Notice of Changes to the Scored Review Criteria, Delayed Receipt Date, and Notice of Answers to Frequently Asked Questions for RFA-HL-13-007, Targeted Analyses of Jackson Heart Study Data (R01)

Notice Number: NOT-HL-11-170

Key Dates
Release Date: January 11, 2012

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to:

  1. Amend RFA-HL-13-007 "Targeted Analyses of Jackson Heart Study Data (R01)" by changes to the Scored Review Criteria.
  2. Announce that the due for receipt of applications for  RFA-HL-13-007 "Targeted Analyses of Jackson Heart Study Data (R01)" is delayed to March 9, 2012.
  3. As a result of discussions with potential applicants, a list of answers to Frequently Asked Questions (FAQs) has been developed. 

The FAQs for this FOA can be found at http://www.nhlbi.nih.gov/funding/inits/faq-RFA-13-007.htm .  This information may be updated periodically without additional notice.  NHLBI staff will also respond directly to potential applicants who contact the scientific program, peer review, or grants management staff listed in the Agency Contacts section of the FOA.
  
Now Reads:

Application Due Date(s) February 28, 2012, by 5:00 PM local time of applicant organization.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach
Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?     

Changed to Read:

Application Due Date(s) March 9, 2012, by 5:00 PM local time of applicant organization.

Scored Review Criteria:
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

  • Will successful completion of the analyses contribute to a new understanding of the risk involved in the the biology and natural history of cardiovascular and related diseases in African Americans?

Investigator(s)    
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

  • Have the Principal Investigators/Program Directors demonstrated experience and success in the mentoring of Early-Stage Investigators, particularly young scientists belonging to groups that are underrepresented in medical research?
  •  
  • Inclusion of current Jackson Heart Study (JHS) investigators or current JHS collaborators  is not a criterion for review per se.  Such investigators may be included on an application, but applications should receive no advantage in review scoring beyond that accorded to other investigators with appropriate expertise and training.

Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

  • Does the project propose to use the unique resource of the JHS data to examine questions about the health of African Americans that cannot be adequately addressed using other available data sets?   

Approach
Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for (1) protection of human subjects from research risks, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

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 protected]

Cheryl Nelson, MS
Program in Prevention and Population Sciences
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0451
Email: [email protected]

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: [email protected]