Ethical guidelines

Outcomes from the trial must be communicated to the subjects promptly and in an unbiased way. In addition to the ethical guidelines by the NIH, the World Medical Association has formalized a document called the Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects to describe the constraints on research involving human beings. Those countries that have signed this declaration are bound by the ethical principles. An extract of this document is given in Exhibit 6.3. 

In the absence of any no fault scheme, the participant who suffers injury and believes it to be trial related must rely only on his/her ability to claim compensation through the courts - often a difficult and lengthy process. Most ethical guidelines require a study participant to be told in advance, what provision has been or will be made - if any. However, in practice some ethics committees are unhappy that there are different approaches applicable to compensation in research, depending upon the identity of the sponsor / initiator. 

American Chemical Society, Ethical Guidelines to Publication in Chemical Research (https //paragon.acs.org)... 

CIOMS. International ethical guidelines for biomedical research involving human subjects. Geneva Counsil for International Organizations of Medical Sciences 2002 [cited 2008 Jan 13]. Available from URL http //www.cioms.ch/frame guidelines nov 2002.htm... 

Monitoring and regulating medicine promotion to ensure that it is ethical and unbiased. AU promotional claims should be rehable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. WHO s ethical guidelines (1988) may be used as a basis for developing control measures... 

In addition to the Nuremberg Code and Declaration of Helsinki, The International Ethical Guidelines for Biomedical Research Involving Human Subjects was issued in 1982 and revised in 1993 by the Council for the International Organization of Medical Sciences (CIOMS). Those guidelines define national policies for biomedical research, apply ethical standards to the circumstances often present in research in economically developing nations, and define mechanisms for ethical review of human subjects research. 

Out of the Nuremberg trials in 1947 came the Nuremberg Code, the first code to deal specifically with human experimentation. It created ethical guidelines for the conduct of medical research throughout the world. Although many researchers had customarily obtained consent from volunteers in the past, it was the Nuremberg Code that first established the practice formally. The code deals with self-experimentation in Article 5, which states No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur except, perhaps, in those experiments where the experimental physicians also serve as subjects. ... 

The principles that govern the ethics of scientific publication are no different than for any other endeavor complete and accurate reporting and appropriate attribution to the contributions of others. However, as always, the devil is in the details. The ethical responsibilities of authors and reviewers are sufficiently important and complex that the editors of the American Chemical Society journals have developed a detailed document outlining these responsibilities. (This document, Ethical Guidelines to Publication of Chemical Research is presented in Appendix 1-1.) The purpose of this chapter is not to duplicate this document, but rather to discuss some of the important underlying principles and situations that often arise. 

With these thoughts in mind, the editors of journals published by the American Chemical Society now present a set of ethical guidelines for persons engaged in the publication of chemical research, specifically, for editors, authors, and manuscript reviewers. These guidelines are offered not in the sense that there is any immediate crisis in ethical behavior, but rather from a conviction that the observance of high ethical standards is so vital to the whole scientific enterprise that a definition of those standards should be brought to the attention of all concerned. 

The ethical guidelines are also available in their most recent version on the Web at https // paragon.acs.org. 

It is usually the Committee for Drug Information of the LMI (Norwegian Association of Pharmaceutical Manufacturers) that supervises promotional activities and may impose fines on pharmaceutical companies in cases of breach of ethical rules and guidelines. The fines may be in the order of NOK5000-300 000 The Committee is authorised to make decisions only in cases where the defendant is a member of the LMI or has approved the industry s ethical guidelines. This is the case for the vast majority of companies responsible for the sale of pharmaceutical products in Norway, and in practice the Committee is an important authority. 

The last chapter focuses on questions dealing with legislative concerns, taking both geographic and ethical guidelines into consideration. 

A key component to setting any type of ethical guidelines for modelers must include the responsibilities owed the client and responsibilities owed the employer. Bayles (1989) presents various paradigms for the relationship between clients and modeler based on who has the power to make decisions. Responsibility then lies with the individual making the decisions and depends on the interaction between client and modeler. In one case, the client relinquishes control and input over the model, depending entirely on the modeler to make decisions. A second situation is where the modeler is expected to develop and present the model, but the client, such as a project team or perhaps small biotechnology company who has contracted an analysis to a consultant, has no modeling experience or basis to contribute to development of the model. Both situations can... 

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