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Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants—particularly minorities and participants from rural communities.
The objective of this study is to utilize telemedicine to improve the informed consent process for clinical trials and studies. We aim to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings.
This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina and the University of North Carolina at Chapel Hill, to compare results within and across institutions.
Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018.
In this paper, we present a novel approach for conducting informed consent using a new telemedicine modality, namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants.
RR1-10.2196/11239
Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants—particularly underserved and participants from rural communities [
Multisite and offsite clinical trials often impose considerable travel costs and time commitments on participants [
The Biomedical Informatics team at the Medical University of South Carolina (MUSC) has developed “teleconsent,” an innovative, informed consent approach that leverages telemedicine technology to conduct remote, live consent sessions between participants and researchers. Teleconsent allows research personnel to meet and discuss the study with a prospective participant virtually using a video feed, share an informed consent document that can be collaboratively filled out by a participant and study personnel in real time, and generate an electronically signed informed consent document (
A mock consent form displayed in the Doxy.me software during a live teleconsent session.
We are conducting a study that evaluates participants’ reactions to the teleconsent software, including their feelings regarding privacy and ease of use. We have 3 main objectives. First, we seek to understand the feasibility of using telehealth in rural areas, acceptability among underserved populations, and ethical and privacy concerns of using the teleconsent software and remote communication through participant interviews, particularly among minorities, rural, and elderly participants aged >65 years. Second, we aim to evaluate the quality of informed consent by comparing participants’ perception and comprehension using either teleconsent or paper-based consenting in ongoing clinical studies, through partnerships with investigators conducting those studies, by assigning participants to either teleconsent or traditional paper-based consenting. In addition, we will determine to what extent, if any, the teleconsent process affects participants’ informed consent and the workflow of research staff conducting the studies. Third, we intend to assess the workload on research assistants and their perception of the usability of teleconsent in terms of ease of use and user friendliness of the interface.
Study procedures will be conducted concurrently at 2 institutions, the MUSC and the University of North Carolina at Chapel Hill (UNC) to compare results both within and across institutions.
This study is divided into 2 phases, to be completed in subsequent order and concurrently at both study sites. Phase 1 aims at meeting the first objective by conducting remote mock consent sessions using the Doxy.me software (
In the second phase, we will complete our second and third objectives by partnering with ongoing clinical trials and assigning participants to either teleconsent or traditional paper-based consenting and then assessing the quality of informed consent and workload, among other metrics; of note, this part of the study will be initiated in the winter of 2019. Full procedures for both study parts are outlined in the “Procedures” section of this paper.
For phase 1, prospective participants are required to be, at least, 18 years of age, currently residing in North or South Carolina, speak English as their first language, and have access to the internet and a computer with a microphone and camera. Any participant who does not meet the inclusion criteria will be excluded from the study. Our decision to exclude participants who do not reside in North Carolina is because one goal of this software is to study how North Carolina residents react to the software and compare the data to that of our MUSC. In addition, we choose to exclude participants who do not speak English as their first language to control for potential language barriers in this feasibility study. Moreover, the technological requirements of Doxy.me require participants to have access to a laptop or desktop with the appropriate audio-video capabilities; notably, the software was not compatible with tablets, such as iPads, or smartphone at the time of this publication. For phase 2, the eligibility criteria for our study is the same as those for the clinical trial sites.
Each study site will have a unique recruitment process. For phase 1, in South Carolina, participants will be recruited through the dissemination of Institutional Review Board flyers placed in clinical and community settings and distributed by our Community Advisory Board members, advertisements, word-of-mouth, and at community-based clinic sites. Participants at UNC will be recruited through a researcher-participant networking website called Join the Conquest, word-of-mouth, and direct participant recruitment at Broad Street Clinic in Morehead, North Carolina. In addition, participants’ recruitment at UNC will be facilitated by 2 research assistants, the principle investigator and coprinciple investigator, and the staff at Broad Street Clinic. At MUSC, recruitment will be facilitated by the research coordinator. Both institutions will implement a prescreening eligibility questionnaire. On Join the Conquest, persons interested in the study will be directed to a Qualtrics eligibility survey, which will include demographic information. At MUSC, surveys will be completed through the Research Electronic Data Capture Platform (REDCap) [
The teleconsent software allows the research coordinator and participant to sign the consent form in real time electronically.
For phase 2, participants will not be directly recruited for our study. Instead, we will partner with investigators conducting ongoing clinical research and assign those study participants to use either teleconsent or traditional paper-based consenting for the informed consent process. In total, 64 patients and up to 10 research assistants will be involved in this part of the study at the UNC site, though the number of research assistants may be as low as 2. Patients will be paid each time a set of surveys are completed. Research assistants will be paid upon the completion of each National Aeronautics and Space Administration (NASA)-Task Load Assessment (TLX) form (to be completed after each consent session) and also upon the completion of each System Usability Scale (SUS; to be completed approximately 3 times throughout the study). In addition, research assistants will be paid for participation in a focus group.
For phase 1, participants’ screening will occur through the Qualtrics or REDCap surveys or over the phone. The demographic information collected during the screening process (age, gender, race, ethnicity, and county) will be used to select a group of participants who are coming from a variety of backgrounds to study potential differences between reactions to teleconsent among various demographic groups. For phase 2, participant screening will not occur.
No randomization will be involved in phase 1. For phase 2, if the parent study permits, participants will be either randomly assigned to each of teleconsent or traditional consent. When random assignment is not possible, for example, in studies in which some participants do not have the option of being assigned to traditional consent, thereby negating random assignment, we will use the propensity score matching after assignment to either teleconsent or traditional consent. Once verbally consented through one of these means, participants will undergo the informed consent process.
In phase 1, following the initial eligibility screening and identification as possible participants, interested individuals will be contacted by emails or phone to invite them to schedule a 1-hour mock consent session with a member of the study team. Before the mock consent session, participants at UNC will e-sign an Web-based consent form sent by Qualtrics and those at MUSC provide verbal consent at the time of scheduling, which is confirmed by the coinvestigator prior to participating in study procedures. During the mock consent session, study personnel will give participants a brief overview of Doxy.me and teleconsent before walking participants through a mock consent form created for this study. The purpose of the mock consent form is not to actually complete an informed consent session but to highlight the functionalities of the software. Immediately after the completion of the mock consent process, study personnel will conduct audiorecorded, semistructured interviews with participants about their experiences. After the study completion, participants will either receive cash or a gift card sent electronically or mailed to their residence(s). In total, 40 participants are to complete phase 1 of the study at each site, for a total of 80 participants between UNC and MUSC.
For phase 2, participants (n=64 at each site) will be assigned to either consenting for the clinical trial through teleconsent (n=32) or through paper-based consenting (n=32). Notably, 64 subjects per site (totaling n=128 between sites) will provide 80% power to detect modest differences (effect sizes ~0.50) between groups with respect to the survey instrument scores. After consenting for participation in the teleconsent study, participants will undergo the informed consent process using either teleconsent or traditional consent. After the completion of the consent process, participants will immediately fill out the quality of informed consent (QuIC), Decision-Making Control Instrument (DMCI, and Short Assessment of Health Literacy-English version (SAHL-E). Thirty days postconsent, participants will be asked to fill out this set of surveys once more electronically; they will be paid for each set of surveys completed.
Study personnel who are consenting potential participants will fill out a NASA-TLX form for each patient; they will be paid for each form filled. In addition, they will fill out SUS 3 times throughout the study, once at the beginning of their participation, once toward the middle, and once after they have completed enrolling participants for the teleconsent study; they will be paid for each SUS filled out. Finally, after the termination of the teleconsent partnership, those who will be obtaining informed consent for these studies and will assist in the collection of instruments will be invited to participate in a focus group asking about their workload and perceptions of the Doxy.me software for teleconsent. Focus group participants will be receiving remuneration for completing the focus group.
We will use the cognitive interviewing technique of verbal probing adapted from Willis to evaluate comprehension, decisions, and voluntariness, as proxies for users’ trust and intention to complete trials using the DMCI [
It is important to evaluate the decisional capacity and comprehension in informed consent processes, and research has identified that individuals with lower educational levels, mental illness, and advanced age are at risk of lower comprehension and potentially can be misled regarding the intent of the research [
In addition, validated surveys will be provided to all study personnel engaged in this process at the clinical trial sites to evaluate their level of satisfaction and workload experienced (NASA-TLX Task Index Scale) with the recruitment process [
The design of phase 1 of our study is a qualitative study with a semistructured interview format. The ethical approval was obtained from the Institutional Review Boards at the UNC (17-2769) and the MUSC (# Pro00068715).
The design of phase 2 of our study is a 2-arm, teleconsent study, which assesses various metrics using standardized surveys. The ethical approval was obtained from the Institutional Review Board at the UNC (17-2870).
Survey assessments and demographics will be collected through UNC Qualtrics survey, REDCap survey, or pen-and-paper. Interview audios will be recorded using a handheld device (following participants’ consent) and stored on a secure MUSC Box server.
In phase 1, all interviews will be professionally transcribed and imported into the NVivo 12.0 (QSR International Pty, Doncaster, VIC, Australia) qualitative analysis software. Verification of the transcript accuracy will be performed prior to analyzing the text. An iterative process will be used in the analysis of the data. Then, 2 team members will code the data following its transcription by tagging segments of text in the transcripts to a concept, expanding, refining, and reducing the concepts, and discussing the findings in detail to allow for cross-validation of findings between the 2 sites [
In phase 2, for patient participants, descriptive statistics (means, SDs, medians, etc) of responses to the survey instruments will be used to characterize the 2 groups (ie, teleconsent vs paper-based consent). Participants will be stratified with respect to demographics and clinical study. Each of the survey instrument summary scores and subscale scores will be essentially continuous variables; as such, comparisons between groups will be delineated through analysis of covariance modeling. In these models, the instrument score will serve as the dependent variable, with the experimental group serving as the key independent variable of interest. The analysis of covariance model includes participant factors, such as education and other demographics, as covariates in the models.
For study personnel, descriptive statistics will be used to study the differences in the NASA-TLX between the 2 groups through a 2-sample
Enrollment and data collection for phase 1 is expected to conclude by December 2018. Data transcription and analysis will begin in January 2019. For phase 2, 2 clinical trials have been identified for a potential partnership, and these sites have modified their Institutional Review Board protocols to include the addition of teleconsent. Phase 2 will also begin in January 2019. We anticipate reporting results in June 2019 through professional presentations and publications. Study findings will be disseminated through publications, direct update to Community Board Members, and electronically to participants.
The results of the work from the above aims will be disseminated, throughout the Clinical Translational and Science Award (CTSA) consortium and the broader translational research community, through presentations at national meetings, such as the American Medical Informatics Association Translational Science Summit, relevant CTSA domain task force or interest group meetings, and through publication in peer-reviewed journals. The initial strategy for teleconsent is dissemination through academic research organizations in regional MUSC collaborations, including the Carolinas Collaborative and Mid-South Clinical Data Research Network. The teleconsent underlying framework, Doxy.me is a freely available lightweight telemedicine framework, which will facilitate the dissemination across the CTSA network.
Telemedicine is an innovative health care delivery model that provides care to patients at a distance using telecommunications capabilities [
In phase 1 of this study, participants will be recruited; participants will be residents of South and North Carolina (N=80; 40 from each respective site) from various backgrounds; however, all will meet the inclusion criteria specific to this study. Participants will be walked through the teleconsent process using a mock consent form and then interviewed to determine the overall themes regarding issues such as software difficulties and privacy issues. Results from this part of the study will be used to provide feedback to developers at the MUSC and address potential issues before phase 2, which will be completed in the summer of 2019. In addition, it will provide data on participant preferences, acceptability, and potential barriers to the adoption of teleconsent. For phase 2, researchers partner with ongoing clinical trials and assign participants (n=64 at each site) to either consenting by teleconsent or traditional paper-based consenting. Various validated surveys will be given to participants both immediately after the consent process and 30 days postconsent to determine differences in the understanding of the consent process between groups. Moreover, surveys will be administered to the study personnel who are consenting patients throughout the process to study the additional workload and demand placed upon them. We hypothesize that there will be no significant difference in the quality of informed consent or additional workload demand placed on researchers between traditional paper-based consenting and teleconsent. With these results, we hope to increase the usage of teleconsent in clinical trials to reduce barriers to study enrollment and improve underserved groups’ participation in research.
Notice of Award for Grant funding from NIH.
Summary statement and peer-review comments.
Clinical Translational and Science Award
Decision-Making Control Instrument
Medical University of South Carolina
National Aeronautics and Space Administration
Quality of Informed Consent
Research Electronic Data Capture Platform
Short Assessment of Health Literacy-English version
System Usability Scale
Task Load Assessment
University of North Carolina at Chapel
This work was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant Numbers R21 TR002088, UL1 TR001450, UL1TR002489, and 2KR981704.
BW, a member of the MUSC team is the Founder and Chairman of Doxy.me, LLC. BW has not been involved in the planning or analysis of the research. He has not been involved in the recruitment or consenting of participants. BW’s role on the project is to provide technical support and lead further software improvement cycles on Doxy.me and the teleconsent platform.