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 to join.

Learn more about:

• What informed consent involves
• Contact person
• Participant information
• Privacy

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.

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.

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.

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.

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.

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.