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.
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.
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.
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 on the IRB-approved protocol, this would represent a violation of the requirement that all changes in research not be initiated without IRB review and approval except when necessary to eliminate immediate risks or hazards to the subjects. If over enrollment occurs, the research must address why additional subjects were enrolled. The IRB will offer guidance on how data obtained from over enrollment may be used.
In addition, if relevant to the project, the IRB should receive and review information regarding the number of subjects who discontinued their participation and a summary of the reasons for the withdrawals, if known. IRB review of this information may shed light on problems related to the conduct of the research. For example, a high rate of subject withdrawal may indicate that the risks of the research are greater than expected and may lead the IRB to conclude that the research should not be approved for continuation. In addition, as with a lower than expected enrollment rate, if there is a higher than expected rate of subject withdrawal, it may not be ethical to continue exposing subjects to the risks of the research because the project may not provide sufficient data to answer the scientific question. An IRB may recommend that the reasons behind the high withdrawal rate be explored by the investigator and appropriate steps taken to remedy the situation. In the absence of an adequate plan to remediate a high withdrawal rate, the IRB may determine