What to do if you have any concerns
If you have an undesirable experience associated with the use of a trial drug, device or procedure please report it to the lead researcher as soon as possible.
Clinical trials are closely monitored in Australia; however, problems or issues can arise during a trial. Researchers should have given you information about the expected risks and benefits when you provided your informed consent. However, some problems may be unexpected or may not be due to the way a trial drug, device or intervention works.
If you have concerns about the conduct or safety of the trial, you may also wish to contact either the:
Contact the researchers directly
Contact the researchers directly if you feel the trial is not proceeding as expected or you are concerned about how you are responding to the intervention. Let them know if you are not receiving the care you anticipated or have any other concern.
Contact details, including a phone number, are on the consent form that you signed before enrolling in the trial. If you have been asked to complete a survey or diary and don’t have regular contact with the researchers, you can call them.
Contact the human research ethics committee (HREC) that approved the trial
Contact the ethics office of the HREC that approved the trial if you believe the trial is not:
- following the approved protocol for the research
- consistent with the principles of ethical and responsible research.
You will need to provide enough information so that they can identify which trial you are enrolled in and what your concern is. They will consider whether your problems raise ethical issues with the project and who else you might benefit from contacting.
If appropriate or necessary, an HREC can:
- suspend a clinical trial
- withdraw approval for the trial.
Contact details for the approving HREC are on the consent form that you signed before enrolling in the trial. If you do not have a consent form:
- ask the researcher which HREC approved the study
- ask your family doctor, if they referred you, which HREC approved the clinical trial or they can help you look for it.
Contact the institution running the trial
Contact the institution running the clinical trial, also known as the trial site, if:
- you are unsatisfied with the response of the HREC
- you cannot identify which HREC approved the study.
Sometimes the institution might just be a doctor’s office.
Contact details for the trial site are:
- on the consent form that you signed before enrolling in the trial
- on the trial site’s website
- available from the reception or information desk of the venue where the trial is taking place
- in our list of clinical trials.
Contact your state or territory healthcare complaints body
If you are still not satisfied with the response to your concern, you can contact the healthcare complaints body in your state or territory. These bodies have formal powers to investigate complaints against healthcare providers and registered health professionals.
- ACT – ACT Human Rights Commission
- NSW – Health Care Complaints Commission
- NT – Health and Community Services Complaints Commission
- Qld – Office of the Health Ombudsman
- SA – Health and Community Services Complaints Commissioner
- Tas – Health Complaints Commissioner
- Vic – Health Complaints Commissioner
- WA – Health and Disability Services Complaints Office
If you do not know which state or territory a health professional is registered in, contact the Australian Health Practitioner Regulation Agency.
If your concern is about:
- privacy matters – contact the Australian Privacy Commissioner, or their state or territory equivalent.
- other government matters – contact the Commonwealth Ombudsman or their state or territory equivalent.
Contact the National Health and Medical Research Council (NHMRC)
If you do not wish to approach the trial site, you can contact NHMRC for advice. However, the NHMRC does not investigate allegations of research misconduct or potential breaches of the the Australian Code for the Responsible Conduct of Research. This is the responsibility of the relevant research institution, as stated in the code.
Report your concern to the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices (also called therapeutic goods) in Australia. The TGA assess these therapeutic goods based on what type of product they are, and whether they pose a higher risk or lower risk.
Report a clinical trial involving therapeutic goods to the TGA if you believe it is not being conducted properly, or have significant safety concerns.
Not every clinical trial involves therapeutic goods, so you should not report side effects to the TGA. Instead report these directly to the researcher.
Leaving a clinical trial
Remember, taking part in a clinical trial is voluntary. You can stop taking part in a trial at any time.
You can decide to stop taking part in a trial if:
- your condition is getting worse
- you are finding it difficult to participate
- you have concerns about the intervention.
If you decide to withdraw you can notify a member of the research team. They will let you know:
- if there are any special requirements before you leave the trial
- what will happen to information they have collected about you during the trial.
If you do withdraw, researchers can ask you to complete and sign a ‘withdrawal of consent’ form.
If you withdraw, it will not affect your routine care nor will it affect the relationship between you and your doctor.
After you leave the trial, your doctor will talk to you about any other available and recommended treatment for your disease or condition.
Researchers, or regulators, will stop a clinical trial if:
- there are signs that the intervention in a trial could be unsafe
- they find, during the trial, that the new intervention is clearly superior or inferior – this reduces the number of people who receive the less beneficial intervention.