New research projects
- Commercial clinical trials – Clinical trials of interventions in which the protocol/study report is owned by a commercial entity.
- Collaborative clinical/research studies – Clinical trials of interventions and/or qualitative research studies in which the protocol/study report is owned by not-for-profit institutions such as universities.
- Lifehouse investigator-initiated studies – Clinical trials of interventions in which the protocol/study report is owned by a commercial entity.
Chris O’Brien Lifehouse/Royal Prince Alfred Hospital
The Chris O’Brien Lifehouse/Royal Prince Alfred Hospital (Sydney Local Health District, SLHD) is a new private/public partnership in which the private, not-for-profit facility, Lifehouse, is contracted by the SLHD to treat public patients. This means the SLHD has purchased the oncology services of Lifehouse to treat their public health patients. This partnership results in two key changes in the conduct of clinical trials.
- Lifehouse studies must be approved through the Royal Prince Alfred Hospital (RPAH) or Concord Repatriation General Hospital (CRGH) HREC. If studies have been approved at another lead HREC, then the RPAH or CRGH HREC will need to ratify the National Ethics Application Form (NEAF).
- To enable us to conduct clinical trials at Lifehouse, we are obliged to ensure that the sponsor for the clinical trial is also able to provide indemnity to the SLHD to cover the public patients that are contacted to our care. This means that sponsors will need to provide two indemnities one for Lifehouse and one for the SLHD.
Conducting research at Lifehouse
Please refer to Lifehouse advice for Patient Information Sheet/Consent Form.
HREC full review needed for all studies which contain an intervention including blood tests.
Low/negligible risk studies reviewed by the HREC executive ie medical records reviews/audits.
- RPA HREC guidelines for Lifehouse
- General RPA HREC guidelines
- CRGH HREC guidelines
- Access to NSW Low and Negligible Risk Research Ethics Application Form (LNR-NSW)
Access request for studies in which the researchers wish to access the patients, however, none of the research occurs at Lifehouse.
Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they allow to be conducted under their auspices. Good research governance is an essential component of the responsible conduct of research. It enhances ethical and scientific quality, promotes good research practice and accountability, reduces adverse incidents and ensures lessons are learned, thus reducing the likelihood of poor performance and research misconduct.
Research governance is a way of thinking about and managing research and applies to all individuals involved in research – staff and students, in all professional groups, no matter how senior or junior. Research governance is about how research is conducted and aboutfacilitating good, ethical and worthwhile research. It is about responsibility and about managing risk.
Below is a list of the list of the overarching elements of research governance, required to set up and conduct a research project, for the life of a project.
Many of these elements overlap with one another and this is not necessarily an exhaustive list:
- Compliance with legislation, regulations, guidelines and codes of practice.
- Ethical approval.
- Monitoring and auditing of research projects.
- Legal and Insurance – consent, indemnity, agreements.
- Policies for responsible research conduct, research misconduct, monitoring, complaints, conflicts of interest.
- Credentialling, induction, training, accreditation.
- Intellectual property and managing collaborative research.
- Financial management.
- Performance measurement, reporting and planning.
- Risk management.
There are numerous guidelines and regulations, at national and international levels, which prescribe best research governance practice to help ensure research is conducted to the highest governance and ethical standards possible. The principal documents that govern human research in Australia are listed below:
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research (2007)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000)
- Access to unapproved therapeutic goods – Clinical Trials in Australia (2004)
- The Australian Clinical Trial Handbook – A simple practical guide to the conduct of clinical trials to international standards of Good Clinical Practice (GCP) in the Australian Context (2006)
In addition to being familiar with the principles and requirements of the above guidelines, all researchers at Chris O’Brien must conduct their research in accordance with the Research Governance Policy.
Human Research Ethics Committee
Below are details for the Human Research Ethics Committees at Royal Prince Alfred Hospital and Concord Repatriation General Hospital.
A/Prof Lisa Horvath
Acting Director of Research
Phone: (02) 8514 0142
Nurse Unit Manager, Clinical Research Unit
Phone: (02) 8514 0194
Research Governance Manager
Phone: (02) 8514 0410