The Research Permission Management System (RPMS) project was undertaken in South Carolina with Grand Opportunity grant funding from the National Library of Medicine. This collaboration included an Ethical, Legal, and Social Issues (ELSI) committee led by Duke University. Project execution followed a multidisciplinary approach and included team members with informatics, systems engineering, software engineering, project management, ethics, and regulatory expertise. Following the specific aims of the grant and instituted software development practices, the team employed the following iterative software development lifecycle throughout the project:
Analysis → Requirements Gathering → Design → Development → Testing → Implementation → Training
Clemson University led the initial phase involving substantial analysis focused on two key areas: 1) Systematic analysis of existing business practices, registration processes, and consent collection workflows at each of the HSSC member healthcare facilities and 2) Investigative analysis of best practices for presenting information to users via tablet technology and capturing permissions and consent data electronically.
The analysis of the existing hospital processes for obtaining patient permission to treat revealed specific areas in which electronic forms would most effectively replace paper-based forms. This analysis influenced the design for the detailed workflow embedded into the RPMS application. The general workflow included presentation of the information to a patient or participant, collection of information from checkbox options and signatures, registrant review of information and witness signature. Institutional business requirements include the ability to select appropriate forms applicable for each patient visit and the need to accommodate multiple language.
Best practices for presenting and collecting information electronically were investigated using participants at Palmetto Health. For example, the use of long forms with scrolling pages versus the presentation of the information one page at a time with the use of navigation buttons. Also, the use of a tablet-based device (Apple iPad®) versus. a fixed touch screen. Results showed a preference by both registration clerks and patients for a portable device. In addition, the paginated interface was prefered over the scrolling interface with less handling errors. These results influenced the design of the RPMS user interface. The design was also informed by the results of a Video Assisted Consent study conducted at the Medical University of South Carolina (MUSC) in collaboration with regulatory knowledge experts using a mock-up of RPMS code.
A customized implementation of the RPMS software was piloted in select patient registration clinics at MUSC starting in November 2011. The Implementation was designed specifically for the statewide infrastructure that is being established by HSSC. The stand-alone RPMS software was extended to communicate with the Enterprise Master Patient Index (EMPI) to optimize patient lookups and to store collected data in the clinical data warehouse (CDW). As a result, the final extended RPMS was inherently distributed with data transmitted from source registration areas at the member institution to the centralize HSSC CDW. For this pilot implementation, information from several paper-based forms typically used for consenting during patient registration were converted into electronic format and displayed on an iPad via the RPMS user interface.
In addition to permission to treat, the intention of the RPMS is to replace the current, paper-based informed consent process used in clinical studies with an electronic system with minimal disruption to the research workflow. The introduction of this new medium to the consenting process has several potential benefits. Patients are often presented with increasingly complicated informed consent forms during enrollment in clinical studies. The forms are verbose and difficult to comprehend. The electronic format opens new avenues for richer content in consent forms, such as audio or video that can enhance the information presented and improve comprehension of the complex concepts and/or procedures being researched. RPMS enables study coordinators to embed rich media into consent forms. The results of the VAC study suggest that using video to convey details about study procedures may increase participant understanding. Finally, consent collected electronically can be presented back for patient or research participant review via a patient research portal allowing them to review the list of research protocol and research authorizations to which they have consented. The information presented in this manner empowers patients by allowing them to be better informed, to make informed decisions about research and to provide access to the research team.
HSSC has developed an electronic system designed to simplify the collection and management of research authorizations and informed consents. The captured data is fed into the CDW with associated clinical data. The result is a system that can facilitate the versioning and tracking of informed consents, enhance the consent process, and facilitate research participant recruitment as well as the coordination and management of a statewide clinical trials network. Future plans include the development of best practices for the presentation of multimedia in consents; the incorporation of Institutional Review Board workflow; a detailed analysis of the impact of RPMS on the consent process and research recruitment; and the addition of other components to RPMS such as a patient portal to empower patients and research participants about their decisions on consents and authorization that accrue during their interactions with the research enterprise.
The final version of RPMS, which offers new features such as the support of the workflow of the informed consent to participate in research and consent form design tool, has been completed and released under an open source license. The platform is extensible and configurable with the ability to be used in multiple consenting environments such as patient registration for routine care or informed consenting for clinical trials.
