Chris O’Brien Lifehouse is a not-for-profit comprehensive cancer treatment and research hospital for public and private patients, located alongside Royal Prince Alfred Hospital and the University of Sydney in Camperdown, NSW.
All research conducted at Chris O’Brien Lifehouse is required to undergo Ethics and Governance review prior to commencing.
COVID-19 Risk Mitigation Strategy for Clinical Trials
Human Research Ethics Committee – HREC
HRECs review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines.
Chris O’Brien Lifehouse is able to accept ethical review from NHMRC Certified Lead HRECs (NSW and interstate) in the National Mutual Acceptance initiative. Please refer to the relevant HREC’s website for information regarding submission and meeting dates, Standard Operating Procedures, Terms of Reference, submission requirements and fees.
Human Research Ethics Application – HREA
The HREA is the only application form that can be used when submitting to public hospital HRECs.
The form is the same whether the project is low risk or more than low risk. The form is predictive, this means that for low risk projects researchers will only be asked to answer questions that relate to the type of research being conducted i.e. surveys; the questions generated will be specific to survey research.
As of December 2018, all new submissions to NSW public hospital HRECs must be completed via REGIS
Researchers will need to register for a REGIS account before they can login and complete a HREA via REGIS. For more information about REGIS please visit the REGIS website
Early Phase Clinical Trials
Early Phase Clinical Trial definition includes all clinical trial phases up to and including a Phase I component.
Lifehouse Early Phase Clinical Trial applications are required to be submitted to either Bellberry HREC (adults) and Sydney Children’s Hospitals Network HREC (paediatrics). These HRECs have been appointed as NSW Health’s statewide Early Phase Clinical Trials HRECs.
Please refer to the SPIRIT Statement for recommended minimum set of scientific, ethical and administrative elements that should be addressed in a clinical trial protocol.
The below protocol template can be downloaded.
For research involving participant consent, one of the NHMRC standard Participant Information Sheet and Consent Form templates must be used including the ‘Form for Withdrawal of Participation’ page.
The NSW Office for Health and Medical Research is responsible for developing, communicating, implementing and evaluating policies, frameworks and guidelines to ensure that ethical considerations are given proper weight in medical and clinical practice, and research within the NSW public health system.
The Research Governance Office will now be accepting Electronic Submissions. Please note that the SSA, Contracts and Indemnities are still required to be submitted in hard copy to the Research Governance Office located on Level 6. Please include scanned copies of these documents in the electronic submission. Sponsors will receive a copy of contracts and indemnities once fully executed.
Site Specific Assessment – SSA
A Site Specific Assessment (SSA) submission needs to be submitted and authorised prior to the commencement of research projects at Chris O’Brien Lifehouse. Please find below the Lifehouse SSA form and checklists to assist you in preparing the SSA submission
- SSA Form
- Additional Associate Investigators for LH SSA Form
- SSA Checklist – Commercially Sponsored Research
- SSA Checklist – Commercially Sponsored Research GMO
- SSA Checklist – Collaborative Sponsored Research
- SSA Checklist – Low Risk Research
- Fee Schedule and Payment Form – Lifehouse Governance
- Modified MA Standard Indemnity for SLHD (Devices)
- Modified MA Standard Indemnity for SLHD (Medicines)
- Modified MA Standard Indemnity for SLHD (GMO)
- SLHD Offer of Indemnity Letter
The Principal Investigator at LH is responsible for notifying the Research Governance Manager of all HREC approved amendments (this includes updates to Investigator’s Brochures or equivalent) to a research project.
HREC approved amendments need to be submitted for governance review prior to implementation at the site.
Submit the completed ‘Amendment Request for Site Authorisation Form’ , signed by the site Principal Investigator.
Access Request Submissions
‘Access Request’ submissions seek authorisation from the organisation to assist an external site with their approved research project. Examples are as per the following:
- Assisting the external site with recruitment (e.g. displaying posters or handing out ‘letters of introduction’)
- Distribution of surveys or questionnaires
Access Request Applications
Completion of the Access Request Form and attach copies of the following:
- HREC approval letter
- Copy of the HREA
- Copies of HREC approved documents to be handed out to patients
- Other HREC approved advertising material – please ensure that any materials include a HREC approval statement and HREC reference number
- Please also include written confirmation from the Lifehouse employee who will assist with the researchers access request (i.e hand out flyers etc)
Other Governance resources:
- NSW Health Policy Directive (PD2017_039) Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Safety Monitoring and Reporting in Clinical Trials NHMRC Nov 2016
- Reporting of Serious Breaches of Good Clinical Practices (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018
- National Statement on Ethical Conduct in Human Research
- Australian Code for the Responsible Conduct of Research
- Therapeutic Goods Administration (TGA) – accessing unapproved products
- Ethical Considerations in Quality Assurance and Evaluation Activities
- Declaration of Helsinki 2013
- NSW Civil and Administrative Tribunal – Guardianship Clinical Trials
- The Australian clinical trial handbook
- Safety Monitoring and Reporting in Clinical Trials NHMRC Nov 2016
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018
Lifehouse Executive Approval
•NHMRC Guidelines under Section 95 Privacy Act 1988 A framework in which medical research involving personal information obtained by Commonwealth agencies should be conducted.
•NHMRC Guidelines approved under Section 95A Privacy Act 1988 A framework to ensure privacy protection of health information that is collected, used or disclosed in the conduct of research.
Our Research is conducted in accordance with the Australian Code for the Responsible Conduct of Research (2007) and the National statement on Ethical Conduct in Human Research 2007 (updated 2018). These documents outline research related complaint management processes.
The NHMRC provides further guidance regarding the ‘Responsible Conduct of Research’.
Any feedback relating to research and research staff is welcomed by Chris O’Brien Lifehouse, please contact:
The Research Governance Manager on
(02) 8514 0410
Postal address: 119-143 Missenden Road
Camperdown NSW 2050
PO BOX M33 Missenden Road NSW 2050