NCI ACCELERATED EXECUTIVE REVIEW OF R01 APPLICATIONS AS EXCEPTIONS NIH GUIDE, Volume 25, Number 9, March 22, 1996 P.T.34 Keywords: Cancer/Carcinogenesis Grants Administration/Policy+ National Cancer Institute As an experiment in reinvention of its extramural programs, the National Cancer Institute (NCI) announces its intent, through the use of solicited applicant responses and an accelerated executive review (AER) exceptions process, to consider for funding meritorious original unamended type 1 and type 2 research project grant (R01) applications that receive a score that is within a defined percentile zone near established grant pay lines. Each fiscal year, the NCI intends to establish separate percentile zones for: (1) basic and (2) patient oriented research project applications beyond the anticipated R01 payline that will be subject to accelerated executive review by the NCI Executive Committee for award as an exception. This policy is subject to the availability of sufficient funds and a sufficient number of applications of clear and unambiguous merit in these categories. The standard payline for percentiled R01 awards will be set based upon a formula to be determined annually after a final budget has been established for a fiscal year. For FY 1996, a zone beyond the payline has been established that equals approximately four percentile points for basic science and 10 percentile points for patient oriented R01 research applications. NCI estimates that approximately 130 unamended R01 applications might be within the stated distances of the anticipated R01 pay line in FY 1996. Thus, this process potentially may result in award for up to 40 percent of the anticipated eligible applications. This paradigm is being adopted to expedite funding of high quality, innovative research. It is hoped that this program will substantially raise the number of clinical research applications submitted and funded. For applications where peer review has identified easily addressable concerns, it will avoid for many investigators attendant delay (eight months for a full amendment) and uncertainty of funding, and will lessen the burden on peer reviewers. For clinical research applications, it will permit more timely and effective use of unique cohorts and resources that often are temporally unique assets. Definition of Patient Oriented Research Patient Oriented Research applications for these purposes will be defined as follows: Research conducted with human subjects and/or on material of human origin such as tissues, specimens, and cognitive phenomena for which an investigator or colleague directly interacts with human subjects. This area of research includes: development of new technologies, mechanisms of human disease, therapeutic interventions, clinical trials, epidemiologic and biobehavioral studies, and outcomes and health services research. Applicability Accelerated executive review will apply to original (unamended) submissions of competing type 1 and type 2 R01 applications. It will not apply to applications submitted in response to RFAs. R01 applications receiving only raw scores due to ad hoc review will be assigned derived percentiles based on the average of the scores of all R01 applications reviewed by the Division of Research Grants. INQUIRIES For specific questions on this process, applicants may contact the NCI program director sending the original communication. General policy questions may be directed to: Marvin R. Kalt, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Suite 600 EPN Bethesda, MD 20892-7405 Email: KALTM@DEA.NCI.NIH.GOV .
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