Clinical researchers have many resources available help to insure patient safety, maintain ethical standards and enhance compliance with governmental regulations, comply with local context issues, but these are voluminous and can be difficult to navigate. These resources include ethical principles, IRB regulatory monographs, OHRP guidance documents, templated consent language, local context issues (legal liability, institutional policies, etc) and investigational drug safety issues. Other useful tools include automatic search for """"""""sensitive"""""""" words (e.g. pregnancy, incarceration, gene therapy, etc), reading level evaluation for consent form fields, spell checking and frequently asked questions. We hypothesize that providing investigators with well-integrated, electronically-linked/triggered decision support tools to use at the time of IRB proposal development will improve the quality of IRB applications and the protection of human subjects. These improvements will decrease the time and complexity of IRB review allowing investigators and reviewers to focus on more complex issues that, by necessity, fall outside the standardized decision support system we will develop. The goal of Project PROTECT, therefore, is to develop an electronic system that assists investigators in the development of human subject protection by teaching investigators important human subject protection regulatory and ethical issues precisely at the time of proposal development. The system will be developed and rigorously tested in a research intensive setting in a major university IRB using human subjects researchers throughout the process. Upon completion of the development phase, the decision support system will be fully integrated into the workflow of the Vanderbilt University IRB.
