Overcoming Recruitment Hurdles in Clinical Trials: An Investigation of Remote Consenting Modalities and their Impact on Workload, Workflow, and Usability

Abstract

Travel constraints can hinder the recruitment of eligible research participants in clinical trials, causing research timeline extensions, added costs, underpowered results, and early termination. Remote consenting can help solve these issues by allowing researchers and potential participants to connect remotely. This controlled experimental study investigates the effect of remote consenting on workload, workflow, usability, and barriers and facilitators to its implementation. Using a mixed experimental design, simulated consenting sessions were conducted with three different modalities (remote paper consent, eConsent, and teleconsent) with 23 researchers and 93 research participants. Each session involved a single researcher who experienced all three modalities, while three different research participants were assigned to each modality individually. Research participants and researchers completed surveys measuring workload and usability. Remote consenting allows researchers and participants to connect at their preferred location and time, and teleconsenting was found to be the preferred modality by the researchers, primarily due to its ability to exchange visual cues. However, challenges such as training requirements and technology dependence need to be addressed for widespread implementation. Future research should aim to eliminate these barriers and improve remote consenting modalities to facilitate clinical research participation.

Introduction

Clinical trials play a vital role in evaluating the efficacy and safety of new clinical interventions and thus help improve healthcare effectiveness and quality. Clinical research contributes heavily to improving knowledge about diseases, treatment and prevention techniques, and quality of life (Sygna et al., 2015). Despite their importance, obtaining timely, high-quality, and actionable information through clinical trials is hard due to the prevalence of specific challenges (Welch et al., 2016). These challenges may include budget restrictions, length of the study, lack of trained personnel, ethical requirements, and difficulty recruiting and retaining suitable participants (Welch et al., 2016; Sung et al., 2003). Recruiting participants for clinical trials can be particularly challenging. For instance, in a 2015 study, 1,562 cancer patients and their caregivers were contacted for participation in a randomized controlled trial. However, when the on-site and routine care letter recruitment method was introduced, 65.6% of the participants (n=1209) declined to participate in the study (Sygna et al., 2015). Recruitment processes can be challenging and time-consuming, especially in studies that include seriously ill patients (Sygna et al., 2015; Sully et al., 2013; Leblanc et al., 2013). In an analysis of studies involving cancer patients, Feller (2015) found that 25% of the cancer trials failed to recruit the desired number of participants, and 18% of the trials failed to generate any substantial results due to insufficient participation. Geographical and temporal inconvenience is among the factors contributing to the ineffectiveness of current participant recruitment methods. (Giffin et al., 2010; Sygna et al., 2015; Welch et al., 2016). There has been a shortage of public participation in medical studies, and participant numbers continue to decline (Obeid et al., 2013; Ponathil et al., 2018; Welch et al., 2016). The failure to recruit adequate participants in clinical trials ultimately hinders the transition of biomedical discoveries into potentially life-saving interventions in clinical practice (Glick et al., 2014; Welch et al., 2016).

The informed consent process is an essential communication between the research team and a patient to go over the essential elements of informed consent (e.g., description of the research or procedure, risks, benefits, voluntariness, and alternatives) that results in the patient’s authorization or agreement to proceed with the research or medical treatment. It is one of the core tenets of the ethical conduct of research with human subjects and ensures that research participants can make voluntary and knowledgeable decisions about whether to take part in a research study. Informed consent must be accessible and understandable to the potential research participant; however, it can prove to be a challenging task and can impact the overall success of a study (Khairat & Obeid, 2018; Welch et al., 2016). The challenges associated with the informed consenting process may include patient travel burden, travel cost, scheduling difficulties between the participant and the research team, difficulty understanding the consent documentation, and temporal inconvenience (Chamberlain et al., 2009; Schenker & Meisel, 2011).

Clinical trials are often conducted in proximity to the research team and the researcher, which makes it difficult for participants who live far from the study site to participate in clinical research (Welch et al., 2016; Khairat & Obeid, 2018). Current consenting methods involve participants having face-to-face interaction with the research team. In a study conducted by Mathur et al. (2015), 303 participants were invited to partake in an online questionnaire aimed at identifying barriers to conducting comprehensive clinical trials for Parkinson's disease. The study found that multiple visits to the research facility were required, with the first visit primarily dedicated to the informed consent process, including completing consent forms and understanding potential risks and benefits. Notably, sixteen percent of participants expressed concerns that the risks of trial participation outweighed the benefits, while thirty percent were uncertain about reclaiming all personal costs incurred during the trial. Ensuring that participants have a comprehensive understanding of the research is essential for making informed decisions about participation.

Introducing a mechanism that enables potential participants to access research-related information remotely, including potential risks and benefits, would not only save them the time and effort of traveling to the research site but also alleviate travel-related costs associated with clinical research participation (Welch et al., 2016). By conducting the consent process remotely, participants can conveniently and comprehensively acquaint themselves with the study's particulars, making informed decisions from the comfort of their own surroundings. Participant recruitment and retention depend on their willingness to travel to and from the study site; longer travel time may discourage potential participants (Ory et al., 2002). Transportation requirements and costs associated with traveling are long-standing challenges for obtaining consent from research participants (Ory et al., 2002; Fogel, 2018). Traffic congestion and longer travel times, particularly in urban areas, negatively affect participation irrespective of the age of the participants (Fogel, 2018).

During the COVID-19 pandemic, in-person informed consent for research has become a barrier to conducting research studies, especially with the added exposure risk in vulnerable populations (Padala et al., 2020; Bierer et al., 2020). With the onset of the COVID-19 pandemic, usability investigations into how to convert services such as consenting to a remote application are more imperative than ever before. Health systems have accelerated the adoption of digital tools and technologies such as telehealth and virtual care, which refer to the delivery of healthcare services digitally or at a distance using Information and Communications Technology (ICT) to provide treatment to patients considering the pandemic (Bokolo, 2021).

Currently, obtaining consent for research can be done remotely via telephone, fax, mail, or email. However, these approaches have their shortcomings. Participants’ understanding during the consent process is difficult to be assessed through a telephone or a faxed form (Fortun et al., 2008; Reidenberg, 2005). Past research has found that study participants do not read consent forms sent in the click-through format on computers and mobile devices, making it difficult to gauge the non-verbal cues if the researcher does not witness the process (Grady et al., 2017). As clinical studies and trials become increasingly complex and the demand to integrate trials into routine care increases, there is an added need for accessible solutions for obtaining consent (Check Hayden, 2012).

To overcome these consenting-related challenges, different remote consenting solutions have been introduced. One such method is remote paper-based consenting via mail. In this method, a paper copy of the consent form is mailed to the potential participants. The potential participants are then tasked with setting up a telephonic conversation with the research team wherein they would ask questions and get more clarity on the different elements of the consent form. Another remote consenting modality is eConsent. This modality makes use of survey-based software such as REDCap to send consent forms in a survey format that can be distributed to potential participants via email as a clickable link (Lawrence et al., 2020). Participants sign the consent form through this system with study personnel walking the participant through the consenting process in only an audio format, such as through a phone call (Welch et al., 2016; Harris et al., 2009; Lawrence et al., 2020). Boutin et al. (2016) conducted a study to identify the potential benefits and challenges of electronic consent or eConsent and identified that eConsent was an effective strategy for large-scale research projects that depend heavily on patient recruitment. Consent forms were emailed to the patients, and they had to log in to the system in order to give consent which negatively affected the patient's likelihood of using the electronic consenting method. Providing patients with an easy way to unsubscribe from the email thread through which the consent forms were sent was an essential requirement (Boutin et al., 2016). Madathil et al. (2013) conducted a study to test the efficacy of electronic consenting interfaces and found that electronic consenting can improve the consent process for research studies and reduce the burden on participants and research staff. Remote paper consenting via mail and eConsenting both come with the challenge of being unable to observe nonverbal cues from the participant that would indicate discomfort or confusion about aspects of the study or consent form (Welch et al., 2016). Furthermore, it is important to consider that research participants may have distinct experiences when using these two consenting modalities, as a previous study has demonstrated variations in reading performance between paper and screen (Holzinger et al., 2011). Consequently, there is a need for further investigation into the effectiveness of these two research consenting modalities in order to gain a comprehensive understanding of their efficacy and potential implications.

Teleconsent is a research consenting method that enables both audio and video-based communication between the researcher and the participants (Welch et al., 2016). Through the active exchange of verbal and non-verbal cues, teleconsenting aims at replicating the capabilities of an in-person consent process (Welch et al., 2016; Khairat et al., 2018). The development of teleconsent supports questions to be asked synchronously as researchers share the screen with potential participants as they work through the consent process together (Khairat et al., 2018; Sawant et al., 2022). An electronic data capture system (e.g., REDCap) can be used in conjunction with audio communication tools, where study personnel can save the signed consent forms (Welch et al., 2016). Previous research has shown that teleconsenting is an effective method that eliminates the geographical challenges associated with in-person consenting (Welch et al., 2016; Khairat et al., 2018; Obeid et al., 2013). Teleconsent helped improve the overall satisfaction of caregivers (Yun et al., 2022) and patients (Turner et al., 2022). Teleconsenting can reduce the time associated with collecting consent by eliminating the need to travel to research sites (Welch et al., 2016; Khairat & Obeid, 2018). This could be particularly helpful for busy individuals to participate in healthcare research who otherwise do not have time to travel to research sites. Individuals with mobility impairments or transportation challenges could also benefit immensely from these platforms as it provides them with an alternate means for consenting. In addition to this, teleconsenting platforms can offer features such as adjustable font sizes, color contrasts, and screen reader compatibility (Welch et al., 2016). These accessibility features could make the consenting process easier for participants with visual or hearing impairments or reading difficulties. Despite numerous studies conducted to evaluate the efficacy of electronic consenting systems, only some have explored the barriers and facilitators to the implementation of remote consenting platforms in supporting clinical research. To address this gap, this study aims to analyze the effectiveness of the teleconsent system and workflow by comparing it with eConsent and remote paper consent via mail. The study will evaluate the effectiveness and usability of each method by measuring workload, preference, and perceived usability, to answer the following two research questions.

• RQ1: What are the facilitators and barriers associated with using remote consenting modalities for clinical research?

• RQ2: What is the efficacy of the three consenting modalities based on participants’ perceived workload, perceived usability, and preference ratings?

Methods

2.1. Participants

Based on the results of the power analysis, a total of 69 individuals (24 females and 45 males) were chosen from a major research University to participate in the study as mock research participants. Additionally, 23 other individuals (16 females and 7 males) with prior experience as research coordinators and obtaining consent from participants for research studies were recruited to serve as mock researchers. For convenience, we will be referring to mock research participants as research participants and mock researchers as researchers in the following sections of this research article. The research participants read and verbally consented to a consent form approved by the Clemson University Institutional Review Board. The research participants had a mean age of 27.84 (SD = 6.78), while the researchers had a mean age of 28.30 (SD = 7.31). Table 1 includes additional details on the demographics of the participants.

Table 1.

Demographic data

Participant type	Variable	Number
Researchers	N = 23
	Gender
	Male	7
	Female	16
	Ethnicity
	Caucasian	10
	African American	1
	Asian	10
	Other	2
Research participants	N = 69
	Gender
	Male	45
	Female	24
	Ethnicity
	Caucasian	14
	African American	2
	Asian	51
	Other	2

2.1.1. Inclusion criteria

The participants had to satisfy the following three conditions to participate in this research study:

1. At least 18 years of age.

2. Able to speak and read English.

3. Willing to provide verbal consent prior to study entry.

In addition to the above three conditions, the participants in the researcher role were required to have at least one year of prior experience in obtaining consent for research studies.

2.2. Experimental design

The study was conducted in a controlled lab-based environment. The researchers and research participants were placed in two different rooms during the study. A member of the research team moderated the study as the research coordinator. Each station was equipped with a computer system with a Google Chrome browser and an active internet connection, keyboard, mouse, and headsets. The mock consent form used in this study was designed and developed by the Medical University of South Carolina (MUSC), as shown in Appendix A. Figure 1 shows the experimental setup.

Figure 1.

Experimental setup

2.2.1. Independent variables

The three consenting modalities evaluated during this study were remote paper consent, eConsent, and teleconsent. For the remote paper consenting condition, both the researchers and research participants were given a paper copy of the consent form. The researcher then provided a walkthrough of the consent form to the research participants via Zoom. Only audio communication was permitted between the two sets of participants. Figures 2 and 3 show the general layout of the mail-based consenting modality and a representation of the paper consent form, respectively.

Figure 2.

Mail-based consent setup

Figure 3.

Sample representation of the paper consent form

For the eConsent condition, researchers and research participants accessed the consent form via a REDCap survey link. Similar to the remote paper consenting condition, there was only audio communication between the researcher and the research participants, which was facilitated via Zoom. The researcher and the research participants used a desktop computer with audio capabilities to complete the consent form walkthrough, as shown in Figure 4. Figure 5 shows a representation of the mock consent form as displayed via the REDCap software.

Figure 4.

eConsent setup

Figure 5.

Sample representation of the consent form as a REDCap survey

For the teleconsenting condition, we used a novel teleconsenting software designed and developed by MUSC. The specialized teleconsenting platform evaluated in this study is compliant with the Health Insurance Portability and Accountability Act (HIPAA). The platform allows both the researcher and the participants to access the consent form together, enables digital Signature on consent forms, and secure downloads of the signed documents. The researcher and the research participants used a desktop computer with audio-video capabilities to complete the consent form walkthrough, see Figure 6. The consent form was integrated into the software, which both sets of participants could access. Figure 7 shows the interface of the software used for the teleconsenting condition.

Figure 6.

Teleconsent setup

Figure 7.

Teleconsenting session

2.2.2. Dependent variables

The research team recorded the perceived workload for the researchers and research participants through the NASA task load index (Hart & Staveland, 1988) and perceived system usability through the IBM computer system usability questionnaire (Lewis, 1995). Researchers reported their preference ratings via a ranking questionnaire. Both researchers and the research participants went through a semi-structured interview process with a research team member to report their pain points, preferences, and suggestions regarding the use of remote consenting modalities.

2.3. Procedure

A mixed experimental design was used for the study. The method of collecting consent was the distinguishing factor between the evaluated conditions. Verbal consent was obtained from each participant before the start of the study. The researcher and the research participant were placed in a controlled setting in two separate rooms during the study to mimic a remote consenting process. The researchers completed the training on collecting consent from the participant using the 3 different consenting conditions. Each research participant was randomly assigned to one of the three test conditions to address potential order effects. For the control condition (mail-based consent), a paper copy of the consent form was provided to the research participants and the researchers. The researcher then briefly described the different sections of the consent form and answered any questions that the research participants had. Only audio communication was permitted during this consenting condition. We used Zoom to establish audio communication between the researcher and the research participant. In the eConsent condition, a copy of the consent form was sent to the participants via email as a clickable REDCap survey link. The researcher provided a walkthrough of the entire consent form with the participant, answering any questions or resolving any queries the participant had before the participant made an informed decision about the consent. The research participants signed the electronic consent form via REDCap. This condition only made use of the audio-based communication facilitated via Zoom.

In the teleconsent condition, the communication between the research participants and the researcher was a two-way audio-video communication. The condition used a teleconsenting platform, which enables the research participants to be in a “medical consultation” where both the researcher and the participant can see the consent form as well as each other. The researcher then walks through the consent form and answers any research participants’ questions. This consenting method is designed to mimic an in-person consenting process. The researchers had to complete the study for 3 different research participants, one for each of the 3 consenting conditions.

After completing their assigned tasks, the research participants completed a series of questionnaires to rate their experience with the consenting method they were assigned. The surveys include the IBM Computer System Usability Questionnaire (CSUQ) (Lewis, 1995) to gauge the perceived usefulness of the consenting method and the NASA Task Load Index (TLX) (Hart & Staveland, 1988) survey to measure the workload associated with the use of the consenting method. After completing all 3 sessions, the researchers had to fill in a ranking questionnaire to understand their preference for the consenting method. Upon completion, the research participants and the researchers were thanked for their time. The researchers received a $25 gift card, and the research participants received a $10 gift card. Figures 8 and 9 show the procedure followed by the research participants and the researchers during the study.

Figure 8.

Flowchart outlining the experimental procedure for the research participants

Figure 9.

Flowchart outlining the experimental procedure for the researchers

2.4. Analysis

The usability of the software used for the different consenting methods was determined by analyzing the dependent variables of the time taken to complete the consenting process, the IBM CSUQ questionnaire scale, the workload associated with each consenting process through the NASA TLX questionnaire ratings, and the preference of the researchers based on their response to the ranking questionnaire. To analyze the dependent variables, IBM Statistics 22 was used. The repeated measures ANOVA was carried out at a 95% confidence level to determine the significant differences between the control group and experimental groups for the researchers’ data. The one-way between-subjects ANOVA was used for the research participants’ data. The post-hoc analysis was conducted to examine the differences in mean scores between the control group and experimental groups. The analysis was conducted using Fisher’s least significant differences to adjust for multiple comparisons. The Friedman test was used to analyze the preference rating given by the researchers, with the Wilcoxon signed ranked test used for post hoc analysis. Thematic analysis was done to identify the underlying themes from the qualitative data obtained through semi-structured interviews with the participants. Codes were developed and by a single coder and were then used to develop the themes and subthemes related to the facilitators and barriers associated with the implementation of remote consenting modalities.

Results

The goal of this study was to evaluate the efficacy of three remote consenting modalities in clinical research: teleconsent, eConsent (without video communication), and remote paper consent via phone. The study recognized the importance of remote consenting modalities in improving the participation rate in clinical research and aimed to identify the barriers and facilitators associated with the widespread implementation of remote consent. This section presents the findings of the study, focusing on the demands placed on the end users and the factors that hinder or support the utilization of remote consenting platforms. The section provides details of the challenges and opportunities associated with electronic consent in the context of clinical research.

3.1. NASA-TLX results

3.1.1. Perceived overall workload experienced by researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the overall workload experienced by the researchers using the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 0.847, p = 0.655. The results showed significant differences in the level of perceived overall workload experienced by the participants serving as researchers, F (2, 44) = 4.652, p < 0.05, partial η² = 0.175, as shown in Figure 10 and table 2. Significant differences were found between teleconsent (M = 26.986, SD = 14.352) and eConsent (M = 39.015, SD = 18.136), p = 0.004.

Figure 10.

Perceived workload scores of the researchers

Table 2.

Perceived workload scores of the researchers

NASA TLX measures	F(2,44)	Partial η2	M(SD)
			Teleconsent	Remote paper consent	eConsent
Mental demand	2.819	0.114	8.564(5.964)	8.825(5.947)	11.491(8.125)
Physical demand	1.022	0.044	0.608(0.972)	1.609(3.976)	1.043(2.262)
Temporal demand	4.477* (p < 0.05)	0.169	2.623(2.233)	3.463(3.134)	4.435(3.444)
Effort	2.718	0.110	6.450(5.623)	8.970(7.033)	9.217(7.325)
Performance	4.906* (p < 0.05)	0.182	5.305(5.111)	6.739(5.542)	9.202(6.595)
Frustration	0.020	0.001	3.435(4.875)	3.492(4.642)	3.623(4.447)
Total workload	4.652* (p < 0.05)	0.175	26.986(14.352)	33.101(16.473)	39.015(18.136)

3.1.2. Perceived temporal demand experienced by researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the temporal demand experienced by the researchers using the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 1.006, p = 0.605. The results showed significant differences in the level of perceived temporal demand experienced by the participants serving as researchers, F (2, 44) = 4.477, p < 0.05, partial η² = 0.169, as shown in Figure 10 and table 2. Significant differences were found between teleconsent (M = 2.623, SD = 2.233) and eConsent (M = 4.435, SD = 3.444), p = 0.011.

3.1.3. Perceived level of performance of researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the perceived performance of the researchers using the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 0.572, p = 0.751. The results showed significant differences in the level of perceived performance by the participants serving as researchers, F (2, 44) = 4.906, p < 0.05, partial η² = 0.182, as shown in Figure 10 and table 2. Significant differences were found between teleconsent (M = 5.305, SD = 5.111) and eConsent (M = 9.203, SD = 6.595), p = 0.008.

3.1.4. Perceived physical demand experienced by research participants

A one-way between-subjects ANOVA was conducted to determine if there were statistically significant differences in the perceived physical demand placed on the research participants while using the three consenting modalities. The results showed significant differences in the level of perceived physical demand experienced by the research participants, F(2,66) = 6.651, p = 0.002, partial η² = 0.168, as shown in Figure 11 and table 3. Significant differences were found between remote paper consent (M = 5.217, SD = 7.844) and teleconsent (M = 1.073, SD = 1.453), p = 0.004, and between remote paper consent and eConsent (M = 0.710, SD = 1.194), p = 0.002.

Figure 11.

Perceived workload scores of the research participants

Table 3.

Perceived workload scores of the research participants

NASA TLX measures	F(2,66)	Partial η2	M(SD)
			Teleconsent	Remote paper consent	eConsent
Mental demand	0.328	0.010	9.420(8.665)	8.449(8.524)	10.493(8.474)
Physical demand	6.651* (p < 0.05)	0.168	1.073(1.453)	5.217(7.844)	0.710(1.194)
Temporal demand	0.980	0.029	3.217(2.870)	5.347(6.350)	5.146(6.990)
Effort	0.186	0.006	5.551(5.486)	4.551(5.810)	5.059(5.370)
Performance	2.687	0.075	2.276(2.526)	2.594(3.269)	4.681(5.171)
Frustration	1.669	0.048	1.014(1.606)	3.290(4.430)	2.666(5.912)
Total workload	0.928	0.027	22.551(14.260)	29.449(19.040)	28.754(22.518)

3.2. System usability

The responses to the CSUQ evaluated four metrics: overall satisfaction, system usefulness, information quality, and interface quality (Lewis, 1995). Lower scores indicate higher usability. This was done to assess both researchers' (Fig. 12, Table 4) and research participants' (Fig. 13, Table 5) perspectives.

Figure 12.

Perceived system usability scores of the researchers

Table 4.

Perceived system usability scores of the researchers

IBM CSUQ measures	F(2,44)	Partial η2	M(SD)
			Teleconsent	Remote paper consent	eConsent
System usability	3.100	0.124	1.657(0.569)	2.150(1.102)	2.067(0.661)
Information quality	4.379* (p < 0.05)	0.166	2.267(0.818)	2.905(1.306)	2.553(0.749)
Interface quality	9.980* (p < 0.05)	0.312	1.792(0.665)	2.735(1.312)	2.558(1.089)
Overall usability	5.548* (p < 0.05)	0.201	1.941(0.617)	2.555(1.093)	2.355(0.688)

Figure 13.

Perceived system usability scores of the research participants

Table 5.

Perceived system usability scores of the research participants

IBM CSUQ measures	F(2,44)	Partial η2	M(SD)
			Teleconsent	Remote paper consent	eConsent
System usability	2.291	0.065	1.645(0.621)	2.146(0.996)	2.080(0.921)
Information quality	0.334	0.010	2.130(0.662)	2.319(0.841)	2.224(0.829)
Interface quality	2.277	0.065	1.932(0.912)	2.527(0.892)	2.242(1.027)
Overall usability	1.845	0.053	1.876(0.564)	2.277(0.812)	2.167(0.796)

3.2.1. Perceived system usability reported by the researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the perceived usability of the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 4.183, p = 0.124. The results showed significant differences in the level of perceived system usability reported by the participants serving as researchers, F (2, 44) = 5.548, p < 0.05, partial η² = 0.201, as shown in Figure 12 and table 4. Significant differences were found between teleconsent (M = 1.941, SD = 0.617) and eConsent (M = 2.355, SD = 0.688), p = 0.01, and between teleconsent and remote paper consent (M = 2.555, SD = 1.093), p = 0.01.

3.2.2. Perceived information quality reported by researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the perceived information quality of the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 5.745, p = 0.570. The results showed significant differences in the level of perceived information quality reported by the participants serving as researchers, F (2, 44) = 4.379, p < 0.05, partial η² = 0.166, as shown in Figure 12 and table 4. Significant differences were found between teleconsent (M = 2.267, SD = 0.818) and remote paper consent (M = 2.905, SD = 1.306), p = 0.012.

3.2.3. Perceived interface quality reported by researchers

A one-way repeated measures ANOVA was conducted to determine whether there were statistically significant differences in the perceived interface quality of the three consenting modalities. Mauchly’s test indicated that the assumption of sphericity had been satisfied, χ² (2) = 5.077, p = 0.079. The results showed significant differences in the level of perceived interface quality reported by the participants serving as researchers, F (2,44) = 9.980, p < 0.05, partial η² = 0.312, as shown in Figure 12 and table 4. Significant differences were found between teleconsent (M = 1.792, SD = 0.665) and eConsent (M = 2.558, SD = 1.089), p = 0.002, and between teleconsent and remote paper consent (M = 2.735, SD = 1.312), p = 0.002.

3.3. Preference ratings of the researchers

Friedman test results indicated that there were statistically significant differences in the preference ratings given by the researchers χ² (2) = 20.957, p < 0.05. Post hoc analysis with the Wilcoxon signed ranked test was conducted with a Bonferroni correction applied, resulting in a significance level set at p < 0.017. The median rank for the remote paper consent, eConsent, and teleconsent modalities was 3,2,1, respectively. There was no significant difference between the preference ranking of teleconsent and eConsent (Z = 1.940, p = 0.052). However, there were significant differences between the preference ranking of teleconsent and remote paper consent (Z = 3.872, p < 0.01) and between eConsent and remote paper consent (Z = 3.154, p = 0.002).

3.4. Barriers and facilitators to the use of remote consenting modalities

Themes related to the barrier and facilitators to using remote consenting platforms were developed independently for each evaluated modality based on the analysis of the interview data. The interview data were analyzed to generate codes which were then used to identify underlying themes and subthemes. For the remote paper consenting condition, 3 themes and 9 sub-themes were developed related to the barriers to the use of remote paper consenting. Whereas 2 themes were developed related to the facilitators to the use of remote consenting. For the eConsenting condition, 2 themes and 4 sub-themes were developed related to the barriers, and 1 theme and 3 sub-themes were developed related to the facilitators to the use of eConsenting. For the teleconsenting condition, 2 themes and 4 sub-themes were developed related to the barriers, and 2 themes were developed related to the facilitators to the use of teleconsenting. In the following sections, the themes will be explained and supported by quotes from the interviewees.

3.4.1. Barriers to the use of remote paper consenting

The themes identified as barriers to the use of remote paper consenting modality were issues with sending and receiving the paper consent forms via mail, the nonavailability of visual cues, and privacy-related concerns. The themes, their associated subthemes, and their illustrative quotes can be seen in Table 6.

Table 6.

Themes describing the barriers to the use of remote paper consenting

Themes	Sub Themes	Example Quotes
Issues with sending and receiving the paper consent forms via mail.	Difficulty obtaining patient information to mail the consent form.	“Physicians will not be comfortable sharing their patients’ sensitive information, such as their address.”- R
	Higher wait times to hear from potential participants.	“I am lazy to check my mail sometimes. This could stay in my mailbox for weeks.” - RP “I might not open it if it doesn’t concern me.”- RP
	Lower response rates	“If they never open this mail, I will never hear back from them. It’s not possible to know beforehand how many I need to send to get the required number since I don’t know how many would respond.”-R
	The physical workload associated with mailing the consent forms.	“I would prefer it on a computer as an electronic form.”-RP “E-form is easier because you don’t have to mail. “-R
	Health-related concerns with handling paper consent forms sent from a hospital or a healthcare research facility	“There should be methods to sanitize the packet before I receive it. I would be more comfortable using electronic consent instead of actual physical mail.”-RP
Nonavailability of visual cues	Difficulty following along with the consent form walkthrough.	“I just wanted to read the entire document by myself. The researcher was reading it to me, and that made it difficult to focus and understand.“-RP “I do like it when there is some kind of video interaction. I would have appreciated it if that person was on video.”- R
	Difficulty in gauging participants’ understanding and involvement in the consenting process	“I wouldn’t know if the participant on the other side is following along or not. Sometimes just by seeing somebody’s expressions, we can make out if they were getting what we are saying or are confused.”-R
Delay in research timeline and other privacy concern	Loss of mail.	“Some of my mail has been lost in the past, so that’s something I am always worried about when I have used postal services.”-RP “There is a trade-off to safety. If you are sending a physical copy via mail, there is a chance that it might get lost in the mail along the way. It compromises safety, which means my consent form doesn’t reach the destination.”-RP
	Loss of confidential information	“I don’t know where paper consent forms can go, but I can trust with electronic consent forms that they would keep my data safe.”-RP

3.4.1.1. Issues with sending and receiving the paper consent forms via mail

Issues with sending and receiving the paper consenting form were a central theme for the researchers and the research participants. All the researchers and the research participants who experienced the remote paper consenting modality (n = 23) raised concerns with the accessibility of the consent forms. For the researchers, the major issues were related to the distribution of the consent form. They explained that physicians would not be comfortable sharing their patient’s private information, such as names, addresses, or phone numbers. Without this information, sending consent forms to patients would be difficult. Another issue was that not everybody checks their mail diligently. This would lead to higher wait times to conduct the consenting walkthroughs and obtain consent, thus negatively affecting the research timeline. There is a possibility that potential participants might not open the mail at all, and that would mean the response rate can be lower. For the research participants, the physical workload associated with receiving the consent form via mail and sending it back to the researcher was a critical issue. Research participants expressed that they would prefer using the electronic consent form over the paper copies that are mailed to them. Another important issue for the research participants was health concerns. Because of the pandemic, handling mail coming from a hospital or a healthcare research facility was seen as a potential way that the COVID-19 virus could transmit.

3.4.1.2. Nonavailability of visual cues

In addition to the above-mentioned challenges, 78.26% of the research participants (n = 18) expressed that the nonavailability of visual cues affected their overall consenting experience. One of the major concerns for the research participants was to follow along and make sense of the information provided to them by the researchers. Most participants preferred reading the consent form over listening to the walkthrough provided by the researcher (n = 15). However, the participants liked that the mock researcher was available to answer any specific question and mentioned that having their questions answered helped them make an informed decision (n = 6). Four research participants stated that seeing the mock researcher elicited trust in the study and the researcher. Three research participants stated that the unavailability of the video component for the study did not affect their understanding or decision-making during the consenting process. Whereas two research participants expressed that video communication would have negatively affected their consenting experience as it would have been daunting for them to say no to participation if they could see the mock researcher. The ability to see the research participants was considered important by 82.61% of the researchers (n = 19). They stated that audio and video-based communication resulted in a more natural conversation that felt more engaging. Four researchers stated that they would provide the research participants with a choice to select just audio-based communication or include the video component. Seven researchers stated that they were unsure if the research participants were following along or not because of the absence of visual cues.

3.4.1.3. Privacy-related concerns

The research participants expressed concern that paper copies of the consent form could get lost in the mail. This would also mean that researchers couldn’t include these participants in their research. Another alternative would be resending the consent form to these participants, which would result in extended research timeliness and monetary losses associated with resending the consent forms.

3.4.2. Facilitators to the use of remote paper consent

The themes identified as facilitators of the use of remote paper consenting modality were familiarity with the process and no technology dependence. The themes, their associated subthemes, and their illustrative quotes can be seen in Table 7.

Table 7.

Themes describing the facilitators to the use of remote paper consenting

Themes	Sub themes	Example Quotes
Familiarity with the process		“People are more comfortable with mail and postal services, so this would be easier for them.”-R
No technology dependence		“We can do this over the phone, and that eliminates the need for a computer.”-RP

3.4.2.1. Familiarity with the process

Even though the remote paper consenting modality is associated with a certain level of physical workload, The participants expressed in the interviews that it was the most familiar method among the three consenting modalities. Researchers expressed that older adults, and individuals who are not tech-savvy might find this process easy (n = 16).

3.4.2.2. No technology dependence

The most significant advantage of the remote paper consenting modality, as seen by the research participants, was that the process did not involve using software or a computer device (n = 12). Potential participants can connect with the researchers via phone, eliminating the requirement of any video conferencing software. However, the physical workload associated with this consenting modality was still seen as a major challenge to implementing this consenting modality.

3.4.3. Barriers to the use of eConsent

The themes identified as barriers to using electronic consenting were the nonavailability of visual cues and the requirement of technology. The themes, their associated subthemes, and their illustrative quotes can be seen in Table 8.

Table 8.

Themes describing the barriers to the use of eConsenting

Themes	Sub Themes	Example Quotes
Nonavailability of visual cues	Difficulty following along with the consent form walkthrough.	“It can be a little bit distracting as we are trying to engage in a conversation but at the same time looking at a consent form.”-RP “There was no one to guide me. When you said can you hear me my system was on mute. When I was unmuted, I could hear you, but I couldn’t locate you on the consent form. I can see how this can be a challenge.”-RP
	Difficulty in gauging participants’ understanding and involvement in the consenting process	“It would be better if I could see the person I am talking to. I would be able to communicate better in that case.”-R “For more sensitive studies, I would like to be in person. Especially if it’s not a video call, it would be difficult for me to gauge their body language, and that is how I built trust. I would consider a video consenting modality for these.”-RP
Technological requirements	Equipment requirement	“I would need a computer to access the electronic document. Having a phone version would be even easier because most people nowadays have a cell phone.”-RP
	Internet requirement	“Availability of internet facility could be a challenge in certain areas.”-R

3.4.3.1. Nonavailability of visual cues

Fifteen research participants expressed that they were finding it difficult to follow along with the walkthrough provided by the mock researcher using only the audio capabilities. They would have preferred to read the consent form prior to the walkthrough. They suggested that this would allow them to understand the content better and be ready with any specific questions they might have. A total of 5 research participants also mentioned that they felt a loss of personal connection because of a lack of visual cues.

3.4.3.2. Technological requirements

Requirements related to the use of technology, such as the internet services and equipment to host these remote consenting platforms, were also seen as a potential barrier to implementing and using remote electronic consenting modalities. Five researchers emphasized the fact that internet availability and participants’ ability to use technology can influence the use of such consenting modalities.

3.4.4. Facilitators to the use of eConsent

The theme identified as facilitators of the use of electronic consenting modality was the convenience associated with consenting. The theme, their associated subthemes, and their illustrative quotes can be seen in Table 9.

Table 9.

Themes describing the facilitators to the use of eConsenting

Themes	Sub Themes	Example Quotes
The convenience associated with consenting	Eliminates the need to travel to research sites.	“I come from the Midwest, and during the winter times, we can have terrible blizzards, and in these conditions, especially because I am old, I wouldn’t want to get out but using these remote technologies, I would be happy to be a part of your study.”-RP
	Easy access to consent forms.	“What I liked the most is how we use this system is so easy.”-RP “We just have to click on a link; that’s easy.”-RP “Sending a link to participants is easy; I can reach out to more people.”-R
	No training is required to conduct the consenting process.	“It is more familiar as I have signed e-forms before.”-RP

3.4.4.1. The convenience associated with consenting

78.26% (n = 18) of the researchers stated that electronic consent forms were easy to use as they involved the potential participants clicking a link to access the consent form, and the only other requirement from them would be to sign and date it. Research participants also stated that they feel secure using the electronic consenting modalities as they are familiar with electronic forms and have used them before (n = 20). All the research participants expressed that electronic consenting would be a safer option during the COVID-19 pandemic (n = 23).

3.4.5. Barriers to the use of teleconsent

The themes identified as barriers to the use of the teleconsenting modality were training requirements and the requirement for technology. The themes, their associated subthemes, and their illustrative quotes can be seen in Table 10.

Table 10.

Themes describing the barriers to the use of teleconsenting

Themes	Sub Themes	Example Quotes
Training requirement	Not ideal for people who are not comfortable using technology.	“I have seen that issue with my wife. She does consent via video, and it was a pain. Struggling hard with older people as they are not used to this technology. So, if it usually takes 20 minutes, it would take 40-45 minutes for them to complete the process.”-RP
	Researchers need initial training to understand the system workflow.	“I liked how you explained to me the process of uploading the consent form to the system, inviting the participant, starting the call, and sharing the consent form.”-R
Technological requirements	Equipment requirement	“You need to have a webcam which not everyone might have.”-R
	Internet requirement	“For remote areas, setting up centers with internet facilities and workstations could get more participants.”-R

3.4.5.1. Training requirements

Three researchers expressed the need to be trained in the teleconsent system workflow before the start of the consenting session. Researchers expressed that a walkthrough of the system functionalities would help them perform efficiently and in a timely manner. Researchers also stated that participants who aren’t tech-savvy might need more time to complete the consenting process using teleconsenting systems (n = 2). There is a need for evidence-based training methods to ensure the effective use of the teleconsenting modality.

3.4.5.2. Technological requirements

The need for specific software, the equipment to host this software, and internet requirement were the major barriers to the widespread implementation of teleconsenting modalities. The research participants stated that, although it’s a convenient method of consenting, its use is subject to the availability of the internet and a computer device (n = 8). In the interviews, the researchers explained that it might be difficult to set up clinics with internet connectivity in remote areas (n = 13). Setting up such clinics could add costs and possibly affect the research timeliness. Potential participants would need training related to the use of video conferencing software. If not, this could possibly discourage them from participating in the research studies.

3.4.6. Facilitators to the use teleconsent

The themes identified as facilitators of using the teleconsenting modality were that it eliminates the need to travel and facilitates the exchange of visual cues. The themes, their associated subthemes, and their illustrative quotes can be seen in Table 11.

Table 11.

Themes describing the facilitators to the use of teleconsenting

Themes	Sub Themes	Example Quotes
The convenience associated with consenting	Eliminates the need to travel	“I can do this sitting at my home or office.”-RP “Sending a link to participants is easy; I can reach out to more people.”-R
	Facilitates exchange of visual cues	“Video has the capacity to provide natural conversation which is more engaging.”-R

3.4.6.1. The convenience associated with consenting

The major advantage of using the teleconsenting modality is that it facilitates conducting the consenting process at a mutually convenient time and location for both the researcher and the potential participants. It eliminates the need to travel to the research sites, which has negatively affected clinical research participation in the past. In the interviews, researchers stated that they liked having potential participants join remotely at a mutually convenient time (n = 16). They explained that this would encourage more participants to come for the consenting process, as it eliminates the inconvenience of traveling. Joining in from their preferred location and time could help the participants relax, and this could help them make an informed decision. Research participants liked that they only had to press a link sent by the mock researcher to connect with them (n = 14). 82.6% (n = 20) of the researchers stated that having the ability to see the participants helped them explain the consent form better. Research participants expressed that audio-video-based communication facilitates the exchange of visual cues that enables more natural, more engaging communication (n = 8). Three of the research participants also explained that they felt more comfortable asking questions to the researcher because of the video-based communication.

Discussion

Traditional consenting techniques require potential participants to travel to research sites to make a decision regarding their participation in research studies. This was found to be a bottleneck in clinical trial recruiting and has negatively affected the impact of clinical research (Welch et al., 2016). The recruitment and retention of participants in a study are dependent on their readiness to travel to and from the research location, and lengthy travel duration may discourage potential participants (Ory et al., 2002). Transportation demands and expenses linked to traveling pose persistent obstacles for potential participants who wish to participate in research studies (Ory et al., 2002; Fogel, 2018). To overcome the challenges associated with traditional consenting techniques, we evaluated the efficacy of three remote consenting modalities in this study by comparing the informed consent process using teleconsent, eConsent, and remote paper consent. The aim was to understand the barriers and facilitators to the widespread implementation of remote consenting modalities. We conducted experimental studies, interviews, and surveys, followed by qualitative and quantitative analysis to address our research questions. Below we first discuss the emerging themes from our analysis and the theoretical implications of our findings. We conclude this section by presenting this research’s limitations and directions for future work.

4.1. Remote consenting as an alternate method for obtaining research consent from participants

Remote consenting modalities can overcome the gaps and barriers associated with the traditional consenting process by offering a medium for researchers to obtain consent from participants remotely via video conferencing software (Welch et al., 2016; Khairat & Obeid, 2018). During the interviews, research participants expressed that remote consenting modalities would encourage them to participate in various research studies, especially clinical research, from the comfort of their homes. This perception is supported by past research related to remote consenting platforms, which has shown that by eliminating the need to travel, remote consenting modalities have allowed individuals in underserved areas and poor populations who may lack transportation means but have access to the internet via community centers, clinics, or mobile devices to participate in clinical research studies (Ford et al., 2005; Welch et al., 2016; Khairat & Obeid, 2018). Through the use of remote consenting modalities, we could possibly improve the representation of minority communities in clinical research studies. This may satisfy the demographic requirements of clinical research and gather findings that could be generalized for a broader range of populations.

The interviews found that research participants were comfortable using these remote consenting modalities and could effectively make an informed decision regarding their participation. Moreover, participants serving as researchers expressed that they could recruit nationwide and worldwide by using remote consenting modalities. For studies involving rare disease research, genetic testing, and the development of new drugs, worldwide recruitment is often necessary (Kermani & Narayan-Dubois, 2005). The major advantage of using remote consenting modalities, as seen in the interviews, was that both sets of participants could participate in the consenting process at a mutually convenient time and from the place of their preference. This could help in the recruitment of older adults, people with disabilities, and mobility constraints, patients with critical illnesses, and working professionals in clinical research.

Researchers highlighted the notion that the choice of consenting modality should be contingent upon the specific nature of the research being conducted. In cases involving studies with substantial risk or invasive procedures, participants expressed a preference for the option of personal interaction with the researcher. The inclusion of visual cues in such studies was deemed important, fostering a sense of trust between participants and researchers. Conversely, for studies primarily involving older adults or individuals less adept with technology, the utilization of remote paper consenting modalities appeared more appropriate due to participants' familiarity with traditional paper-based processes, including mail. Nevertheless, participants expressed a desire for the flexibility to choose from multiple consenting modalities for any given study, providing them with a sense of autonomy in the decision-making process.

4.2. Video-based communication facilitates the exchange of visual cues

In their interviews, the mock participants and the researchers indicated that they particularly liked the audio and video-based communication channels offered by teleconsent. The exchange of verbal cues and the ability to connect virtually through specialized software designed to obtain consent helped elicit trust. It also helped the researchers better understand the potential participant and explain the content of the consent form to them. The ability to download the signed copy of the consent form at the participants’ end was considered important by both sets of participants. Previous research has also shown that video-based communication has facilitated active interaction between participants and improved the overall consenting experience (Synnot et al., 2014; Khairat & Obeid, 2018; Wilson et al., 2019). The usability of video communication in collaborative work is on par with in-person collaboration (Narasimha et al., 2018). In the interviews, both sets of participants expressed that teleconsenting facilitated by audio-video communication is their preferred alternative for in-person consenting. Through the use of video-assisted modalities, participants groups who want to consult with their physicians but do not want to be physically present in a healthcare setting can do so easily from their preferred location and time. Using such modalities could also be helpful, especially during the pandemic, where it eliminates the need to travel to healthcare settings and offers a safer alternative for healthcare consultation.

4.3. Need for evidence-based training materials for effective use of remote consenting modalities

Newer technologies often need a certain level of training for end users to be comfortable using them. In the interviews, the researchers expressed the need to be trained on the functionalities of the teleconsenting software. This included activities such as signing up to use the system, uploading the consent form to the system, inviting the potential participants to the consenting session, starting the session, sharing the consent form, and downloading the consent form at the end of the consenting session. Past research on remote consenting modalities has also shown that participants preferred getting a structured walkthrough of the functionalities of the consenting software before starting the session (Wilson et al., 2019; Agnisarman et al., 2017). A practical training module would help researchers navigate the system better and thus improve the usability of these consenting modalities. Acceptance of technology is critical for its widespread implementation. During the interviews, researchers explained that using video conferencing software could be especially challenging when dealing with older adults or individuals who are not tech-savvy. The absence of proper training materials could cause confusion and frustration among participants. This could further discourage them from participating in the research and thus affect the research timeliness. Research participants expressed that an email from the researcher with training material on the software to be used would improve their overall experience of the consenting process. There is a need to develop training materials that would adhere to the mental model of the end-users and help them navigate the system better.

As with any study, this study is not without its limitations. First, it was conducted using a sample of university students and staff, which may not be representative of the general population. Another limitation was that this study was conducted in a controlled lab-based setting with standardized equipment and a stable internet connection. Therefore, it is possible that different results may be obtained in different work environments and with different operating systems and browsers. We tested a specialized teleconsenting software. Participants could have different experiences performing the consenting procedure on other teleconsenting software. We used the CSUQ questionnaire to evaluate the usability of a paper-based consenting method. It is possible that future research may obtain different outcomes if they employ alternate usability measurement techniques.

Conclusion

Electronic consenting has the potential to mitigate the geographical issues related to healthcare research participation (Khairat & Obeid, 2018). Much of the research has focused on the application of telemedicine in healthcare settings, patient management systems, and the impact these systems have made on modern-day healthcare (Rogers et al., 2021). However, there has not been much research focusing specifically on the usability of electronic consenting modalities. Electronic consenting modalities can play a vital role in improving the participation rate in clinical research. Thus, it is necessary to understand the barriers associated with the widespread implementation of electronic consent, especially for clinical research. To address this need, this study evaluated the efficacy of three remote consent modalities – teleconsent, eConsent without video communication, and remote paper consent. This research aimed to identify the demands placed on end users and the barriers and facilitators to the use of remote consenting platforms.

The results suggested that remote consenting modalities especially teleconsenting is a preferred alternative to traditional consenting as it facilitates active communication between the researchers and potential participants and eliminates the need to travel. The ability to see visual cues helped elicit trust among the potential participants. The study findings indicated that remote consenting modalities offered a convenient method for obtaining consent from participants. However, the utilization of such methods also presented challenges, including the need for researcher training, dependence on technology, and equipment requirement, underscoring the importance of addressing the challenges associated with remote consenting modalities through system design. These challenges directly affect the usability of these systems, which then negatively contributes to technology acceptance. There is a need for evidence-based training materials for research to better understand the system functionality that could help them navigate the system and assist the potential participants during consenting sessions. While current research in telehealth has found process efficiency and improved patient outcomes, many of these studies do not focus on the main stakeholders in the work system, the caregivers, researchers, and research participants, who must make sense of and use these systems in their workflow. The themes developed through the interviews provide a new perspective on the demands placed on the researchers and potential participants using remote consenting modalities and help understand the end users’ perception of using these technologies.. The challenges identified in this study indicate that while remote consenting can be considered as alternate means of obtaining consent, there is a pressing need for further studies to enhance their widespread user acceptance. Based on the barriers and facilitators found through our interviews, future research should focus on using human-centered design principles to develop training modules for remote consenting platforms by considering the end user’s needs. Additionally, to assess the effectiveness of remote consenting modalities more comprehensively, future studies could be conducted with a diverse population group encompassing a wider range of demographic characteristics. This approach would provide valuable insights into the generalizability and applicability of remote consenting methods across different segments of the population.

Highlights.

• Remote consenting can address travel-related issues associated with in-person consent.

• The use of visual cues in remote consenting can be effective in building trust.

• Reliance on technology and training are major barriers to adopting remote consenting.