(11 IEEE Engineering in Medicine and Biology Magazine #2, pg. 88 (June 1992))
This series of articles discusses the Federal statutes and regulations related to research misconduct, the effects of these laws on scientists, and how to minimize allegations of misconduct. These laws apply to everyone who receives federal funding or works for an institution that receives federal funding. Persons who violate their provisions can be banned from receiving federal funds and are subject to criminal prosecution. Persons who are investigated may lose substantial time from their research, incur large legal fees, and be subjected to public humiliation and epitaphs to their careers.
Professionals engaged in scientific research have a duty to maintain a laboratory notebook according to standards dictated by the profession. As described below, the time-honored professional standards for maintaining lab notebooks comprise a conservative version of an exception to the legal rule of evidence preventing the introduction of hearsay evidence in a trial. The reason the professional and legal standards coincide is no accident. In research, the goal of recording information is future access to accurate data; in law, the goal of using written records at trial is the introduction of accurate information.
Much has been written about keeping laboratory notebooks. The questions raised in the investigations of the laboratories of both Robert Gallo and David Baltimore indicate that even expert laboratory personnel have trouble maintaining proper records. What many scientists and engineers do not appreciate is that lawsuits center on paper trails. (These "paper trails" increasingly involve computer records as well.) This article discusses standards for keeping scientific records. The application of these standards to keeping laboratory notebooks will be discussed in a subsequent article.
Scientific fraud and abuse investigations are new perils for most scientists. There is little legal precedent that directly addresses laboratory notebooks. It is possible, however, to draw a useful analogy between laboratory notebooks and the medical records of patient care. Both are records kept by experts to document their actions. Most importantly, in neither case is the record an end in itself: medical records are a log that documents the care a patient receives to assure the continuity and quality of that care; laboratory records are a log of the procedures and results that documents the conduct of scientific research.
Lessons from Medical Malpractice Litigation
The Hearsay Rule
Custodians of Notebooks
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