Clinical and translational research is an integral part of environmental health science, whereby scientific insights are gained by evaluating human subjects, and findings are converted into human health gains. NIEHS has entered a new era of clinical research that is aided by the advent of big data, electronic health and clinical research records, increased capacity for monitoring, real-life biological and exposure assessments, and precision and personalized medicine approaches. I&IT systems are integral to all these processes. However, several I&IT−specific challenges have also been introduced along with these research capabilities, including privacy; encryption; safety; integration and cross-communication between disparate databases; big data storage and analysis capacities; accessibility across institutes and among NIH intramural and extramural institutions; and electronic interactions among investigators and with study subjects (electronic consenting, real-time data entry, web-based questionnaires and data forms, telemedicine, etc.). The goal for clinical research data also includes governing principles that foster FAIR+ and machine and algorithm readable models.
Integrate Clinical Databases and Repositories Among Clinical Research Branch (CRB), NIEHS, and Other NIH Institutes and Centers, and Between CRB and Extramural Institutions
- Large clinical databases and specimen repositories in the NIH Clinical Center (CC), NIEHS Clinical Research Unit (CRU), and other collaborating facilities exist, but their searchability and interoperative use are hampered by the inability to integrate data and samples in a user-friendly and efficient way.
- Clinical I&IT will enable integration of high-priority databases and repositories, and assist in the planning of prospective database and repository logistics and storage, to enable better access, interoperability, and integration.
Provide Secure Interfaces Among Clinical Investigators and Study Subjects, and Enhance Study Recruitment
- CRB investigators are located primarily in the CRU in Research Triangle Park, North Carolina, and in the CC in Bethesda, Maryland. However, they collaborate with many other researchers around the world, to assess and enroll subjects into studies from many different locations. These diverse locations make secure, real-time, high-resolution, audiovisual communications among clinical researchers, and among clinical staff and subjects, a critical need that is difficult to achieve with the current infrastructure.
- The public is increasingly familiar with electronic formats of communication and interface on multiple devices. These are often the preferred method of interaction, and aid subject recruitment and retention.
- Electronic remote interfaces among clinical researchers, and among investigators and study subjects, is a cost-effective, resource-sparing, and versatile addition to paper-based, on-site interactions.
- Subject recruiting for clinical studies is mostly a passive and inefficient process. Social media and other novel approaches have the potential to allow for more active, directed, and effective ways to connect subjects with appropriate studies.
- Clinical I&IT will address communications, data, technology, and privacy and security challenges that need to be overcome to enable seamless, real-time audiovisual interactions among clinical researchers, as well as between researchers and subjects in multiple locations, to allow the efficient recruiting, assessment, and enrollment of subjects remotely.
- The NIEHS Freedom of Information Act (FOIA) and Privacy Office will work closely with I&IT providers to ensure that existing measures for collecting, maintaining, and sharing personally identifiable information (PII) for all human research study participants are sufficient and in accordance with NIH and NIEHS requirements, including, but not limited to, Privacy Impact Assessments, Office of Management and Budget [OMB] clearance, and records management requirements.
Enable Big Data Storage, Analysis, and Backup
- Hypothesis-generating and testing clinical research projects increasingly rely on the analysis of large data sets from electronic, multiomics (e.g., genome, metabolome, microbiome, exposome, etc.) or phenotypic sources (e.g., electronic health records, U.S. Environmental Protection Agency [EPA] pollution monitors, laboratory assessments, imaging data, wearable personal health monitors, etc.).
- NIEHS will develop the capability to store, organize, analyze, and back up large clinical data sets, including environmental and genomic information on Environmental Polymorphism Registry (EPR) participants, as well as other principal investigator-generated projects.
Support I&IT Alignment and Infrastructure Lifecycle Support, as Well as Security, Access, and Reusability of Data
- Clinical data and metadata infrastructure and policy will ensure I&IT alignment and infrastructure lifecycle support, data accessibility, security, integrity, and provenance, as well as support and foster FAIR+ data principles.
Strategic Capability Priorities
Develop Coordinated Architecture and Development Plans for Addressing Strategic Capability Priorities and Resource the Implementation of the Clinical I&IT Plan
Strategic Clinical I&IT goals and priorities represent significant development and deployment efforts. If these are done separately, the institute risks inefficiencies and misaligned architectures. NIEHS will develop an overarching architecture for both systems and software development, and to resource the development and ongoing operations of the plan. Success will be defined by establishment of an architecture that has full support from I&IT areas, and by implementation of the planned systems in user-friendly and reliable ways.
Develop, Plan, and Implement an Approach for Managing EPR and Other CRB Genomic Data
The planned sequencing of the EPR and other CRB cohorts will provide a significant and important research data set. To make use of the genomic data, plans for managing the data, including curation, archiving, moving, storage, and processing, will be generated and implemented. Success will be defined by the ability to search for and identify genetic associations with high-priority phenotypes.
Integrate CRB, NIEHS, and Trans-NIH Clinical and Genomics Data Sets and Repositories
Many databases (e.g., CTDB, Clinical Conductor, GDC, CRIS, BTRIS, PAX, REDCap, BSI, EPR, dbGaP, EAG, SSS systems, etc.), other sources of clinical information (CRU and CC clinic notes, discharge summaries, etc.), and clinical specimen repositories are used by the CRB, but there is no current capability to search these systematically, create interactive databases from this information, or integrate databases across these platforms. Also, this limitation does not allow researchers to know what NIH resources are currently available for possible clinical studies, thus limiting the capability to assess data across platforms, and results in redundancy of efforts. Multiple datasets also contain, at least in part, the same information, which necessitates multiple redundant entries or access points. This multiplies the cost and potential for significant errors in PII and other data entry and analyses. Success will be defined by the number of high-priority use cases, including operational (e.g., reducing data entry) and scientific, that are addressed in a user-friendly and functional way, after integrating and linking databases and repositories.
Integrate CRB and Extramural Clinical, Environmental, and Genomics Data Sets and Repositories
The ability to search, access, and utilize electronic health records, environmental, geospatial, other medical and research data; and sample repositories in existing online databases and collaborating institutions, will exponentially increase the research capacity of the CRB, and is becoming the state of the art for clinical research. Novel methods can also translate historic written clinical notes and summaries into useable databases. Currently, there is no such ability for these functions in CRB. Success will be defined by the number of high-priority use cases, including operational (e.g., reducing data entry) and scientific, that are addressed in a user-friendly and functional way, after integrating and linking databases and repositories.
Establish Reliable Secure Interfaces With Research Investigators
The CRB will have highly reliable, real-time, high-resolution, secure audiovisual interfaces with other collaborating clinicians, researchers, and staff across the U.S. and ideally around the world. This includes the capacity to share clinical and research information from medical institutions on subjects, including databases, slide sets, clinical and radiographic images, and videos. Some capability now exists, but it is often unreliable and of limited capability. Success will be defined by the number of goals that are achieved with multiple collaborators in a user-friendly and fully reliable system.
Establish Reliable Secure Interfaces With CRB Research Subjects
The CRB will have the ability to maintain and use systems that interface with research subjects remotely, securely, and confidentially. This includes modalities, such as uploading and downloading of subject-supplied medical records and high-resolution images; electronic consenting; patient access to, and completion of, electronic questionnaires and secure data entry sites; and ability to use smart device apps for monitoring and data entry over time. Success will be defined by the number of effective user-friendly interfaces with subjects’ data (e.g., medical record access, electronic consenting, secure access, and ability to complete questionnaires and study websites, etc.).
Establish Telemedicine Capabilities
The ability for health care personnel to reliably interact with remote subjects in real time and at high resolution by audiovisual means is crucial to the evolution of CRB to the worldwide scope of the institute’s planned research. This is also increasingly the accepted state-of-the-art mode in research and medicine, and is expected to substantially expand research capacity, while curtailing costs (e.g., travel, space, etc.). Some capabilities for limited interactions between the CRU and the CC have been recently established, but these are not as reliable, user friendly, or expansive as desired. Success will be defined by the ability to develop user-friendly, reliable, seamless, secure, encrypted, confidential interactions with subjects at home and in multiple collaborating medical facilities.
Develop Stable CRB Support Systems Alignment and Infrastructure Lifecycle
Alignment of the network, data center, and other systems to diverse and domain-specific clinical I&IT needs, including legacy systems, emphasizing usability, agility, and flexibility, is required. Clinical research hardware and software pose specialized security and reliability needs. For example, the Omnicell medical cabinet cannot afford to fail, because it would block access to medications and must be secure to protect sensitive patient data. CRB local area networks and computers have access to sensitive PII and must have additional security. New high-priority clinical care and research devices will be incorporated into these networks and provided with appropriate I&IT support. Success will be defined by user satisfaction of support systems alignment and the percentage of lifecycle-compatible I&IT equipment in the CRB.
Enhance Recruitment of Subjects for Clinical Studies
A major roadblock to the successful and timely completion of clinical studies is identifying and enrolling adequate numbers of appropriate subjects. Subject recruiting for clinical studies is currently a passive and generally inefficient process. Social media and other novel approaches, such as ResearchMatch, will allow for more directed and effective ways to connect subjects with appropriate studies. Success will be defined by increased numbers of subjects enrolled per protocol and more rapid completion of clinical studies.
Enhance Systems That Promote Software Developers Building Data Sharing and Interoperability Services Into Clinical Projects
NIEHS sponsors the development of diverse independent software applications and databases that host and generate data and metadata to fit variable clinical needs. The institute further supports modifications and enhancements to existing applications and databases. To promote data sharing and interoperability, NIEHS will work across the entire development lifecycle to define and build services that enable effective data search and access. NIEHS clinical software and database development efforts will include requirements for data interoperability and portability, and integration services. Projects will provide metadata visibility across scientific and clinical fields, to allow monitoring of data sharing opportunities. Success will be measured by the number of development efforts that include systems for effective clinical data and metadata sharing and integration.
Clinical/CRU Theme Map
|I&IT Landscape||Agility||Analytics||Communications & Transparency||Foster Collaboration||Governance||Optimize Resources||Workforce Development|
See Appendix A: I&IT Priorities Support NIEHS Strategic Themes