An unexplored ethical issue in clinical research: disclosure of individual findings in the Creando Posibilidades [Creating Possibilities] study.

Individual disclosure refers to the presumptive ethical responsibility of an investigator to communicate to a study participant information that was collected as a part of a research study protocol and is specific to the individual. Currently, there are no federal regulatory guidelines specifying the conditions and management of disclosure of health-related individual-specific information. In this report, the authors discuss the challenges associated with individual disclosure in the context of a longitudinal descriptive study. Arguments favoring disclosure and those challenging disclosure as a general ethical duty are presented. Finally, strategies for addressing individual disclosure are discussed using a research exemplar in which risk behaviors related to health outcomes were measured.