What are the international protections for biomedical research?

Biomedical research is largely regulated by international law and conventions. In the United States, the National Institutes of Health (NIH) sets standards for the ethical and legal conduct of biomedical research. These standards are broken down into three main categories: the Belmont Report, Good Clinical Practice regulations, and the Helsinki Declaration. The Belmont Report, published in 1979, outlines three key ethical principles for medical research: respect for persons, beneficence, and justice. Respect for persons requires that researchers respect the autonomy of those involved in the research, while beneficence requires researchers to do no harm and maximize benefit. Lastly, justice mandates that researchers must ensure that the distribution of the benefits and harms of research are fair. Good Clinical Practice (GCP) regulations are a set of international ethical and scientific quality standards for conducting, monitoring, and reporting clinical research. These regulations ensure that research is conducted ethically and that patient safety and welfare are protected. The Helsinki Declaration, also commonly referred to as the World Medical Association Declaration of Helsinki, is an international ethical code for medical research involving human subjects. It sets principles for informed consent, research team safety, and the rights of participants and their families. The combination of these international protections for biomedical research ensure that researchers are held to a high standard in regards to the ethical and legal conduct of their work. By adhering to these standards, researchers can help protect the community, ensure patient safety, and provide fair and beneficial outcomes.

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