Ethical dimensions of psychiatric research: A constructive, criterion-based approach to protocol preparation. The Research Protocol Ethics AssessmentTool (RePEAT)

Preparing experimental protocols that are ethically sound possess scientifi c merit, and meet institutional and national standards for human subject pr otections is a kelt responsibility of psychiatric investigators, This task has become increasingly complex due to developments in biomedical science, bioethics, and society at large. Practical and constructive approaches to h elp investigators in their efforts to create protocols that are ethically a cceptable have nevertheless received little attention. To better address th is gap, the Research Protocol Ethics Assessment Tool (RePEAT) was developed as an educational instrument to help assure that ethically important eleme nts, including scientific design features, are explicitly addressed by inve stigators in their work with protocols involving hyman participants. The Re PEAT is a brief evaluative checklist that reflects rigorous ethical standar ds, particularly with respect to criteria for studies that may involve indi viduals with compromised decisional abilities, For this reason, it may be e specially beneficial as a self-assessment tool for investigators and protoc ol reviewers in psychiatry. To stimulate education and dialogue, this repor t presents the RePEAT and outlines its content, format, use, and limitation s. (C) 1999 Society of Biological Psychiatry.