Grant Opportunities at NIH: Analytical Chemistry Applications Are Not

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Anal. Chem. 2008, 80, 6467–6471

Grant Opportunities at NIH: Analytical Chemistry Applications Are Not Square Pegs in Round Holes! Vonda Smith National Institutes of Health (NIH) A short guide through the complicated landscape of NIH grants. At first thought, it is perhaps a strange idea. Analytical and bioanalytical chemistry seem worlds away from the stated mission of NIH to be “the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.” Where does the “square peg” of analytical chemistry fit? In today’s research environment of blurred disciplines, analytical and bioanalytical chemistry can be found everywhere. Applications submitted to NIH are no exception. They cover areas as diverse as new bio- and chemical sensors, diagnostics, assay development, drug discovery and development, instrumentation, laboratory-ona-chip devices, microfluidics, nanotechnology applied to biomolecules, environmental toxins, and bioterrorism agents, to name just a few. The techniques can cover separations, spectroscopy, MS, and magnetic resonance. Targets include cancer and other disease biomarkers, cells, the brain, genomics, proteomes, and lipidomes. Target analytes are sampled and analyzed in simple to complex matrices such as biological fluids or even wastewater samples. Analytical and bioanalytical chemistry applications submitted to NIH must address a problem relevant to biomedicine or public health. An applicant truly needs to focus on this and take the necessary steps to ensure that the biomedical problem is well defined and addressed in the research proposal. Submissions can be in response to requests for application (RFAs) or program announcements (PAs) from the various institutes or can develop out of an applicant’s work. (Table 1 lists NIH acronyms and abbreviations for the grant process.) However, with the advent of e-submission of research applications, there is less distinction between PAs and RFAs, because a funding opportunity announcement (FOA) is required for everything. 10.1021/ac801490y Not subject to U.S. Copyright. Publ. 2008 Am. Chem. Soc. Published on Web 08/29/2008

The number of applications that focus on analytical or bioanalytical chemistry has grown because of funding announcements from the various institutes. FOAs are the primary way that NIH solicits or announces research opportunities. In addition, opportunities exist across different grant mechanisms or programs from the familiar R01 to the R21 to the R41/42/43/44 smallbusiness mechanisms. The R01 mechanism is for health-related R&D based on the mission of NIH. R01s can be investigatorinitiated or can be in response to a PA or RFA. The R21 mechanism is usually investigator-initiated (unsolicited) and is intended to encourage exploratory and highly innovative research projects in the early and conceptual stages of development. However, not all NIH institute/centers (ICs) accept investigator-initiated R21 applications. Additional possibilities are the R15, R03, F30/31/32/33, S10, and K01 mechanisms. The R15 or AREA grant mechanism is intended for small-scale Analytical Chemistry, Vol. 80, No. 17, September 1, 2008

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Table 1. NIH acronyms, abbreviations, and websites. Abbreviation R01 R03 R15

Definition/type

Research project Small grant Academic research enhancement (AREA) R21 Exploratory/developmental research project R41/42 (phases I and II) Small business technology transfer research (STTR) R43/44 (phases I and II) Small business innovation research (SBIR) F30/31/32/33 Fellowships K01 Research Scientist Development S10 Shared Instrumentation NCI National Cancer Institute NCRR National Center for Research Resources NHGRI National Human Genome Research Institute NIBIB National Institute of Biomedical Imaging and Bioengineering NIEHS National Institute of Environmental Health Sciences NIGMS National Institute of General Medical Sciences CSR Center for Scientific Review BCMB Biological Chemistry and Macromolecular Biophysics IRG BACB Bioanalytical Chemistry, Chemistry, and Biophysics SBIR/STTR SEP EBT Enabling Bioanalytical and Biophysical Technologies F04A Chemical and Bioanalytical Sciences Fellowships BST Bioengineering Sciences and Technologies IRG BMBI Biomaterials and Biointerfaces ISD Instrumentation and Systems Development MI Microscopic Imaging PHS 398 Public Health Service grant SF424 Electronic submission gradually replacing the PHS 398

URL http://grants.nih.gov/grants/funding/r01.htm http://grants.nih.gov/grants/funding/r03.htm http://grants.nih.gov/grants/funding/area.htm http://grants.nih.gov/grants/funding/r21.htm http://grants.nih.gov/grants/funding/sbir.htm http://grants.nih.gov/grants/funding/sbir.htm http://grants.nih.gov/training/F_files_nrsa.htm http://grants.nih.gov/training/careerdevelopmentawards.htm www.ncrr.nih.gov/biomedical%5Ftechnology/shared%5Finstrumentation www.cancer.gov www.ncrr.nih.gov www.genome.gov www.nibib.nih.gov www.niehs.nih.gov www.nigms.nih.gov www.csr.nih.gov http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BCMBIRG http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BCMBIRG/ BCMBSEPS.htm http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BCMBIRG/EBT.htm http://cms.csr.nih.gov/PeerReviewMeetings/Fellowship/F04A.htm http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BSTIRG http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BSTIRG/BMBI.htm http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BSTIRG/ISD.htm http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/BSTIRG/MI.htm http://grants.nih.gov/grants/funding/phs398/phs398.html http://grants1.nih.gov/grants/funding/424/index.htm

research projects in the biomedical and behavioral sciences conducted by students and faculty who have not been major recipients of NIH research grant funds. The R03 mechanism is for small research projects that can be carried out in a short period of time with limited resources. Not all ICs accept investigatorinitiated R03 applications, and different ICs may have specific purposes for which they use this funding mechanism. The S10 mechanism provides a cost-effective way for groups of NIHsupported investigators to obtain commercially available equipment in the $100,000-500,000 range. The F mechanisms (Table 1) are for predoctoral, postdoctoral, and senior research fellows to pursue full-time research training in designated biomedical or behavioral science areas. SBIR (R43/44) and STTR (R41/42) mechanisms are set-aside programs for small businesses or cooperative small businesses 6468

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and U.S. research institutions, respectively, conducting innovative research that has the potential for commercialization. The two phases for small-business applications are phase I feasibility studies and phase II full R&D studies. For SBIRs, the principal investigator (PI) must be primarily employed by the small business, whereas for STTRs the PI can be employed by either the small business or the research institution. The URLs listed in Table 1 provide in-depth definitions of the different grant mechanisms, although it is not an all-inclusive list. INSTITUTES AND CENTERS For analytical chemistry, funding opportunities can be found in most institutes, but the majority come from the following. NIGMS supports basic biomedical research that is not targeted to specific diseases. NIGMS funds studies on, for example, genes,

Figure 1. Flowchart of the submission and review process.

proteins, and cells, as well as on fundamental processes such as communication within and between cells and how we respond to medicines. Examples of areas in which analytical chemistry can be found include cell biology and biophysics targets in which analytical and separation techniques, nanotechnology, singlemolecule methods, cellular imaging, spectroscopy, structural biology, and structural genomics may be applied. NIBIB improves health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering. Analytical chemistry opportunities can be found in magnetic, biomagnetic, and bioelectric devices; spectroscopy; micro- and nanosystems; nanotechnology; microscopy (in vitro); and sensors. NCRR provides laboratory scientists and clinical researchers with the environments and tools they need to understand, detect, treat, and prevent a wide range of diseases. With this support, scientists make biomedical discoveries, translate these findings to animal-based studies, and then apply them to patient-oriented research. Ultimately, these advances result in cures and treatments for common and rare diseases. The Division of Biomedical Technology supports infrastructure development for new and existing instrumentation, software development, and biomedical technology. NIEHS reduces the burden of human illness and dysfunction from environmental causes by defining how environmental exposures, genetic susceptibility, and age interact to affect an individual’s health. Analytical chemistry opportunities can be found in imaging, biosensor development, nanotechnology, and general analytical chemistry in matrices as diverse as food, environmental, and biological samples. NCI coordinates the National Cancer Program, whose interests are the cause, diagnosis, prevention, and treatment of cancer. The Clinical Proteomic Technologies Initiative and the Innovative Molecular Analysis Technologies Program seek to develop technologies to measure, analyze, identify, and detect cancer proteins and to understand the biology of and relationships between cancers and their host environments. NHGRI supports the development of resources and technology that will accelerate genome research and its application to human

health. The Genome Technology Program and Genetic Variation Program include but are not limited to the development of new methods, technologies, and instrumentation to study single nucleotide polymorphisms, haplotypes, and DNA sequencing. WHERE ARE THE APPLICATIONS REVIEWED? Most of the applications are reviewed at CSR, the focal point at NIH for the conduct of initial peer review. CSR carries out peer review of ∼70% of research and research-training applications in >200 study sections and regularly recurring special emphasis panels (SEPs). Visit http://era.nih.gov/roster to view rosters of recurring CSR and other NIH review groups. A flowchart of the submission process is shown in Figure 1. A great reference site for applicants is the Insider’s Guide to Peer Review for Applicants at http://cms.csr.nih.gov/ResourcesforApplicants/Advice.htm. HOW DO APPLICATIONS GET TO THE APPROPRIATE STUDY SECTION FOR REVIEW? The office of Receipt and Referral is composed of professional scientists, usually at the Ph.D. level, who conduct the first sort of the applications. They are known as referral officers and may also serve as scientific review officers (SROs) of CSR study sections. Receipt and Referral is the central processing point for most PHS 398 and SF424 grant applications and is responsible for assignment to an integrated review group (IRG) in CSR or to an institute. Specific review guidelines are used to assign applications; these guidelines are based on the overall mission of the institute and/ or specific programmatic mandates and interests. A PI also may request an institute and/or study section assignment in the optional cover letter that accompanies the grant application. Cover letters are highly recommended and may also include potential reviewer conflicts and suggestions of additional appropriate expertise areas needed to evaluate the application. CSR has started to use text-fingerprinting software to enhance the assignment process. IRGs are clusters of scientifically related study sections. Each of the 24 IRGs within CSR has 5-8 standing study sections. Within an IRG, applications are assigned to study sections by the IRG chief when the subject matter of the application matches the Analytical Chemistry, Vol. 80, No. 17, September 1, 2008

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referral guidelines for the study section. Assignment to a SEP is made when the subject matter does not fit into any study section or when assignment of an application to the most appropriate study section would create a conflict of interest. Standing or recurring SEPs are also used for special mechanisms (e.g., fellowships, SBIRs) that are reviewed every round. Once the application is assigned to a study section, the SRO checks that the application does fit within the study section. Every effort is made to ensure proper placement of an application to a study section. The manual and some computer-assisted sorts that began in Receipt and Referral, through the IRG, the IRG chief, and finally, the SRO, remain the cornerstone of the process to ensure proper assignment of an application. Each study section has 12-24 standing and temporary members or peer reviewers, primarily from academia, who confidentially review 50-100 applications at each study section meeting. The SRO is the designated federal official with overall responsibility for the review process. In addition to application assignment, the SRO is responsible for administrative and technical review of applications, selecting reviewers, managing the study section, and preparing summary statements. Peer reviewers are selected on the basis of their scientific expertise, doctoral degree or equivalent, maturity of judgment, ability to work effectively in a group, breadth of perspective, impartiality, and interest in serving. An adequate representation of women and minority scientists is desired. WHERE ARE THE APPLICATIONS ASSIGNED IN CSR? Under the Division of Molecular and Cellular Mechanisms, the BCMB and BST IRGs are the main analytical and bioanalytical groups at CSR. The BCMB IRG reviews research applications on biochemical, biophysical, and chemical approaches to biomedical problems. This IRG encompasses the basic physical sciences that underlie biology at the molecular level and also bridges the development of technologies with a molecular focus and their application to biological problems. The relevant study sections in this IRG are EBT, BACB, and F04A. The BST IRG reviews grant applications that focus on fundamental aspects of bioengineering and technology development in gene and drug delivery systems, imaging principles for molecules and cells, modeling of biological systems, bioinformatics and computer science, statistics and data management, instrumentation, chips and microarrays, biosensors, and biomaterials. ISD is the most relevant study section in this IRG, followed by the MI and BMBI study sections. The majority of the bioanalytical and analytical chemistry proposals, including academic and small business, are assigned to the EBT, BACB, and ISD study sections. However, other study sections may receive applications when the primary tools to study the targets of interest are bioanalytical or analytical. Study sections in the BCMB IRG. EBT focuses on reviewing research concerned with the development of new bioanalytical and biophysical tools, emerging techniques, and instruments to probe the molecular aspects of biological systems. This includes but is not limited to sensor development, separations science, MS, optical spectroscopy, array development, microfluidics, assay development, and nanotechnology. BACB reviews small business applications in the general area of bioanalytical chemistry, 6470

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chemistry, and biophysics. Some of the specific areas covered by BACB are MS, sensors, separations, spectroscopy, arrays, microfluidics, and novel assays; nanotechnology; instrumentation and systems development for proteomics and protein analysis; magnetic resonance techniques; optical, electron, and X-ray microscopies; and X-ray and neutron diffraction techniques. F04A reviews fellowship applications covering the chemistry of biologically and medicinally important molecules. The analytical and clinical chemistry areas include development of MS, CE, microfluidics, laboratory-on-a-chip and other microfabricated devices, and fabrication methods for biomaterials and biosensor development. Study sections in the BST IRG. ISD is focused on applications that cover the design and development of novel instrumentation and systems for biological research in areas including MS, separation technologies, sensors, 2D and 3D imaging technologies, scanning tunneling microscopy, vibrational spectroscopic microscopy, and sensing devices for the detection and quantification of biomolecules. MI reviews applications that include the development and improvement of instrumentation for microscopy, image acquisition, and analysis. BMBI concentrates on applications that include nanodevices, fabrication of microscale devices, chip- and microarray-based microtechnology, and biosensors. WHAT HAPPENS TO AN APPLICATION DURING PEER REVIEW? The peer-review process at NIH occurs three times a year. Grant applications receive two levels of review. The first level is conducted by the study section, which assesses the applications for scientific and technical merit, rates them, and makes recommendations for the appropriate level of support and duration of award. The second level is conducted by the advisory council of the assigned NIH institute, which assesses applications for their relevance to the institute’s priorities and public-health needs and makes recommendations on funding. The applications are reviewed on the basis of specific criteria for the basic grants (R01, R03, R21, R15) and different or additional criteria for special mechanisms (R41/42/43/44, S10, F31/32/33). Reviewers are allowed 4 weeks or more to review their assigned applications. For the basic grants, the five main review criteria are significance, approach, innovation, investigator(s), and environment. Under significance, the review panel is asked to assess whether the research addresses an important problem; how scientific knowledge or clinical practice will be advanced if the aims of the application are achieved; what effect this project will have on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field; and how the project will move the field forward. When considering approach, the review panel is asked to ascertain whether the conceptual or clinical framework, design, methods, and analyses are adequately developed, well integrated, well reasoned, and appropriate to the aims of the project. In addition, they must consider whether the applicant has acknowledged potential problem areas and considered alternative tactics. For the innovation criterion, the review panel is asked to decide whether the project is original and innovative. Does the project challenge existing paradigms or clinical practice or address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or use novel concepts, approaches,

methodologies, tools, or technologies for this area? When considering the investigators, the review panel is asked to assess whether the PIs and other key personnel are appropriately trained and well suited to carry out this worksis the work proposed appropriate to the experience level of the PIs and other researchers? Under environment, the review panel is asked to determine whether the scientific environments in which the work will be done will contribute to the probability of success, the proposed studies will benefit from unique features of the scientific environments and subject populations, and the collaborative arrangements will be useful. Specific grant application programs are evaluated with additional criteria. For example, for phase II SBIR or STTR applications, what’s known as a commercialization plan is included in the review criteria. SUMMARY STATEMENTS Once applications are reviewed, the results are documented by the SRO in a summary statement that is made available to the PI and the NIH institute where a funding decision will be made. The overall re´sume´ and summary of the review discussion is written by the SRO and conveys the issues that were most important in determining the priority score of the application by the study section. The essentially unedited reviewer critiques are based on the five review criteria and additional criteria that are grant-dependent. The priority score is the average of the individual ratings of the scientific merit given by the entire study section; the percentile ranking is the relative position of each application’s priority score among all scores assigned by a study section at its last three meetings. The R01 mechanism is percentiled; for other mechanisms, the institute may calculate percentiles, but these may or may not be released to the individual applicant. The section on budget recommendations will note, if necessary, that the budget is not reasonable and justified in terms of the aims and methods of the research. This section may also list recommended deletions of specific items, reduction of the amount budgeted for a class of item, or reduction in the percent effort of individual(s), or it may just indicate the amount that the study section views as being appropriate to accomplish the proposed work. Budget concerns do not affect the scoring because budgets are discussed after the study section has recorded their final priority scores. AFTER REVIEW, THERE ARE SEVERAL STUDY SECTION ACTIONS Scored, scientific merit rating (priority scores and percentiles). On the basis of the relevant review criteria, the application is judged to be in the upper portion of applications reviewed by the study section. The recommendation can be for the requested time and amount or for an adjusted time and amount. A priority score is provided and a summary statement prepared to incorporate the written critiques of the reviewers plus a summary of the discussion provided by the SRO. Usually, three people are

assigned to review an application: two reviewers and one discussant or reader. The reviewers must provide written comments. Unscored. An application is unanimously judged to be in the lower portion of applications reviewed. No priority score is assigned, but the summary statement consisting of the reviewers’ critiques and any administrative notes is given to the applicant. Deferral. The study section cannot make a recommendation without additional information; this may be requested from the applicant, or the study group may make a rare project site visit. Resubmission after the Review. If a PI decides to resubmit an application, he or she is encouraged to discuss the summary statement with the assigned program officer and to modify the proposal accordingly. The PI should make sure the introduction section is clear and adheres to the application instructions, and the application should address all criticisms thoroughly, objectively, and constructively; results should be updated if necessary, including adding any preliminary results. The study section will get the previous critique but will not get the previous proposal. Checking the Status of an Application. As soon as an application is received and assigned to a study section, notices are posted to the PI’s online NIH Commons account (https:// commons.era.nih.gov/commons). The PI may question either the study section or the IC assignment by contacting the SRO named in the notification or the CSR referral office (301-435-0715). It usually takes weeks to refer the thousands of applications submitted during each round. If a notice is not posted to the PI’s account within 3 weeks of submission, the PI should contact the referral office. A few days after the study section meeting, the priority score and percentile ranking are available on the NIH Commons. Within a month, the summary statement, along with any recommendations and administrative notes, will be available. For those curious about what goes on inside the NIH review process, CSR has produced a video of a mock study section meeting that provides a look at how grant applications are reviewed for scientific and technical merit (www.csr.nih.gov/ video/video.asp). Analytical chemistry has always been relevant to NIH activities, and recently it has moved more to the forefront. The square-peg perception has been modified, perhaps reshaped with a little nanotechnology, to fit the round hole in the dynamic and multidisciplinary science and engineering biomedical research promulgated by NIH. Vonda Smith is an SRO in the EBT study section at NIH. She works to ensure that the study section identifies the most meritorious science for the ICs to consider for funding. Her additional duties include referring bioanalytical and biophysical applications to the appropriate study section, choosing members for the EBT study section, implementing review policy, and coordinating between applicants and study section members. Address correspondence about this article to Smith at 6701 Rockledge Dr., MSC 7806, Rm. 4148, Bethesda, MD 20892 ([email protected]).

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