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Clinical Trials (cont.)

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What is informed consent?

Informed consent is giving your consent to participate in the clinical trial after having learned about the trial and having had the opportunity to ask questions. You should be fully aware of all the details, risks vs. benefits, and expectations of the trial before agreeing to participate. When you give informed consent, you sign a document - which should be in a language that you understand - that describes the rights of the participants as well as gives details of the study and names of the investigators who are conducting the study and contact information for these people.

Is patient privacy maintained in a clinical trial?

Clinical trials are required to maintain strict patient privacy. Your name will not be published anywhere that data about the trial are published or included in any publicly available information. Some clinical trials may require that you be seen and examined by a larger treatment team than would typical medical care. For example, this may include research nurses who only see patients enrolled on clinical trials.

Who can participate in a clinical trial?

Each trial has specific inclusion and exclusion criteria to determine the exact patient populations that may participate. Individuals who fit the predefined and preapproved inclusion criteria for a trial may participate if the trial is currently accepting participants. Inclusion criteria are based on factors such as patient age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Some clinical trials seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

Are people paid for participating in clinical trials?

Some clinical trials offer monetary compensation for participants. Other trials may offer their participants free health care that is related to the condition being studied, or screening examinations. There are no requirements for those who sponsor clinical trials to pay or otherwise compensate participants.

Medically Reviewed by a Doctor on 11/4/2016


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