What is the legal framework for medical research?

The legal framework for medical research in Washington is guided by several federal laws. The most important of these is the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This act protects patients’ privacy and their rights to control how their health care information is used and shared. Additionally, it regulates how health care providers can use and store patient information, as well as how they should dispose of those records. The Food and Drug Administration (FDA) plays a key role in regulating medical research. It ensures that new medicines and treatments are safe and effective for use in the public. The FDA reviews and approves protocols for any research involving pharmaceuticals and medical devices and provides regulatory guidance for research that includes human participants. Other laws that influence medical research include the Patient Safety and Quality Improvement Act of 2005, which encourages health care providers to report and analyze patient safety data, and the Clinical Laboratory Improvement Amendments (CLIA), which set standards for the regulation of clinical diagnostic laboratories. Finally, specific state laws may also regulate medical research in Washington. For example, the Washington State Legislature has passed the Human Subject Research Protection Act, which provides protections for participants of research studies. These laws, taken together, form the legal framework that allows medical research to be conducted safely and ethically in Washington.

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What is the legal framework for medical research?

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