A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Clinical research is a vital part of finding new treatments and cures for diseases. Carefully conducted clinical studies are the fastest way to find treatments that are safe and effective. By volunteering for a clinical study, you would be participating in research that may result in a new treatment for a deadly or debilitating disease.
Before you agree to participate in a study, you must be given complete information about the study, known as “informed consent.” Informed consent involves two essential components: a document and a process. The informed consent document gives a summary of the research project (including the study’s purpose, research procedures, potential benefits and risks, etc.) and explains the individual’s rights as a research participant. This document is part of an informed consent process, which consists of conversations between the research team and the participant, and may include other supporting material such as study brochures. The informed consent process provides research participants with ongoing explanations that will help them make informed decisions about whether to begin or continue participating in the research project (See: Informed Consent for Genomics Research). The Food and Drug Administration (FDA) provides details about informed consent with the information page: Informed Consent for Clinical Trials [fda.gov].
Because participating in a clinical study is an important decision, there are many questions that you should consider before agreeing to participate. The Centers for Disease Control and Prevention (CDC) have prepared a list of questions to help you get the information you need to make a decision about participating: Taking Part in Research Studies: What Questions Should You Ask? [cdc.gov].
Participation is completely voluntary. Participants may withdraw at anytime.
Your safety is our highest priority. The ethical and legal codes that govern medical practice also apply to clinical trials, and most clinical research is federally regulated with built in safeguards to protect participants.
No, there is no cost to the patient to participate in a clinical research.
This form will allow us to collect information about your health history. Your participation in completing this form is completely voluntary.
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