The relationship between the researcher and the Institutional Review Board (IRB), including the stages of the ethical review process and the IRB's role at each stage, is illustrated in Figure 3.
Researchers are required to conduct their studies in accordance with the protocol approved by the IRB. If any modification to the approved protocol becomes necessary during the course of the study, the proposed changes must be submitted to the IRB and receive approval before they are implemented.
Such modifications may include, but are not limited to, changes in the study design, participant recruitment, sample size, informed consent procedures, survey or interview questions, data collection methods, or any other aspect that may affect the ethical conduct of the research. No changes to the approved protocol may be implemented without prior IRB approval.
Figure 3: The process of researcher submission and IRB work flow