Frequently asked questions

No trial is without risk, and the consent form sets out the known risks for each study in full. A number of safeguards apply. Medicines are studied in the laboratory and in animals before they are given to people. Every study is reviewed and approved by an independent Human Research Ethics Committee. In first-in-human studies the starting dose is calculated to be well below the level expected to produce an effect, and participants are dosed one or a few at a time before others follow. A medically qualified investigator is present during dosing and the observation period.

It depends on the study. Some studies recruit healthy volunteers, because the aim is to understand how a medicine behaves in a body that is working normally. Others recruit people living with a specific condition, and are usually run by the specialist who treats that condition. Each study page states clearly which applies.

The amount varies by study and is stated on each study page. Reimbursement covers your time, travel and inconvenience. The amount is reviewed by the Human Research Ethics Committee to ensure it is not set at a level that would unduly influence a decision to take part.

Reimbursement received for participation in research may need to be declared, depending on your circumstances. Vitalis cannot provide tax advice; please consult the Australian Taxation Office or your accountant.

Taking part is confidential. We do not notify your employer or your insurer. Whether you tell them is your decision.

Tell staff immediately — day or night. You will be assessed by a doctor, treated, and the event recorded. If you need hospital care there is a documented procedure to get you there. Reporting a side effect never counts against you, and it does not mean you are removed from the study unless that is medically necessary.

Yes. At any point, without giving a reason, and you are paid for what you completed. The consent form is not a contract that binds you to finish.

Study criteria are narrow and often unrelated to health — a blood test result slightly outside a range, a medication you take, a recent study you did elsewhere. It very rarely means anything is wrong. If a screening test does find something that matters for your health, a doctor will discuss it with you and advise you to see your GP.

A minimum interval between studies applies for participant safety, and is recorded by the site. You will be advised when you next become eligible. Please inform the site of any study you have taken part in elsewhere, as this affects your eligibility.

No referral. Eligibility for Medicare is not usually required, though some studies have criteria about residency or how long you will be in Australia, because they need you available for follow-up.