As a clinical trial participant in Australia, you have important rights designed to protect your safety, wellbeing and ability to make your own decisions.
You have the right to fully understand the study information before you agree, to ask questions at any point, to withdraw at any time, to have your privacy protected and to be told about new information that may affect your decision to continue.
These rights sit under the NHMRC National Statement, the ICH good clinical practice guideline and the Declaration of Helsinki.
They're not favours. They're the conditions on which the trial was allowed to open.
The rights you have
As a clinical trial participant in Australia, you have the right to:
- Understand what the trial involves, in plain language. You should be told what's being studied, what participation involves, the known risks and potential benefits, how long it lasts and what other options you have.
- Take your time before deciding. That includes taking the consent form home and discussing it with your GP, specialist, family or anyone else.
- Ask any questions. You can ask questions before you consent and throughout the study.
- Refuse, with no consequences. Declining a trial cannot affect the standard care you receive.
- Withdraw at any time. Participation is voluntary, and you can choose to leave the trial at any time.
- Receive new information. If something emerges during the trial that might change your decision to continue, you must be told, and you may be asked to re-consent.
- Privacy and confidentiality. Your identifiable information is protected, and study data about you is coded rather than named.
- Know who is paying for the trial. The sponsor, and any financial interest the investigator has, should be disclosed to you.
- Medical care for study-related injury. The arrangements are set out in your consent form.
- Complain to someone independent. That means the ethics committee that approved the study, not just the site running it.
What is informed consent in a clinical trial?
Informed consent is the process of making sure you understand a clinical trial before voluntarily agreeing to participate. It is more than simply signing a consent form.
Before joining a clinical trial, you will receive a Participant Information and Consent Form (PICF) explaining the research, what will happen, the potential risks and benefits, and your rights as a participant.
You should have the opportunity to read it, ask questions and make your decision without feeling pressured.
Three important things to know:
- Consent is ongoing. Signing a form at the start doesn't lock in your agreement forever. If the protocol changes materially or new risks are identified, you're re-consented.
- You can consent to some things and not others. Many trials have optional components: an extra biopsy, a genetic sub-study, long-term storage of samples. These have separate tick boxes. You can decline them and stay in the main trial. Ask which parts are optional, because it isn't always obvious.
- A rushed consent is a red flag. You should have enough time to understand the information and make an informed decision. If you're not ready to decide, tell the research team.
Can I withdraw from a clinical trial once I've started?
Yes. Participation in research is voluntary, and you can withdraw if you decide you no longer want to take part.
Talk to the study team if you're considering withdrawing so they can explain what happens next.
Two things are particularly worth understanding:
- A safety visit is usually requested. You aren't obliged to attend, but stopping some study treatments abruptly carries its own risk, and a final check is in your interest. Ask what a safe stop looks like.
- Data already collected is generally kept. Information gathered up to the point of withdrawal usually stays in the study, because removing it would distort the results. You can normally decline further data collection from that point on. The specifics are in your consent form, so read that clause before you sign, not when you want out.
What happens to my personal information in a clinical trial?
Your study records are coded, so the data leaving the site is identified by a participant number rather than your name. The site keeps the link between the code and your identity.
Who can see your identifiable records: site staff involved in the study, sponsor or CRO monitors and auditors, the ethics committee, and regulators such as the TGA. In every case the purpose is to verify that the trial was conducted properly and the data is accurate. You consent to this access when you enrol, and it's how fraud gets caught.
Handling of personal information is governed by the Privacy Act 1988 and the Australian Privacy Principles, along with state and territory health records legislation.
Three questions to ask about your data:
- Will my samples or data be sent overseas, and where?
- Will samples be stored for future research, and can I decline that part?
- Will I be recontacted about future studies, and can I opt out?
Do I have to pay to participate in a clinical trial?
The study treatment and the tests required by the protocol are provided at no cost to you, and you should never be asked to pay to take part. Most sites reimburse travel and parking; ask how and when reimbursement is paid.
Before joining, ask the research team what is covered, what isn't and how reimbursements are paid.
Who do I contact if I have a problem with a clinical trial?
Your Participant Information and Consent Form should tell you who to contact if you have questions, concerns or complaints about the clinical trial.
Depending on your concern, this may include:
- Your study coordinator: first stop for anything practical or clinical
- The principal investigator: the doctor responsible for the trial at your site
- The human research ethics committee: named in your consent form, with contact details, and independent of the sponsor. This is the right channel for a complaint about how you were treated or how the study was conducted
- The institution's research governance office: for complaints about the site itself
- The TGA: for concerns about the product or the conduct of the trial under its notification scheme
You don't have to wait for something serious to happen before raising a concern.
What should I check before signing a clinical trial consent form?
Before signing a clinical trial consent form, make sure you understand what you're agreeing to, including the risks, time commitment and your options if you change your mind.
Check these five things:
- The HREC name and approval reference are on the form
- The trial's registry number (ANZCTR or ClinicalTrials.gov) is on the form
- The withdrawal clause, including what happens to your data
- The injury and compensation clause
- Which components are optional
If any of the five is missing or vague, ask before you sign. A well-run site will answer without hesitation, and the way they respond to that request tells you most of what you need to know about how the next twelve months will go.
Sources
- National Health and Medical Research Council (NHMRC), National Statement on Ethical Conduct in Human Research.
- International Council for Harmonisation, ICH E6 Guideline for Good Clinical Practice.
- World Medical Association, Declaration of Helsinki.
- Office of the Australian Information Commissioner (OAIC), Privacy Act 1988 and the Australian Privacy Principles.
- Therapeutic Goods Administration (TGA), Clinical trials in Australia.
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