• Be universal. Across all research disciplines and not confined to clinical research.
• Be official and published. The rules must be promulgated by some official and widely accepted body having the legal power to make them stick, and these rules must be published.
• Have a clear and specific definition. With internal descriptions of the critical elements.
• Have a clear and fair process. Essential elements include: • Notice to those accused of the charges against them.
• Opportunity to respond to the charges and to all evidence used to draw conclusions.
• Opportunity to have an advocate or representative accompany all those participating in official proceedings (including those accused, those serving as witnesses, and those bringing allegations).
• Appropriate powers in those charged with performing investigations to have access to all relevant evidence and witnesses. An investigation cannot stand if those charged with establishing relevant facts do not have full access to all relevant evidence and witnesses. This may require subpoena power.
• Separation of investigation and adjudication (that is, those who perform investigations and make findings of fact should be separated from those who judge the totality of the case and impose sanctions).12,19
• Meaningful consequences for those who violate standards, institutions that countenance misconduct, and for any form of retaliation against those who, in good faith, raise questions about the propriety of scientific conduct.
• Must allow appeals. After a proceeding is complete, there must be one opportunity to seek review of the procedures and fundamental fairness employed in reaching the conclusions.
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