When conducting continuing review, the IRB should start with the working presumption that the research, as previously approved, does satisfy all of the above criteria. The IRB should focus on whether there is any new information provided by the investigator , or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB also should assess whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. IRBs have the authority to disapprove or require modifications in (to secure re-approval of) a research activity that does not meet the above criteria (45 CFR 46.109(a)). If research does not satisfy all of the above criteria, the IRB must require changes that would result in research satisfying these criteria, defer taking action, or disapprove the research. When conducting continuing review and evaluating whether research continues to satisfy the criteria for IRB approval of research, IRBs should pay particular attention to the following four aspects of the research:under HHS regulations at subpart B, C, or D, respectively, of 45 CFR part 46.