What is a Clinical Trial?
Before a new treatment can be made available in the United States, it must be approved by the Food and Drug Administration (FDA). The FDA bases its approval on the results of several phases of clinical trials, which are conducted to ensure that the drug is both safe and effective.
Benefits of Clinical Trials
People who volunteer in clinical trials may benefit from new and better investigational medication, which is not otherwise currently available to the public. In addition, you will receive medical attention for the condition being studied. Throughout the study, you may receive certain medical exams, laboratory test or procedures at no cost. You may also receive financial compensation for your time and travel should you qualify for a study.
Your Rights and Health
Experimental Research Subject’s Bill of Rights:
California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to:
Be informed of the nature and purpose of the experiment.
Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
Be given a copy of the signed and dated written consent form.
Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.
For more information about Los Angeles clinical research studies, contact us today.