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Investigator-Initiated Epidemiology (non-clinical trial, non-intervention) Studies Guidelines

National Heart, Lung, and Blood Institute
National Institutes of Health

July 2004

In this document:


  • This document describes how to prepare and submit an investigator-initiated application for an epidemiology (non-clinical trial, non-intervention) study. 
  • It also describes where the review of such applications will take place.
  • This is NOT a solicitation for such applications. 
  • This guidance does NOT apply to clinical trials or studies that involve an intervention - guidance for such studies can be found at
  • This guidance is supplemental to the instructions in the PHS 398 - all applications must conform to the PHS 398 instructions, guidelines, and policies.



  1. Application Format
  • Single-center applications must conform to the PHS 398 guidelines, including page limitations. 
  • Multi-center applications must be submitted in one of two formats - as a single application (with subcontracts) or as an aggregate of two or more applications (sent individually or in a single container).
  • A multi-center application, whether submitted as a single application (with subcontracts) or as part of an aggregate must conform to the PHS 398 guidelines, including page limitations. 
  • For multi-center applications in the aggregated format:
    • Each application must have a cover letter listing the names/institutions of each of the other applications in the aggregate
    • The research plan for each of the field centers must be identical
    • A data coordinating center or reading center can have a separate plan and should be included in the list of institutions in the cover letter.
  • Details of the two alternative formats can be obtained during early conversations with NHLBI Staff.
  1. Applications with Direct Costs Equal to or Greater than $500,000 in any One Year

    • If an application has direct costs equal to or greater than $500,000 in any one year, the NHLBI policy applies. The policy applies to single-center and multi-center studies submitted as a single application (with direct costs of $500,000 or more) or as an aggregate of two or more applications (with direct costs of the aggregate being $500,000 or more).  Details of the requirements of the policy, which include NHLBI agreement to accept an application and inclusion of a data sharing plan can be found on the NHLBI public web site at ( and on the NIH web site ( Applicants should contact NHLBI Program Staff as early as possible when contemplating submission of an application

  2. Study Population Composition
  • Tables for reporting race and ethnicity data for subjects in clinical research should be completed as described in the instructions to the PHS 398. For multi-center studies, a table should be completed for each field center in addition to a table that summarizes the race and ethnicity data for all enrollment centers.


Applicants should read the NHLBI policy on establishing OSMBs at  If creation of an OSMB is appropriate, plans for the monitoring board must be included in the application.   The responsibilities of OSMBs in NHLBI studies are also available on the NHLBI web site at  Discussions with NHLBI staff are encouraged regarding how to address monitoring plans and OSMBs in an application.


Before making an award for an investigator-initiated epidemiology study, the NHLBI determine whether substantial continued staff involvement in an assistance mode is appropriate.  If it is, the award mechanism will be a cooperative agreement. 

However, regardless of the mechanism of support, the NHLBI staff will closely monitor progress during the award. Monitoring may include regular communications with the principal investigator and staff, as well as attendance at the steering committee, observational and safety monitoring board, and related meetings. The Terms and Conditions for an award for a large epidemiology study will include recruitment milestones expected to be met at specific time periods, accrual goals for women and minorities (as appropriate), any requirements regarding minimum effort of specific investigators, and any other identified requirements for completion of the approved research. For multi-center studies, the Terms and Conditions will address milestones for each center and for the overall study. As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NHLBI will consider ending support and negotiating a phase-out of the award. The NHLBI retains an option to request and conduct periodic external peer reviews of progress.


Recruitment progress reports (including recruitment of women, children and specific minority groups) are required quarterly. Indices of quality control and related operational features must be reported upon request by the NHLBI program office. Annual and final reports are required as for any grant.


Standard CSR receipt dates and submission procedures described in the PHS 398 apply to single-center and multi-center epidemiology applications.



Single-center and multicenter epidemiology study applications are reviewed by the Center for Scientific Review (CSR). CSR assigns applications to study sections based on established referral guidelines in association with key words in the title and abstract.  Applicants may request assignment to a study section in a cover letter and such requests will be considered but may not be accommodated for a variety of reasons.  Description of study section organization, descriptions, rosters, and other information is available at The peer review will be based on standard review criteria as described in the PHS 398.

All applications undergo further review by the National Heart, Lung, and Blood Advisory Council prior to award. The purpose of this review is to consider the study in the context of the overall program plans and planning activities of NHLBI.  The Council is responsible for the second level of review and makes recommendations to the Director of the NHLBI regarding funding.  These recommendations reflect such factors as program priority, program balance, cost, and cost benefit of the study.


Director, Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 9160
Bethesda , Maryland 20892-7950

Director, Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10018
Bethesda , Maryland 20892-7952

Director, Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10160
Bethesda , Maryland 20892-7950

Director, Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 8100
Bethesda, Maryland 20892-7938


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