Final Answer:
The given statement Changes to a study protocol, via a protocol amendment, can be implemented at the site as soon as it is submitted to the IRB is FALSE. Thus the correct option is B.
Step-by-step explanation:
Changes to a study protocol, through a protocol amendment, cannot be implemented at the site until the Institutional Review Board (IRB) has reviewed and approved the proposed modifications. The IRB plays a crucial role in ensuring the ethical conduct of human research, and any alterations to the study protocol must undergo thorough scrutiny before being implemented. This process is in place to safeguard the rights and well-being of research participants.
The IRB, composed of diverse members with expertise in various fields, evaluates proposed changes to study protocols to assess their ethical implications, scientific validity, and potential risks to participants. The submission of a protocol amendment triggers a comprehensive review process, and until the IRB grants approval, the changes should not be executed at the research site. Adhering to this protocol is essential for maintaining the integrity of the research process and upholding ethical standards in human subjects research.
In summary, the statement is false because immediate implementation of changes without IRB approval could compromise the ethical principles governing research. The IRB serves as a crucial oversight body, ensuring that modifications to study protocols align with ethical guidelines and do not pose undue risks to research participants.