Is a Research Study for You?
A Guide to Understanding Your Rights and Responsibilities as a Participant in a Research Study

The Informed Consent Process

You have been asked to think about participating in a research study. A research study helps find new treatments or cures for diseases and new approaches to behavior correction. Often, a research study needs human volunteers.

There are different reasons why you might volunteer to participate in a research study. The reasons might be to:

• Help find a new treatment or a future cure
• Help others who have the same disease or symptoms as you
• Help advance medicine and science

The United States Government has laws and regulations to make sure that people who participate in research are given complete information about the research study before they agree to participate. This process is called Informed Consent.

Informed Consent is a process of communication between the research team and the research volunteer about the details of the research study. The Informed Consent process has two parts:

1. Information
2. Consent

Information The information you will learn includes the reason for doing the research study (its purpose), an explanation of what will be done during the research study (the procedures), the possible good and bad effects (benefits and risks) of the research study, and an explanation of the rights of the volunteer.

Consent Once you understand the information about the research study, you can decide if you want to volunteer. If you decide to volunteer, you are consenting or agreeing to participate in the research study. Usually you will be asked to sign the Informed Consent Document.