Good Clinical Practice (GCP) Practice Exam

The protection of subjects at risk of exploitation or coercion is crucial in clinical trials because these individuals are often more vulnerable due to various factors such as socioeconomic status, educational background, or health conditions. Such vulnerabilities can lead to situations where participants may feel pressured to enroll in a study or may not fully comprehend the risks involved.

Regulations such as the Belmont Report emphasize the ethical principle of respect for persons, which includes protecting those who may not have the capacity to make informed decisions or who may be coerced into participation due to their circumstances. This is why extra safeguards must be established to ensure that informed consent is genuinely obtained, that participants are not unduly influenced, and that their rights and welfare are prioritized throughout the research process.

In contrast, economically stable individuals, those in equal power dynamics, and highly knowledgeable individuals are generally perceived as possessing the ability to make informed decisions about participation and are less likely to be exploited or coerced. As such, ethical guidelines focus more intensely on protecting those who may not have the same level of agency.