10.1007/BF03351236

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Australian Government Department of Health and Aged Care

Revised national statement on ethical conduct in human research

The National Statement on Ethical Conduct in Human Research 2023 sets the requirements for the ethical design, review and conduct of human research in Australia.

The National Statement on Ethical Conduct in Human Research 2023 (National Statement) is for use by:

• any researcher conducting research with human participants
• any member of an ethical review body reviewing that research
• those involved in research governance
• potential research participants.

It will replace the 2007 National Statement (updated in 2018) on 1 January 2024. This timeframe is to give researchers, research offices and Human Research Ethics Committees the opportunity to:

• familiarise themselves with the new guidance
• make necessary adjustments to policies and processes.

Medical Research Future Fund (MRFF) grant agreements require all grant recipients to comply with the National Statement.

We encourage all MRFF grant recipients to learn more about the revised guidance, including the public consultation on Section 4.

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Research ethics and governance in Nepean Blue Mountains

All research we are involved in meets strict standards of ethical conduct and integrity, in line with Australian guidelines and international best practice.

Australian standards

In Australia, all research involving humans requires ethical approval before it starts.

The ethics of human research is governed by the  National Statement on Ethical Conduct in Human Research issued by the National Health and Medical Research Council (NHMRC). 

Human Research Ethics Committee (HREC)

Within Nepean Blue Mountains LHD this approval is the responsibility of a Human Research Ethics Committee (HREC).

The HREC reviews applications for single site research to be conducted at facilities and services within Nepean Blue Mountains Local Health District (LHD).

It is also able to review applications for multi-centre human research being done in NSW public health organisations as well as Queensland, Victoria, South Australia, Western Australia and the Australian Capital Territory.

Our HREC members

• Clinical Professor Ian Seppelt, Chair
• Dr Alison Poulton - Deputy Chair
• Dr Faraz Pathan, Researcher
• Dr James Mallows, Researcher
• Jane Thomas, Health Professional
• Jeni Stevens, Researcher
• Junie McCourt, Researcher
• Kate Rafton, Lawyer
• Michael Turner, Religious Member
• Neil Checkley, Religious Member
• Michael Wood, Health Professional
• Penny Mahairas, HREC Executive Officer
• Art Sideris, Lay Member
• Dr Sonya Burgess, Researcher
• Jana Smetana, Lay Member
• Dr Rui Dan (Vicki) Xie, Researcher
• Richard Norris, Researcher
• Min Ye, Health Professional, Pharmacist

HREC roles and responsibilities 

The HREC meets 11 times a year and considers many new applications as well as reviewing the progress and compliance of all currently approved studies.

• HREC Terms of Reference (PDF 239.27KB)
• HREC Standard Operating Procedures (PDF 670.85KB)

Subcommittees

The Low and Negligible Risk (LNR) Committee meets fortnightly to review low and negligible risk projects. 

The Apollo Subcommittee provides ethical review of smaller scale projects such as audits, quality improvement and quality assurance type projects.

Research Governance Officers

We have a framework for overseeing research, to ensure it meets appropriate standards of quality, safety, privacy, risk management and financial management. The Local Health District, facilities, managers and researchers have a shared responsibility and accountability for the conduct of research.

The Research Governance Officer (RGO) is responsible for assessing the suitability of a project to be conducted at a particular site and making a recommendation to the Nepean Blue Mountains Local Health District Chief Executive (or delegate) about whether to authorise the study to be conducted at their site.

Information for researchers

The approval of research applications involves:

• Scientific and ethical approval through HREC
• Site governance approval, through a Site Specific Application (SSA) 

Applications are made through the  Research Ethics and Governance Information System (REGIS) .

Fees apply, and vary depending on the nature of the research project and its funding. Contact the Research Office for details. 

Our standard operating procedures (SOPs) will guide you through the various stages of your research application.

Different procedures apply for research with different levels of risk.

Staff undertaking approved research must follow a strict set of guidelines throughout their project, and ensure that:

• no research is conducted without ethics approval from the HREC
• site authorisation is received from the relevant Research Governance Officer (RGO)
• all relevant information has been provided to the HREC
• all relevant guidelines and legal requirements are complied with
• monitoring requirements are complied with e.g. annual reports
• proposed protocol modifications and amendments are submitted to the HREC Committee for approval and to Research Governance for Authorisation
• significant safety issues, urgent safety measures and suspected unexpected serious adverse reactions are promptly notified to the HREC or RGO.

For more information see the Australian Code for the Responsible Conduct of Research 2018 .

Case reports

A case report is a detailed narrative that describes, for medical, scientific or educational purposes, a medical event experienced by one or several patients. Case reports present clinical observations, usually collected in health care delivery settings.

They play an important role in advancing medical knowledge and training, and can help identify adverse and beneficial effects of treatments, or new diseases.

Case reports may require ethics approval as well as patient consent if they involve sensitive information or risk to privacy or the organisation. Contact the Research Office for advice.

Call (02) 4734 1998 or email  [email protected] .

Correspondence to the Nepean Blue Mountains HREC can be sent to:

Postal address

The Chair, Human Research Ethics Committee

Research Office

Penrith NSW 2750

Street address

Building D, Level 5

Nepean Hospital

Kingswood NSW 2747

Note : Please include the study title and (once known) HREC reference number, eg. YYYY/ETH in all correspondence.

Related information

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• National Health and Medical Research Council