Should I Volunteer?

Volunteering to participate in a clinical drug study is one way you can contribute to the understanding of disease that affect people and the development of new therapies. Volunteers are important to the clinical study phase in the drug approval process. As a volunteer, you are an important link in a long chain of research and testing in the development of new medications for a broad range of health problems.

Each year, thousands of people volunteer to participate in clinical drug studies. Benefits to you as a volunteer may include:

• Participating in the research process that may lead to new therapies.
• Receiving medical care from physicians during the study.
• Learning new information about your condition, as well as meeting people with similar conditions.

What is a Clinical Study?

A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug's ability to treat a condition, its safety and its possible side effects.

How is a Drug Approval for Testing?

The U.S. Feed and Drug Administration (FDA) typically must authorize a drug company's proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.

Who Can Be in a Clinical Study?

People with the condition being studied as well as healthy people can volunteer to participate in a study. The FS has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied. Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer's medical history and the study requirements to determine who can participate. Known ricks and discomforts will be explained by the study physician prior to participating in the study. In addition to the know risks, there may be unknown risks such as medication side effects involved in participating in a clinical study. Study procedures, risks, and benefits are explained to the volunteers during the informed consent process.

What is informed consent?

Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.

What is the Institutional Review Board (IRB)?

The IRB is a group of health care professionals and non-scientific members which must review and approve the clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.

How Can I become a study Volunteer?

Health clinics that do research are often looking for study volunteers.