YES. A clinical study cannot begin without governmental approval, and an independent group of professionals called an Institutional Review Board (IRB) must also approve the study before it can be initiated by the study physician. An IRB is a group of medical and non-medical professionals whose primary responsibility is to review the study, and to ensure that it poses no undue risks to the study participants. While the study is being conducted, your physician will be asked to provide the IRB with periodic progress reports. Additionally, your medical records will be kept under strict rules of confidentiality. Please know that you may terminate your participation in a study at any time without jeopardizing your access to other medical treatments.
Before entering a clinical study, it is important that you and your child fully understand the study and what your involvement will entail. Our staff members will help by providing you with an informed consent statement, which has detailed information about the study, including the length of the study, the number of visits required, and medical procedures and medication included. It also provides expected outcomes, potential benefits, and possible risks.
We will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement and talking with our staff, you will need to sign the informed consent statement. If you are signing for your child, and if your child is able to, they may also have to “assent” to participate (agree even though they are not legally of age to sign the contract). Your signature indicates that you understand the study and agree to participate voluntarily. The informed consent tells the patients that they have a right to leave the study at any time.
All clinical trials are governed by rules that are set up by the federal government. Specialized training is required for all of the investigators and coordinators who help to conduct a clinical trial. The investigators who lead the clinical trials at Randomize Now have been working on clinical trials for as long as ten years.