The traditional approach has commonly focused on the ethical aspects of human subject research and little has been said about the implications of human experimentation on the enjoyment of basic rights. This article will place the discussion of human subject research within the larger context of human rights law, at both the international and regional level, and examine existing normative human rights frameworks that can be used to protect research subjects. Some companies have already sought permission from European regulators and are planning to seek approval from the US Food and Drug Administration to begin CRISPR clinical trials in humans for metabolic, autoimmune, and neurogenerative diseases, among others. For instance, new gene editing technologies, such as CRISPR-Cas9, pose serious risks and challenges to the protection of peoples’ human rights and basic ethical principles in terms of, for instance, human dignity, informed consent, and the rights of future generations. With the advent of new technologies, the links between ethical principles and human rights in research involving human participants become particularly relevant. For example, recent cases include oxygen experiments conducted on premature babies without the parents’ knowledge, and studies on whether cooling kidneys before a transplant would result in fewer complications, conducted without adequate assessment of the risks to transplant recipients. While experimentation with human subjects is widely practiced, it is often done without due regard to the human rights of participants. The later Declaration of Helsinki, adopted in 1964, reaffirmed the need for informed consent in all research and warned that the “interest of science and society should never take precedence over considerations related to the wellbeing of the subject.” In 1978, the Belmont Report framed these issues into “broader ethical principles provide a basis on which specific rules may be formulated, criticized, and interpreted,” and focused on three main principles: respect for persons, beneficence, and justice. The Nuremberg Code, the first of its kind, was created to prevent a recurrence of the horrors committed in Nazi Germany, and it paved the way for the development of medical ethics and greatly influenced the evolution of human rights law. Their trial led to the 1947 drafting of the Nuremberg Code, a set of guidelines governing research on humans, which included 10 principles focused on patient consent and autonomy. The Nazi doctors’ trial exposed torture, deliberate mutilation, sterilization, and murder. It took two years after the end of the war for 16 German physicians to be found guilty of nefarious crimes against humanity. When the research came to an end, they were killed and their organs autopsied and analyzed. The largest German Nazi concentration camp, Auschwitz, witnessed Josef Mengele’s egregious experiments performed on Gypsy children, twins, dwarfs, and people with abnormalities. A human rights approach to bioethics, and particularly to human subject research, can bring about a defined system and universally accepted set of rules in a field where sociocultural and religious diversity come into play.ĭuring the Second World War and the Holocaust, Nazi researchers committed mass-scale atrocities against Jews and other prisoners under the name of medical research. The difference between ethical principles and human rights is clearly determined by the non-enforceability of ethical norms and the legally binding nature of human rights obligations. This article will place the discussion of human subject research within the larger context of human rights law, both at the international and regional level, and examine existing normative human rights frameworks that can be used to protect research subjects.
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