What to do if you have a concern about a Clinical Trial?

Please note: this page is not about reporting ‘Adverse Events’ or ‘Suspected Unexpected Serious Adverse Reactions’. If you have an undesirable experience associated with the use of a trial drug, device or procedure please report it to the investigator as soon as possible.

Clinical Trials are an important way to develop and advance our knowledge of diseases and their treatments. In some cases, they may also lead to improved health for yourself or others with the same disease or condition. Clinical trials are closely monitored in Australia; however, problems or issues can arise during a trial. While the expected risks and benefits should have been explained to you when the investigators obtained your informed consent some problems may not be due to the way a trial drug, device or intervention works.

This page includes some information on what to do if you have a concern or complaint about a trial. Unless there is a serious or imminent risk to human health or life, it is recommended that you start with the Option 1 (below).

Contact the Human Research Ethics Committee that approved the study (Option 2) or the Healthcare Complaints Body in your State or Territory (Option 4) if you believe there is a serious risk to human health or life.

Option 1 – Raise your concern with the investigator or researcher directly.

If you feel the trial is not proceeding as expected, e.g. you are not receiving the care you anticipated, or if you have another concern, you should raise the concern with the investigator/researcher directly.

Contact details including a contact number should be included on the Participant Information and Consent Form (PICF) which you signed before being enrolled in the trial. If you do not have face-to-face contact with the researchers (for example, you have been asked to complete a survey or diary) you may wish to call them.

Option 2 – Raise your concern with the Human Research Ethics Committee that approved the trial.

If you believe the trial is not following an approved protocol or is not consistent with the principles of Ethical and Responsible research you may wish to contact the Ethics Office of Human Research Ethics Committee (HREC) that approved the study.

You should also contact the HREC if you believe there is a serious risk to human health.

The contact details for the approving HREC should be listed on the Participant Information and Consent Form you signed before being enrolled in the trial. If you do not have a Participant Information and Consent Form, ask the researcher which HREC approved the study. If you were referred by your family doctor, they may also know which HREC approved the clinical trial or they can help you look for it on www.australianclinicaltrials.gov.au.

HRECs that approve clinical trials should be registered with the National Health and Medical Research Council (NHMRC). A full list of HRECs registered with NHMRC are available on the NHMRC website

When contacting the HREC, try 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 study. An HREC can suspend or withdraw approval for human research, if appropriate or necessary.

Option 3 – Raise your concern with the Institution at which the trial is being conducted.

If you are unsatisfied with the response of the HREC (Option 2), or you cannot identify which HREC approved the study, you should contact the institution at which the clinical trial is being conducted (i.e. the ‘trial site’).  Sometimes the institution might just be a doctor’s office.

Contact details for the trial site may be listed on the Participant Information and Consent Form you signed before being enrolled in the trial. They may also be available on the trial site’s website, the reception of the venue where the trial is taking place or on www.australianclinicaltrials.gov.au

Option 4 – Raise your concern with the Healthcare Complaints Body in your State or Territory

If you are still not satisfied with the response to your concern you may wish to contact the Healthcare Complaints Body in your State or Territory.

You should contact a Healthcare Complaints Body if you believe there is a serious or imminent risk to human health or life.

These bodies have formal powers to investigate complaints against health care providers and registered health professionals.

A list of Healthcare Complaints Bodies is included below:

ACT
Health Services Complaints Commissioner
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
Office of the Health Services Commissioner
WA
Health and Disability Services Complaints Office
If you do not know which State or Territory a health professional is registered in, you can contact the Australian Health Practitioner Regulation Agency.

If your concern is not related to the conduct of a healthcare provider (for example a hospital) or medical practitioner you can raise your concern with:

Option 5 – Raise your concern with the National Health and Medical Research Council (NHMRC)

If your complaint is about research misconduct, NHMRC may be the appropriate place to raise the concern. Information about how to raise a concern about research misconduct in relation to research that NHMRC funds (including clinical trials) is available on the NHMRC website

It is important to note that NHMRC does not investigate allegations of research misconduct or ethical breaches external to NHMRC. This is the responsibility of the institution that is conducting the research.

Option 6 – Report your concern to the Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) regulates medicines and medical devices (collectively called therapeutic goods) in Australia. Therapeutic goods are assessed by the TGA based on what type of product they are, and if they pose a higher risk or lower risk.

If you believe that a clinical trial involving therapeutic goods is not being conducted ethically, or you have significant safety concerns, you can report the trial to the TGA. Through the Secretary of the Department of Health, the TGA has the power to intervene and stop trials which are not in the public interest.

Because clinical trials may deal with unapproved therapeutic goods, you should not report side effects to the TGA. Instead report these directly to the researcher or investigator (see Option 1). The TGA is not notified about every clinical trial because not every clinical trial involves therapeutic goods.

Contact details for the TGA are available on the TGA website

General Advice 

Remember, taking part in a clinical trial is voluntary. You can stop taking part in a trial at any time.

You may decide to stop taking part in a trial if your condition is getting worse, you are finding it difficult to participate or you have concerns about the intervention. You can also choose to leave the trial at any time without giving a reason and without it affecting the care that you receive.

If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected; however, it is important to discuss your decision to leave a trial with the research team so that they can advise you about any other effects of leaving the trial and what will happen to information about you that has been collected for the trial.

After you leave the trial, your doctor will talk to you about any other available treatment for your disease or condition, if it is recommended.