Frequently Asked Questions for RFA-13-007, Targeted Analysis of Jackson Heart Study Data (R01) , updated March 6, 2012 `

IMPORTANT BUDGET CLARIFICATION:

The detailed budgeting mechanism MAY be used in applications for RFA-HL-13-007, Targeted Analysis of Jackson Heart Study Data.

The standard rule for R01’s is that if the application requests $250k or less in direct costs for each budget period, the modular budget should be used. However, the cap of $649k of this RFA does not fall nicely in the modular budget $25k increments. Therefore the detailed budgeting mechanism MAY be used for this RFA.

In responding to the RFA, the following Warning may be ignored:

WARNING The direct cost requests of $250K or less each year (on the 424 R&R Budget page section F-K) must be in modules of $25K, using the PHS 398 Modular Budget Form and not the R&R Budget Form. Incorrect applications may be delayed in the peer review process or rejected. (7.15.3)

Q1. Has the receipt date been extended by this notice?

A: The application receipt date has been extended from February 28, 2012 to March 9, 2012. Letters of intent remain due by January 28, 2012.

Q2. In the FOA Purpose, please explain the meaning of ‘working groups’: “This FOA will fund external topical working groups to collaborate with Jackson Heart Study researchers to analyze the data collected to date.”

A: The intent of this FOA is to expand the JHS research community to include additional researchers with expertise in hypertension, diabetes and obesity, physical activity and nutrition, heart failure, and chronic kidney disease; other topics may be considered. The purpose of each funded working group shall be to prioritize, lead, and coordinate analytical projects addressing these topical areas. The purpose of the grant award is, therefore, not meant to support one particular research project, but rather to support the formation and operation of a collaborative group of researchers interested in applying JHS data to this area of investigation. Researchers funded under this RFA will provide content expertise and guidance for the working group, whose membership will be expected to expand and may also include current JHS investigators; current members of a JHS working group that may already exist on the topic; and interested non-affiliated investigators, including early career investigators.

Q3. How will newly-funded topical working groups interact with existing JHS topical working groups and current JHS collaborators?

A: The JHS has posted on their website a list of all current working groups and collaborators: http://jhs.jsums.edu/jhsinfo/ForResearchers/DataSummaries/Workinggroups/tabid/168/Default.aspxExternal Link Icon. Depending on the focus of new RFA-funded working groups and the existing working groups or collaborators, there may be mergers of working groups, or formalized cross-memberships, and certainly close coordination among all working groups on overlapping manuscript topics.

Investigators currently collaborating with the JHS are welcome to apply for funding from the RFA, although being a current JHS investigator or a current JHS collaborator will not result in any advantage in scoring of the application at the time of review.

Q4. How do you explain the wording "Funding under this FOA will not support the collection of additional data?”

Any data generation that requires either participant burden or use of a finite resource (such as stored biospecimens) that would require the permission of the JHS Steering Committee is considered to be the collection of new data; funds from the RFA may not be used for these purposes. Use of personnel time and effort to create new derived variables from existing previously collected data (such as from the dietary questionnaires, actigraphy, and imaging) will not be considered new data collection; funds from the RFA may be used for these purposes. Such derived variables should be made available as a resource to the working group members for analysis and publication, and will become incorporated into the main JHS database according to the JHS Ancillary Study Guidelines, found at http://jhs.jsums.edu/jhsinfo/Portals/0/pdf/Ancillary%20Study%20Guidelines_10-10-2011.pdfExternal Link Icon.

Q5. Is it necessary to contact current JHS investigators regarding the RFA process?

A:RFA respondents are encouraged to contact the NHLBI scientific program officers listed on the RFA, rather than the Jackson Heart Study (JHS) Investigators, with questions regarding the intent of the RFA and the application process.  If there is a question that is better addressed by a member of the Study’s Coordinating Center, NHLBI staff will ensure that the appropriate person is identified and that the inquiries from all potential respondents are adequately addressed.  This will lessen the burden on the JHS Coordinating Center, and allow NHLBI to track the nature of the inquiries and clarify the RFA in a uniform, consistent manner for all respondents.

It is the intent of this RFA to fund investigators at institutions other than those currently being supported by the current NHLBI JHS contracts with Tougaloo College, Jackson State University, or the University of Mississippi Medical Center.  Current contract-supported JHS investigators or other investigators at those institutions may initiate or be included on an application in response to this RFA; however, the inclusion of current JHS investigators, whether current contract-supported staff or current JHS collaborators will not be a criterion for the scoring of RFA applications.  A letter of support from the current JHS contract investigators is not needed as part of the application.

All funded grantees will, however, be expected to include JHS investigators as full participants in the activities of topical working groups, and in the preparation of manuscripts.

Q6. Does an application to the RFA require JHS-approved proposals for ancillary studies or manuscripts?

A: There is no expectation that manuscript proposals will have been submitted to or approved by the JHS Publications and Presentations Committee at the time of the grant application. There is also no requirement for permission to conduct an ancillary study at the time of the RFA submission, as this RFA does not support the collection of new data, the usual purpose of an ancillary study. However, it is the intent of the RFA that the grants funded will seed topical working groups that will then generate multiple manuscript proposals, analyze JHS data applicable to these proposals, and report the results in published manuscripts. It is also the intent that the funded topical working groups will provide a fertile ground for germinating ideas for new ancillary study proposals; approved ancillary studies will then be expected to seek additional separate funding for the collection of new, complementary data, including the re-reading of existing images or the measurement of additional analytes from stored biological samples.

Q7. What will be the expectation for mentoring of early-stage investigators and how will that be structured?

A: Reviewers will be instructed to consider how well the principal investigator(s) of the proposed grant have demonstrated their capability and success in mentoring the careers of junior investigators, particularly persons from groups that are underrepresented in the medical research professions. For awardees of these RFA-funded grants, the NHLBI especially encourages the mentorship of higher-level research trainees, i.e., at the post-doctoral and junior faculty levels. Support for trainees should be written into the parent grant. Support may also be sought via the competitive NHLBI Diversity Supplement mechanism: http://www.nhlbi.nih.gov/funding/training/guid-app.htm.

Upon notification of award funding under the Jackson Heart Study RFA, HL-013-007, expected to take place during autumn 2012, each successful grantee may be eligible to seek a well-qualified candidate for an NHLBI Diversity Supplement for potential supplemental funding to the parent RFA-funded grant to start within the first year of the parent grant. [Please note: Persons funded on a grant are not eligible for additional funding through a Diversity Supplement to the grant.]

Q8. Will there be access to Jackson Heart Study data for the purpose of preparing an RFA application?

A: Potential applicants may view data summary files at http://jhs.jsums.edu/jhsinfo/ForResearchers/DataSummaries/tabid/162/Default.aspxExternal Link Icon. These data summaries include descriptions of all data files and variables for Exam 1, Exam 2, and Annual Follow-up Interviews. Variable means, ranges, and numbers of non-missing values are included in these summary files. Components of each of the three Jackson Heart Study clinical examinations can be found at: http://jhs.jsums.edu/jhsinfo/ForResearchers/StudyComponents/tabid/88/Default.aspxExternal Link Icon

The JHS and the NHLBI have agreed that potential applicants may acquire temporary and restricted access to JHS clinical and interview data collected from Visit 1 (2000-2004), Visit 2 (2005-2008), and interim annual follow-up telephone interviews. These data will not include results of genetics analysis or geo-coded residential addresses. A Data Distribution Agreement must be signed by the Principal Investigator and a legally authorized representative of the parent institution JHS RFA DDA. DATA OBTAINED THROUGH THIS TEMPORARY ACCESS MUST BE DESTROYED ON OR BEFORE FEBRUARY 28, 2012 AND MAY NOT BE USED FOR ANY PUBLICATION.

Complete Jackson Heart Study data sets will be made available to RFA grant awardees upon execution of a data security agreement signed by the investigators and the grantee institutions.

Regardless of RFA award status, any researcher may at any time receive access to the JHS data sets upon approval of a manuscript proposal that includes a current JHS investigator. Manuscript proposals shall be submitted to the Jackson Heart Study Publications and Presentations Committee at: http://jhs.jsums.edu/jhsinfo/ForResearchers/Publications/SubmitManuscriptProposal/tabid/156/Default.aspxExternal Link Icon. Upon approval of the manuscript proposal, a data use agreement is signed by the investigator and parent institution; the investigator will then receive access to the Jackson Heart Study data sets for the purpose of completing the approved analysis and manuscript.

Q9. How many cardiovascular events have occurred among Jackson Heart Study participants to date?

A: The Jackson Heart Study has posted a summary of the number of cases of coronary heart disease, heart failure, and strokes through 2008 at http://jhs.jsums.edu/jhsinfo/ForResearchers/DataSummaries/tabid/162/Default.aspxExternal Link Icon

Successful grant applicants will obtain, with the full dataset, complete events data including patient identification for linkage to covariates, and time since enrollment to event or censor. All hospitalizations for JHS participants are captured and will available in the full dataset, but only hospitalizations with ICD codes for CHD and heart failure are reviewed and adjudicated.

Q10. Are cross-cutting topics, rather than disease-focused topics, acceptable?

A: The particular topics named in the RFA — hypertension, heart failure, chronic kidney disease, diabetes and obesity, and physical activity and nutrition — are cardiovascular or related diseases or risk factors for which great disparities exist between African Americans and other Americans, and for which JHS data may be an important key to understanding these disparities. Alternative topical areas or research may be considered if a strong case can be made for fruitful exploration using data from the JHS. To the extent that cross-cutting approaches to disease risk — e.g., health care access, geographic and contextual factors, or psychosocial factors — may be used to explore the reasons for this excessive burden of disease for African Americans, the NHLBI welcomes these analytical approaches within the structure of these disease- or risk factor-focused working groups.

Q11. Can co-investigators on a grant application be located at different institutions?

A: The NHLBI welcomes collaborative grant applications in which co-investigators are located at different institutions. As for most NIH grants, the expectation is that the funding will go to a primary institution which will then distribute any funded support to co-investigators at the other institution(s).

Q12. How might the Hypotheses sections of the R01 application differ from those in a usual R01 application?

A: The grants funded through this RFA are meant to address current hypotheses that may explain the differential burden of CVD and related diseases among African Americans. However, the funded working groups are also meant to be a venue for further hypothesis generation and manuscript preparation as well as the generation of potential ancillary studies that extend the initial analyses conducted by the group, for which additional funding would be sought. Successful progression of the grant through its project period will show increasing engagement of an expanding circle of collaborating investigators and a growing number of new research questions generated and explored.

Q13. How do you explain the wording ""...funds offered by this announcement are not intended to be used for primary genetic analyses." in the Jackson Heart Study RFA?

A: Genetic analyses are not seen as appropriate as the central focus for an RFA-funded topical working group, as there has been substantial genetic analysis undertaken and completed with the JHS data, largely because of the Study’s membership in various genetics consortia. The purpose of the RFA-funded topical working groups is to fully use JHS data to address disease-focused domains for which the potential contributions of these data have not yet been fully explored. Each working group may incorporate genetic analyses into their proposed analyses, as appropriate, but this is not seen as a primary objective of the RFA-funded grants.

RFA Inquiries

Please direct all inquiries to:

Jane Harman, DVM, PhD
NHLBI\DCVS\DPPS\EB
6701 Rockledge Drive - Suite 10018 - MS 7936
Bethesda, Maryland 20892-7936
Tel: 301-435-1290
Email: Jane.Harman@nih.gov

Cheryl Nelson, MSPH
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0451
Email: Cheryl.Nelson1@nih.gov

Jean Olson, MD, MPH
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0397
Email: Jean.Olson@nih.gov

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