What is the scope of legal protection for clinical trials conducted in developing countries?
The scope of legal protection for clinical trials conducted in developing countries depends on both the laws in the host nation and those established by the International Covenant on Civil and Political Rights (ICCPR). In South Carolina, the legal protections of clinical trials in developing countries are based on the regulations of the Federal Drug Administration (FDA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH-GCP). The FDA requires that all clinical trials conducted in developing countries must be conducted in accordance with the principles of good clinical practice (GCP). In addition, the ICCPR provides a basic set of human rights protections for those who participate in clinical trials, including the right to informed consent, the right to refuse to participate, and the right to be free from exploitation or coercion. These rights must be respected both by the sponsors of the clinical trial and by the healthcare professionals involved in conducting the trial. In short, the scope of legal protection for clinical trials conducted in developing countries is based on both the International Covenant on Civil and Political Rights (ICCPR) and the Federal Drug Administration (FDA) requirements for good clinical practice (GCP). The ICCPR ensures that all participants in a clinical trial have certain basic human rights, while the FDA regulations ensure that clinical trials are conducted in a safe and ethical manner.
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