Certified in Public Health (CPH) Practice Exam

In the context of clinical trial data, what did Dr. Smart question regarding sharing her data?

1. If the data sharing could proceed without informed consent from subjects

2. If the data was adequately anonymized for sharing

3. Whether sharing would require institutional review board approval

4. If the data was relevant to the research project at the university

The correct answer is: If the data sharing could proceed without informed consent from subjects

Dr. Smart's concern regarding data sharing, particularly whether it could proceed without informed consent from subjects, is fundamental in research ethics and legal considerations. Informed consent is a critical aspect of conducting ethical research, ensuring that participants understand how their data will be used and that they voluntarily agree to this use. If the data sharing does not include informed consent, it risks violating participants' rights and can lead to legal ramifications for the researchers and the institution involved. This contemplation underscores the importance of respecting participant autonomy and maintaining trust in the research process. While the other options pertain to legitimate considerations within the context of data sharing—such as the adequacy of anonymization, IRB approvals, and relevance of data to research—failing to secure informed consent addresses a foundational ethical obligation that could compromise both the integrity of the study and the rights of the subjects involved. In public health and clinical trials, participant welfare should be a priority, making informed consent a critical factor.