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.
