NEWS FROM THE NHLBI
How One Program at the National Heart, Lung, and Blood Institute Establishes its Scientific Priorities
Diane E. Bild, MD, MPH* and
Michael S. Lauer, MD
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland
Manuscript received January 9, 2009;
accepted March 26, 2009.
* Reprint requests and correspondence: Dr. Diane E. Bild, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 10018, Bethesda, Maryland 20892 (Email: bildd{at}nhlbi.nih.gov).
Key Words: NIH • funding • scientific priorities • grants • contracts
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Abbreviations and Acronyms
| | DCVS = Division of Cardiovascular Sciences | | PSP = Population Sciences Program | | RFA = Request for Applications | | RFP = Request for Proposals |
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The scientific priorities of the National Heart, Lung, and Blood Institute (NHBLI) are delineated in the NHLBI Strategic Plan, which was released in March 2007 (1). The plan lays out a broad agenda for government-funded biomedical research and training in cardiovascular disease, lung and blood diseases, and sleep disorders; approximately 90% of the Institute's research budget supports extramural researchers, through grants and contracts. One of the major roles of the NHLBI program staff is to establish, implement, and evaluate specific priorities identified by the Strategic Plan.
The Division of Cardiovascular Sciences oversees cardiovascular research supported by the NHLBI. In a later column, we will describe the branches of the Division in detail. The Population Sciences Program (PSP)* oversees epidemiological research and trials that are specifically concerned with primary prevention or management of cardiovascular risk factors.
Extramural research supported by the NHLBI can be classified into 5 major types: - 1 Investigator-initiated projects with total direct costs of no more than $500,000 per year (e.g., R01 grants): investigators are free to submit proposals for review without any special pre-review consideration.
- 2 Investigator-initiated projects with total direct costs exceeding $500,000 in at least 1 year but not exceeding a cap, currently set at $1.515 million in any year: investigators must first contact the NHLBI staff for a pre-review in order to obtain permission to submit a formal application. The pre-review occurs on a division level (2,3).
- 3 Investigator-initiated projects with total direct costs exceeding a cap of approximately $1.5 million in at least 1 year (see #2 in the preceding text): investigators must first contact the NHLBI staff for pre-review in order to obtain permission to submit a formal application. This review is more extensive than category 2, with a formal review involving leadership throughout the entire Institute.
- 4 Institute-initiated grant programs: NHLBI program staff members develop formal Requests for Applications (RFAs) for research grants that address issues felt to be of high priority by the Institute. These RFAs undergo a process of internal review, followed by external review by our Board of External Experts and Advisory Council.
- 5 Institute-initiated contracts: NHLBI program staff members develop a formal Request for Proposals (RFP) for contract work deemed to be of high priority by the Institute. This typically is used for "big science projects," like multicenter clinical trials, major cohort studies, and making resources (such as genotyping) available to investigators. As with RFAs, these projects undergo a process of internal review, followed by external review by our Board of External Experts and Advisory Council.
In a later column, we will review the processes for applying for large grants in detail.
To help scientific staff in our Program (PSP) articulate how they develop scientific priorities and make rational, transparent, and fair decisions, we polled them to identify factors they use to establish priorities. Through a process of collecting, culling, and combining factors, we identified a set of 16 factors, shown in Table 1. We then asked staff to apply these factors by ranking their importance in prioritizing a set of sample research proposals for large-scale projects (categories 3 and 5 in the preceding text). We later discussed the composite results and explored why individuals applied specific factors to specific projects.
The most important factor our staff identified was "impact on population health." The next 4 most important factors were "feasibility," "relevance to the PSP mission," the "need for or previous lack of studies on this topic," and "quality of the proposed methods." Some factors were not considered as important in the rankings because of overlap in the content with better-ranked factors. For example, since the PSP mission is subsumed within the NHLBI Strategic Plan, the factor related to the Strategic Plan did not fare as well. "Study cost" ranked in the middle; the importance of cost might be expected to be subject to general budget pressures and has been a particular subject lately as the Program considers research on costly medical technology.
Several of these factors coincide with other lines of thought on research priority setting. The Institute of Medicine outlined and endorsed 6 criteria that are used in priority setting at the National Institutes of Health: 1) public health needs; 2) scientific quality of the research; 3) potential for scientific progress (the existence of promising pathways and qualified investigators); 4) portfolio diversification along the broad and expanding frontiers of research; and 5) adequate support of infrastructure (human capital, equipment and instrumentation, and facilities) (4). The first 3 criteria, in particular, echo the top-ranked PSP factors. The World Health Organization budget is set, in large part (and at least in principle), based on evidence of burden of disease (5). Some of our staff's thoughts are also consonant with another recently described construct for making research priority decisions within a context of insufficient evidence for clinical decision making. Chalkidou et al. (6) suggest 3 major questions: 1) Is there a net benefit? 2) Is it worthwhile to collect additional evidence? and 3) Should we wait to get this information? The first 2 questions overlap our identified factors of "impact of population health," "relevance to the PSP mission," and "previous lack of studies on this topic."
It is critical to point out that our work in establishing, implementing, and evaluating scientific priorities is distinct from peer review. Our staff places high value on peer review, particularly to determine scientific merit of specific proposals or ideas, and we do not try to supplant this process. Some of the factors that peer reviewers use to evaluate proposals overlap with the factors our staff uses to consider overarching priorities; perhaps the most relevant overlapping factor is "feasibility," as this issue clearly directly ties into our responsibility as stewards of public monies. Nonetheless, in general, factors used to establish scientific priorities will differ based on the specific mission of the funding agency or group, and hence transcends the specific strengths or weaknesses of any one specific scientific idea or proposal.
It is also critical to point out that the establishment, implementation, and evaluation of scientific priorities are not activities that the NHLBI staff members undertake in isolation. Just as the NHLBI Strategic Plan was conceived and developed in close consultation with the extramural scientific community, activities of program staff also occur in nearly constant communication with extramural scientists. There are, for example, formal mechanisms for this, such as NHLBI-sponsored working groups or workshops; in other cases, ongoing dialogue about scientific priorities occurs within other settings, such as scientific meetings. In presenting this summary of our own internal discussions about how best to consider scientific priorities, we hope to stimulate ongoing dialogue with the scientific community not only on specific fields of endeavor but also on how best we can work together to ensure that NHLBI taxpayer-supported funds are best used in the public interest.
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Footnotes
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* In May 2009, the NHLBI merged the Division of Prevention and Population Sciences (DPPS) and the Division of Cardiovascular Diseases into the Division of Cardiovascular Sciences (DCVS). DPPS became the Population Sciences Program within DCVS. This paper has been written from the perspective of the reorganization. 
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References
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1. National Heart, Lung, and Blood Institute Strategic Plan: Shaping the Future of Research http://apps.nhlbi.nih.gov/strategicplan/Accessed December 9, 2008.2. National Heart, Lung, and Blood Institute Guidelines for Applications With Direct Costs of $500,000 or More in Any One Year http://www.nhlbi.nih.gov/funding/policies/500kweb.htmAccessed December 24, 2008. 3. National Heart, Lung, and Blood Institute Allowable Requested Direct Costs for Program Projects http://www.nhlbi.nih.gov/funding/policies/grantcaps.htmAccessed December 24, 2008. 4. Committee on the NIH Research Priority-Setting Process, Institute of Medicine Scientific opportunities and public needs: improving priority setting and public input at the National Institutes of HealthWashington, DC: The National Academies Press; 1998. 5. Stuckler D, King L, Robinson H, McKee M. WHO's budgetary allocations and burden of disease: a comparative analysis Lancet 2008;372:1563-1569.[CrossRef][Web of Science][Medline] 6. Chalkidou K, Lord J, Fischer A, Littlejohns P. Evidence-based decision making: when should we wait for more information? Health Affairs 2008;27:1642-1653.[Abstract/Free Full Text]
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