Real-world evidence (RWE) research, which is the study of data from real-world settings, is founded on a number of ethical principles, including:

Respect for autonomy: This principle recognizes the importance of individuals’ ability to make their own decisions regarding their healthcare. In RWE research, this means obtaining informed consent from individuals before using their data.

Beneficence: This principle requires that researchers seek to maximize the benefits of their research while minimizing any potential harm. In RWE research, this means ensuring that the research is designed to answer important questions that will improve health outcomes for individuals.

Non-maleficence: This principle requires that researchers avoid causing harm to study participants. In RWE research, this means minimizing any risks associated with data collection and use, such as breaches of confidentiality.

Justice: This principle requires that researchers treat individuals fairly and equitably, ensuring that the benefits and burdens of the research are distributed fairly. In RWE research, this means ensuring that the use of data is transparent and that individuals are not unfairly excluded from research opportunities.

In addition to these principles, RWE research is also guided by ethical standards established by international bodies, such as the World Medical Association’s Declaration of Helsinki. These standards emphasize the importance of obtaining informed consent, protecting privacy and confidentiality, and ensuring that research is conducted in a manner that respects the dignity and rights of study participants.