Journal of Biology and Today's World
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In general, informed consent assumes that you are legally able to make your own decisions. For informed consent to take place, the information that’s given must be understood. The informed consent process is meant to give patients ongoing explanations that will help them make informed decisions about whether to start or stay in a clinical trial. The most important part of this process is their everyday interaction and discussions with the research team and other medical staff before, during, and after the trial. The consent form can be a great tool to help get this conversation started. This is all done so that patients can make the best decision for him/her, and to be sure that they are able to choose freely whether to enroll in or stay in the study. Much of this information may be on the consent form itself, which also regularly describes that they can withdraw from the study at any time without penalty. Before, during, and even after the clinical trial, patients will have the chance to ask questions and voice their concerns. Informed consent for clinical trials goes on for as long as the research lasts, and even afterward. Also IOMC Publisher and Journal of Biology and Today's World confirmed and followed WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
FDA is responsible for protective the community health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical procedures, nation’s food supply, cosmetics, and products that release radioactivity. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With many revisions, it is the most extensive law of its kind in the world. The law is planned to assure the user that foods are pure and healthy, safe to eat, and produced under healthy conditions; that drugs and devices are safe and effective for their proposed uses; that cosmetics are safe and made from suitable ingredients; and that all labeling and packaging is truthful, informative, and not deceptive. The authors on human medical studies should use of FDA approved products, IOMC Publisher and Journal of Biology and Today's World required it.