Clinical Trials: An Overview
Clinical research is crucial to the advancement of medicine, and if you are considering participating in a research trial, you are making a very important contribution to the medical field and to future patients. That being said, it is necessary for you to protect yourself and/or your child. Any treatment that is considered experimental should take place under the auspices of an Institutional Review Board (IRB)-approved protocol.
An IRB is an independent oversight committee within a medical institution, comprised of lay persons as well as health care professionals. Each IRB has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical scientific, ethical, and regulatory oversight functions for research conducted on human subjects.
Any IRB-approved research study must obtain written informed consent from all participants (or their legal guardian).