Demystifying the Consent Process in Clinical Trials

What informed consent really means

Informed consent in clinical trials isn’t just about signing a form, it’s a conversation between you and the research team.  There are different types of clinical trials, and each study can involve multiple steps, procedures, and requirements. The consent discussion is designed to ensure you fully understand what’s involved before deciding whether to participate, and that understanding continues throughout the study.

In Australia, informed consent must meet strict ethical standards set out in the National Statement on Ethical Conduct in Human Research, overseen by the National Health and Medical Research Council (NHMRC).

You have the right to:

• Receive information about the study in clear, plain language
• Ask questions and receive honest, balanced answers
• Take time to consider your decision without pressure
• Withdraw from the trial at any time without penalty or impact on your ongoing care

Importantly, consent is not a one-time event. If new information arises during the trial, such as updated safety data or changes to procedures, you will be informed and may be asked to re-consent.

This process ensures respect, understanding, and safety, core values at the heart of ethical research.

Informed consent in Australia: what makes it different

Clinical trials conducted in Australia are held to globally recognised ethical standards, with additional safeguards built into the system.

Participants are provided with a Participant Information and Consent Form (PICF), which must:

• Be written in clear, non-technical language
• Outline all relevant information about the trial
• Be reviewed and approved by a Human Research Ethics Committee (HREC)

The consent process must also:

• Be voluntary and free from coercion
• Allow sufficient time for consideration
• Be appropriately tailored for cultural, language, or accessibility needs

For some studies, additional protections are in place for vulnerable participants, including minors or individuals requiring support in decision-making. These safeguards are designed to ensure that consent is truly informed, not just documented.

Your rights and responsibilities

When considering participation in a clinical trial, you have rights that protect you and responsibilities that help ensure research quality.

Your rights include:

• Receiving written information about the trial’s purpose, procedures, risks, and potential benefits
• Having your privacy and confidentiality protected
• The freedom to say no or withdraw at any point
• Access to contact details for both the research team and the HREC Australia that reviewed the study

Your responsibilities include:

Carefully reading the Participant Information and Consent Form (PICF), asking questions about anything you don’t understand, reporting any changes in your health during the study, and following the study protocol.

What should be disclosed before agreeing to join

Before giving informed consent, the research team must provide all essential details, including:

• Purpose: Why the study is being conducted and who is sponsoring it
• Procedures: What you’ll be asked to do and how long it will take
• Risks and benefits: What you might experience, both positive and negative
• Alternatives: What other treatments or options are available
• Privacy: How your personal information will be stored and used
• Costs and reimbursements: Any expenses or compensation
• Contacts: Who to reach if you have questions or complaints

Full disclosure not only builds trust but is crucial to a clear and consensual process, values that sit at the centre of clinical trial ethics and participant safety.

Why speaking with your GP matters before joining a trial

Before deciding to participate in a clinical trial, it is strongly recommended that you speak with your General Practitioner (GP) or treating healthcare professional that is if they haven’t suggested it as an option for you. 

Your GP understands your medical history, current treatments, and overall health, and can help you consider whether a clinical trial is appropriate for your individual situation.

Talking to your GP can help you:

• Understand how the trial may interact with your current care plan
• Identify any potential risks based on your medical history
• Clarify whether standard treatments or alternative options are available
• Prepare questions to ask the research team
• Make a more informed and confident decision

Clinical trials are designed with safety in mind, but they are not one-size-fits-all. A discussion with your GP adds an important layer of personalised medical advice to support your decision-making. This step also supports better communication between your healthcare providers and the research team, helping to ensure continuity of care throughout the study.

Why ethics approval matters — and the role of HRECs

Every clinical trial in Australia must be reviewed by a Human Research Ethics Committee (HREC). These independent committees ensure that research meets ethical, legal, and scientific standards before it begins.

• The research complies with the National Statement on Ethical Conduct in Human Research
• The risks to participants are clearly explained and minimised
• The consent process is fair, transparent, and appropriate
• Participant welfare is prioritised at all times

Independent organisations along with hospitals play a key role in this process.

This rigorous review helps safeguard participants and upholds the principles of clinical trial ethics — respect, justice, and beneficence.

Tips for potential participants

• Bring a friend, family member.
• Take time to read the information sheet carefully
• Write down questions before your appointment
• Don’t feel pressured — participation should always be voluntary and your choice 

The bigger picture: building trust through awareness

Understanding the informed consent clinical trials process is vital to building trust between researchers and the community.

Through education, advocacy, and collaboration, White Coats Foundation works to disseminate information and raise awareness to help possible participants  to make informed choices and strengthen confidence in the research that shapes better health outcomes in Australia.

Informed consent ensures respect, understanding, and autonomy, while clinical trial ethics protect participants and uphold research integrity; NHMRC Australia oversight further ensures transparency, accountability, and safety, and speaking with your GP adds personalised medical guidance before participating.