Encompass Clinical Research (ECR) FAQs

1. What is a Clinical Study?
2. How is a Drug Approved for Testing?
3. Who can be in a Clinical Study?
4. What is Informed Consent?
5. Can volunteers change their mind about participating after starting a study?
6. What are some of the benefits of being in a clinical study?
7. What is an Institutional Review Board (IRB)?
8. Would you like additional information?

1. 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 and needed medications available to the general population. They measure the drug's ability to treat a condition, its safety and possible side effects.

2. 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 studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans. It should help to know that even investigational treatments are well-tested for safety before their use in our clinical studies.

3. Who Can Be in a Clinical Study?
People with the condition being studied can volunteer to participate in our studies. 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 study requirements to determine if the volunteer qualifies to participate. Known risks and discomforts will be explained in detail prior to participating in the study. Although rare, there may be unknown risks such as medication side effects involved in participating in a clinical study.

4. What is Informed Consent?
Study procedures, risks, and benefits are explained to volunteers during the informed consent process. During the informed consent, volunteers are given the information needed to make an "informed" decision about participating in a clinical study. All volunteers are given the opportunity to ask questions and exchange information freely with the clinical study physician during informed consent.

5. Can volunteers change their mind about participating after starting a study?
Participants are not obligated to participate and may decide to withdraw from a study at any time. Participation remains voluntary throughout the course of the study.

6. What are some of the benefits of being in a clinical study?
Participating in a clinical research study may allow volunteers to try new treatments before they are widely available. The clinical research physician and study coordinators may offer a degree of care that volunteers might not get otherwise. Volunteers learn more about the medical condition and receive study-related medication and study-related medical care at no cost throughout the course of a study (some studies last as long as 5 years). Study participants may receive compensation for their time and travel.

7. What is an Institutional Review Board (IRB)?
The purpose of IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of volunteers participating in research studies. Under FDA regulations, an IRB is an appropriately constituted group formally designated to review and monitor research studies involving humans. An IRB has the authority to approve, require medications, or disapprove research studies.

8. Would you like additional information?
If you have any additional questions, or would like any additional information regarding Encompass Clinical Research or our Clinical Studies, please feel free to contact us by phone at our Toll Free number, 1-800-New-Study, or e-mail us at info@ecrstudies.com.