Frequently Asked Questions
Free and Voluntary Participation
It's up to you. We can give you information, but joining a study is 100% your decision. If you do not want to join the study, we fully support your decision. If you join the study and later change your mind, we will fully support that decision too.
You need information to make your decision. Since joining a study is your decision, you need to know some facts about the study. It's not enough for you to just hear them - you need to understand them and think about how they apply to you.
Clinical Research is Not Clinical Care
A clinical study is an experiment. When you visit your doctor normally, the purpose is to take care of your health. A clinical study is different - it is a scientific experiment to find out whether an unproven treatment works safely for people with some health condition. The treatment might work safely for you, but that is not the main purpose of the study.
Randomization and Blinding
Neither of us will know if you are getting the unproven treatment. In many clinical studies, we are comparing an unproven treatment to a placebo/no treatment. For the experiment to work, we can't tell you which one you are getting. In fact, we won't know either most of the time. The treatment you get will be chosen at random, like flipping a coin. Neither of us will know whether the coin came up heads or tails.
Both treatments seem ok to us. If we knew that the unproven treatment is better or worse than a placebo/no treatment, we would not do the study because we would already know the answer. This means that, if you join a study, you should be ok with either getting or not getting the unproven treatment.
Risks vs. Benefits
There are risks, but they do not seem unreasonable to us. We do not know whether a study will help you. It might harm you. This study will help us find out about possible harms. No matter what we think, you have to decide for yourself whether the possible benefits make the risks worth taking for you.