HOW DOES THE IRB PROTECT THE RIGHTS AND WELFARE OF HUMAN RESEARCH SUBJECTS?
IRBs are responsible for prospective review of all research involving human subjects. They evaluate proposed research activities using the following criteria: the design of the study is consistent with sound scientific principles and ethical norms; the protocol meets the NIH criteria necessary for approval; the necessary elements of informed consent have been fulfilled, and additional appropriate safeguards have been provided if potentially vulnerable subjects (e.g., children, prisoners, fetuses) are to be studied. NIH IRBs follow the IRB review criteria found attached to Information Sheet 3. In addition, IRBs conduct continuing review of each approved research protocol or activity at least yearly, although an IRB may request earlier evaluations or updates if it determines that the research presents significant physical, social, or ethical risks to subjects. The IRB may modify, suspend, or terminate approval of research that has been associated with serious harm to subjects or is not b
