GCP describes protecting which aspects of trial participants?

• A. Data ownership only
• B. Confidentiality only
• C. Financial compensation only
• D. Rights, safety, and well-being

Answer: (D)

GCP frames the protection of participants around their rights, safety, and well-being. Trials must be designed and conducted to safeguard these aspects throughout the study. This includes obtaining voluntary informed consent with clear information about risks and benefits, ongoing assessment of risk versus benefit, monitoring for adverse events, and promptly addressing safety issues. An independent ethics review (IRB/IEC) helps ensure these protections are in place, and measures to safeguard privacy and the confidentiality of participant data are essential as part of protecting well-being. While confidentiality and fair treatment matter, they are components of the broader aim, not the sole focus. Thus, the emphasis is on protecting participants’ rights, safety, and well-being.