Deploying Universal Consent & Return of Results
New biomarker identification entails sampling from sufficiently large and diverse populations through which we can understand the significance of a given characteristic (e.g., a genomic variation, an imaging finding) and its impact on human health. Scalable patient education around precision health – about its potential and social implications – and secure communication are an essential element of building these cohorts. Working with community representatives, UCLA Health System, the Institute for Precision Health (IPH), the Clinical & Translational Science Institute (CTSI) and diverse experts from across our campus, we developed and tested new methods for consenting patients:
- Video consent. The Center for SMART Health created a video-based consent for adult patients, allowing individuals to choose if they want their deidentified biospecimens and clinical data made available to researchers. Based on a successful, validated pilot this universal video consent is now the primary recruitment tool used a part of IPH’s ATLAS initiative, implemented at over 18 clinical sites within the healthcare enterprise. Through this mechanism, ATLAS has enrolled >50,000 participants with an average of 800-1,000 consented patients per week.
- SMS consenting. We are also exploring innovative consenting approaches including text-based messaging. Presently, patients with an upcoming UCLA appointment are reminded of the appointment via a text messaging service. If a patient has not already completed the universal consent process, they will receive an additional link as part of the text allowing for completion of a universal consent application.
- Pediatric assent. Unlike adults, obtaining a child’s assent to participate in research is quite different. We are presently developing and testing an animated video for our pediatric patient population.
Messaging (video and SMS) are available in multiple languages. Information from the consent process is automatically incorporated into UCLA’s electronic health record (EHR) infrastructure.
Health beliefs often drive participation in precision health initiatives. Our universal consent process, as originally envisioned, indicates that participants will not receive the results of any testing. Recognizing the longer-term ethical issues and considerations, particularly as our ability to treat certain diseases changes over time, we are assessing how individuals perceive the return of results from genomic testing. The Center for SMART Health performed a pilot study at UCLA, asking 600 individuals three questions after completion of the universal consent process, covering: Q1) interest in receiving results that could provide additional knowledge around an existing disease; Q2) interest in receiving results that were incidental findings but actionable with respect to their health; and Q3) if the option of receiving the return of results would alter their initial consent decision. Individuals who opted into the universal consent clearly wanted disease-specific return of results (Q1, 70%) and actionable incidental findings (Q2, 83%). Of those who opted-out, 23% wanted disease-specific information and 36% wanted incidental actionable findings. Notably, of those who initially opted-out, 9.3% would be willing to opt-in and 26.4% might be willing to consider opting-in given the return of results. In contrast, of those that initially opted-in but only were willing to provide remnant clinical material, 21% would change and opt-out, and another 15% would consider opting out. Based on these finds, we are refining our strategies for future consenting and return of results.