What are the international protections for biomedical research?
International protections for biomedical research generally fall under the ethical principles of the Nuremberg Code of 1947. This code, created after the Nuremberg Trials following World War II, is considered the first international law that regulated the medical experimentation of human subjects. This code created a set of 10 guiding ethical principles to ensure the safety and protection of the human subject at the forefront of any biomedical research. The principles of the Nuremberg Code include the voluntary and informed consent of the human subject, the risks of the research must outweigh the potential benefits, and that the researcher is adequately qualified to carry out the work and perform research only within their area of expertise. The Code also stipulates that the researcher must ensure the safety of the subject and be prepared to terminate the experiment if any risks become too great, as well as refrain from performing unethical experiments on human subjects. Furthermore, the Declaration of Helsinki, which was adopted in 1964 by the World Medical Association, laid the framework for standards of medical ethics with regards to human research. This declaration has since been updated numerous times in order to keep up with the changing landscape of biomedical research. This document expands on the Nuremberg Code and includes ethical considerations for research on vulnerable individuals, such as prisoners or those without capacity to provide informed consent due to cognitive disability. International organizations, such as the Council for International Organizations of Medical Sciences (CIOMS) and the International Ethical Guidelines for Biomedical Research involving Human Subjects provide international standards and guidelines for researchers to ensure the safety and ethical conduct of biomedical research. Additionally, these organizations provide a platform for researchers and governments to discuss complex ethical issues and ensure the protection of human subjects is paramount.
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