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

Abstract

Preparing experimental protocols that are ethically sound, possess scientific merit, and meet institutional and national standards for human subject protections is a key 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 help investigators in their efforts to create protocols that are ethically acceptable have nevertheless received little attention. To better address this gap, the Research Protocol Ethics Assessment Tool (RePEAT) was developed as an educational instrument to help assure that ethically important elements, including scientific design features, are explicitly addressed by investigators in their work with protocols involving human participants. The RePEAT is a brief evaluative checklist that reflects rigorous ethical standards, particularly with respect to criteria for studies that may involve individuals with compromised decisional abilities. For this reason, it may be especially beneficial as a self-assessment tool for investigators and protocol reviewers in psychiatry. To stimulate education and dialogue, this report presents the RePEAT and outlines its content, format, use, and limitations.