Before becoming part of a clinical trial or other research study, all participants have to give “informed consent”. This means you will be asked to confirm you have read and understood the purpose, risks and possible outcomes of the research before deciding to join.
Learn more about:
What informed consent involves
Informed consent involves:
| Written information | After talking to you about the study, members of the research team will give you a written document known as the participant information. This written information explains the purpose of the study, what is expected of you if you join, what the possible risks are, how your information will be used, and how the results will be presented. You should read the participant information carefully and note down any questions you have for your doctors and the clinical trials or research team. |
| Informed consent discussion | After you have read the participant information, you can discuss the study in more detail with the clinical trials or research team. You should ask them to explain any parts of the written information that seemed unclear to you. |
| Agreement in writing | Once all your questions have been answered, you can then decide whether or not to join the study. If you do choose to take part, you will be asked to sign the informed consent form. |
This confirms that you understand the purpose of the study, what is involved, the potential risks and benefits, and you agree to participate.
For people under 18, a parent or guardian has to give legal consent as well. Signing the form is not a contract and you can change your mind at any time. You will receive a copy of the consent form signed by you and the researcher.
The process of informed consent continues throughout the study. If the study changes or new information becomes available while you are involved, you will be given updated participant information. You will need to sign an updated version of the consent form if you are willing to continue.
Sometimes you may need to consent to each aspect of a study. For example, you might agree to take part in a trial of a new surgical procedure, and then need to consent for your tissue to be collected and banked during that surgery. You might also need to consent again if you are given an extra survey or interview.
For some low-risk studies, written informed consent may not be needed. For example, if you are doing a survey, just completing the survey may be taken as consent, or you may be able to say you consent over the phone.
Contact person
All clinical trials and other research studies have a contact person. You can talk with this person before you decide to take part and at any stage during the study if you have questions or concerns. The contact person is often a clinical trials nurse or study coordinator.
You will also be given details of who to contact if you have a complaint about the study (e.g. about how the study was run or how you were treated). This person is independent of the research team and is usually a senior member of the human research ethics committee. Complaints about research are rare, but it is your right to have your concerns heard if you have a problem.
Participant information
Researchers must provide written information about the research study to anyone thinking about joining. This is called participant (or patient) information. It answers a range of questions about the study, including:
- the purpose of the study
- if it is a clinical trial, and what phase it is in
- who can participate in the study
- who is running the study (institution and researchers)
- who has approved the research
- who is funding the study
- how the study will be run and what you need to do
- how the study will be monitored
- whether you will need to have tests, scans or other procedures
- how long you need to be involved
- where you need to go for appointments, treatments or meetings
- whether the researchers need to see your medical records
- whether you will be paid back (reimbursed) for any expenses related to the study (e.g. transport or parking costs)
- information about possible side effects or other risks
- information about possible benefits
- any restrictions on things you can do while you are on the study (e.g. treatments you can’t have)
- who to contact for more information or if you have any problems or complaints during the study (see Contact person)
- information about your rights, such as keeping your records private and your ability to withdraw from a study.
My doctor suggested I take part in a study and I thought it sounded beneficial. I found the thorough disclosure of both the trial and the possible side effects reassuring.
Piers
Privacy
Medical records are private and confidential, including those about your involvement in a clinical trial or any other research study.
Who can access your information?
Health professionals directly involved in your care or study can access your personal and medical information, but only if it’s necessary for their work. They can’t give any information about you to others unless it is relevant to your health care or the study.
How your data is used in research
Clinical trials and other research studies collect personal data about you. The participant information may mention who will and won’t have access to your personal data. For example, it might state that your regular treatment team won’t see your survey responses, but the researchers will. You might be asked to consent to the research team seeing your existing medical records or particular test results.
De-identification of data
Information collected during the study is often de-identified. In most cases, this means that your name will be removed and replaced with a unique participant number so your identity cannot be revealed unless necessary, e.g. for safety reasons. Being de-identified means when the results are published in medical journal articles or discussed at medical conferences, you will not be named.
Addressing privacy concerns
If you have questions or concerns about your privacy in a clinical trial or other research study, talk to the clinical trials or research nurse.
For general information about privacy issues in health care, talk to the social worker at your hospital.
At the end of a clinical trial, all personal information is stored in a secure place for at least 15 years before it can be destroyed. This is a legal requirement.
→ READ MORE: Your role in the trial or study
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Key resource
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More resources
All updated content has been clinically reviewed by A/Prof Brett Hughes, Senior Staff Specialist, Medical Oncology, Royal Brisbane and Women’s Hospital and The Prince Charles Hospital, and Associate Professor, The University of Queensland, QLD. This edition is based on the previous edition which was reviewed by the following panel: A/Prof Brett Hughes (see above); Christie Allan, Clinical Trials Lead, Cancer Council Victoria, VIC; Dawn Bedwell, 13 11 20 Consultant, Cancer Council Queensland, QLD; Joanne Benhamu, Senior Research Nurse, Team Lead, Lung, Colorectal and Palliative Care Trials, Parkville Cancer Clinical Trials Unit, Peter MacCallum Cancer Centre, VIC; Louise Dillon, Consumer; Sabina Jelinek, Clinical Nurse Research, St John of God Murdoch Hospital, WA; Chloe Jennett, Program Coodinator, Cancer Research, Cancer Council NSW; Carmel McCarthy, Consumer; Alison Richards, Research Unit Manager, Medical Oncology Clinical Trials Unit, Flinders Medical Centre, SA; Prof Jane Ussher, Translational Health Research Institute (THRI), School of Medicine, Western Sydney University, NSW; Prof Janette Vardy, Medical Oncologist, Concord Cancer Centre, and Professor of Cancer Medicine, The University of Sydney, NSW.
View the Cancer Council NSW editorial policy.
