C. OBSERVATIONAL STUDY MONITORING BOARD
(OSMB)
Applicants should read the NHLBI policy on establishing OSMBs
at http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm. 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 http://www.nhlbi.nih.gov/funding/policies/osmb_inst.htm. Discussions
with NHLBI staff are encouraged regarding how to address monitoring
plans and OSMBs in an application.
D. INSTITUTE STAFF INVOLVEMENT
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.
F. REPORTING REQUIREMENTS
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.
G. APPLICATION SUBMISSION
Standard CSR receipt dates and submission procedures described
in the PHS 398 apply to single-center and multi-center epidemiology applications.
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H. APPLICATION REVIEW
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 http://www.csr.nih.gov.
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.
I. CONTACTS FOR FURTHER INFORMATION
Director, Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room
9160
Bethesda , Maryland 20892-7950
(301-435-0466)
Director, Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10018
Bethesda , Maryland 20892-7952
(301-435-0233)
Director, Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10160
Bethesda , Maryland 20892-7950
(301-435-0080)
Director, Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 8100
Bethesda, Maryland 20892-7938
(301-435-0422)
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