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

If an unconscious adult subject is enrolled in a study with consent from a legally authorized representative (LAR), what should the investigator do once the subject regains consciousness?

1. Terminate the study

2. Inform the subject about the study and obtain their consent

3. Continue treatment without consent

4. Notify the LAR of the subject's recovery

The correct answer is: Inform the subject about the study and obtain their consent

When an unconscious adult subject regains consciousness after being enrolled in a study with consent from a legally authorized representative (LAR), it is essential to inform the subject about the study and obtain their consent to continue participation. This process is rooted in the ethical principles of autonomy and respect for persons. Once the subject becomes conscious, they have the right to be informed about what happened during their unconscious state and to make an informed decision regarding their participation in the research. This means that the investigator must provide the subject with details about the study, what it entails, any potential risks, and the benefits associated with it. Only after the subject understands this information can they give their consent to continue. This is crucial because consent is a fundamental ethical requirement in research involving human subjects. The initial consent obtained from the LAR is valid only for the duration of the subject's incapacity. Once the subject is able to make their own decisions, their right to control their involvement in the study must be recognized and protected. Notifying the LAR of the subject’s recovery is important from a communication standpoint but does not fulfill the requirement to obtain consent directly from the now-conscious subject. Continuing treatment without consent undermines the ethical standards governing human subject research, and terminating the