Frequently Asked Questions (FAQs)
All research involving humans occurring at NSW Health sites requires ethical review.
Quality Assurance and Quality Improvement projects do not require ethical review. Please see further guidance under Does my project require ethical review?
No, research being conducted at a NSW Health facility must be approved by an HREC of a public health organisation.
LNR Research describes research in which the only foreseeable risk of harm is one of discomfort and any foreseeable risk is no more than inconvenience. Research in which the risk for participants is more than discomfort is NOT low risk.
The Office of Health and Medical Research (OHMR) has a Guideline which may assist you to determine if your research is LNR. You can also review the National Statement on Ethical Conduct in Human Research - Chapter 2.1.
LNR research may include surveys/interviews/focus groups, observational studies or retrospective audits.
You must select the risk review pathway when completing your Human Research Ethics Application (HREA). When you make your submission via REGIS, the Research Office will also asses the risk level of your submission on an initial review of the application.
- Prepare your Study Protocol using the template available here. Review the National Statement on Ethical Conduct in Human Research to ensure that key ethical requirements are addressed within the Protocol.
- Prepare your supporting documents (e.g. Patient Information and Consent Form etc. using the templates on our Guidelines, Forms &Templates page). Ensure that the supporting documents reflect the content within your Study Protocol.
- Complete the HREA in REGIS. You will need to set aside 2-3 hours to provide thorough information that will assist the HREC to understand:
- Your study objectives
- Your methodology including participant selection and consent
- How you will collect, store and analyse data
- How you will cater to participant groups identified in the National Statement on Ethical Conduct in Human Research
- How you will conduct research involving bio-specimens or genomics
Select the correct type of PISCF template for your study and adapt it to reflect your Study Protocol. The PISCF needs to be written in language that can be understood by your participants. The templates for a PISCF and letter of invitation can be found here.
Review outcomes are not immediately available after the meeting date. Meeting minutes must be finalised by the Committee Chair before the Research, Ethics and Governance Officers can create correspondence back to the applicants with the outcome.
Most submissions will not be approved by the Committees on the first review. It is important that you have considered the requirements of the National Statement prior to making your submission, as this will reduce the amount of feedback made by the Committees.
You must obtain ethical approval and Site Authorisation before commencing research within any NSW Public Health facility. Please see information under Governance for information relating to your Site Specific Application and Site Authorisation.
The Committee is reviewing your application to assess its compliance with the requirements of the National Statement on Ethical Conduct in Human Research.
A pre-read of the National Statement on Ethical Conduct in Human Research and incorporation of its requirements into your protocol, study documents and application will assure the Committee that your study is ethically acceptable.
Researchers must use REGIS.
You will need to submit:
- A covering letter, and
- Documentation for review by the HREC, for example:
- Protocol (mandatory for all projects)
- Participant Information Sheet and Consent Form
- Questionnaires/surveys
- Invitation Letter
- Telephone Scripts
- Data collection form
- Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors)
- Signed declaration & undertaking by the Data Custodian and Co-ordinating Investigator (if seeking access to a NSW Health owned or managed state-wide data collection)
- Curriculum vitae of the Co-ordinating Investigator and Principal Investigators.
Under normal circumstances consent must be sought to access and use the identifiable or potentially identifiable health information of an individual for purposes other than for which it was directly collected. However, the HREC may make exceptions under the Statutory Guidelines for Research if it is in the public interest.
If a proposed activity is to be conducted by a person who does not normally have access to the patient’s records for clinical care or a directly related secondary purpose, there is the potential for the privacy and confidentiality of that patient to be breached.
As a general principle, quality assurance and research activity data should not be identifiable where possible before being given to third parties who would not normally have access to them. Review of medical records or other health data by anyone who would not normally have access to information contained therein, unavoidably compromises the privacy of individuals.
Please contact the Research Office to discuss this further.
We can only accept electronic copies submitted via REGIS.
A new NSW Health fee policy and information bulletin has been introduced and a Method of Payment Form is now mandatory for all submissions.
Please see information on the Contact Us page.
Researchers are responsible for identifying and declaring their own conflicts of interest, including actual, potential or perceived conflicts.
Please check the NSW Health Policy - Conflicts of Interest and Gifts and Benefits for further details or the SESLHD Internal Audit website (only available to view when connected to the network):
Definitions of research types in REGIS applications:
Clinical trial
Any research project that prospectively assigns human participants or groups to one or more health-related interventions to evaluate the effects on health outcomes.
Clinical research
Studies, including observational studies in the clinical setting, which are designed to understand, find and treat illnesses and other health issues. These studies involve a wide range of activities from genetics to assisting medical staff and patients to communicate better. Examples include finding how genetics lead to disease or finding the best ways to counsel people who have a genetic mutation that predisposes them to a certain disease such as cancer; disease registries; and, studying the relationship between smoking and heart attacks.
If the clinical research also meets the definition of CT, please only select CT.
Health Research/ Social Science
Health Research studies are designed to gain information and understanding about health. The goal is to find ways to improve human health. Social science studies seek to understand social behaviour through (a) the measurement of social phenomena, (b) the discovery of social regularities, and (c) the creation of social theories. Examples include: interviews involving one or more participants, focus groups discussing a specific set of topics, observing the participant in his/her own environment or in the environment being studied.
Other
Other is a study that does not fall into any of the other available categories. Examples include: Population and public health studies which aim to develop or contribute to generalisable knowledge to improve public health practice; the collection and analysis of qualitative and quantitative survey data; the analysis of administrative datasets; economic evaluation of health care interventions or health care financing priorities; evaluation of health services and health policy; GIS studies; and, knowledge translation. It includes population-level and health-system research, but not clinical or biomedical research.
If the purpose of a project is to improve the performance of a program or service as judged by accepted standards or to ensure it conforms to expected norms; or, is to improve a specific program, it may not be research. If you have any questions about whether or not your project is research, contact your HREC.