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Understanding Clinical Studies

WHO SPONSORS A CLINICAL RESEARCH STUDY?

Private organizations and government agencies sponsor clinical research studies to find better ways to treat diseases. Drug companies also sponsor studies of their products and may work together with medical centers, the government, or doctors' offices.

WHO MAKES SURE MY RIGHTS ARE PROTECTED?

An ethics committee must review clinical research studies before they begin. In addition the FDA (Food and Drug Administration), a department of the US government, sets requirements for drug testing. They also review the results from certain clinical research studies to decide if an investigational drug should be made available to the general public. An ethics group that reviews a clinical research study is called an IRB (Institutional Review Board). The IRB is a group of doctors, nurses, and people from the community. The IRB'S job is to review all clinical research studies to help protect participants' rights and safety.

WHO CONDUCTS A CLINICL RESEARCH STUDY?

A research team conducts the clinical research study. The team is led by a doctor or other researcher, known as the Principle Investigator. The team may include nurses, coordinators and others. This team may conduct the clinical research study in a hospital, university, local medical center, or doctors' office.

WHO CAN BE IN A CLINICAL RESEARCH STUDY?

Each clinical research study has different requirements for participants such as age, sex or medical condition. It is important that different kinds of people are involved in the trial, men and woman from different races. People respond differently to medicines and other treatments so it is important to include all kinds of people.

The research team will look at your medical history and study requirements to find out if you are eligible. The team will also tell you what it means to be involved in the study and what the risks and benefits are during the informed consent process.

WHAT IS THE INFORMED CONSENT?

Informed consent is the process that takes place before you join the study. A doctor, nurse or study coordinator on the team will explain why the study is being done, and what you can expect. You can ask any questions about the study.

You will be told about who will see your personal medical information, and how it will be kept confidential. You will also be given a consent form to read. You should ask questions about any part of the consent form you do not understand. If you decide to take part in the study, you will be asked to sign the consent form. If you sign the consent form, you can still change your mind and stop at any time.

WHAT CAN I EXPECT AS A STUDY VOLUNTEER?

During the study, the study team will review your medical history, give you instructions on participating, and monitor your health. Some clinical research studies may involve more test and doctor visits than you would normally have for an illness or condition.

HOW CAN I BECOME A STUDY VOLUNTEER?

If you are interested, you can talk to your doctor or healthcare provider to see if a clinical research study is right for you. To learn more about being in a clinical research study, please call 800-325-2202.

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