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H.R. 4697, the Human Research Subject Protections Act of 2002, was designed to establish a uniform set of safety and ethical standards for all medical research involving human participants in the United States. The bill aimed to close regulatory gaps by requiring both privately funded and federally funded studies to follow the "Common Rule," which includes strict requirements for informed consent and oversight by Institutional Review Boards. For everyday citizens, this legislation sought to ensure that any person participating in a clinical trial—regardless of who was paying for the study—would be protected by the same federal transparency, privacy, and safety protocols. Additionally, the bill proposed creating a dedicated Office of Human Research Protections to monitor high-risk trials and prohibited the use of federal funds for secret or classified human experimentation.
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