Informed consent

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 whether to join.

Learn more about:

• Informed consent steps
• Participant information
• Contact person
• Privacy
• Communicating with the treatment team

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Informed consent steps

Informed consent involves two steps:

• Written information – You will receive written information about the study, explaining its purpose, what is expected of the participants, what the possible risks are and how the results will be presented. This is called participant information. You can also talk to your doctors and/or clinical trials or research nurse about any aspect of the study.

• Agreement in writing – You agree to participate by signing the informed consent form. For people under 18, a parent or guardian has to give legal consent. Signing the form is not a contract and you can withdraw at any time. You will receive a copy of the consent form signed by you and the researcher.

The process of providing informed consent continues throughout a study. If the study changes or new information becomes available while you are involved, you will be given updated participant information and 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 be given an extra questionnaire, which may also require you to consent again.

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Participant information

Researchers must provide written information about the study to anyone thinking about getting involved. This is called participant (or patient) information.

It answers a range of questions about a 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 or other procedures
• how long you need to be involved for
• where you need to go for appointments, treatments or meetings
• whether your medical records need to be accessed
• whether you will be reimbursed for any related expenses
• 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. other treatments you can have
• who to contact for further 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.

The participant information can help people decide whether they want to join or continue participating in a study. You can also ask the research team any questions you have about the study. It’s a good idea to mark any questions on the information sheet so that you can raise them with the doctor or study coordinator.

  — Piers, diagnosed with chronic lymphocytic leukaemia

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Contact person

All studies have a contact person. You can talk to this person before you decide to participate 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, for example, how it was run or how you were treated. This person is independent of the research team. Complaints about research are rare, but it is one of your rights as a participant to have your concerns heard if you have a problem.

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Privacy

Medical records are private and confidential, including those relating to your involvement in a trial or study. 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 disclose anything about you to others unless it is relevant to your health care or the study.

The participant information may mention who will and won’t have access to your personal data. For example, it might state that your regular medical team won’t have access to your questionnaire responses but the researchers will. You might be asked to consent to the research team accessing your existing medical records or particular test results.

Information collected during the study is often de-identified. This means that it won’t have your name on it so the results cannot be linked to you. Sometimes not even the researchers know which results belong to which individuals. When the results are published in journal articles and discussed at conferences, you will not be named.

For more information about privacy issues in health care, talk to the social worker at your hospital or call Cancer Council 13 11 20.

At the end of a clinical trial, all personal information is stored securely for at least 15 years before it can be destroyed. This is a legal requirement.

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Communicating with the treatment team

• Keep contact information handy if you have questions before and during the study.
• Sometimes a trial is run at a different hospital to the one where you are having treatment. This means you may have two treatment teams. If this is the case, make sure your medical information and any relevant test results are available to both treatment teams, and ask who your main contact person is. It may also help to take your own record of test results to the hospital.
• If you are in a clinical trial and develop significant problems, go to your hospital’s emergency department and/or contact the oncology registrar. Make sure to tell them you’re in a clinical trial. If you go to hospital, let your trial team know.

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