$567,015
MITRE CORPORATION
Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Centers for Medicare & Medicaid Services (CMS) Alliance to Modernize Healthcare Federally Funded Research and Development Center (Health FFRDC) Strategic Services in Support of Standardize Governance Metadata for Pediatric COVID-19 Data Linkage for the National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services (HHS), is the nation’s primary medical research agency, making important discoveries that improve health and saves lives. NIH is now one of the world’s foremost biomedical research agencies and serves as the focal point for biomedical research within the Federal Government. NIH began in 1887, and today, is comprised of 27 separate Institutes and Centers (ICs), most of which are located in Bethesda, Maryland. The NIH works toward that mission by: 1) conducting research in its own laboratories; 2) supporting non-Federal scientists at universities, teaching hospitals, and other academic institutions around the world; 3) sponsoring training programs for research investigators; and 4) fostering the communication of research-based health information. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is leading an effort to assess the usage of privacy preserving record linkage (PPRL) for pediatric patient-centered outcomes research, with a focus on pediatric COVID research. PPRL holds significant promise for enhancing the value of de novo clinical research data collection, through linkages across different studies and linkages with HHS administrative and survey datasets. NIH has determined that individual-level dataset linkages could enable researchers to deduplicate subjects across studies, introduce new variables into analysis plans, and reduce costly redundancies in the generation of genomic sequencing data. In order for individual-level datasets to be linked using PPRL or any other linkage method, however, researchers and data stewards must ensure that the linkages are appropriate, based on if or how the data were consented for use by the research participant, whether the scope of linkage encompasses other data sources, and if there are regulatory and/or legal frameworks that apply to the use of the data. It is important to understand how the resulting linked dataset inherits consent and/or regulation-based data use limitations that are associated with the original datasets and if new limitations arise, for example through increased identifiability of linked datasets. This project shall develop a technical approach to streamline decisions made by researchers, data stewards, and linkage honest brokers about the acceptable linkage of clinical research and administrative health datasets and the subsequent usage of linked datasets. The broader purpose of the project is to enhance appropriate development and analysis of research datasets that track research participants’ demographics, treatments, health outcomes, multiple modalities of –omics data, and other related variables such as social determinants of health, over time. The project may develop a governance database for multiple NIH and HHS clinical and administrative datasets, providing structure and provenance for all dataset governance information regarding linkage and use of those data. The project shall summarize the relevant standards in use or in development by US and international research organizations. The project shall then develop and validate approaches to standardize and digitize as contextual metadata consent, policy, and regulation-based data use requirements, based on initial analyses of pediatric COVID-19 and other high-priority HHS clinical and administrative datasets. The approach will include the development of a generalizable governance metadata schema, the integration of that governance metadata schema into real-world data collection tool(s), and a pilot evaluation of the tool enhancement to support record linkage decision making. Standardized, digitized consent and regulatory metadata shall provide the foundation for streamlining decision making processes about the appropriateness of linking individual-level datasets and using the linked data for research purposes. This project is intended to provide a biomedical and health research data governance use case and supporting technology resource to the broad field of privacy preserving data sharing and analytics. NIH NICHD requires the support of a qualified Health FFRDC to address specific long-term business and technical needs that cannot be met by any other contractor or in-house resources. The unique institutional characteristics of the Health FFRDC provide the following essential benefits to NIH NICHD: Objectivity and Freedom from Conflicts-of-Interest - The work described in this statement of work (SOW) necessitates the engagement of the Health FFRDC because this work contains sensitive information that requires an impartial, objective party that has no conflicts of interest in the planning and decision-making to best meet the needs of NIH and advances the taxpayer interest. NIH has considered and determined that a private contractor would not be suited for this work because of the potential self-interest in benefiting from either competing for downstream work or indirectly benefiting from connections to other entities that may benefit from the competition. As such, NIH has determined that the Health FFRDC is uniquely positioned to provide objective and unbiased advice because it maintains a not-for-profit status, does not compete for downstream work, and does not have financial or other interests related to the program, thus ensuring that the advice and support provided are solely in NIH’s best interest. Access to Propriety and Sensitive Information – By design, FFRDCs are given access to information that is beyond that which is common to the normal contractual relationship. This work may contain government sensitive information that a contractor is not allowed to access and commercial proprietary information that a contractor may use for competitive advantage, thus necessitating the engagement of the Health FFRDC. Comprehensive Knowledge of NIH needs and Long-term Continuity - This project requires an understanding of NIH’s key mission and objectives as well as understanding of technology expertise. The Health FFRDC has access to a strong team of members who are well-versed in the technical aspects of the work as well as are knowledgeable about HHS agencies’ mission and work. Developing a technical approach to streamline dataset linkage decision making requires this expertise. This project is funded by the HHS Office of the Secretary’s Patient Centered Outcome Research Trust Fund (OS-PCORTF) as part of the OS-PCORTF strategic plan for building data capacity for patient-centered outcomes research through coordinated, systematic efforts across federal agencies. Data capacity, in PCOR context, refers to the availability and sustainability of data and analytic resources to address national health priorities. The OS-PCORTF strategic plan addresses a broad range of data sources, including clinical, clinical trial, social services, administrative and claims data, and notes that issues of availability, quality, accessibility, and interoperability are significant hurdles to PCOR research. Health data sources, data linkage, and data analysis are the cornerstones of the PCOR data infrastructure. This project addresses the “Linking of Clinical and Other Data for Research” goal within the OS-PCORTF plan.