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Dr. Smart's concern regarding sharing her data revolves around the ethical and legal implications of data sharing, specifically the need for informed consent from the subjects involved in the clinical trial. Informed consent is a fundamental principle in research ethics, as it ensures that participants are fully aware of the nature of the study, what it involves, and how their data will be used, including considerations about sharing that data.

If data sharing were to proceed without obtaining informed consent, it could potentially violate the rights and privacy of the participants. This could lead to ethical breaches and undermine trust in the research process. The emphasis on informed consent ensures that participants maintain control over their personal information and are aware of how their data may be utilized in the future. In this context, questioning the necessity of informed consent before sharing data highlights a critical ethical consideration in the conduct of clinical research.

The other options touch on important aspects of data sharing, such as anonymization and regulatory approvals, but Dr. Smart's primary concern focused on the ethical requirement of obtaining informed consent from subjects, making it a pivotal consideration in the context of her question.