The Helsinki Declaration, research guidelines and regulations: present and future editorial aspects

HE NUREMBERG code of 1947, the first international T document on research ethics, was a consequence of semnd world war experiments on unconsenting prisoners and detainees. The Declaration of Helsinki was promulgated in 1964 by the World Medical Association (l), and later revised three times (Tokyo, Venice, Hong Kong). It provides recommendations guiding physicians in biomedical research involving human subjects. The cornerstones are the requirements of informed consent of subjects, the distinction between clinical and non-clinical research and the ethical review of the research protocol. Research ethics committes (RECs) are established to ensure that biomedical research is done in accordance with the Helsinki Declaration. They guarantee high ethical standards and prevent the undertaking of unreasonable studies. RECs should protect research subjects from unacceptable risks associated with research. The handling of a study plan by the REC enforces the investigator to improve protocols, leading to higher scientific standards in biomedical research. As a consequence of the thalidomide tragedy of the 1 %Os, further regulations regarding biomedical research involving drugs have been introduced. Before starting clinical drug trials it is commonly required to obtain permission from a regulatory body, for instance the Food and Drug Administration (FDA) in the United States of America. In order to ensure the quality of such research, elaborate “good clinical practice (GCP)”guidelines have been introduced, for instance by the European Community (2). There are also regulations to secure confidentiality of research subjects. First, access to patient records is under strict regulation. Researchers or other third parties may have to obtain a permit to be granted access ta patient records. Furthermore, it is not a trivial undertaking to enter sensitive information into electronic data handling systems. Consequently, it is commonly required that permission is needed before such databases are established. The final important aspect in biomedical research involving human subjects is their right to compensation for accidental injury. This right is not acknowledged in all countries; however, most western countries probably have guidelines, recommendations or regulations to secure subjects their rights. It is important to be aware that all these regulations and guidelines in fact find their basis in the Declaration of Helsinki. Consequently, one may assume that physicians who are not conducting research in accordance with these regulations also violate the spirit of the Declaration of Helsinki. It should be noted, however, that there may be inherent conflicts between such guidelines and the Helsinki Declaration, for instance when guidelines require that research subjects have to waive their right to privacy before they are allowed to enter a clinical drug trial (3). What are the consequences of the above guidelines for the editorial process in Acta Anaesthesiologica Scandinavica? Our journal requires that research involving human subjects should be in accordance with the Declaration of Helsinki which states that “reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication”. Thus we will generally reject studies which have not been reviewed by an appropriate research ethics committee. However, although a prerequisite, research ethics committtee approval does not automatically guarantee publication. Our editorial board has rejected studies that were found to be unethical, although approved by an ethics committee. On the other hand, it should be kept in mind that the Council for International Organisations of Medical Sci-