Certified Clinical Research Coordinator (CCRC) Practice Exam

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What is the primary purpose of informed consent in clinical trials?

  1. To ensure funding for the study

  2. To verify participant eligibility

  3. To ensure that participants are aware of the study and agree to participate

  4. To collect baseline data

The correct answer is: To ensure that participants are aware of the study and agree to participate

The primary purpose of informed consent in clinical trials is to ensure that participants are aware of the study and agree to participate. Informed consent is a fundamental ethical requirement that helps protect the autonomy of individuals by providing them with comprehensive information about the study's purpose, procedures, risks, benefits, and their rights as participants. This process enables participants to make an informed decision about whether or not to take part in the study, ensuring that their participation is voluntary and based on a clear understanding of what it entails. While securing funding and verifying participant eligibility are important aspects of conducting a clinical trial, they are not the central focus of the informed consent process. Similarly, the collection of baseline data, although essential for evaluating the outcomes of a clinical trial, does not encompass the primary ethical concerns that informed consent addresses. Thus, the essence of informed consent lies in safeguarding the rights and well-being of participants by making sure they are fully informed and can give their voluntary agreement to participate.