What governs ethical principles in medical research involving human subjects?

The Declaration of Helsinki is a set of ethical principles specifically designed to guide medical research involving human subjects. Established by the World Medical Association, it emphasizes the importance of prioritizing the welfare and rights of participants in clinical trials. This document outlines essential aspects such as informed consent, the necessity for scientific soundness, and the requirement for risk assessment versus potential benefits to participants.

In contrast, other options, while significant in their own rights, do not primarily govern ethical principles in medical research. The Declaration of the Rights of Man pertains to broader human rights and is not specific to medical research ethics. Good Clinical Practice Guidelines establish standards for conducting clinical trials, but they focus more on regulatory and procedural aspects rather than ethical considerations. The International Conference on Harmonisation provides guidelines related to the registration of pharmaceuticals but is not solely concerned with ethical issues in human research. Thus, the Declaration of Helsinki stands out as the primary document addressing ethical concerns directly related to human subjects in medical research.