Ethical principles in human biomedical research in Russia: historical review of the first half of the twentieth century

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL MEDICINE 2001, 15:251–254

251

REVIEW ......................................................................................................................................................................

Ethical principles in human biomedical research in Russia: historical review of the first half of the twentieth century O.I. Kubar St Petersburg Pasteur Institute, Russia Correspondence to: Dr Olga Kubar, The Head of Clinical Department, St Petersburg Pasteur Institute, Mira St. 14, Pasteur Institute, St Petersburg, 197101, Russia.

Summary The second half of the twentieth century has seen the development and implementation of international procedures for the conduct of human biomedical research. In part, these responded to unacceptable practices, but mainly to principles that were developed in the first half of the century. However, these principles have been enunciated more clearly and universally in the second half. The number of regulations and guidelines has multiplied. In Russia, as in other European countries, ethical issues in clinical practice and in medical research were considered, and opinions and judgements were delivered in the first half of the century. There is evidence that the quality and the clarity of both was equal to that elsewhere, but it has been less well known outside Russia. Keywords: human biomedical research, ethics, law, Russia, principles and practice

Introduction According to the ethical principles and the legal regulations dealing with biomedical research involving human subjects that are accepted today, the research subject must be maximally protected from risk and damage to his/her health and well-being. At the same time, the research subject has the right to all the benefits from the successful outcomes of the scientific studies in which he/she participates. These principles have been adopted by the world community in the last half century and serve as one of the practical expressions of the generally accepted moral values of the medical profession, such as the respect for human autonomy, independence, mercy and justice. The expressions of these principles are found in the many international guidelines, declarations, codes, resolutions and the other documents on bioethics that now exceed 250 editions. The number of normative acts on the ethics and human rights protection in biomedical research adopted at national levels can

hardly be estimated, but in the last decade it has the tended to increase. Thus, according to the Spanish specialist in bioethics, Gonzalo Herranz [1], in 17 European countries and 15 LatinAmerican ones, there are 74 codes or guidelines related to the medical profession that were adopted in the period from 1947 to 1998 (p. 128). One of the most important events in the history of ethical regulation of biomedical research was the Nuremberg Code in 1947 [2] from the verdict of guilty passed by the Military Tribunal on the Nazi doctors who made inhuman experiments on the prisoners in concentration camps during the Second Wo