Final answer:
Logistic or administrative changes in research involving human subjects may need IRB approval if they affect participant welfare, the risk-benefit ratio, or data integrity. All significant changes should be submitted for IRB review to ensure ethical compliance and participant protection.
Step-by-step explanation:
Logistic or administrative changes may require Institutional Review Board (IRB) approval if they affect any aspects of the research involving human subjects. The primary purpose of an IRB is to protect the rights and welfare of human research participants. This includes ensuring informed consent, confidentiality, and minimizing potential risks.
When a research study is planned, it must be approved by the IRB to ensure that the proper guidelines are followed. This includes the ethical treatment of participants, which is critical to the integrity of the research. If the changes proposed are substantive to the way human participants are involved, then these changes must be reviewed and approved by the IRB before they are implemented.
Examples of changes that might need an IRB review could include modifications to the study design, changes in recruitment procedures, or new methods of data collection that could impact participant confidentiality or the risk-benefit ratio. Even changes that seem minor may influence the study in ways that affect participant welfare and should be submitted for IRB review. However, minor administrative changes that do not affect participant safety, the risk-benefit ratio, or the integrity of the data may not require IRB approval.