Research undertaken at the Women’s is conducted according to the principles of Good Clinical Practice (GCP) and the NHMRC National Statement on Ethical Conduct in Human Research (2023).
Good Clinical Practice (GCP)
NHMRC National Statement on Ethical Conduct in Human Research (2023)
The welfare of individual participants, their rights, safety and dignity are paramount. Research governance is based on a strong regulatory framework, in accordance with the relevant codes of conduct and both state and federal legislation.
Here is a link to the Women's Research Policy.
Research must be conducted in accordance with the appropriate codes and legislation, including but not limited to:
- The Australian Code for the Responsible Conduct of Research (2018) (the Code)
- NHMRC National Statement on Ethical Conduct in Human Research (2023)
- National Clinical Trials Governance Framework
- NHMRC Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders.
- NHMRC Keeping research on track: A companion document to Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)
- Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice ICH E6 (R2)
- Therapeutic Goods Act 1989
- Health Records Act 2001 (Vic)
- Freedom of Information Act 1982 (Vic)
- Medical Treatment Planning and Decisions Act 2016 (Vic)
- Australian Privacy Act 1988 (Commonwealth).
The NHMRC has a range of Guidelines and tools for specific research including:
- assisted reproductive technology
- clinical ethics
- embryo research, stem cells and human cloning
- organ and tissue donation and transplantation
- privacy
- research involving Aboriginal and Torres Strait Islander peoples
- quality assurance activities.
For guidelines specific to your research, please visit the NHMRC website.
Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
Research at the Women’s involving Aboriginal and Torres Strait Islander peoples, adheres to the principles outlined in:
The National Clinical Trials Governance Framework (NCTGF) supports the integration of clinical trial service provision into routine hospital care for improved patient outcomes.
Clinical trials provide:
- early access to innovative treatments and interventions for patients and
- improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.
The Framework is aligned with the National Safety and Quality Health Service (NSQHS) Standards and in particular, the Clinical Governance and Partnering with Consumers Standards.
There are five components within these two Standards:
- governance, leadership and culture
- patient safety and quality improvement systems
- clinical performance and effectiveness
- safe environment for the delivery of care
- partnering with consumers.
Assessments of the NCTGF Framework commenced in May 2023, in alignment with the NSQHS Standards assessment of health service organisations.
Resources
Video: What is the National Clinical Trials Governance Framework?
Webinar recording: A guide to the Clinical Trials Portal and web-based tools
NCTGF Fact Sheet for Principal Investigators
NCTGF Fact Sheet for Clinical Trial Workforce
NCTGF Fact Sheet for Trial Sponsors