Information to Consider before Entering a Trial
To help you decide if you want to be a research participant in a study, the National Statement on Ethical Conduct in Human Research (2007 incorporating all updates) requires that you be given information about the study before you agree to take part. This is known as informed consent.
Research participants must be told:
- information about an unproven drug or device if involved in the study
- the purpose of the research
- the duration of the study
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other options that you might want to consider instead of the treatment being studied (i.e. other procedures or treatments) if involved in a clinical trial
- who to contact with questions about the study, your rights, and any injuries related to the research
- being in the study is voluntary and you can withdraw at any time.
Before you agree to participate in a study, you must be given complete information about the study, this is usually in the form of a Participant Information Sheet. It must include possible side effects and benefits, and you must be given the opportunity to ask questions. You must sign an agreement called an Informed Consent Form before taking part in the study.
At any time you can leave the study and you don’t have to give a reason.
Participant Information Sheet
The Participant Information Sheet provides information to potential research volunteers to enable them to reach an informed decision regarding their involvement in the research.
A Participant Information Sheet must accompany each Consent Form. It must not replace personal communication between the investigator and the participant. Informed consent information should be written so you can understand it. If you don’t, be sure to ask your doctor, the researcher, or other medical person to explain it. Make sure you understand all of it before you agree to be in the study. The informed consent form should state that you can leave the study at any time, for any reason after you have joined, without penalty to you. The Investigator/Researcher must ensure that you are given sufficient time to consider the verbal and written information provided and given the opportunity to discuss it with other people (your general practitioner, friends and/or your family) before being asked to consent to being involved. You should be allowed to bring someone along with you during the consent process. The Participant Information Sheet is to remain your property and a copy of the signed Consent Form must also be provided to you.
Risks and discomforts
Any foreseeable risks, side effects, discomforts, inconveniences and restrictions that may occur to you during the study, including travel and absence from work should be stated in the information sheet. These should be explained in simple language and should help you decide to participate in the study or not.
The Consent Form should include the following:
- a statement about the purpose and reason for conducting the study
- a statement to the effect that you may freely withdraw from the project at any time without prejudice to further treatment
- a statement informing you that there may be no direct clinical benefit to you as a result of the trial
- where reimbursement for out of pocket expenses is to be made, the terms should be clearly set out
- a statement that information collected will be kept confidential, however consent for access for specific purposes such as quality assurance, auditing and in the event of serious adverse events must be obtained
- a statement that you have been given the opportunity to ask questions about the study.