PubMed · 8770615
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R J Bernstein. 1995. Rethinking responsibility.. https://pubmed.ncbi.nlm.nih.gov/8770615/
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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.
Federal regulations governing human subjects research call for additional protections for the "mentally disabled." However, there is currently no consensus definition of mental disability or guidelines for how these research subjects should be protected. This ambiguity complicates the work of institutional review boards (IRBs) charged with the review and approval of protocols involving psychiatric medication discontinuation and symptom provocation. It is particularly important for these studies to be reviewed within the larger context of the research program in which they are conducted. The author proposes a process for IRB review of these studies, which includes the implementation of additional safeguards for subjects determined by the IRB to be vulnerable. Recommendations also are made for training psychiatric clinical investigators in issues related to research bioethics.
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