What are clinical research studies?
Clinical research studies are conducted to determine whether an investigational drug is safe and effective in treating a particular disease or condition. They also check for any unexpected or undesirable health changes that may develop while taking the investigational drug.
Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help ensure that patients’ rights are protected in the study while valuable information about the investigational drug is collected. Once a clinical research study is completed, government agencies review the information and decide whether the investigational drug should be made available for public use.
What is informed consent?
Informed consent is the process through which you learn the most important facts about a clinical research study. Before participating, the study team will take you/your child through a written Informed Consent Form (ICF) and answer any questions you/your child may have. This document provides details about the study, what participation entails, and how the clinical information will be used. Potential risks and benefits, as well as your/your child’s rights and responsibilities, are also explained in the ICF.
After you/your child have read, understood and discussed all of the information about the study, you/your child can decide whether or not to sign the form and to participate in the study. The ICF is not a contract and you/your child are always free to leave the study at any time and for any reason, with no penalty.
What should I consider before participating in a clinical research study?
Taking part in clinical research requires careful thought. Before deciding whether to participate, make sure that you/your child understand any potential risks involved; these will be explained by the study doctor. There is no guarantee that you/your child will benefit from taking part in this study and you/your child should never feel obligated to participate in clinical research.
Are clinical studies safe?
Clinical research studies follow a specific set of standards and are closely regulated. Precautions are put in place to protect people who participate in clinical research. Studies follow a written plan that is called a protocol. The protocol describes the goals of the study, how the study is organized, and what doctors and participants will have to do during the study. Protocols and studies are reviewed by independent groups to evaluate whether the trials are safe and ethical.