All human research that takes place in NSW public health organisations must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee in accordance with the National Health Medical Research Council National Statement on Ethical Conduct in Human Research (2007), and the Policy Directive Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations.
This includes but is not limited to clinical research, clinical trials, epidemiological research, health services research, population health research, and qualitative research.
In Australia, Coordinating Principal Investigators (CPIs) or other applicants must use the Human Research Ethics Application (HREA) form to apply for Human Research Ethics Committee consideration.
NSW supports single ethical review for studies taking place in more than one NSW public health organisation. NSW is also part of the National Mutual Acceptance scheme, where research taking place in public health organisations in more than one participating Australian jurisdiction needs only one ethical and scientific review. Some exemptions apply and are available on the National Mutual Acceptance page.
Human Research Ethics Applications to a NSW or ACT Human Research Ethics Committee should be completed in the Research Ethics and Governance Information System (REGIS) or in Online Forms. As sites are at different stages in their adoption of REGIS, check with your local research office for guidance before submitting your ethics and site assessment applications.
The role of Human Research Ethics Committees is to protect the welfare and rights of research participants. There are 22 HRECs that serve the public health system in NSW. A directory of HRECs can be accessed on the ethics and governance contacts page.
The NSW Ministry of Health supports and develops the network of NSW HREC through:
- information sharing
- policy development
- mechanisms for the streamlining of processes
- development and implementation of policies to manage emerging research ethics issues.
Selecting a NSW Human Research Ethics Committee
For single centre research projects in NSW, an application should be submitted to the local HREC.
For multi-centre research projects where all sites are within NSW, an application may be submitted to any NSW Health lead Human Research Ethics Committee, provided that the Committee is accredited in the research area of the project. This applies to both full and expedited HREC review. For example, clinical trials must be submitted to a lead Committee accredited in clinical trials/interventional clinical research. In addition, if the lead Committee operates within a specialised therapeutic area, only research in that therapeutic area may be lodged with that Committee. Where possible, the application should be submitted to a lead Human Research Ethics Committee associated with one or more of the sites at which the research is to be conducted.
The Human Research Ethics Application (HREA) is the National Health and Medical Research Council’s online ethics application form developed for all research involving humans. The HREA is designed to guide applicants through the ethical principles of the National Statement on Ethical Conduct in Human Research (2007).
The HREA aims to streamline and simplify the ethics review application process by only asking the questions that apply to the research in question. The HREA is applicable to all human research, from low-risk projects to complex multi-centre clinical trials.
All new ethics applications to NSW Human Research Ethics Committees, regardless of study risk level, must be completed on a Human Research Ethics Application (HREA) on the Research Ethics and Governance Information System (REGIS).
IMPORTANT: Please do not create a HREA for a NSW public health HREC at the NHMRC’s HREA website as the NSW Health ethics committee will not be able to import and review the application.
Resource: NHMRC Project Description-Protocol Template Source is HREA, or should be. This would be a useful resource for Research Office’s when discussing projects with Research communities.
Quality Improvement/Assurance and Program Evaluation
NSW Health encourages the widespread implementation of quality assurance (QA) programs as an essential part of a learning health care organisation. QA should be conducted as part of conventional clinical service delivery or ‘business-as -usual’. In almost all routine situations, QA projects should not require prior ethical review.
NSW Health adopts the distinctions between projects requiring ethical review and those that do not as set out in the NSW Health Guideline: GL2007_020 – Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW.
• Researchers conducting human research are required to submit their projects to a Human Research Ethics Committee as per NSW Health Policy.
QA practitioners should assess the characteristics of their project against the NSW Health Guideline to determine if any of the ethical risks described within are present in their project statement.
- If so, review by an ethics review body should be sought. If advice is required, contact should be made with their local Clinical Governance Unit.
- If not, QA practitioners are free to commence their projects, after adhering to any institutional requirements.NSW Health policy is that ethics review and approval is not required merely for the mechanism of obtaining publication in a journal [see Q16 in GL 2007_020].
However, NSW Health observes that an increasing number of journals have required from QA practitioners a statement by an ethics review body prior to accepting a manuscript for publication.
To ensure that potentially valuable findings resulting from QA activities are communicated to the broader clinical governance community and that those findings are tested in the peer review literature; should a journal require a statement in such a circumstance, NSW Health has developed the attached letter which an ethics review body (including a Human Research Ethics Committee) may issue to QA practitioners retrospectively to state that, given the characteristics of the project statement, the project did not contain any of the ethical risks set out in the NSW Health Guideline, and that in accordance with NSW Health policy, was not required to be submitted for review by an ethics review body.
The letter itself is not a statement of ethical approval of the project.
|Research||Quality Improvement/ Assurance||Program Evaluation|
|Purpose||Develop or contribute to generalizable knowledge (e.g., testing hypotheses), test a hypothesis or establish clinical practice standards where none are accepted.||Improve the performance of a program, or service as judged by accepted standards or ensure it conforms with expected norms.||Assess the implementation and effectiveness of a specific program with the aim of monitoring a specific program or making policy adjustments.|
|Design||Develop or contribute to generalizable knowledge.||Not applicable to populations other than that under evaluation.||Provide feedback to program to improve that program.|
|Mandate||Activities not mandated by institution or program.||Activity mandated by institution or department/clinic as part of its operations.||Activity mandated by program as part of its operations.|
|Findings||Expected to answer a research question. Findings are not expected to directly affect institutional or programmatic practice.||Promptly improve a program/process/system. Findings are expected to directly affect institutional practice and may identify needed corrective actions.||Findings are expected to directly affect conduct of program and identify improvements.|
|Population||Usually involves a subset of individuals; generally, statistical justification for sample size is used to ensure endpoints are met.||Includes all or most receiving a particular treatment or process.||Information on all or most participants within or affected by receiving a particular treatment or undergoing a particular practice or process.|
|Benefits||Designed to contribute to generalizable knowledge, subjects may or may not directly benefit.||Designed to promptly benefit a process, program or system, Participants may directly or indirectly benefit from activities.||No direct treatment benefit to participants is expected. Evaluation aims to benefit the society and concentrates on program improvements.|
|Risks/ Burdens||May place subjects at risk and stated as such.||By design, do not increase patient’s risk, with exception of possible privacy/confidentiality concerns.||By design, do not increase patient’s risk, with exception of possible privacy/confidentiality concerns.|
|Dissemination||Dissemination of information usually occurs in research/scientific publications; results expected to develop or contribute to generalizable knowledge by filling a gap in scientific knowledge, developing hypotheses or supporting, refining or refuting results from other research studies.||Publication in peer-reviewed literature as original research is not necessarily an expectation. Dissemination of information does not necessarily occur beyond the institution evaluated; dissemination of information may occur in quality improvement publications; when published or presented to a wider audience, the intent is to suggest potentially effective models, strategies, assessment tools or provide benchmarks or base rates rather than to develop or contribute to generalizable knowledge.||Publication in peer-reviewed literature as original research is not necessarily an expectation. Dissemination of information to program stakeholders and participants may be posted to ensure transparency of results; when published or presented to a wider audience, intent is to suggest potentially effective models, strategies, assessment tools.|
|Testing/ Analysis||Usually designed to statistically prove or disprove a hypothesis.||Compare a program/process/system to an established set of standards; utilize descriptive statistics that demonstrate change/trends.||Quantitative and qualitative analysis may be used.|
|Timeline||Research may take considerable time.||Often has clear start and finish dates.||Often has clear start and finish dates.|
|External Funding||Mostly required.||Mostly not required.||Mostly not required.|
*This resource is based on national/international guidance compiled from:
Quality Assurance, Quality Improvement, or Program Evaluation by Michigan State University 21-11-2012
Different of Research, Quality Improvement and Program Evaluation by the Department of Evaluation and Research Services 12-09-2011.
FAQ Ethical & Scientific Review
Does student research require ethical review?
Yes. Student research involving humans that takes place in NSW public health organisations is subject to the same ethical and scientific review processes as other research.
Do pilot studies require ethical review?
Yes. Pilot studies involving humans that take place in NSW public health organisations are subject to the same ethical and scientific review processes as other research.
Do quality improvement projects require ethical review?
This depends on whether or not the quality improvement project poses any ethical risks to participants. The NSW Health Guideline GL2007_020 Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW provides advice on determining when quality improvement activities require ethical review. The draft table “Distinction between Research, Quality Improvement/Quality Assurance and Program Evaluation” provides further guidance on these distinctions.
Individuals engaged in quality improvement projects should consult each NSW public health organisation involved in the project in order to identify the process adopted by that public health organisation for the ethical review of such projects.
What is the difference between full and expedited Human Research Ethics Committee review?
Human Research Ethics Committees established by NSW public health organisations provide full and expedited ethical and scientific review. Full Committee review must be undertaken for all human research that involves more than low risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007). Expedited Committee review can be conducted for human research that only involves low or negligible risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007).
Can I apply for expedited Human Research Ethics Committee review?
Only human research that involves low or negligible risk to participants, as defined in the National Statement on Ethical Conduct in Human Research (2007), is eligible for expedited Committee review. You should consult the NSW Health Human Research Ethics Committee associated with the site(s) at which you propose to conduct the research to determine if your project can be classified as low or negligible risk research before making an application.
Will a Human Research Ethics Committee automatically accept my application?
Human Research Ethics Committees can limit the number of research protocols they review at each meeting. If your application arrives after the limit has been met, the Committee will inform you that your application can be held over to the following meeting, or that you can apply to another Committee.
Investigators are encouraged to contact the Executive Officer of the Human Research Ethics Committee before submitting an application.
Some Human Research Ethics Committees will not accept an application if they are not certified to review research proposals in a particular area of research. For example, a Human Research Ethics Committee certified to review general research only, will not review applications for clinical trials. In addition, any Human Research Ethics Committee within NSW Health can advise an investigator that it does not have the appropriate expertise to review a particular project and suggest another, more appropriate Committee.
Also, when an investigator intends to submit an application as a low and/or negligible risk project for expedited Human Research Ethics Committee review, the Committee Executive Officer has the discretion to request that the research project be reviewed under full Committee review.
Can an application be withdrawn from one Human Research Ethics Committee and submitted to another?
An application can be withdrawn at any time prior to receipt of the Human Research Ethics Committee review outcome. Where an application is subsequently submitted to a different Committee, all documentation associated with the initial application and the reasons for withdrawal must accompany the submission. The new Human Research Ethics Committee can request that the application is re-submitted to the original Committee for any reason.
What is NSW Health's system of single ethical and scientific review of multi-centre research and how does it work?
Single ethical and scientific review of multi-centre research in NSW ensures that every research project that takes place in the NSW public health system is ethically and scientifically reviewed once only. NSW Human Research Ethics Committees certified through the National Health and Medical Research Council can carry out a single ethical and scientific review of multi-centre research on behalf of all sites within the NSW public health system.
Can investigators opt out of the system?
No. All multi-centre research projects that take place in the NSW public health system must be reviewed under the single ethical and scientific review system.
Does the system apply outside of NSW Health?
No. The NSW Health system of single ethical and scientific review is provided only for the benefit of NSW public health organisations. If the study is proposed to be conducted in more than one Australian public health organisation, the National Mutual Acceptance scheme applies. More information is available on the National Mutual Acceptance page.
Are there any exceptions to the single review principle?
Yes. The following types of research project have specific review requirements:
Research projects involving persons in custody or staff of NSW Justice Health & Forensic Mental Health Network
All human research projects involving persons in custody in NSW and/or staff of NSW Justice Health & Forensic Mental Health Network must be reviewed by the NSW Justice Health Human Research Ethics Committes.
Research projects specifically affecting the health and wellbeing of Aboriginal people and communities
Approval from the Aboriginal Health & Medical Research Council Ethics Committee is required where a research project involves research in, or concerning, NSW and any one of the following applies:
- the experience of Aboriginal people is an explicit focus of all or part of the research
- data collection is explicitly directed at Aboriginal people
- Aboriginal peoples, as a group, are to be examined in the results
- the information has an impact on one or more Aboriginal communities or
- Aboriginal health funds are a source of funding.
Clinical trials requiring access to statewide data collections
All research projects requiring access (including linkage) to statewide data collections owned or managed by NSW Health or the Cancer Institute NSW must be reviewed by the NSW Population & Health Services Research Ethics Committee.
The NSW Population and Health Services Research Ethics Committee is jointly convened by the Cancer Institute NSW and NSW Ministry of Health. The Committee is accredited in NSW as a lead Human Research Ethics Committee for population health and/or public health research. The Committee reviews:
- population health research utilising and/or linking routinely collected health (and other) data, including:
- data collections owned or managed by NSW Ministry of Health (e.g. NSW Admitted Patient Data Collection; Perinatal Data Collection; NSW Emergency Department Data Collection; and NSW Population Health Surveys)
- data collections owned or managed by the Cancer Institute NSW, (e.g. NSW Central Cancer Registry, NSW Pap Test Registry, BreastScreen Registry).
- applications from the NSW Ministry of Health and Cancer Institute NSW in relation to the conduct, management or modification of their data collections (referred to in 1 above).
Information including application forms and meeting dates can be found at NSW Population and Health Services Research Ethics Committee.
Where should I use the Human Research Ethics Application?
For applications to NSW and ACT public health Human Research Ethics Committees, the Human Research Ethics Application is located in both Online Forms and REGIS. As sites are at different stages in their adoption of REGIS, check with your local research office for guidance before submitting your ethics and site assessment applications.
Please do not create a Human Research Ethics Application for a NSW public health Human Research Ethics Committee through the National Health and Medical Research Council’s Human Research Ethics Application -generating website, because the ethics Committee will not be able to import and review the application.
What is the difference between REGIS and the National Health and Medical Research Council Human Research Ethics Applications?
Essentially the two forms are the same. Online Forms and REGIS use a licensed copy of the National Health and Medical Research Council’s Human Research Ethics Application. The questions are identical to those on the National Health and Medical Research Council’s Human Research Ethics Application.
How do I use the Human Research Ethics Application?
For applications in REGIS: The Question Reference Guide: Completing an Ethics Application gives step-by-step instructions for completing the Human Research Ethics Application in REGIS.
For applications in Online Forms: When you log in to Online Forms after 31 August 2017, select ‘Create New Project’ and then ‘HREA’. The Online Forms HREA is used in exactly the same way as the NEAF; complete the form, upload supporting documents, create SSAs, electronically authorise, and submit the application to the reviewing organisation. The Online Forms User Manual, which provides guidance on how to complete application forms and supporting documents required for making an application, will be updated to reflect the HREA. Under the Help menu, select User Manual.
What are the Human Research Ethics Application questions?
There is no published list of Human Research Ethics Application questions. The best way to get to know the Human Research Ethics Application is to log into Online Forms or REGIS, create a new Human Research Ethics Application, and to activate different questions to see what subsequent questions result. The National Health and Medical Research Council has provided question-specific guidance for many of the questions, which will be visible in the system.
I'm not sure how to answer some of the Human Research Ethics Application questions - who can I ask?
Your organisation’s research office can assist you with the content of your ethics application.
What if I accidentally created a Human Research Ethics Application at HREA.gov.au?
The Online Forms or REGIS websites must be used to complete and submit a Human Research Ethics Application to NSW Health Human Research Ethics Committees. If you have used another website to create a Human Research Ethics Application, contact the REGIS Helpdesk for assistance.
Importing the external Human Research Ethics Application into Online Forms might be possible in limited circumstances; you may contact the Office for Health and Medical Research’s Ethics and Governance Unit for more information.
What about applications for low and negligible risk studies?
The process for submitting an ethics application for LNR review has not changed. However, all applications will be submitted on a Human Research Ethics Application form regardless of risk level, because the Human Research Ethics Application has been designed as a smart form to accommodate all risk levels: you only need to answer questions which relate to the type of research you are proposing.
Human Research Ethics Application question 4.5 will ask under which review pathway you are intending to submit the application (greater than low risk, low risk, negligible risk). NSW Health Guidelines for Low and Negligible Risk (LNR) Research Review Processes or Exemption from Ethical Review provides further guidance on interpreting and clarifying some of the concepts contained in the National Statement.
When an investigator intends to submit an application as a LNR project for expedited Human Research Ethics Committee review, the Committee’s Executive Officer has the discretion to request that the research project be reviewed under full Human Research Ethics Committee review. This has not changed.
How will the Human Research Ethics Application affect the Site Specific Assessment?
The process for research governance/Site Specific Assessment remains the same under the Human Research Ethics Application.
What applications should I use to apply for Human Research Ethics Committee review under National Mutual Acceptance?
All National Mutual Acceptance Human Research Ethics Committees now use the Human Research Ethics Application. Please see National Mutual Acceptance for more information about applications submitted under that scheme (e.g. for multi-centre, multi-jurisdictional projects).
If you are submitting an ethics applications to a Human Research Ethics Committee that is located in a jurisdiction that is not currently part of National Mutual Acceptance (Northern Territory, Tasmania), please contact that Committee to obtain its local submission requirements.
What are other National Mutual Acceptance jurisdictions doing about low and negligible risk studies?
The Human Research Ethics Application must be used for any multi-jurisdiction research application where ethical approval is being sought under the National Mutual Acceptance system.
If I have a site in Victoria, do I still have to complete the Victorian Specific Module?
Yes. When the Human Research Ethics Application is used and the research project involves a site in Victoria, the Victorian Specific Module (VSM) must be uploaded as a supporting document to the Human Research Ethics Application and submitted to the reviewing ethics committee (even if the committee is outside Victoria).
Assistance and feedback on the HREA
Contact the National Health and Medical Research Council if you wish to provide feedback on the Human Research Ethics Application questions/question-specific guidance specifically.
Phone: 02 6217 9902
Updated 10 months ago