Final answer:
The correct answer is 'd. human subject' for the three new terms included in the final rule of clinical trials. Understanding this term is essential for protecting participants in research and adhering to ethical principles.
Step-by-step explanation:
The final rule in the context of clinical trials typically refers to a regulatory update that defines key terms related to human research. Among the three new terms defined, the correct answer is (d). human subject. This term, alongside 'clinical trial' and 'written or in writing,' is important in the context of ethical standards and regulatory compliance for clinical research. Understanding the definition of a human subject is crucial in ensuring the protection and rights of participants in research studies. Trials involving human subjects have historically raised ethical issues, which is why adherence to the principles of autonomy, beneficence, nonmaleficence, and justice is essential for maintaining ethical integrity in clinical trials.