The sixth criterion for approval of research reads, “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects” [45 CFR 46.111(a)(6)]. This criterion is particularly applicable to studies looking at new treatments or other interventions that may have an impact on subjects’ health, safety, or well-being. The submission should indicate what kind of data monitoring will be done to ensure risks are not greater than originally anticipated. This kind of monitoring will also help determine if the proposed intervention is much more successful than initially imagined. In that case, it may be unethical to continue the study; the preferred course may be to end the study early and make the intervention available to all who qualify for it. Multisite, sponsored studies typically have a data safety monitoring board that will periodically review data to ensure the risks and benefits are in line with what was originally anticipated. Studies that originate with a local PI should also document that adequate data monitoring will occur.