Frequently Asked Questions About Volunteering For a Clinical Trial

What is a clinical trial?

A clinical trial tests the effects of a medication, medical treatment, or device on a group of volunteers. Clinical trials are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and possible side effects.

How is a drug approved for testing?

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

Who can be in a clinical trial?

People with the condition being studied as well as healthy people can volunteer to participate in a trial. There are strict requirements that specify which trials involve healthy volunteers and which trials involve patients with the condition being studied.

Each trial has specific requirements such as age, sex, or medical condition for participants. The physician conducting the trial will review each volunteer’s medical history and the trial requirements to determine who can participate. Known risks and discomforts will be explained by the trial physician prior to participating in the trial. In addition to the known risks, there may be unknown risks such as medication side effects involved in participating in a clinical trial. Trial procedures, risks, and benefits are explained to 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 trial. 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 trial.

What is the Institutional Review Board?

The Institutional Review Board (IRB) is a group of healthcare professionals and membersof the local community who must review and approve a clinical trial before it begins. The IRB reviews trial activities because its primary responsibility is to protect the safety and rights of the trial participants.

Why should I volunteer?

Patients who volunteer to participate help shape health care for the future. They also enjoy the following benefits:

• Receive all related tests, procedures, exams, and medications free of charge
• Earn money for participating
• Gain access to emerging treatments not yet available elsewhere

How can I become a trial volunteer?

For more information about participating in clinical trials, contact Saginaw Valley Medical Research Group at (989) 497-5851 or dandrosuk@womensob.com.