{
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            "text": "which informed consent is being obtained. The IRB may consider any new information indicating that the investigator may not be obtaining informed consent under circumstances that provide subjects with sufficient opportunity to consider whether or not to participate or that minimize the possibility of coercion or undue influence."
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            "text": "Continuing review also provides the IRB with an opportunity to determine whether there is any new information or any significant new finding that should be communicated to subjects who have already enrolled in the research. This could include, for example, important new toxicity information or new adverse event information related to the research interventions that are identified during analysis of the research data."
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            "text": "Investigator and Institutional Issues",
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            "text": "When appropriate, the reviewing IRB should consider issues regarding the investigator and the institution(s) where the research is being conducted during its continuing review, such as the following: changes in the investigator's situation or qualifications; evaluation, investigation, and resolution of any complaints related to the investigator's conduct of the research; changes in the acceptability of the proposed research in terms of institutional commitments (such as adequacy of facilities); changes in applicable regulations, state and local laws, or standards of professional conduct or practice; and reports from any third party observations of the research."
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            "text": "Progress of Research Project",
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            "text": "When evaluating research progress, the IRB should consider the consistency of information submitted at the time of continuing review with that of the IRB-approved protocol and, if relevant, the subject enrollment and subject withdrawal."
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            "text": "The IRB should confirm that the information provided by the investigator at the time of continuing review is consistent with the research protocol previously approved by the IRB. If this information suggests that the investigator is not conducting the research in accordance with either the IRB- approved protocol or the requirements or determinations of the IRB, the IRB should defer approving a continuation or research or approve the research for a limited period of time (such as two or three months) and seek an explanation from the investigator regarding the apparent discrepancies."
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            "text": "If relevant to the project, the IRB should pay special attention to the total number of subjects enrolled. If enrollment in a research project is occurring at a much slower rate than expected and there are concerns about enrolling enough subjects to provide sufficient data to answer the scientific question(s) being addressed, it may not be ethical to continue exposing subjects to the risks of the research. The IRB may request the PI to explore the reasons for low enrollment and take appropriate steps to remedy the situation. If no such a remedy exists, the IRB should not approve continuation of the study because the risks to subjects are not reasonable in relation to the anticipated benefits to the subjects and the importance of the knowledge that may reasonably be expected. On the other hand, if the investigator has enrolled more subjects than the number indicated"
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