NCI Grant Policies

Research grants are subject to a variety of policy requirements. Below are highlights of policy announcements or changes specific to NCI. The NIH Grants Policy Statement and the NIH Guide to Grants and Contracts contain the comprehensive grants administration policies, laws, and regulations for NIH research.

Data Management and Sharing (DMS) Policy

Sharing scientific data accelerates biomedical research discovery, enables validation of research results, provides access to datasets of sufficient quality, and promotes data reuse for future research studies. The 2023 NIH Policy for Data Management and Sharing (DMS) aims to promote the broad and equitable sharing of scientific data. The DMS applies to all intramural and extramural research, regardless of funding mechanism.

Under the 2023 DMS policy, NIH expects investigators and their institutions to:

prospectively plan and budget for the management and sharing of data
submit a DMS plan for review when applying for funding
comply with the approved DMS plan

In addition to the DMS policy, Cancer MoonshotSM investigators should also review the NCI Cancer Moonshot Public Access and Data Sharing Policy.

Genomic Data Sharing (GDS) Policy and Requirements

Genomic research helps to advance our understanding of factors that influence health and disease. Sharing genomic research data is essential for translating research results into knowledge, products, and procedures that improve human health. The NCI Office of Data Sharing (ODS), headquartered within the Center for Biomedical Informatics and Information Technology (CBIIT), advocates for the proper balance of open-access, open-source, and open-data-sharing policies. ODS provides specific NCI guidance for navigating the NIH Genomic Data Sharing Policy and associated procedures, including when the policy applies, templates, exceptions, and additional information for intramural investigators, grantees, and non-NIH funded investigators. For more information about the policy, please see Data Sharing on the CBIIT website.

Clinical Trials Access Policy

Consistent with the mission of the NIH to provide evidence-based approaches to cancer therapy, NIH believes that the full value of NIH-Supported Interventional Clinical Trials can be realized only if the final results of clinical trials are published as rapidly as possible. Timely and comprehensive access to the final results of clinical trials by investigators, clinicians and patients is particularly important for interventional cancer research studies because of their potential to directly impact patient care. The NIH Clinical Trials Access Policy applies to all NIH funded research grants, cooperative agreements, and/or contracts that support covered interventional clinical trials.

Clinical Trial Requirements for Grants and Contracts

NIH has made several policy changes to improve the stewardship of clinical trials across the life cycle of the trial that impact the ongoing conduct, review, and management of NCI-funded clinical trials. These policies have changed the way clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees research progress, and how results and aggregate data are shared broadly and rapidly to ensure rigor and efficiency in the U.S. clinical trial enterprise. For current funding opportunities, see NCI Funding Opportunity Announcements that Allow Clinical Trials.

Type 2 Direct Cost Cap Policy

The NCI has a specific policy limiting the amount requested for the direct cost budget for a renewal application. No more than a 10% increase over the budget awarded for the last year of the prior project period (the last Type 5) may be requested. The policy applies to all Type 2 R01, U01 and P01 renewal applications regardless of the amount of the budget request or the budget format (modular or non-modular). Any deviation or alternative calculation requires prior approval from the NCI Program Director and Grants Management Specialist at least six weeks prior to submission of the renewal application.

Unsolicited R01s Over $700K

To ensure that all areas of the cancer research continuum are appropriately supported, a separate NCI payline has been established for unsolicited R01 applications submitted with direct cost requests in excess of $700,000 in any single year. Every effort will be made to maintain the large R01 payline as close as possible to the general R01 payline; however, the payline will be determined at each round. Large R01s submitted in response to RFAs or PARs, which are not reviewed by the Center for Scientific Review (CSR), are currently not percentiled and are not affected by this policy.