Please note the following: From 1st June 2023: all studies that do not provide information within the requested timeframe of 30 days will be withdrawn from REGIS and a new application will be required. New versions of the original submission will not be accepted once withdrawn.
IMPORTANT: PLEASE REFER TO THE PRE-SUBMISSION GUIDE BEFORE CONTACTING THE RESEARCH OFFICE. THE PRE-SUBMISSION GUIDE CAN BE FOUND WITHIN THE PRIOR TO STARTING WITHIN THE MENU LIST
NEW from 1 January 2023
From 2023, all investigators conducting research in SESLHD must provide evidence of current Good Clinical Practice (GCP) compliance. This will be a requirement for both ethics and governance (SSA) submissions at SESLHD.
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Complying with GCP helps to ensure that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible.
Free and low-cost options for GCP training are available for all SESLHD staff.
Evidence of GCP compliance will be required from 2023, or you will not be able to commence your study at SESLHD. This evidence will be mandatory from 1 July 2023.
For more information, contact SESLHD-RSO@health.nsw.gov.au.
Research at SESLHD
Research is an intrinsic part of core business at SESLHD. It drives innovation to improve the health of the community we serve. Our vision is to be recognised as an internationally leading, research-oriented health service that embeds research and innovation into practice.
Click here for the research strategy
The Research Office processes Ethics and Governance applications, amendments, annual reports as well as provides secretariat to the SESLHD Human Research Ethics Committee (HREC). Please note that Governance (Site Specific Applications) must be authorised BEFORE a study can commence activity. Ethics and Governance (SSA) are separate applications. Ethics approval is required to apply for a Site Specific Application (SSA).
Please ensure that you have engaged with your key stakeholders (Head/s of Dept/s) to ensure that:
- The details of the Head of Department (HoD) are correct within your application
- You are providing an opportunity for the HoD to pose questions concerning your study
- That you have verbal approval before proceeding to submit your ethics application via REGIS
Before submitting into REGIS, please ensure you have provided your correct contact details and you are aware and committed to responding to any requests by the Research Office in a timely manner. Otherwise, your study may be withdrawn after 30 days.
Queries concerning Ethics & Governance:
|Drop in Q & A online session||
Weekly Q&A Webinars can be accessed here.
Every Tuesday 1.30pm-2.30 pm and Thursday, 11am-12pm
|Phone||(02) 8797 7605 - Please leave your details so the office can return your call|
For researchers who are familiar with the process, please find below a table of 'quick links' to save you time:
|Submission Forms & Templates|
|Method of Payment (MoP)||MANDATORY with REGIS submissions|
|Ethics Eligibility Checklist||MANDATORY with REGIS submissions|
|Governance Checklist||MANDATORY with REGIS submissions|
|Forms and Templates||Other relevant forms and templates|
|SESLHD Policies & Procedures|
|SESLHD 2017-21 Research Strategy||Priorities, vision and strategy for research within SESLHD|
|SESLHD Research Standard Operating Procedure||Guidelines for review & processing of HREAs by the SESLHD Research Office|
|SESLHD Responsible Conduct of Research||Guidelines for the responsible conduct of research within SESLHD|
|SESLHD Research Fees Policy||Classification of fees applying to all documents submitted and reviewed by HREC|
|Policies and Guidelines||Contains policies relating to research within local, state and national jurisdictions|
|Recommended Research Links|
|REGIS||Research Ethics Governance Information System|
|OHMR||Office of Health and Medical Research|
|NHMRC||National Health and Medical Research Council|
|ARC||Australian Research Council|
Research Ethics & Governance Information System (REGIS)
All applications must be submitted through the state-wide platform, REGIS, led by the Ministry of Health (MoH). We recommend familiarising yourself with REGIS in order to manage your study throughout its duration for Ethics and Governance applications, and post approval management such as amendments and annual reports.
Please refer to the REGIS website: https://regis.health.nsw.gov.au/ to book researcher training, and to access quick reference guides and video tutorials.
> To keep abreast research news and updates, you can sign up to the REGIS newsletter here.