A Database of IRB Guidance for Psychiatry

本提案是针对RFA编号OD-02-003：人类受试者研究提交的 增强计划。纽约州精神病研究所的IRB在保护参加社会心理、流行病学、治疗和生物学研究的精神病患者方面积累了相当多的专门知识。这一累积的政策、先例和方法指导我们的IRB审查，并在批准前推动研究的修订和修改。然而，这些资料大多是不成文的，即使是书面的，调查人员本身也不容易获得。在NYSPI的教育活动期间，研究者和IRB的反馈意见在很大程度上建议需要“捕获”这一专业知识，并使其可供研究者和IRB成员使用，因此提出了拟议的项目。我们计划通过创建一个富含诊断特异性和程序特异性IRB指南的关系数据库来加强我们的人类受试者保护计划。该数据库将描述IRB审查研究的现有先例和现有原型的基本原理。将参考人类受试者保护的相关概念对信息进行解释。该数据库还将作为一系列应用程序的平台，主要是精神病学研究的智能，基于网络的协议提交表格和IRB审查员的资源库。它将支持更明智和更有时效性的安全和道德上合理的协议，同意书和受试者设计。 反馈工具

This proposal is submitted in response to RFA number OD-02-003: Human Subjects Research Enhancements Program. The IRB of the New York State Psychiatric Institute (NYSPI) has developed considerable expertise relevant to the protection of individuals with mental illness who participate in psychosocial, epidemiological, treatment, and biological research. This accumulated policy, precedent, and methodology guides our IRB review and drives the revision and modification of studies prior to approval. Yet, this information is largely unwritten or if written is not easily accessible to the community of investigators themselves. The proposed project arises to a large extent from investigator and IRB feedback during educational initiatives at NYSPI which suggested the need "capture" this body of expertise and make itusable by investigators and IRB members. We plan to enhance our human subjects protections program by creating a relational database rich with diagnosis-specific and procedure-specific IRB guidance. This database will describe the rationale for existing precedent and present prototypes from IRB-reviewed studies. Information will be explained with reference to relevant concepts of human subjects protection. This database also will serve as a platform for a range of applications, primarily an intelligent, web-based protocol submission form for psychiatric research studies and a resource library for IRB reviewers. It will support the more informed and time-efficient design of safe and ethically sound protocols, consent forms, and subject feedback instruments.