All Questions

What should be considered before participating in a research project?

Since the aim of clinical studies is to gain medical knowledge, the safety and efficacy of the medical intervention is not always fully known at the time of the clinical study. Most clinical studies contain some type of risk of harm or injury to the participant. Clinical studies approved by the Research Ethic Committees (REC) within the EU, USA's Institutional Review Boards (IRB), and Health Canada's Research Ethics Board (REB) are under a restriction, since these institutions have decided that the risks of participation have been minimised and are reasonable in relation to the expected benefits of participating in the trial. All studies that the Health Panel informs about are approved by these respective ethic institutions.

It is important that you have clear expectations when participating in a research project, and thus becoming comfortable with the process. We recommend that you write down as many thoughts and questions as possible, which you and your doctor can go through together and review in the initial interview.

What is required from me as a participant?

Before the study begins, you will visit the clinic for a screening (at the clinic tests are performed to determine if you qualify to participate in the study). Here you will be asked to read and sign an informed consent before any study-related procedures are performed. The informed consent document informs you about the process and other relevant information about the research project, such as the duration of the study, the possible side effects and potential benefits.

During the study, you will visit the clinic periodically for treatment and/or clinical evaluations and tests. This may be on a weekly basis, every other week, or once a month, depending on which stage of the study you are in.

If you do not wish to participate in the research project after the initial interviews, we respect your decision. If you want to participate and you sign the informed consent document but subsequently do not want to complete the study, we also respect this decision. You should feel safe and want to go through with the study because you wish to do so and not because of pressure. You always have the option of quitting the research project if you want to.