Who can participate in a clinical trial?
Each study has its own rules about who can or cannot participate. This is called “eligibility.” Your eligibility may be based on your age, gender, overall health, type and stage of a disease, treatment history, and other conditions.
Not everyone is chosen to participate. You may be turned down simply because you do not have certain characteristics, such your gender or age. Things that allow you to participate are called “inclusion criteria,” and things that disqualify you are called “exclusion criteria.”
People who participate in clinical trials do so freely and of their own will. They are volunteers. In many studies, the volunteers will have a common health condition, such as kidney disease, high blood pressure, or diabetes.
What is “Informed Consent”?
Before you can participate in a trial, the researchers must make sure you understand all the possible risks, benefits, and alternatives to the study. As part of this process, you may be given verbal instructions, printed materials to read, questionnaires, and other forms of information. If you have any unanswered questions about the trial, be sure to ask.
At the end of this process and if you are still willing to participate you will be asked sign a document stating that you understand the risks, benefits, and alternatives. This is called “informed consent.” Remember, the “informed consent” document is not a contract. It is meant to protect you, not bind you. You can withdraw from the study at any time, for any reason, even if the study is not over.
Should I participate in a clinical trial?
You are the best judge and the only person who can answer this question. Participating is not without risks, but it may give you an opportunity to improve your own health. For example, you may have access to a treatment that’s not otherwise available.
Or the new treatment might be safer or work better than current treatment options. Some people who have participated in clinical trials believe they receive more attention from the healthcare staff, and more careful monitoring of their condition and possible side effects of treatment. You may even have all or part of your medical care and other expenses paid for by the study sponsors. Also, you may be helping future generations that experience kidney problems.
But there are also some possible downsides to consider. The new treatment may have unknown side effects or risks, or it may not work for you even if it helps others. You may find some of the requirements inconvenient, such as traveling a long distance for appointments, frequent office visits and tests, or long time commitments.
One thing to ask yourself is whether the potential health benefits will outweigh the possible risks. You should learn as much as you can about the study and feel comfortable asking the research team questions. Be sure to ask who covers the costs and other expenses, such as travel. Tell your own healthcare provider that you are considering a trial and discuss the advantages and disadvantages together.