External Data Sharing

The RURAL Cohort Study is committed to sharing data from the RURAL Cohort Study participants according to the FAIR principles, i.e., Fair, Accessible, Interoperable, and Reusable. As such, the RURAL Cohort Study will share all research data as broadly and as soon as possible and for as long as possible, consistent with National Institutes of Health (NIH) policies to maximize the benefits and scientific yield to the community.

The RURAL Cohort Study team will:

• Clarify details of data availability, accessing, and sharing.
• Promote data discovery and integration through the development and the utilization of standard, unambiguous terminology.
• Highlight creation and the enhancement of data dictionaries and ontologies.
• Actively support the development and the application of methodologies to support interoperability of the RURAL Cohort Study data with other relevant data sets.
• Allow formatting and depositing of individual-level, de-identified data in existing NIH repositories.
• Promote the development and implementation of a searchable web-based platform for the RURAL Cohort Study data sharing and integration.
• Ensure the linkage and integration of multiple RURAL Cohort Study data sets from different sources such as the baseline. examination in the mobile examination unit, mHealth data, and data from geospatially-referenced and health records.
• Enable the development and implementation of techniques for data visualization and to support big data analytics.

The RURAL Cohort Study is committed to broad sharing of de-identified data to the extent possible, while remaining consistent with applicable laws, regulations, NIH rules, and policies, including the Federal Policy for Protection of Human Subjects (also known as the Common Rule).

All RURAL Cohort Study data is subject to extensive quality assurance and control measures led by our Statistical Data Coordinating Center at the University of Pennsylvania. The RURAL Cohort Study can share all finalized, clean, and de-identified phenotypic and genotypic data from the RURAL Cohort Study participants consistent with their informed consent provisions.

• Our phenotyping spans several different domains and includes both questionnaire-based responses, imaging, and physiological measurements at rest and upon dynamic testing. The RURAL Cohort Study participants will also undergo genotyping using a novel customized array.

Requests for DNA, or biosamples of the RURAL Cohort Study participants will require a more extensive research proposal than requests for existing phenotypic and genotypic data. The RURAL Cohort Study DNA and Laboratory Subcommittees and the Study Coordinating Center as well as the NHLBI Program Officials will review proposals for accessing these samples.

The RURAL Cohort Study will deposit all appropriate phenotypic data in the NHLBI BioLINCC data repository and all genomic data in dbGaP. Both resources have data access policies and procedures that are consistent with the NIH data sharing policies.

For more information on the exact location and processes for accessing shareable study data, please contact the RURAL Cohort Study Coordinating Center at Boston University: rural@bu.edu

Please review the Policy prior to the request of data. The following is a list of the current documents and forms:

• External Data Sharing Policy
• Data and Materials Distribution Agreement
• Dataset Request and Notice of Intent to Analyze Form

Note: These policies and processes are subject to change based upon the growth and needs of the RURAL Cohort Study, NHLBI requests, OSMB review, and internal input.

For additional information or assistance, please contact the RURAL Cohort Study Coordinating Center at Boston University: rural@bu.edu.