Electronic Video Consent to Power Precision Health Research: A Pilot Cohort Study

Introduction

Informed consent for biospecimens is an essential component for a robust program in precision medicine (PM). The use of deidentified remnant (leftover) biospecimens has come under recent scrutiny. Although the Notice of Proposed Rule Making (NPRM) to Human Subject Federal Regulations (common rule) [1] considers such tissue as not “human subjects” research, the National Institutes of Health (NIH) Genomic Data Sharing Policy expects informed consent for future research use and broad data sharing to be obtained even if the cell lines or clinical specimens are deidentified [2] (see Textbox 1 for a summary of key components of a broad consent for biospecimens). Moreover, there are many advocates and ethicists who feel there is an obligation to communicate that tissue may be used for research and to obtain informed consent [3]. Patients also want the opportunity to have their preferences dictate the use of clinical specimens for research [4].

Traditionally, in-person paper consents are often resource intensive, not easily scalable, and preclude digital responses from being incorporated in the electronic health record and laboratory information management systems. Given that PM requires large-scale patient engagement, innovations in consenting in conjunction with broad public education [5,6] are required. The emergence of digital health plays a substantial role in defining population-based approaches to electronic consent. Interactive and multimedia slideshow consents have been used for enrollment of participants in biobanks [7,8], but such slideshow consents require increased participant time. Animated video consent approaches have been effective in providing comprehensive information and improving participants’ understanding of content [9,10], but such video consents have not been used in biobank research associated with PM.

EngageUC, an NIH-funded study, examined biobanking in the University of California system with community constituents to better define the innovative and accessible consent materials needed as part of a scalable institutional biobanking program in support of PM [4,11]. The following key themes emerged: the public should be educated about biobanking, consent content source should be considered knowledgeable and trustworthy, consent process should be low stress with an opportunity to get answers to questions, format and language of the consenting material should be easy to understand, and oversight should be conducted by the community and stakeholders.

In this study, we engaged the community and stakeholders across the University of California, Los Angeles (UCLA) Health System, David Geffen School of Medicine at UCLA, UCLA Institute of Precision Health, and the UCLA Clinical and Translational Science Institute (CTSI) to create and pilot an innovative potentially scalable universal video consent that asks patients to give a “broad” or “one time” consent that allows researchers to use their biomaterial and clinical data in a manner that meets the criteria defined by both the NIH and NPRM [1].

Methods

This study was approved by the UCLA Institutional Review Board (IRB; #15-001395IRB) with a waiver of written informed consent.

Governance Structure

We formulated a strong governance structure, including a community advisory board (CAB), to oversee and give feedback on the consent design and process [11].

Community Advisory Board

Our study team assembled a CAB consisting of 11 respected leaders that were highly involved with organizations in the Los Angeles region that understood our diverse communities and represented their perspectives. The members were racially diverse (2 were African American, 2 were Latinx, 1 was Asian American, 1 was Native American, 1 was Persian-American, and 4 were non-Hispanic White) and equitable with respect to gender (5 were males and 6 were females).

The committee held five meetings between July 2015 and June 2019 to review and guide the video design. The CAB’s primary focus was to ensure the video was easy to understand and explained the purpose of the consent. The board additionally focused on three key areas: inclusion of diverse patients in PM education, outreach, and research; integration of research and clinical operations; and potential return of genetic results.

Internal Advisory Board

The internal advisory board included our institutional research leaders from the David Geffen School of Medicine, Institute of Precision Health, CTSI, UCLA Health, and additional faculty with expertise in bioethics, patient engagement, biobanking, and IRB. The members of the internal advisory board provided substantial feedback to ensure the video content was informative, met NIH standards, addressed both genetic testing and the potential for collaborations with external companies and federal partners, was culturally sensitive, and represented the diversity of Los Angeles.

Video Development

The content for both the text and animated video consents were adapted from paper versions of a biobanking consent developed by EngageUC [4]. The animated consent included a statement about collaboration with governmental agencies, commercial entities, and other academic institutions, and a statement that potential secondary use of data could include genomic sequencing. The videos were targeting a seventh grade reading level. Both video consents were designed to be 4 to 5 minutes in length. These pilot videos were in English and Spanish, with voiceovers for the animated consent. All the essential components for an NIH informed consent were included in the videos (see Textbox 1) [12].

Phase 1

A text-based video (text moving from screen to screen) was first designed to consent patients around the use of their remnant tissue for research. A convenience sample of 125 patients were enrolled but only 123 completed postconsent surveys (see Figure 1).

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Phase 2

Our CAB and internal advisory board guided the adaptation of the universal consent video to a fully animated (cartoon-like) video to better communicate content to lay audiences and use this to power the Institute of Precision Health ATLAS biobank (see Figure 2). The video conveyed that this sample would be collected at one time and as a piggyback to any standard lab draw or intravenous placement. For this phase, an additional convenience sample of 50 patients were enrolled, of whom 47 completed postconsent surveys (see Figure 1). Phase II pilot testing was mainly to evaluate if the additional animation improved the user experience of the consent video.

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Consenting Process

The first pilot was conducted at five distinct locations within UCLA Ronald Reagan Hospital: (1) hospital admissions, (2) clinical lab, (3) mammography clinic, (4) oncology clinic, and (5) liver clinic. Technical assistance was available at all these locations. Sites were selected because of their diverse populations and high volume (eg, mammography). All patients were approached and technical assistance from study staff was made available. The second pilot was expanded to include perioperative suites. Patients had to validate their identity before viewing the video and responding to the consent questions (see Figure 2).

Patients were asked to choose their preferred language (English or Spanish) and then validate their identity by entering their medical record number, selecting their birth year (out of 6), and entering the initials of their first and last name. Once validated, individuals could view the video and provide consent. There was no prompting from study staff or clinic personnel. A paper brochure with frequently asked questions (FAQs; available in English and Spanish) was handed to patients with the iPad. Both the video and the FAQs let patients know they could change their consent status at any time. After watching the video, patients were asked: where they wanted to opt in or opt out of having remnant biospecimens used for research and if they would be open to recontact for future research.

Data Collection and Outcome Measures

Demographic data, including age, race or ethnicity, highest level of education, and language preference for the convenience sample, were collected.

A postconsent survey was developed in English and Spanish to evaluate the effectiveness of the universal consent videos and understand drivers of consent choice. Patients were approached after completing the universal consent videos. Volunteers received a US $5 dollar Target gift card to compensate them for their time. Patient impressions of the universal consent videos were evaluated with three questions (how useful did you find the information, how easy was the information to understand, and how much did you feel you could trust the information) using a five-point Likert scale (not at all, not really, somewhat, mostly, and very).

Drivers of Consent Choice

The internal advisory board helped develop questions used to understand the reasons patients’ opted in or out. Individuals who opted in received additional questions to determine drivers (hoping the research will help me in the future, hoping the research will help my family and friends in the future, hoping to advance science, or hoping to find a cure for a disease). Individuals who opted out received additional questions to determine drivers (do not want my tissue used for anyone else, concerns about privacy, concerns that a product will be made with my tissue and I will not benefit, or did not understand what I was being asked).

Patient Health Beliefs Regarding Medical Research

The study team developed a 10-item questionnaire to evaluate patients’ beliefs about biomedical research using validated instruments as guides [13-16]. This new survey measured attitudes about science, optimism, altruism, privacy, social support, justice, and conflict of interest.

Opt-in or Opt-out Status

The patient’s decision to either opt in or opt out of sharing their remnant samples was recorded. We also tracked the number of patients who agreed to be contacted for future research.

Statistical Analyses

Demographic information, consent rates, and patient ratings about consent were summarized using descriptive statistics including medians, ranges, and percentages. The video script was run through the Flesh-Kinkaid Readability Test tool in Word (Microsoft Corporation) to determine the grade level of the universal consent videos. The patient characteristics between those that opted in and opted out were compared with chi-square tests for homogeneity. The consent rates were compared between phases 1 and 2 consents with chi-square tests for homogeneity. Patients’ evaluation of the usefulness, ease, and trustworthiness of the videos in phases 1 and 2 were compared using Wilcoxon rank sum tests since the variables had skewed distributions. To determine the internal consistency of the 10-item beliefs survey, Cronbach alpha was used. Univariate logistic regression was used to examine the association between patients’ beliefs and their consent decision. We used the AUC receiver operating characteristic curves to predict which patients opted in versus opted out. Two-sided P values were reported, and variables were considered statistically significant if the P value was <.05. All analyses were conducted using Stata 15 (StataCorp) [17].

Results

Community Advisory Board Suggestions

The CAB played a significant role in the video design, which made the video rich in content, ensured that the language was appropriate for the lay population, addressed the most concerning questions from the community, was applicable to a diverse population, and was less than 5 minutes in duration. The board’s primary focus was to ensure that the video was understandable and appropriately explained why UCLA was asking them to donate biosamples and clinical data for research. The board additionally focused on three key areas: (1) how to ensure the inclusion of diverse patients and communities in PM program education, outreach, and research; (2) if and how to return PM research findings to individual patients who contribute samples and data to the biobank; and (3) how to appropriately bridge research and clinical operations.

Participants

A total of 175 patients enrolled across the two pilot phases, of which 173 actually went through the electronic video consent (see Figure 1). The population was mostly middle age (n=130, 75% were younger than 60 years), female (n=123, 69%), White (n=86, 50%), and educated (n=104, 60% had at least college education; Table 1). The majority of patients preferred English (n=161, 93%). There were no significant differences for age, education, gender, or race between patients who opted in or opted out.

Consent Rate

There was no significant difference for consent rate between the two phases (44/50, 88.0% vs 112/ 123, 91.1%; P=.41). Across the entire cohort, 56% (97/173) of individuals agreed to be recontacted to participate in other biomedical research projects.

Patients’ Health Beliefs on PM Research

The 10-item questionnaire had good internal consistency with an alpha coefficient of .93, which means the results were consistent among similar questions. Univariate logistic regression analysis showed that there were significant differences on all 10 items between the groups who opted in versus opted out (all P<.001). Additionally, we calculated AUC to evaluate the ability of the questions to discriminate which question predicted patients opting in. The results showed that “I trust researchers to use leftover biological specimens to promote the public's health” and “Sharing a biological sample for research is safe because of the privacy protections in place” discriminated opt-in statuses were the strongest predictors (both AUC were 0.88; Table 2).

Evaluation of the Universal Consent Video

We also examined whether there was a difference between the video consent evaluations of patients who opted in and opted out regarding the ease of use, usefulness, and the trustworthiness as three outcomes: useful and not useful, easy to understand and not easy to understand, and trustworthy and not trustworthy, respectively. In terms of where it was useful or easy to understand, the universal consent video did not differ between two groups (those who opted in vs opted out). However, 88.4% (136/158) of the patients who opted in felt they could trust the information in the video compared to only 53.3% (8/15) of the patients who opted out (P<.001).

We compared the evaluations of the phase 1 text-based video and the phase 2 animated video among patients regarding the ease of use, usefulness, and trustworthiness. We found that there was a statistically significant difference between the text-based video and the animated video regarding the ease of use (P=.005) and the ability to understand this information (P<.001). There was no significant difference regarding the trustworthiness between the text-based video and animated video (P=.20; Table 3).

Important Factors for Opting In and Opting Out

Questions that garnered a large majority of patients (≥80%) responding as “moderate” or “very important” were a key focus. Among the four questions we asked the patients who opted in (Table 4), three of four made this threshold: “research benefiting me,” “hoping PM research could advance science,” and “cure diseases.” Among the four questions we asked the patients who opted out (Table 5), only 1 question about “privacy” made this threshold and was a factor for all the patients.

Discussion

Our study indicated that our universal consent animated video is easy and informative. Because it is short and self-administered, this is a possible solution for a scalable consent method for population-based PM research. Compared to in-person paper consent, electronic video consent requires fewer human resources and less physical space. As designed in this study, it could be deployed to any number of devices and applied at multiple medical locations. Hence, it is suitable for large-scale efforts to collect informed consent from a large population with a modest incremental cost. Furthermore, it allows patients a safe space to participate in the consenting process without the pressure an in-person process might create. To apply it broadly and effectively to diverse populations, it is critical that the universal consent video addresses potential concerns participants may have about the research project to build trust, reassure potential participants about privacy concerns, be transparent (which further increases trust), and address the potential of the research.

In line with other studies, we found that trust is one of the most important factors for patients opting in to biomedical research [18]. Multiple studies have identified reasons for reduced trust between patients and researchers: participants are not clear about their rights over their data in the biobank [19]; patients did not understand biobanking or the aims of the clinical trial [20]; patients might have concerns about allowing researchers to use their data for the unforeseen secondary research via a broad consent process [21]; patients who consented to participate in clinical trials heavily depended on how much they trusted the physician [22], whereas in this consent process, there are no health professionals communicating with patients; or there is no immediate benefit for patients in PM research.

Delivering comprehensive information about biobanking and PM research is necessary for truly informed consent and to build patients’ trust. However, it is important to balance the video content and length, as patients might lose interest or read or watch the consent cursorily if it is too long or if the content is not presented in language that average individuals can understand [23-25]. One solution to increase patients’ understanding of and trust in PM research and biobanking may be to provide more concrete examples of clinical research and PM. A complementary approach may be to provide personal stories of successful PM in UCLA patients. Such educational videos could help interested individuals learn more about the value of remnant biospecimens, clinical data, and clinical research in advancing science. It is important to ensure patients understand that PM research takes time, so the benefits of participation will not be immediate.

In this study, all (100%) patients who opted out responded that concerns about privacy were moderately or very important to them. This is consistent with results from multiple studies suggesting that patients were concerned about misuse of their personal data [26]. If patients do not understand how their data might be used or who might use the data, they are less likely to give permission to share the data [27]. As PM research requires hundreds and thousands (or more, depending on the specific question) of unique biological samples, emphasizing how clinical information will be protected should be embedded in the consent process. Furthermore, a transparent policy to efficiently manage data access and protect individual’s privacy through a variety of data access controls and an oversight committee for ethical governance of the biobank is a necessity [4]. In fact, some authors believe this represents the only way to build public trust and protect participants’ privacy [28]. Researchers, scientists, and policy makers should embrace the notion that that if privacy concerns are well addressed in the consent and clearly communicated in a trustworthy way, this could enhance potential participants’ understanding of and trust in the research process.

Our study found that potential participants’ health beliefs were the most significant driver of their willingness to participate in a precision health initiative. Patients who opted in believed that their participation could advance science, find cures for disease, and help others. This confirms previous studies that participation in biobank research was based on altruistic motivations and responsibilities to assist future generations [18]. Together with early studies, our findings suggested that emphasizing the importance of patients’ participation to benefit others and contribute to science is associated with the high participation rate in clinical research. From these 10 health belief questions, we again confirmed that if patients trust the researchers and believe their personal privacy is protected, they are more likely to donate their biospecimens.

This pilot study has its limitations. This study only included a convenience sample of patients who agreed to do the electronic consent and answer the additional survey. The sample size was small, and there were smaller subgroups in each category of race, age, gender, and educational level, which limited our ability to evaluate any differences between these populations. We also did not evaluate the participants’ health statuses, which prevented us from understanding if differences in consent rate and health beliefs exist among patients with different diagnoses or disease burden. Future research needs to evaluate the electronic video consent performance in a larger population, so these and other potentially important variables such as low health literacy can be studied more comprehensively.

In summary, we created and piloted an innovative electronic video consent that was self-administered and easy to understand for patients. This approach will next be tested for scalability as an enterprise solution by expanding across 18 clinical sites across the UCLA health system. Future goals include expansion to other University of California sites and piloting the video and process in affiliated county hospitals within the larger Los Angeles County. We believe our video consent and process offer an approach that would allow for more robust inclusion of institutions that do not have the financial resources to use employees for in-person consent. Given the reality that many such institutions will serve patients who are chronically ill, of lower socioeconomic status, and who are from underrepresented minority populations, our video consent and process offer the possibility for these groups to become better represented in PM research. The importance of participation in PM remain unclear especially among ethnic minority populations.