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Do I need health insurance to participate in clinical trials?

No. We do not ask for any information related to your insurance or participation in government programs. There is no cost to you.


What is a clinical trial/study?

A clinical trial is a controlled biomedical study where researchers treat human subjects following strict guidelines and after informed consent. Data is collected prospectively to determine whether the new drug or device is safe and effective.


Benefits and Risks of Phase II-IV studies

You may be receiving a medication not yet approved by the Food and Drug Administration. Benefits cannot be guaranteed, but we conduct late clinical trials when previous studies have suggested possible benefits to you and to others by advancing medical science. We do not conduct phase I (early) studies. Some risks are known at the time of obtaining your informed consent to participate. However, some other side effects may be uncovered during study participation. The primary investigator, who is a physician, will monitor you closely to minimize risks related to study participation. Some studies use a placebo (Inactive compound) as part of the protocol. Those subjects getting a placebo (at times called control group) will not gain any benefit from the study participation.


Can I withdraw my consent and stop participating?

You may withdraw from participating anytime and for any reason. Your participation is completely voluntary.


What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is a continuing process throughout the study to provide information to participants. Our staff will explain the details of the study in your preferred language. This document includes details of the study, such as purpose, duration, procedures and contacts. Potential risks and benefits are described in the consent. If the participant decides to participate, he/she will sign the document. A signed copy will be provided to you. Bring a friend or family for support and to capture as much information as possible from the study presentation.


What is a side effect or adverse drug reaction?

These are undesired actions or effects of the drug being tested. You should report any side effect to the research staff.


What is a protocol?

It is the study design that will be followed throughout the trial.

Where can I get more information?

Visit www.clinicaltrials.gov, a website of the US National Institutes of Health for additional information.

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