Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

If a protocol change occurs, what is the implication for informed consent?

1. A new informed consent must be obtained from all subjects.

2. Only new subjects require informed consent.

3. Informed consent is not necessary for protocol changes.

4. Subject's consent is only needed if changes affect their participation directly.

The correct answer is: A new informed consent must be obtained from all subjects.

When a protocol change occurs in a clinical trial, it is critical to address how the change affects informed consent. Obtaining a new informed consent from all subjects is essential to ensure that participants are fully aware of the updated information, the nature of the changes, and any implications these changes may have on their rights, welfare, and participation in the study. Informed consent is a dynamic process that requires researchers to continually ensure that participants understand the study they are involved in, which includes any modifications to the protocol. Even if the changes do not seem substantial, participants must be informed and given the opportunity to reconsider their participation based on the new information provided. This practice upholds ethical standards and regulatory requirements, reinforcing the participants' autonomy and the integrity of the research process. The other options do not acknowledge the importance of maintaining clear communication with all participants about their rights and the current status of the trial. While some may suggest that informed consent could be limited to only new subjects or made unnecessary in certain scenarios, it overlooks the fundamental ethical principle that all participants have the right to be informed about any changes that may affect their involvement in the research. Hence, obtaining new informed consent from all subjects is the most responsible and ethical course of action when a protocol change occurs.