How Baylor College of Medicine is Engaging Patients to Build a Biorepository for Genomics Research
Background
Baylor College of Medicine is both a medical school and research center located in Houston, Texas, and is affiliated with the world’s largest medical center, Texas Medical Center. In its creation of an Institute for Genomic Medicine, Baylor College of Medicine is building a repository of biospecimen and clinical data. A cohort of 100,000 participants over 18 will consent to provide biospecimens, EHR data, and optional research survey responses.
The institution is no stranger to genomics, with its Human Genome Sequencing Center being one of 20 global institutions involved in the Human Genome Project. This project was a 15-year effort that pioneered the DNA sequencing of an entire human genome. To-date, it has been the largest collaborative biological project and has paved the way for advances in medicine and biotechnology.
In terms of funding from the National Institutes of Health (NIH), Baylor College of Medicine receives the most grant money out of any medical school in Texas. Additionally, its Department of Molecular and Human Genetics receives the most funding out of any medical school department in the United States, and it has eight over departments in the top 30 departments nationwide who receive the most NIH funding.
Scientific Aims
The goal for Institute for Genomic Medicine cohort study is to build a research database with genotypic and phenotypic information that can be used to fuel future research studies across its many disciplines.
The initial collection of genotypic data via biospecimens (primarily blood) will take place over the course of three years. Corresponding phenotypic data will be collected both via active data collection throughout the research and passively through participant medical records. Participants will consent for return of results, which will serve as the basis for future clinical utility studies. The consent process will also allow for the mining of de-identified patient data for other further research.
Cohort
The Institute for Genomic Medicine cohort research team will recruit 100,000 participants over the course of 12 months from study launch. The study will use following the eligibility criteria:
- Ages 18 and older
- Received services within the Baylor College of Medicine system
- Able to provide a blood sample
Baylor's Study by the Numbers
Methods for Assessment and Data Collection
The Institute for Genomic Medicine cohort study team determined to collaborate with Vibrent Health to develop a study infrastructure that would accelerate eConsent and data collection for participants. As part of this collaboration, Vibrent implemented a highly secure and privacy preserving participant portal and eConsent experience built on Vibrent’s Participant Experience Manager and Research Cloud products.
The study uses the following methods of data collection:
Informed eConsent
The eConsent process in the participant portal is created with the highest security and privacy standards. And it has several features that help increase participant comprehension over traditional paper and basic eConsent processes.
Baylor College of Medicine has a single-tier electronic consent that includes a video to review the study activities, as well as a knowledge check where participants answer basic questions to indicate they understand the consent content. Research Cloud enforces a baseline level of informedness for consent, as participants must answer at least 3 out of 5 consent questions correctly to demonstrate study understanding before signing. If after 3 attempts a participant cannot demonstrate study understanding, the participant is not allowed to self-consent and a member from the study will contact them to review and sign consent.
For Baylor College of Medicine, there is also a Certified Spanish translation of eConsent documents to ensure optimal comprehension of Spanish-speaking populations in the catchment areas that Baylor College of Medicine serves.
Participants have access to their signed consent documents and can withdraw consent at any time via the secure participant portal. The status of the participant’s consent in the study is kept up to date in Baylor College of Medicine’s EMR system.
Epic EHR MRN Verification
Baylor College of Medicine requires that participants who sign up for the study remotely to confirm they are patients in Baylor’s EHR system. To do this, the patient enters information such as name, date of birth, and other personally identifiable information in the secure portal, and this information is then matched with the patient’s corresponding medical record number (MRN) to verify their status as a patient. The study system also verifies that the patient has not signed up for the study before to avoid duplicated data.
Participant Survey
Participants are invited to complete one optional survey, with the possibility of more surveys in the future. This survey is taken from Vibrent’s library of validated instruments to ensure quality and consistency. A request to complete the survey in the participant portal is sent to participants via email or SMS, depending on their specified communication preferences. They can review their survey responses before submission.
Participants who choose to do this can also create an account on the participant portal, where they can perform future surveys, and receive additional information from the study team.
Biospecimen Sample Collection
Biological specimens are obtained from consented participants using:
- Blood sample discards collected from pathology and research labs, emergency room visits, as well as in-clinic visits.
- Sample draws in-clinic or from ER, pathology labs, and research labs.
Recruitment and Engagement
Baylor College of Medicine will recruit for their Institute for Genomic Medicine cohort study by research staff, encouraging word of mouth from other participants, and with the help of collaborating clinicians.
Study Website
For all methods of recruitment, interested individuals are directed to the study website, built through Vibrent Research Cloud. The website includes introductory information about the study, FAQs, and links to the participant portal where study recruits can fill out the consent form and an optional survey for data collection.
Email and MyChart Recruitment
Study staff can recruit potential participants by messaging them through Epic’s MyChart application.
In-clinic Enrollment
Baylor College of Medicine and their affiliate sites will tell their patients about the study, give potential participants time to ask questions, as well as a copy of the consent form pending interest. Potential participants are told that their participation is voluntary and that their choice whether to participate will not impact their usual care.
Patients who are enrolled onsite can use their blood draw discards or go to a pathology lab to provide their biospecimen following consenting to participate in the study. Consent is obtained using a kiosk or tablet in-clinic.
Participant Engagement
Participants can be engaged on an ongoing basis by receiving communications via email or SMS messaging, including notices of completion of activities (e.g. consent, specimen collection), reminders that action is needed or availability of new surveys, and when errors or problems occur (e.g. locked out of account, forgot password).
Participant Portal
Participants can configure their communication preferences to receive updates via SMS or email. Communications may include when their return of results is ready, and if they need to complete additional surveys. They can also change their contact details to ensure that they receive these communications.
Research Impact
Baylor College of Medicine is a world-renowned leader in clinical care and genetics and serves as the hub of the largest medical center in the world. Moreover, Baylor College of Medicine is a tertiary referral center for many common and rare disorders and sees a high volume of patients across ancestries given the uniquely diverse makeup of Houston and the surrounding areas. This is critical as there is a substantial underrepresentation of individuals from non-European ancestries in genomic and biological research leading to healthcare inequities.
In choosing a broad goal of trying to understand the fundamental biological basis for disease, Baylor College of Medicine has plans for the study to have interdisciplinary aspects and to create further research studies as a result. The college also plans to integrate the use of genomics and genetics in routine clinical practice for the advancement of precision medicine at their institution.
