As a clinical trial participant in Australia you have the right to full information before you agree, the right to ask questions at any point, the right to withdraw at any time without giving a reason and without affecting your usual medical care, the right to privacy, and the right to be told if new safety information emerges during the study. 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 ten rights you have
- To be told what the trial involves, in plain language. What's being tested, what's known and unknown about it, what will be done to you, how long it lasts, and what the alternatives are, including no treatment.
- To take your time before deciding. That includes taking the consent form home and discussing it with your GP, specialist, family or anyone else.
- To ask any question and get a straight answer. Before consent, and at any point after.
- To refuse, with no consequences. Declining a trial cannot affect the standard care you receive.
- To withdraw at any time, without giving a reason. Your usual care continues unaffected.
- To be told about 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.
- To privacy and confidentiality. Your identifiable information is protected, and study data about you is coded rather than named.
- To know who is paying for the trial. The sponsor, and any financial interest the investigator has, should be disclosed to you.
- To medical care for study-related injury. The arrangements are set out in your consent form.
- To complain to someone independent. That means the ethics committee that approved the study, not just the site running it.
What informed consent actually is
Consent is a conversation, not a form. The form documents it.
A proper consent process gives you the Participant Information and Consent Form (PICF) in advance, walks you through it section by section, invites questions, tells you what's routine care and what's extra because of the study, and confirms you understand before you sign. You get a signed copy to keep.
Three things worth knowing:
- Consent is ongoing. Signing 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. If you're asked to sign at the same visit you first heard about the trial, and you don't feel ready, say so and take it home
Can I withdraw from a clinical trial once I've started?
Yes. At any time, for any reason or none, and you don't have to justify it. Tell the study coordinator or investigator. Your usual medical care continues unaffected.
Two practical caveats, both worth understanding before you enrol:
- 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?
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 anything?
No. 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.
What you should clarify: what happens to costs if you need medical care because of something the study caused. That belongs in the consent form.
Who do I contact if I'm unhappy?
Escalate in this order:
- 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
Your consent form must contain a complaints contact. If it doesn't, that's a problem with the trial, not with you.
Before you sign, 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.
