RURAL Ancillary Studies

RURAL Investigators are encouraged to consider AS and to use other investigators, within and outside of RURAL in this process. Please read the below information provided here if interested in submitting a study proposal:

• AS that require additional questionnaires for collection of data at the time of initial mobile examination unit (MEU) visit that were not originally outlined (to be posted on the RURAL Cohort Study website) in the initial funded RURAL Cohort Study U01 grant application
• AS that require additional visits to the MEU for additional tests, including additional phenotyping, imaging, and/or questionnaires
• AS that require access to stored biospecimens collected from the RURAL Cohort Study participants
• AS that require additional mHealth measures and equipment
• AS that perform secondary analyses of the RURAL Cohort Study data, whose research questions are not a part of the main/central RURAL Cohort Study aims and for which funding is sought¹
• AS that require the use of the RURAL Cohort Study data in pooling projects or consortia
• AS that involve relatives of the RURAL Cohort Study participants²

¹AS that perform secondary analyses but seek no funding are reviewed by the RURAL Cohort Study Publications and Presentations committee

²AS that involve relatives of RURAL Cohort Study participants will be assessed on an individual basis

Yes. Applications from non-RURAL Cohort Study Investigators will be considered by RURAL’s Ancillary Studies Subcommittee and Steering Committee. Non-RURAL Cohort Study investigator applications must involve sponsorship of their AS by a RURAL Cohort Study Investigator(s) to ensure compliance with RURAL Study policies and procedures. Non-RURAL Investigators have access to RURAL data either through National Institutes of Health (NIH) repositories or through collaboration with a RURAL sponsor. All AS will have the same review process regardless of the status of affiliation to the RURAL Cohort Study. Please see our Ancillary Studies Policy* for a contact list of liaisons from RURAL’s respective cores.

* Ancillary Studies Policy is available by emailing the RURAL Cohort Study Coordinating Center at the University of Texas Health Science Center at San Antonio: rural@uthscsa.edu.

Applicants who propose an AS should refer to the RURAL Ancillary Study Review Process document and Ancillary Study Processes and Procedures Flowchart for detailed instructions on submitting a Concept Proposal and Full Proposal.

Submissions require a proposal through the RURAL Ancillary Proposal portal . A website account is required prior to submission of Ancillary Study Proposal. Your sponsoring RURAL PI should review the entire process with you.

• Submit a RURAL Ancillary Proposal here.

If you are interested in submitting a proposal for an AS, please contact one of our study PIs or email us at rural@uthscsa.edu.

Please see the RURAL Ancillary Study Review Process document and Ancillary Study Processes and Procedures Flowchart for detailed information on the review and approval processes.

The RURAL Observational Studies Monitoring Board (OSMB), convened annually by the National Heart, Lung, and Blood Institute (NHLBI), provides oversight of the RURAL Cohort Study and AS. Please note that the OSMB must review and approve, on a rolling basis, all proposals that involve participant burden.

Multi-PIs and Ancillary Studies Subcommittee Chairs: Rolling

Lab Committee: Rolling

DNA Committee: Rolling

Ancillary Studies Subcommittee: First Monday of every month

Steering Committee: Third Friday of every month

Observational Study Monitoring Board: Rolling

Data analyses can be conducted at the RURAL Cohort Study Statistical Data Coordinating Center at the University of Pennsylvania or a local institution. For analysis performed at the local institution, data will be provided in de-identified formats with unique identifiers where appropriate. Data will be provided in comma separated values (CSV) and SAS formats.

Please note that for investigators that do not reside at a RURAL Core, a data use agreement (DUA) between the University of Pennsylvania and the receiving institution is required prior to data sharing. Additionally, the investigator will be asked to sign the RURAL Data Access Agreement for access to the data. In the Data Access Agreement, the investigator will appoint a Data Steward who will have responsibility for downloading the data and maintaining data security. The Data Steward will be the only individual at the receiving institution with access to download the datasets.

To ensure accuracy and consistency in reporting RURAL Study data, all data requests must be submitted to the Study Coordinating Center (SCC) via this Dataset Request REDCap Form. All data requests will be assessed by the SCC in collaboration with the appropriate sub-committee.

Please see the RURAL Data Request Policy document for detailed information on RURAL Study data-related processes.

Data collected from your project or derived from assays, or measures from images, irrespective of funding source, must be shared with the RURAL Cohort Study, the National Heart, Lung, and Blood Institute (NHLBI), the RURAL Cohort Study Statistical Data Coordinating Center at the University of Pennsylvania, and the RURAL Cohort Study Coordinating Center at Boston University. The derived data must be delivered to Lisa Wesby, RURAL Cohort Study Data Manager, the RURAL Cohort Study Statistical Data Coordinating Center, within one year of compiling a clean and complete dataset for inclusion in RURAL data repositories. Please note that all data will also be deposited in NHLBI repositories (BioLINCC, dbGaP and BioData Catalyst).

Providing data, materials (including DNA), or other research and administrative services for an ancillary study involves costs, which vary based on the scope of the work. None of these costs are covered within the RURAL Cohort Study U01 parent grant.

The cost to RURAL for servicing ancillary studies needs to be reimbursed by the Principal Investigator(s) of the ancillary study. Therefore, it is necessary for you to include RURAL Cohort Study fees in your proposal budget.

An AS manuscript will analyze additional data collected as part of an AS of the RURAL Cohort Study. Manuscripts and abstracts from the AS must be submitted to the RURAL Cohort Study Publications and Presentations Subcommittee for review and approval. Publications based upon data from the RURAL Cohort Study must follow the guidelines as set in the Publications and Presentations Policy*.

*The RURAL Publications and Presentations Subcommittee Policy is available by emailing the RURAL Cohort Study Coordinating Center at the University of Texas Health Science Center at San Antonio: rural@uthscsa.edu.

Please review the Policy prior to the submission of an ancillary study. The following is a list of the current policies:

Ancillary Studies Policy*

* Ancillary Studies Policy is available by emailing the RURAL Cohort Study Coordinating Center at the University of Texas Health Science Center at San Antonio: rural@uthscsa.edu.

For additional information or assistance, please contact rural@uthscsa.edu.

The National Heart, Lung, and Blood Institute (NHLBI) plans to fund a second examination of participants in the RURAL Heart and Lung Study. The examination is expected to begin approximately January-February 2027 with a targeted sample size for examination of approximately 4,000 participants. 

The exam is intended, in part, to serve as a platform for independently funded exam components via investigator-initiated grants or other independently funded projects to enrich the exam data collection with additional hypothesis-driven content. The research aims of such exam-related ancillary projects need not be limited to those within the mission of the NHLBI but must be consistent with and/or complement RURAL study objectives. R01s submitted February 2025 and beyond will be subject to the new peer review framework.

Additional information about the Second Examination Cycle notice can be found here.