Regulations, ethics and governance in clinical trials
Regulations, ethics, and governance play crucial roles in clinical trials, ensuring that studies are conducted responsibly and with the utmost regard for participant safety and scientific validity. Regulations establish the legal standards and procedural requirements for conducting trials.
Ethical oversight, provided by committees such as Human Research Ethics Committees (HRECs), ensures that trials prioritise participant welfare, informed consent, and respect for human rights. Governance frameworks oversee the implementation of these regulations and ethical standards, ensuring that trials adhere to best practices, maintain transparency, and produce reliable and credible results. Together, these elements create a comprehensive system that upholds the integrity and trust in clinical research.
Clinical trial regulations, ethics and governance: A quick summary
- regulations establish the legal standards and procedural requirements for conducting trials
- ethical oversight ensures that trials prioritise participant welfare, informed consent, and respect for human rights
- governance frameworks oversee the implementation of these regulations and ethical standards, ensuring that trials adhere to best practices, maintain transparency, and produce reliable and credible results.
Read on to learn about regulations, ethics and governance in more detail.
An introduction to regulations, ethics and governance in clinical trials in Australia
In Australia, there are a number of regulatory frameworks that govern clinical trial research. The regulations exist to ensure the integrity, safety and ethical conduct of scientific studies. The Australian Code for the Responsible Conduct of Research, 2018 (the 2018 Code) provides a foundation for high-quality research, credibility and community trust in research. It was developed jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia. The 2018 Code has broad relevance across all research disciplines.
To support the 2018 Code a Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research, 2018 has been developed and covers topics such as authorship, peer review, and supervision. In Australia, all research should adhere to the 2018 Code and for, many funders, is a prerequisite for funding.
Clinical trial regulations
Clinical trials in Australia are regulated under Commonwealth, state and territory legislation.
Therapeutic Goods Legislation
The Therapeutic Goods Administration (TGA) regulates the use of therapeutic goods (medicines, devices, biologicals, and diagnostic tests) supplied in clinical trials under the Therapeutic Goods Legislation. For details of therapeutic goods lawfully supplied in Australia, visit the Australian Register of Therapeutic Goods (ARTG) register.
Clinical Trials Notification (CTN) and Clinical Trials Approval (CTA) schemes
The TGA administers the CTN and CTA pathways for clinical trials using “unapproved” therapeutic goods to lawfully supply them for experimental use in humans. Examples include new pharmaceutical drugs or devices used in First in Human trials, and drugs or devices being used for a new indication.
The CTN is a notification only process which requires the completion of an on-line notification form and payment of the required fee, prior to starting to use an “unapproved” therapeutic good, in a clinical trial situation.
The CTA is an approval process using paper-based, postal submission of two forms with supporting preclinical or clinical data, seeking approval to supply “unapproved” therapeutic goods for a clinical trial.
The Australian clinical trial sponsor is responsible for submitting the CTN or CTA.
Good Clinical Practice
In Australia, the TGA has adopted ICH Good Clinical Practice guidelines which are mandatory for trials involving “unapproved” therapeutic goods. Some elements of the guidelines have been modified by the TGA in line with local regulatory requirements.
Good Clinical Practice Inspection program
The TGA has implemented a Good Clinical Practice Inspection program. Clinical trials involving the use of medicines, biologicals and devices are all subject to this program if they are regulated under the TGA’s Clinical Trials Notification (CTN) or Clinical Trials Approval (CTA) schemes.
Ethics and clinical trials
Rigorous ethical review processes are crucial for protecting the safety, rights and wellbeing of research participants. Reviews are conducted by an ethics committee which, in Australia, is known as a Human Research Ethics Committee (HREC).
The role of an HREC is to ensure that research involving human participants is conducted ethically and in compliance with regulatory standards. Investigators, HRECs, approving authorities and trial sponsors should ensure that they comply with the specific requirements for each jurisdiction.
In Australia, HRECs can register with the National Health and Medical Research Council (NHMRC) to demonstrate that their HREC meets the requirements of the National Statement on Ethical Conduct in Human Research, 2025 (National Statement).
The National Statement
Clinical trials and research involving humans must adhere to the guidelines set out in the National Statement. The National Statement identifies four core principles that should govern research: respect, research merit, justice and beneficence.
Privacy legislation
Clinical trials and research involving humans must ensure a research proposal conforms to privacy legislation at both Commonwealth and/or state/territory legislation, as well as the s95 and s95A guidelines.
Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
The National Statement identifies the importance of researchers considering research design, ethics, culture and language when engaging in research with Aboriginal and Torres Strait Islander Peoples and communities. Ethical research relationships with Aboriginal and Torres Strait Islander Peoples is underpinned by respect for and valuing of cultural and language diversity.
The NHMRC has also developed guidelines that includes a set of principles to ensure that research is safe, respectful, responsible, and of high quality and benefit to Aboriginal and Torres Strait Islanders Peoples and communities.
National Mutual Acceptance (NMA)
While NMA is not a guideline per se, it is a national system for mutual acceptance of scientific and ethical review of multi-centre research undertaken in publicly funded health services. It enables the acceptance of a single ethical and scientific review of human research projects in participating jurisdictions. In practice, this means that a clinical trial with multiple public health sites only requires one HREC application to a certified HREC.
Governance
Governance is a framework, systems and processes associated with the authorisation, commencement, conduct and monitoring of a clinical trial.
Ethical oversight
Organisations will require ethics documentation to be viewed and a HREC approval letter.
Risk management
Good research governance involves a risk management plan that identifies potential risk to participants, researchers and your organisation, as well as strategies to mitigate these risks.
Quality assurance
Developing and following detailed research protocols that outline the methodology, objectives and procedures of the study to ensure it complies to regulatory standards is essential as regular monitoring and auditing will occur throughout a trial.
Data management
The governance of data management ensures that data is collected, stored, and analysed in a manner that maintains accuracy and reliability.
Legal requirements
Legal requirements ensure that research adheres to national and international laws and regulations, such as data protection laws, clinical trial regulations, and contracting arrangements for research, including supplier or consulting contracts. When working collaboratively in a clinical trial, Medicines Australia has developed a suite of clinical trial research agreements.
These agreements have standard terms that cannot be amended without approval from the National Clinical Trial Agreement panel. If a trial is using the tele-trials model, a sub-contract has been developed to complement the Medicines Australia suite of agreements.
Other legislation to be considered:
- The Privacy Act
- The Human Tissue Act
- Guardianship and Administration Act
- AUS Radiation Protection and Nuclear Safety Act
Site authorisation
If a public health hospital is used as a research site, a site authorisation application form will need to be completed. It is always best to contact the public hospital’s Governance Office before submitting your application as individual jurisdictions have specific requirements and these can include additional compliance with data protection and radiation safety.
Frequently asked questions
Research governance is a framework of policies, standards, guidelines, and processes designed to ensure that research is conducted responsibly, ethically, and effectively. It involves overseeing and managing research projects to ensure their integrity, quality, and compliance with legal, ethical, and organisational standards.
Research governance is important for:
- protecting the rights, safety, and well-being of research participants
- ensuring the ethical conduct of research
- maintaining the scientific integrity and credibility of research findings
- complying with legal and regulatory requirements
- enhancing public trust in the research process.
Responsibility for research governance lies with multiple stakeholders, including:
- researchers conducting the studies
- research institutions and universities
- Human Research Ethics Committees
- regulatory bodies such as the Therapeutic Goods Administration.
Key components include:
- ethical oversight and approval by ethics committees
- regulatory compliance with national and international laws
- quality assurance through protocols and monitoring
- risk management strategies
- data management practices to ensure integrity and confidentiality
- clear governance structures define roles and responsibilities.
Human Research Ethics Committees review research proposals to ensure they meet ethical standards. They assess the study’s risk-benefit ratio, informed consent process, and measures to protect participants. They also provide ongoing oversight throughout the research project.
Research governance includes policies and procedures for managing data responsibly. This involves:
- ensuring data accuracy and reliability
- implementing secure data storage and handling practices
- protecting the privacy and confidentiality of participants’ information.
Consequences can include:
- harm to participants
- ethical breaches, leading to loss of public trust
- invalid or unreliable research findings
- legal and regulatory penalties for non-compliance
- damage to the reputation of researchers and institutions.
The National Statement is a guideline issued by the NHMRC, Australian Research Council, and Universities Australia that provides a comprehensive framework for the ethical conduct of human research in Australia. It outlines principles and processes for ethical review, participant protection, and research conduct.
Researchers ensure compliance by:
- adhering to ethical guidelines and regulatory requirements
- submitting research proposals for ethical review
- following approved research protocols
- maintaining accurate records and documentation
- reporting any adverse events or changes to the study protocol.
Research organisations are responsible for:
- establishing and maintaining policies and procedures for ethical research conduct
- supporting ethics committees
- providing training and resources for researchers
- monitoring compliance with governance standards.
