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Digitizing Consent and Regulatory Metadata Towards Streamlining Governance of Pediatric COVID-19 Research Data Linkages

Digitizing Consent and Regulatory Metadata Towards Streamlining Governance of Pediatric COVID-19 Research Data Linkages
Agency
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (NIH/NICHD)
Start Date
  • 05/01/22
Functionality
  • Linking of Clinical and Other Data for Research

 

STATUS: Active Project

BACKGROUND

There is an increasing interest in linking datasets—including data from multiple studies as well as clinical and administrative datasets—to conduct longitudinal studies and to address complex research questions. The issue of how to protect the privacy and confidentiality of sensitive information is crucial to successful application of record linkage. Different techniques have been developed to address this, and one of them is known as ‘privacy-preserving record linkage’ (PPRL). However, there is no standardized governance approach to determine how to address informed consent and regulatory requirements associated with the datasets, which places a considerable burden on those performing these data linkages.

Using pediatric COVID-19 data and other high-priority Department of Health and Human Services (HHS) clinical and administrative datasets, this NIH/NICHD project will develop a standard data linkage governance approach. Upon its completion, the project will provide user-friendly and machine-readable standards for metadata that describe data linkage and data use requirements; develop and pilot a research-compatible data collection and exchange tool to test those standards in practice; and make available standardized and simplified processes for data linkage and use to strengthen researchers’ ability to use large-scale datasets for patient-centered outcomes research (PCOR).

PROJECT PURPOSE & OBJECTIVES

The purpose of this proposed project is to develop a technical approach to streamline linking of clinical research datasets with administrative data for patient-centered health outcomes research. That will be achieved through the implementation of the following objectives:

  • Describe collection, use, and linkage requirements for high-priority HHS datasets by extending the Pediatric COVID PPRL Assessment

  • Develop a metadata schema that captures consent and regulatory-based elements relevant to data linkage governance, leveraging existing terminologies and standards

  • Develop and test a research-compatible tool for streamlining decision-making for data linkage and linked dataset usage for research