Good Clinical Practice (GCP) Practice Exam

Who is considered a Legally Acceptable Representative (LAR) in a clinical trial?

1. An individual who sponsors the trial

2. A person authorized to consent on behalf of a prospective subject

3. The investigator overseeing the trial

4. The regulatory body monitoring the trial

The correct answer is: A person authorized to consent on behalf of a prospective subject

A Legally Acceptable Representative (LAR) is defined as an individual who is authorized to provide informed consent on behalf of a prospective participant who may be unable to do so due to various reasons, such as being a minor or having a medical condition that impairs decision-making capacity. The role of the LAR is essential in ensuring that the rights and welfare of the participant are upheld while still allowing for participation in the clinical trial. This mechanism helps to maintain ethical standards and adherence to Good Clinical Practice by ensuring proper consent processes are followed, even when the subject is not able to consent directly. The other roles mentioned, such as the trial sponsor or the investigator, do not serve the function of providing consent on behalf of participants. These individuals have their own responsibilities within the trial framework that do not include making decisions about consent for participants. Additionally, a regulatory body monitors adherence to laws and regulations but does not engage in direct consent processes either. Thus, the correct identification of the LAR aligns with the principles of informed consent and protection of vulnerable populations in clinical research.