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My objective is to provide some background and context for the publication of the two accompanying statements, both of which deal with aspects of the relationships between industry and medicine. The ethical principles that guide clinical investigations are well known and have been codified in numerous statements, including the Nuremberg and Helsinski principles and the National Institutes of Health guideline, "Protection of Human Subjects," as well as in statements published by the Pharmaceutical Manufacturers Association. Investigators performing clinical trials involving humans carry a special ethical burden that involves not only protection of the people participating in the trial but also a heightened requirement for strict adherence to the tenets of scientific investigation. One of the major tenets of science is that experimental results are honestly and promptly reported.
The Pajaro Dunes Agreement was reached in 1982 following discussions between representatives of industry and a group of research-oriented universities. The conference