The history of ethical regulations in human subjects research began with the
Human subjects research ethics regulations can be traced back to the Nuremberg Code, which was created in response to the atrocities committed by Nazi doctors during the Holocaust. Research on human subjects is governed by the Nuremberg Code, a set of ethics principles. The guideline stipulates that the consent of the participant is essential, that the experiment should be designed to avoid foreseeable risks, and that the researcher must take into account the participant’s welfare.
In 1964, the World Medical Association (WMA) produced the Declaration of Helsinki following the Nuremberg Code. The Declaration of Helsinki specifies specific ethical principles for biomedical research involving human subjects. It requires that participants be fully informed about the risks and benefits of participating in research, that they give their free and informed consent, and that the researcher consider the welfare of the participant.
Over the years, the Helsinki Declaration has been amended a number of times, most recently in 2008. There are new provisions in the current version regarding clinical trials, genetic research, and placebo controls. Additionally, it calls for independent ethics committees to review research proposals and requires informed consent.
Despite not being legally binding, the Declaration of Helsinki is widely considered to be the gold standard for ethical conduct in human subjects research. It is enshrined in law or policy in many countries, and major funding agencies such as the National Institutes of Health require researchers to adhere to its principles.
As our understanding of ethics and medicine evolves, the Declaration of Helsinki will continue to evolve as well. Nevertheless, the core principles of respect for the participant’s autonomy and welfare remain core to ethical research.
Answer: The history of ethical regulations in human subjects research began with the Nuremberg Code