1 There must be enough oxygen in the air you are breathing. 2  Your lungs must be able to inhale the oxygen-containing air â and exhale carbon dioxide.  Your bloodstream must be able to circulate blood to your lungs, take up the oxygen and carry it throughout your body.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
FDA always reviews these consent documents. The Agency's review is generally limited to ensuring the presence of the required elements of informed consent and the absence of exculpatory language. Any substantive changes to the document made by an IRB must be submitted to FDA (by the sponsor) for review and approval.