The following represents reasonable guidelines for investigators to observe. The database must be protocol-specific and not contain information unrelated to that project. At the conclusion of the project the data should be removed from the computer, and any storage copies kept in a secure locked site as outlined in the original protocol. Research subjects have both a legal and a moral right to protection from breaches of confidentiality or from unwarranted invasion of privacy. This could pose a direct conflict with the requirements for clinical care and safety if relevant and essential clinical information regarding a patient's participation in a research program is not recorded in the clinical record.
Many sponsors request that a copy of the informed consent be placed in the chart.
Prominent medical chart recording of investigational drug or device use is usually essential for patient safety. Investigators are required to keep all other research data confidential. Advertising for Subjects Advertising for prospective volunteer subjects must receive prior approval. Coercive statements must be avoided and any potential risks must be cited. Compensation may be mentioned, but no dollar amount cited on any advertising.