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Created by the World Medical Council in 1964, the Declaration of Helsinki is an ethics code similar to the Nuremberg Code. A significant standard it added was the requirement that any research involving human participants must be based on a written protocol—a detailed description of the study—that undergoes review by an independent committee. This declaration has undergone several revisions, with the most recent occurring in 2004.

Declaration of Helsinki

A research protocol is a detailed, formal document outlining a proposed scientific study that investigators must submit for institutional approval. It comprehensively describes the study's core objectives, methodological design, step-by-step procedures, risk-benefit assessment, strategies to minimize potential participant harm, and plans for obtaining informed consent and conducting debriefing.

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