The informed consent process for medical treatment and clinical research is an essential component of the ethical and regulatory fabric in modern healthcare in the United States. This process involves providing a patient or research candidate with adequate information concerning the procedure, providing adequate opportunity for them to consider all options, responding to the questions they have and obtaining consent to undergo a treatment or participate in a research study [1], [2]. Currently, hospital management systems still face challenges in effectively capturing and managing such permissions [3]. Many still use paper-based consent forms, which are typically scanned and stored in a document handling system with no mechanism for conducting systematic searches to identify potential candidates for research [4]. Specifically, such systems do not support retrieval of information about potential candidates using specific elements of the consent form such as consent to use tissues for research or other demographic characteristics as the search criteria. Another well-documented problem with current consenting mechanisms is patient comprehension [5], [6], [7], [8], a topic many researchers have investigated given its implications in the consenting process [9], [10].
Converting existing paper-based forms to an electronic format addresses both these issues by enabling (1) the indexing, search and retrieval of consent data, thus enhancing the ability to identify willing research participants and honor patient intent and (2) the inclusion of electronic educational media. The last decade has seen much research on the methods for capturing and managing these patient consent forms [11], [12], [13], [14], [15], [16], a primary focus being on the next generation of electronic consenting infrastructure and its ability to address and balance privacy and compliance issues to make electronic consenting more viable in the current medical environment [17].
Health Sciences South Carolina (HSSC), a research collaborative of three principal research universities and four major health systems in South Carolina, received a research grant to develop a comprehensive infrastructure for managing informed consents and research permissions electronically called the Research Permissions Management System (RPMS). Since the general consent form used in hospitals upon admission for patient care may include statements pertaining to research and education, it has the potential to serve as a vehicle for obtaining patient permission for using excess tissues for research or for future contact for research participation, albeit within the constraints of the Common Rule which dictates federal policy for the protection of human subjects in research [18] and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule [3], [19]. A schematic diagram of RPMS is shown in Fig. 1.
The development of an interface for such an electronic consenting system was a major challenge as it needed to address current issues with hospital staff and patients while providing a sound balance between usability and privacy and incorporating such features as electronic consent and signature capture, multilingual support, portability and the ability to be used in a wide variety of environments such as an emergency room. This development followed a user-centered design approach that involved user research, needs identification and analysis, specification and concept development, and the development of a detailed design followed by iterative testing [27], [28].
The first step in the development of the RPMS required an analysis of the existing flow of the admission and consenting process. To do so, the general registration and emergency room (ER) areas in one of the major hospitals in South Carolina were used to identify the issues and needs of both the patients and hospital registration staff, with a particular focus on determining their needs and the feasibility of adopting an electronic consent capture system. This activity involved five steps:
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20 h of observational studies of the registration process to collect process flow data independently using shadowing and informal interview techniques.
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20 formal structured contextual interviews with the registration staff and patients to obtain detailed information from each perspective concerning issues involved in the current consenting process, conducted using a prospective think-aloud protocol.
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Mapping and development of a hierarchical task analysis modeling the patient's journey through the registration process, focusing on the consenting procedure.
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Refinement of the process flow to ensure an accurate representation of the registration process both in the ER and general registration areas.
One of the key resulting observations was that the general consent for treatment and the consents for specific procedures included requests for permissions in various sections about future contact for research or the use of excess blood or tissues collected during regular patient care for research purposes. These are particularly important because patients are increasingly able to indicate their desire to participate in various aspects of research, in part because of new technologies and experimental procedures. For example, registering as a volunteer for clinical research and obtaining the consent to be contacted about specific research areas during the general consenting process are relatively new, both of which bring legal, ethical, social and informatics challenges to institutions as they begin to collate clinical data with genomic and bio-specimen data for research purposes. Managing research permissions and privacy authorizations becomes even more complicated for distributed clinical trials networks as they are often loose affiliations between collaborating institutions that may not be covered entities under the privacy laws as many fully integrated healthcare delivery networks are. Addressing these issues is a primary need for any electronic consenting system being considered; it should provide for an integrated collection and management mechanism for the consents and privacy authorizations that will accrue for individuals through their direct and indirect interactions with the hospital system.
In addition, the results of this study suggest several requirements needed by an electronic consenting system. For example, observation indicated the advantage of a mobile system over a stationary one, allowing the capturing of the patient consents in areas other than the registration desk, particularly in an ER setting where this process may take place at the patient's bedside [4]. Other requirements include the provision of the signed electronic consent form for the patient to review and modify at any point in time; allowing for authorized signatory, as in the case of the guardian for a minor or a relative for a mentally incapacitated patient; and the capability to capture the patient's specific wishes, such as the refusal to accept blood or blood products for a Jehovah Witness [4]. Finally, the user interface of the electronic consenting system should be easy-to-read and navigate even for patients with limited exposure to electronic devices and computers and for those who may have difficulty using modern electronic systems due to poor eye sight or age-related deterioration of motor skills. Similar studies evaluating the efficacy of touchscreen-based systems have been conducted on electronic voting systems [25], [26].
Based on these findings, product specifications were created, and multiple concepts were generated to accommodate the needs of the stakeholders. Two types of interfaces were proposed for investigation for the RPMS: a stationary touch screen interface to be used in regular patient registration areas, and a tablet-based system presented on an iPad to be used primarily in mobile situations such as an ER. The empirical study reported here investigated the efficacy of these interfaces, comparing them with the current paper- and Topaz-based systems in order to explore how the two concepts were perceived and experienced by the patients and the registration staff. We hypothesized that these proposed systems are at least as good as the conventional systems in terms of the dependent measures of time, errors made, workload, satisfaction and patient comprehension.