The revised Helsinki declaration: Good for patients? Good for public health?

Abstract

In October 2000, a revised version of the Declaration medical or other research but it is important to understand that the decision as to whether or not the Helsinki of Helsinki was adopted by the World Medical Assembly (1). Although many medical journals had declaration is applicable to a given research project is based on rather arbitrary grounds. had editorials and reports on the revised version by the time of its adoption, the absence of public debate I will come back below to other ethical guidelines that may be relevant to public health research, but about the declaration, the revision process, and how it is implemented is remarkable. The declaration of there is today no other set of ethical principles that has the same status as the declaration of Helsinki. First, it Helsinki forms the ethical basis for all medical research. As a basic requirement for a study to be ethically is universal, and accepted by virtually all medical research communities around the world. Second, many acceptable is that it conforms to ` generally accepted scientiŽ c principles’ ’ and that it is approved by ` a bodies, national and international, have linked it to sanctions, such as not paying out grants or not allowing specially appointed ethical review committee’ ’ , it is clear that the procedures for ethical scrutiny of medical publication if the project is not approved by an ethical review committee. This seems quite reasonable research have a potentially immense in uence on the development of medical knowledge. to many, but far from all, researchers. Recently, a Swedish governmental committee suggested that all What can we say today, one year after its adoption, about the impact of this revised version, as well as the university-based research projects, not only medical, involving human subjects should be reviewed by an Helsinki declaration in general, on public health research? There are a number of questions relevant to ethical committee (2). Reactions to this proposal were rapid and strong from scientists in faculties of social the public health community that deserve a much broader and more open debate. and behavioural sciences. Prominent scientiŽ c leaders from these faculties talked reluctantly about a ` Stalinistic control system’ ’ and threats to freedom of thought. IS THE HELSINKI DECLARATION AT ALL RELEVANT TO PUBLIC HEALTH RESEARCH? WHAT DOES ` RESEARCH INVOLVING The coverage of the declaration is, according to the HUMAN SUBJECTS’ ’ MEAN? second subheading, ` all medical research’ ’ . What should be included under the broad term ` medical The declaration of Helsinki was Ž rst adopted in 1964 but has a predecessor in the Nuremberg code, which research’ ’ can be debated, and it is clear that many public health projects would better be classiŽ ed as aimed at preventing the atrocious experiments on humans that were performed under the Nazi regime belonging to the social or behavioural sciences. The dividing line is, however, pragmatic along several (3, 4). Throughout its history, the basis of the declaration of Helsinki has been biomedical research on dimensions: all research performed at medical faculties is generally assumed to be governed by the Helsinki humans, such as trials on drugs and other interventions, taking samples from blood or other  uids for declaration and thus should be submitted to the relevant ethical review committee. All scientiŽ c articles subresearch purposes, performing biopsies, or taking out specimens during surgery, although not necessary for mitted to medical journals are usually considered as reports from medical research and clearance from an treatment. In more recent years, questionnaires and interviews have become commonly used instruments in ethical review committee is mandatory. I have no better suggestion for how to classify research projects into all research on humans, and it has been generally