Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements.

Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool.

The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.

The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

To rigorously develop a tool which enables rapid yet comprehensive appraisal of the consumer food retail environment and provision of real-time feedback to store managers and owners, based on the ‘4Ps’ principles of marketing.

Multi-stage iterative approach including (1) Systematic literature review; (2) Stakeholder consultation; (3) Assessment of existing tools against identified needs; (4) Tool development; (5) Pilot testing and (6) Transition of tool to mobile application (the Store Scout app).

Northern Territory, Australia.

Nine remote Aboriginal community food stores; public health nutritionists, retailers, store board directors, Aboriginal community members, government representatives.

Forty-seven existing tools and thirty-four stakeholder interviews informed the development of the current instrument, which comprised: (1) seven product categories (Fruit & Vegetables, Drinks, Snack Foods, Meals & Convenience Foods, Meat & Seafood, Dairy & Eggs, Breads & Cereals) across the ‘4Ps’ (Product, Placement, Price, Promotion); (2) Store manager questions about context and perceived importance of key principles about the store environment and (3) a scoring and feedback component. The tool was considered feasible and acceptable by all testers.

The developed tool addresses an unmet need to measure the consumer food retail environment across all 4Ps whilst also incorporating manager perspectives and immediate feedback. Our objectives of developing a comprehensive, feasible and acceptable instrument were achieved during pilot testing. The tool will support implementation of best practice within stores to encourage healthy food choices and has potential for broad application in retail settings locally and internationally, as well as for research purposes.

Our institution relocated to a new facility 3.5 miles from our original location in Chicago on June 9, 2012. We describe the tools we developed to prepare, execute, and manage our evacuation and relocation.

Tools developed for the planned evacuation included the following: level of acuity and team composition classification, patient departure checklist, evacuation handoff tool, and a patient tracking system within the electronic health record. Incident Command structure was utilized.

Monthly census tracking exercises were held beginning 12 months before the evacuation. Simulation drills began 6 months before the evacuation. The entire evacuation took less than 14 hours and there were no safety issues. A total of 127 patients were transported to the new facility: 45 patients were moved via the Neonatal/Pediatric Critical Care Transport Team, and the rest were moved with various team configurations.

Documents developed for a planned evacuation can be used for any planned or unplanned evacuation. We believe the tools we used to prepare, execute, and manage our evacuation and relocation would assist any health care facility to be better prepared to safely and efficiently evacuate patients in the event of a disaster, or to create surge capacity, and relocate them to another facility. (Disaster Med Public Health Preparedness. 2017;11:479–486)