Ace the ACRP Clinical Research Pro Exam 2025 – Dash into Data with Confidence!

Question: 1 / 400

If an unconscious subject regains consciousness after treatment, what must the investigator do next?

Notify the data safety monitoring board

Obtain consent from the subject for the study

Obtaining consent from the subject for the study is crucial because, in a clinical research context, informed consent is a foundational ethical requirement. When a participant was unconscious, they were unable to provide informed consent to participate in the study. Once the subject regains consciousness, the investigator must ensure that the individual is adequately informed about the study's details, including potential risks, benefits, and their right to withdraw at any time. This consent process preserves the ethical standards of the study and respects the autonomy of the participant.

The other options are related to the regulatory and operational procedures in clinical trials, but they do not directly address the key ethical requirement of informed consent for subjects who have regained consciousness.

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Discontinue the subject's participation

Start a new consent process with the LAR

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