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RURAL Ancillary Studies: Second Examination Cycle

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

Learn more about the submission process for the second examination cycle with our introduction video to the right. For additional information or assistance, please email the RURAL Study Coordinating Center at rural@uthscsa.edu.

  • About

    Ancillary study investigators are expected to work collaboratively with the RURAL investigators/ the RURAL Study Coordinating Center (SCC) and follow all relevant RURAL policies and procedures. Ancillary study investigators are expected to comply with RURAL and NHLBI requirements for sharing of collected ancillary study data with the RURAL study and the scientific community as outlined in the NHLBI Data Freeze approach. Ancillary studies must adhere to permissible participant burden (as part of the core second exam and remote monitoring post-exam) as determined by the RURAL Study and the NHLBI.

  • External Investigators

    External investigators interested in collaborating with the RURAL Study are not required to be RURAL investigators. However, they must submit a proposal in the RURAL ancillary study portal. Ancillary study investigators are expected to collaborate closely with RURAL investigators and the RURAL Study SCC, adhering to all relevant policies and procedures. External investigators are strongly encouraged to schedule an informational meeting with RURAL leadership prior to the virtual Ancillary Study Retreat 1 (see Retreat 1 below) and prior to submitting their ancillary study proposal. To arrange a meeting, please email the RURAL Cohort RURAL Study Coordinating Center (SCC) at rural@uthscsa.edu.

  • Retreat 1 Study Idea Presentation
    The RURAL Study is hosting an Ancillary Study Retreat 1 to provide investigators with targeted guidance to enhance the quality of their study submissions. During the retreat, investigators will present their ancillary study proposals to a panel of RURAL Study leaders, including the study’s MPIs, Vasan Ramachandran, M.D., and Suzanne Judd, Ph.D., along with experts from the Statistical and Data Coordinating Core (SDCC) and the mHealth Core. The panel will offer constructive feedback to help make these studies more competitive and improve their chances of success in the Study Section review.

    There will be two options for the virtual Ancillary Study Retreat 1: February 21, 11 am – 1 pm EST, and March 19, 11 am – 1 pm EST. 

    To assist investigators in preparing ancillary study proposals, we’ve outlined the key requirements to include in your 10-minute presentation:
    • Title
    • Principal Investigator
    • Background
    • Study Aims and Hypothesis
    • Study Design and Phenotyping
    • Why the RURAL Study?
    • Participant Burden
    • Potential Adverse Effects
    • Sample Size and Statistical Power
    • Clinically Actionable Results
    • Q&A Session

     

    Download a Template for RURAL Ancillary Study Proposals Retreat Presentations to ensure your proposal meets all requirements.

  • Sample Size and Statistical Power Resources

    Investigators within and outside the RURAL family will be able to access detailed resources to support their research.

    • What’s Included:
      • Power Calculations for the estimated 4,600 participants recruited at RURAL Exam 1
      • Anticipated Sample Size by County
      • Statistical Power Across Different Strata

     

    These resources are designed to help you reference and adapt sample size and power data for your studies. Download this document which shares the RURAL Study’s estimated sample size and statistical power for ancillary studies to explore and integrate it into your research. The RURAL study is willing to arrange statistical consultation for PIs interested in submitting ancillary studies. To arrange a meeting, please email the RURAL Cohort RURAL Study Coordinating Center (SCC) at rural@uthscsa.edu. 

  • NIH Review and Award Cycles Calendar

    Grant application submission deadlines are described at https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm.

    Please plan your submission carefully to ensure alignment with RURAL Wave 2 requirements. We encourage PIs submit their ancillary study by the February 5, 2026 deadline.

    A0 Receipt DateCouncil CycleEarliest StartA1 Receipt DateCouncil CycleEarliest Start
    February 5, 2025October 2025December 1, 2025November 5, 2025May 2026July 1, 2026
    June 5, 2025January 2026April 1, 2026March 5, 2026October 2026December 1, 2026
    October 5, 2025May 2026July 1, 2026July 5, 2026January 2027April 1, 2027
    February 5, 2026October 2026December 1, 2026November 5, 2026May 2027July 1, 2027
    June 5, 2026January 2027April 1, 2027March 5, 2027October 2027December 1, 2028
    October 5, 2026May 2027July 1, 2027July 5, 2027January 2028April 1, 2028

  • New Peer Review Framework

    R01s submitted February 2025 and beyond will be subject to the new peer review framework.

    The Simplified Framework for NIH Peer Review Criteria retains the five regulatory criteria (Significance, Investigators, Innovation, Approach, Environment) but reorganizes them into three factors — two will receive numerical criterion scores and one will be evaluated for sufficiency. All three factors will be considered in arriving at the Overall Impact score. The reframing of the criteria serves to focus reviewers on three central questions reviewers should be evaluating: How important is the proposed research, how rigorous and feasible are the methods, and whether the investigators and institution have the expertise/resources necessary to carry out the project.

    • Factor 1: Importance of the Research (Significance, Innovation), scored 1-9
    • Factor 2: Rigor and Feasibility (Approach), scored 1-9
    • Factor 3: Expertise and Resources (Investigator, Environment), to be evaluated as either sufficient for the proposed research or not (in which case reviewers must provide an explanation)

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