The Declaration of Helsinki is a set of ethical principles that govern the conduct of medical research involving human subjects. It was first adopted in 1964 and has been revised several times since then, most recently in 2013.

In the context of real-world evidence (RWE), the Declaration of Helsinki is particularly relevant because RWE often involves the collection and analysis of data from sources that were not originally intended for research purposes, such as electronic health records or claims data. This raises important ethical considerations, such as privacy and confidentiality concerns, and the need to obtain informed consent from study participants.

The Declaration of Helsinki provides guidance on these and other ethical issues related to medical research involving human subjects. For example, it states that research involving human subjects must be conducted in accordance with ethical principles, including respect for persons, beneficence, and justice. It also emphasizes the importance of obtaining informed consent from study participants, protecting their privacy and confidentiality, ensuring that the risks and benefits of the research are appropriately balanced, and ensuring research transparency by publishing the results (both positive and negative).

In the context of RWE, these ethical principles can help guide the development and implementation of research studies that use real-world data. For example, researchers can use the Declaration of Helsinki as a framework for designing studies that protect the privacy and confidentiality of study participants, obtain informed consent, and balance the risks and benefits of the research.

Overall, the Declaration of Helsinki provides important ethical guidance for medical research involving human subjects, including research that uses real-world data. Adhering to these principles can help ensure that RWE studies are conducted in an ethical and responsible manner.