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GRANT CLINIC

Do Reviewers Look at 'Other Support' in Considering Proposals?

Reader Question: Is 'Other Support' truly taken into consideration when a proposal is reviewed by the National Institutes of Health (NIH) or other funding agencies or foundations? I ask because I have a principal investigator who manages more than 30 clinical trials and research projects concurrently. Granted, many are at only 1 percent effort, but if I were a reviewer I would have difficulty believing that a PI could possibly commit the proper effort to any new project in light of so many active ones. How do reviewers look at this — or do they?

Expert comments: This superficially simple question actually demands a complex, multipart answer. Let’s try to break it down into sections.

As to the first question — Is "other support" taken into consideration when reviewed? —the answer is unequivocally Yes, at multiple levels. Information about “Other Support” appears in the review process in two formats. (For NIH’s definition of “Other Support,” go here: http://grants.nih.gov/grants/glossary.htm) The first is in your Biosketch, where it is referred to as “Research Support,” or “Research Ongoing and/or completed in last three years.” This is what reviewers will see when they review your application.

In the Biosketch, each current and past grant is described in terms of sponsor, title of project, dates, role on project, and major goals. Significantly, percent effort, direct costs, and pending projects are not included in the Biosketch information.

How do reviewers weigh this information? In a typical study section, panelists will be asked to score applications based on the impact of the grant in front of them, without considering the influence of other awards a PI may be holding at that time. However, reviewers also must assess whether the budget is reasonable, and here is where they look at the Biosketch page with “Research Ongoing.” For the vast majority of cases, there is no perceived overlap, and the budget is assessed as to its appropriateness for the proposed work.

However, (in my experience), one will see in every meeting one or more examples where there is enough similarity between the reviewed application and the Ongoing awards that a reviewer comments on it during the discussion. (Center for Scientific Review policy on Overlap is here: http://cms.csr.nih.gov/ResourcesforApplicants/OverlapEvaluation.htm)

Under these circumstances, the Scientific Review Administrator (SRA) will ask that an Administrative Note be written to accompany the review about the potential scientific or budgetary overlap. In theory, the note is not supposed to influence scoring.

Once a grant has made its way through the study-section process, the potential influence of “Other Support” will depend on whether it is within a “competitive” or “outside a fundable range.” Keeping in mind that the cutoff may vary from institute to institute, we will use the 20th percentile as rough dividing line. (e.g., for National Institute of General Medical Sciences (NIGMS: http://www.nigms.nih.gov/Research/Application/LetterApplicants.htm). Above that line, your grant will be non-competitive, and you will be unlikely to receive a request for “Just in Time” (JIT) information. Below the line, then NIH Commons will post a JIT request. A key part of this JIT request is information about your ”Other Support.” The “Other Support” document you upload is a more detailed version of the information provided on the Biosketch, and allows NIH program officers a clearer picture of the extent of any scientific or budgetary overlap between the new pending grant and any existing grants.

Information on this “Other Support” request includes Project Number and Code; Source of Funds; Major Goals (i.e., the specific aims); Annual Direct Costs; % of Effort; Overlap. Here, the nature of any real or perceived overlaps between the application and awarded grants will almost certainly have an impact on the likelihood of funding, and different institutes and program officers may weigh Other Support to different extents.

As a general rule, if there is overlap of a scientific or budgetary nature, then there is a potential negative impact on the funding decision. I can’t really comment any more about internal program deliberations because these are a black box as far as PIs are concerned.

The second part of this complex question concerns how a hypothetical PI would be reviewed who has a large number of funded activities, and how his/her effort could broken down into 0.3 calendar months or less increments.

A priority, one could imagine different situations with very different types of PIs: 1) a “basic science” PI with multiple RO1s; 2) a physician-scientist running multiple clinical trials; or 3) a “core director” PI who runs a large lab that performs large-scale analytical services.

The first type of PI would have his/her effort broken into fairly large chunks, built around grants that the PI had personally initiated. A clinical physician/scientist might be engaged in many different clinical trials simultaneously, some initiated directly by the PI, and some where the PI serves merely at one of multiple independent sites accruing patients. (One should also appreciate that there are different types of clinical trials, requiring different extents of investigator direct management, etc.)

Finally, a PI who runs a research “core activity” or center could very well have his/her effort distributed into upward of 20 different small pieces, and manage hundreds of employees.

Clearly, each of these different scenarios requires a different type of review, and the peer reviewers would possess very specific expertise. At the end of the day, the review process requires skilled experts to assess whether the applicant PIs are able to take on the additional activity without compromising ongoing research, clinical trials, or bioanalytical service.

Thus, one should not assume that having one’s efforts separated into many components constitutes automatic disqualification for further funding.

Clarification: A reader of my recent comments on “How can I preserve my data when re-submitting a rejected grant” chided me for insufficiently emphasizing the degree to which a “New Application” must differ from a previously declined A1 application (NIH no longer accepts a 2nd Revision of A2 application) in order to be accepted for review. My principal point was that, while it may be possible to use data from a previous application, your overall goals and hypothesis must change significantly, and you should challenge every assumption that provided the foundation for the previous grant.

In CSR’s own words, “Subsequent versions of an application may be quite different and still considered to be overlapping if many of the hypotheses, aims, and/or outcome measures are the same or highly similar, and particularly if the “new” application is responsive to the critiques of another application.”

For readers wishing to drill deeper into the specifics of this issue, the most detailed policy statements I’ve found are on CSR’s Web site: (http://cms.csr.nih.gov/ResourcesforApplicants/OverlapEvaluation.htm) and in the frequently asked questions (FAQ) section of NIH’s statements about “Enhancing Peer Review (http://enhancing-peer-review.nih.gov/faqs.html).

Comments by Christopher Francklyn, PhD, a former study section chair and veteran reviewer for NIH and NSF study sections. He is a professor at the University of Vermont.