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On July 11, 2001, a message was posted on the DCCPS Web site
(http://cancercontrol.cancer.gov/message0701.html)about a
new NCI policy for large epidemiologic cohort studies. The policy was developed by the Research Project Grant committee convened by Dr. Klausner to deal with the rapidly escalating costs of grants. This increase in the number and dollar value of grants has outstripped NCI's ability to plan and manage the NCI budget. Here, we clarify a number of concerns and questions raised by the scientific community.
There are two important issues related to large grant applications. The first is stricter enforcement of a long-standing policy about advance notice of intent to submit a large budget application. The second pertains to a new Program Announcement (PA) for cohort studies in cancer epidemiology.
1. Advance Notice of Intent to Submit Large Budget Grant Applications
http://grants.nih.gov/grants/guide/notice-files/not-od-02-004.html
With regard to large grant applications, previously, the policy required at least one month's notice of intent to submit for peer review. This was recently changed.
- The NIH requires that grant applicants with a requested budget over $500K direct costs in any year contact the appropriate program staff member at least 6 weeks in advance of submitting the grant to the Center for Scientific Review (CSR) for peer review.
- If the requested dollar amount is > $1.5 million direct costs in any year, then approval must be sought 8 weeks prior to submitting the grant to CSR for review.
Upon notification by an applicant of intent to submit a large budget grant application, the program director then submits a form, Awaiting Receipt of Application (ARA), for approval by the respective Division Director. If approved by the Division Director, the ARA form is filed with Center for Scientific Review (CSR), which then accepts the large budget application for peer review. Large grants (over $1.75 million) require an extra step; the Division Director must get the approval of the Deputy Director for Extramural Science before the applicant is given approval to submit. The Extramural Division Directors committee must approve very large grants (over $2.5M).
Investigators must follow this policy, speak to the appropriate NCI program director, and respond to requests for information. If advance notice about the proposed study and budget is not received, applications will be returned, causing a delay in submission and review of one round. We already have had several instances in which this happened. This policy applies to new, competing continuation, competing supplement and amended/revised applications.
The large budget grant application policy does not apply to applications submitted in response to RFAs or in response to other announcements that include specific budgetary limits.
A related issue is the temporary cap placed by NCI on unsolicited grant applications requesting $700K or more in any one-budget year. That cap was lifted during the summer of 2001 and is no longer in effect.
2. Cohort Studies in Cancer Epidemiology Program Announcement
http://grants.nih.gov/grants/guide/pa-files/PAS-02-009.html
The other issue related to large grant applications is the new policy described in the July 11, 2001 message. Grant applications for cohort studies over $500K direct costs in any budget year must be submitted in response to the NCI's Program Announcement PAS-02-009 for "Cohort Studies in Cancer Epidemiology." This announcement was issued to coordinate the submission, review, and funding of epidemiologic cohort studies. Applications will be reviewed once each year by CSR through a committee of senior investigators with expertise in cancer research and cohort studies.
The Program Announcement does not limit the cost of grants, but will provide the opportunity for peer review to evaluate costs as a component of the applications. We have heard some concern that this policy singles out epidemiology when grants in other fields also are increasing in costs. NCI's analysis of grant applications over the last two years showed that epidemiologic cohorts represent the grant category with the greatest escalation in costs. Among the most expensive RO1s, epidemiologic cohorts represent a major long-term investment by the NCI. Our inability to anticipate the dramatic increase in costs from FY1999-2000 had a major negative impact on the NCI budget. If costs escalate rapidly in other areas of population science, new policies in those areas may emerge as well. We are hopeful that the new approach to epidemiologic cohorts will help us to manage costs while at the same time signaling grantees of the NCI's commitment to this important area of research.
Please understand that this is not merely a cost management action. We appreciate the increasing importance of large cohort studies to understand gene-gene and gene-environment interactions. In fact, we have encouraged the development of a consortium of cohorts to achieve this end. We also have made special efforts to support existing cohorts because of the unique resources they provide. The new Program Announcement allows NCI staff to be more actively engaged in the oversight of the investment in large cohorts.
We believe that reviewing epidemiologic cohorts together, with an emphasis on their resource value and need for continuing support, will be a plus for investigators who direct these cohorts. We will evaluate carefully how this new process works and be ready to modify the policy, if it is not in the best interest of epidemiologic cancer research or the overall needs of NCI. We also appreciate the groundbreaking work conducted by the epidemiologic community in so many areas. As always, we welcome your feedback.
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