What is the requirement for IRB/IEC approval regarding clinical trials?

The requirement for Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is critical in the context of clinical trials, and it specifically mandates that such approval must be obtained before patient enrollment. This process ensures the protection of the rights, safety, and well-being of trial participants. It also addresses ethical considerations and ensures that the study protocol is evaluated for compliance with applicable regulations and ethical standards.

Obtaining IRB/IEC approval prior to enrolling participants is essential for maintaining the integrity of the research process and garnering trust from participants and the general public. This approval process typically involves a thorough review of the clinical trial protocol, informed consent documents, and any other materials that will be used in the study to ensure that they are ethically sound and that risks are minimized.

In contrast, other options do not reflect the established requirements for ethical oversight in clinical trials. Specifically, approval after commencement would compromise participant safety and welfare, while suggesting that approval is not needed misrepresents essential ethical guidelines. Stating that approval is required in all phases may imply unnecessary oversights in cases where modifications may not significantly affect participant risk and where initial approval suffices. Hence, the requirement is clearly centered on obtaining approval before any participant enrollment can take place, safeguarding ethical