INFORMED CONSENT

Patients have the right to receive information and ask questions about treatments that have been recommended to them. This is called informed consent. In all cases there should be an exchange of information, the option to ask questions and have them answered. Patients should be able to fully understand the process, compensation, results and extent of risks, if any.

LEARN MORE ABOUT INFORMED CONSENT

There are two types of informed consent: For Clinical Trials and For Research. An informed consent process should also be conducted for treatment tests and procedures where there is a risk of harm to the patient.

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QUESTIONS ARE THE ANSWER

While it may be difficult for patients to review medical journals, you can ask these questions to help you better determine what to do when your doctor wants your consent to use a medical device.

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FINANCIAL CONFLICT OF INTEREST

Find out if your doctor has a specific financial interest in that device or intervention.

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RESEARCH DEVICE SAFETY

Search the International Medical Devices Database for recalls, safety alerts and safety notices for medical devices and connections with manufacturers.

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COMPASSIONATE USE

Otherwise known as expanded access, which was used in the Macchiarini case, compassionate use enables patients with serious or life-threatening conditions and few options, to be treated with new and unregulated devices or drugs. Learn more by visiting this FDA site.

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