Before deciding to participate in a clinical research study, it's important that you understand the research study and clinical research in general so that you can make an informed decision. Below are some common questions and answers about clinical research studies. You may also find it helpful to talk with your doctor or loved ones before making your decision.
What is a clinical research study?
A clinical research study is a research project done with human volunteers to find out if new medications and treatments are both safe and effective. In a clinical research study, the participants get an investigational medication under the supervision of a doctor and other research professionals. (It's called investigational because the medication isn't approved yet for general use.) As a trial goes on, the doctor and researchers gather more and more information about the investigational medication.
Should I participate in a clinical research study?
It's your decision. People volunteer to participate in a clinical research study for different reasons. Some want access to new investigational drugs. Others want to help advance science. Either way, by participating you may help develop better future medical treatments. Whatever the reason for your interest, be sure to make an informed choice about participating.
How will I be protected?
Clinical research studies are regulated, following rules set by the FDA or other health authorities. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study.
Each research study must also be approved by an institutional review board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and welfare of people participating in research studies. IRBs or ECs are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people.
Your privacy will also be protected. The research team can't tell anyone that you're participating in a research study without your permission. All of the information collected during the study will be kept confidential, and your name won't be listed in any reports based on the study.
What can I expect?
Generally speaking, the study doctors and researchers will check your health at the beginning of the research study, give you specific instructions for participating, monitor you carefully during the study, and then stay in touch after the study is completed.
What is informed consent?
In order to help you decide if you should participate, the study doctor and researchers will explain the research study, then ask you to review an "informed consent document". An informed consent document describes the clinical research study, including its purpose, duration, procedures, possible known risks and benefits of participating, and what is expected of you as a participant.
After being informed of all the key facts about the clinical research study, you decide whether or not to sign the document and join the study.
What are the risks?
Different research studies have different risks. Some investigational medications being tested can have side effects, some of which may be unknown. In some studies, some people receive the active investigational medication while others receive a placebo. A placebo looks like the study medication, but has no active components. Note that whether you receive the placebo or the active investigational medication, you'll receive the same level of study-related care.
Whatever the risks are for the study you choose, your study doctor or research team will review them with you before you sign the informed consent document.
Can I leave a clinical research study after it has begun?
Yes, you have the right to leave a research study at any time. When you want to leave, tell the doctor or research team and explain your reasons for leaving.
What happens after a clinical research study?
After a clinical research study is finished, all of the information is collected and analyzed to help determine the medication's safety, effectiveness, and side effects.
Please talk to your doctor or healthcare provider to find you your treatment options after you complete a study.
How much do you get compensated for your time?
Payments can range anywhere from $1000-$5000 depending on how long the trial is and your travels.
Click here to find and join a clinical study
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