FAQ for PAR-17-338: Continuation of Existing Grant Based Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders (U01-Clinical Trials Not Allowed)

Eligible Cohorts

Q1: Can the proposed cohort be composed of cohorts from more than one project?

A1: Yes, a single cohort study assembled from multiple projects may potentially be eligible. The assembled cohort would need sufficiently harmonized data such that, collectively, the study can address a wide breadth of heart, lung, blood, and/or sleep disorder questions using existing data and, if applicable, biospecimens - essentially, a deeply phenotyped baseline on which this FOA can build.

Q2: Can an existing cohort be enriched with recruitment of new participants to attain the 2,000 participant threshold?

A2: This FOA will support only a basic content examination or data collection cycle as opposed to more extensive data collection typical of a baseline exam or initial participant data collection; therefore, newly recruited participants would lack the depth of data required to meet study objectives. Under certain circumstances, enrichment may be feasible providing that newly recruited participants have phenotyping equivalent to participants already enrolled in the study, such as a cohort of participants from a provider network or an EHR cohort.

Q3: Would a cohort assembled and being followed through electronic health records and administrative data be eligible for support under this FOA?

A3: Yes, a cohort assembled and being followed through electronic health records may potentially be eligible. The applicant would need to demonstrate the capability of the cohort to address a wide breadth of topics related to heart, lung, blood, and/or sleep disorders using existing data and, if applicable, biospecimens from the cohort. The applicant would also need to demonstrate the ability to incorporate ancillary studies proposing innovative hypotheses to build on the cohort’s basic content examination or data collection cycle.

Q4: Are cohorts only being considered for infrastructure support if they include physical examinations of the participants?

A4: No, other means of data collection on participants are permissible, such as mailed questionnaires, home visits, phone contacts, electronic health records, mobile devices and applications, etc.

Q5: Are applications to this funding announcement subject to the NHLBI greater than $500K policy?

A5: Yes, since the funding opportunity is a program announcement with review (PAR) potential applicants must adhere to the greater than $500K policy.

Supported Activities

Q6: Is data analysis supported under this FOA?

A6: Yes, data analysis is a supported activity. As noted in the FOA, “the PD/PI has responsibility for oversight of study activities, such as data analysis and interpretation, manuscript preparation, and dissemination of study results".

Q7: Can this FOA support innovative approaches to data collection from registries or electronic health records?

A7: Potentially yes, this FOA will support activities related to a basic content examination or data collection cycle; therefore, applications to support cohorts assembled from registries, provider networks, etc., will have the opportunity to propose innovative methods to collect these basic data. Specifically, innovative approaches may be proposed to derive the key clinical data from the registry/network/etc. considered to be fundamental to achieving study objectives (see Q8 regarding support for the basic content examination/data collection cycle).

Q8: What data collection activities can be supported for the basic content examination or data collection cycle?

A8: Ultimately, the content of the basic examination or data collection cycle depends on the nature of the study and should be based on those elements considered to be fundamental to achieving the basic objectives of the study: in other words, essential data elements an ancillary study investigator would expect to be collected given the nature and objectives of the study. The illustrative examples below represent two specific examples of studies among a broad spectrum; therefore, potential assessments outside the scope of basic content in one study, may be well within the scope of basic content for a different study.

Example 1, a general population study focused on cardiovascular incidence might collect basic demographics, height, weight, blood pressure, smoking history, lipid profile, medication inventory, fasting glucose, and interim medical history. Examples of activities outside the scope of a basic content examination or data collection cycle for a general population cardiovascular study would include: measures of endothelial function, electrocardiogram, computed tomography, depression assessment, cognitive function assessment, six-minute walk test, imaging studies, wearable monitors, novel biomarkers, etc.

Example 2, data elements considered fundamental in a study of patients with sickle cell disease, would include: basic demographics, anthropometric measures, measures of oxygen saturation, interim pain, medication, transfusion histories, and laboratory tests such as: complete blood count, lactose dehydrogenase, ferritin, reticulocyte count and hemoglobin characterization. Data elements that would be outside the scope of a basic exam or data collection cycle would include: measures of renal, lung, or cardiovascular function, neurologic and emotional assessments, and quality of life.

Applicants may contact program staff to discuss whether the proposed basic content examination or data collection cycle fits within the spirit and intent of the funding opportunity announcement.

Planning for ancillary content

Q9: Does ancillary content need to be described in the application?

A9: This FOA does not directly support ancillary projects; therefore, proposals or descriptions of potential ancillary studies are not required to be specified in the application. However, applicants may prefer to provide a few examples of ancillary projects to demonstrate how the cohort infrastructure can be leveraged to support innovative ancillary research hypotheses.

Q10: The estimated study timeline given in the FOA suggests that approximately 18 months should be allotted from start of the award to the initiation of the basic content examination to allow for ancillary content to be approved by internal study processes and receive funding, can you clarify how applicants should address this aspect of the timeline?

A10: By utilizing the table for question 11 below, an 18 month estimate would represent the lower end of the spectrum for the time from award to examination or data collection start since only ancillary content from an initial application (June receipt date) would be funded in time for integration into the exam or data collection cycle. The illustrative example provided in the table below assumes 30 months from award to data collection start, which would represent the upper end of the spectrum since this timeline permits ancillary content to be funded from multiple receipt dates and/or resubmissions. The exact time should balance the anticipated amount of time for re-recruitment and assessment of participants with sufficient time for innovative ancillary content to receive funding, and for coordination of the ancillary content into the exam or data collection cycle.

Q11: How does the NHLBI envision integrating data collection via ancillary studies into the basic content examination or data collection cycle?

A11: It is expected that an applicant to be funded via this FOA will receive the award following the October meeting of the NHLBI Advisory Council. (For more information, see https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm#review.) Within the first month of the award, it is expected that the start and end dates for the basic content examination or data collection cycle will be decided. Once the examination or data collection cycle timing has been determined, the NHLBI will issue a Notice in the NIH Guide (https://grants.nih.gov/funding/searchguide/nih-guide-to-grants-and-contracts.cfm) announcing the expected cohort examination or data collection start date so that grant applications for exam-related ancillary studies may be submitted.

The hypothetical example below illustrates how NIH grant funding cycles and examination ordata collection start date may influence timing of submissions of applications proposing ancillary content. The example assumes an examination or data collection cycle that begins 30 months after the cohort study grant is awarded. The example also assumes that NIH grant applications to support exam-related ancillary content would not be submitted until at least 4-5 months after the start date of the cohort study grant awarded from this FOA to accommodate internal study processes for review and approval of ancillary content.

Hypothetical Example:

• Study project start date January 2019
• NIH Guide Notice published January/February 2019 announcing basic exam or data collection cycle and timeline
• Proposed basic content examination or data collection cycle start date June 2021

Scenario 1 (refer to Row 1 of the table above):

In this scenario, interested researchers would have sufficient time after the NIH Guide exam announcement is published and before the June 1, 2021 exam start date to:

• Comply with study-specific requirements and obtain any needed study permissions to conduct an exam-related ancillary study in the cohort. 
• Submit an A0 (new) application by the January 2020 Council (FY 2020 Cycle II) receipt date and, if needed, submit an A1 (resubmission) application by the October 2020 (FY 2021 Cycle I) receipt date (per Row 1 of the table above).
• Have ample time (approximately six months or more) after award for planning and preparation in cooperation with the cohort study before the basic examination/ data collection cycle start date.

Scenario 2 (refer to the table’s Row 2):

• New (A0) applications for ancillary content submitted by May 2020 (FY2020 Cycle III) receipt dates would have ample time after award for planning and preparation in cooperation with the cohort study before the basic cohort examination/data collection cycle start date.
• Resubmitted (A1) applications, if funded, may not have adequate preparation time before the exam or data collection cycle begins (per Row 2 of the table).  
• In such cases, the ancillary content might not be incorporated into the examination or data collection cycle until after the basic examination/data collection start. Thus, applicants will need to consider timing of their data collection relative to that of the planned cohort examination/data collection cycle and any additional time and associated costs that may be required to complete their own data collection as proposed. 

Scenario 3 (refer to the table’s Row 3):

• New (A0) applications for ancillary content submitted by October 2020 (FY2021 Cycle I) receipt dates would likely have award dates allowing sufficient time for planning and preparation in cooperation with the cohort study before the basic cohort examination/data collection start date.
• Awards for resubmitted (A1) applications would not be made until after the cohort basic examination/data collection has commenced (per Row 3 of the table). 
• In such cases, the ancillary content would not be incorporated into the examination or data collection cycle until well after the basic examination/data collection start. Again, applicants will need to consider timing of their data collection relative to that of the planned cohort examination/data collection cycle and any additional time and associated costs that may be required to complete their own data collection as proposed.