Notice Number: NOT-CA-16-038
Key Dates
Release Date: August 19, 2016
PAR-13-386
NOT-CA-14-008
NOT-CA-15-043
Issued by
National Cancer Institute (NCI)
Purpose
This Notice is to inform the scientific community that the NCI is modifying PAR-13-386, "Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30)" to clarify that for multi-site institutional trials, the Protocol Review Monitoring System (PRMS) of the lead site is responsible for the full scientific review of the protocol, and that other participating sites may carry out an expedited review.
The following section of PAR-13-386 is revised accordingly.
Part 2. Section IV.2. Content and Form of Application Submission
Protocol Review and Monitoring System
PHS 398 Research Plan (Protocol Review and Monitoring System)
Research Strategy:
Currently reads:
The PRMS scientifically evaluates and prioritizes all cancer center trials derived and supported from institutional sources, including those originating from other cancer centers, or from industry. However, the PRMS:
- Should not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms (e.g., R0ls, U0ls, U10s, P0ls, and P50s, etc.), other approved funding agencies (http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf) and clinical research protocols approved by the NCI’s Cancer Therapy Evaluation Program or the Cancer Control Protocol Review Committee. These protocols may receive an expedited administrative review for the purpose of prioritization.
- Is not required to evaluate or prioritize studies dealing with healthy human subjects and the population sciences, e.g., observational and epidemiologic studies.
Modified to read:
The PRMS scientifically evaluates and prioritizes all cancer center trials derived and supported from institutional sources, including those originating from other cancer centers, or from industry. However, the PRMS:
- Should not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms (e.g., R01s, U01s, U10s, P01s, and P50s, etc.), other approved funding agencies ((http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf) and clinical research protocols approved by the NCI’s Cancer Therapy Evaluation Program or the Cancer Control Protocol Review Committee. These protocols may receive an expedited administrative review for the purpose of prioritization.
- Is not required to evaluate or prioritize studies dealing with healthy human subjects and the population sciences, e.g., observational and epidemiologic studies.
- For multi-site institutional trials, the PRMS of the lead site is responsible for the full scientific review of the protocol (if the PRMS has been approved). The other participating sites are responsible only for an expedited review focused on prioritization, competing studies, and feasibility at that site. Should the PRMS at the lead site be conditionally approved or disapproved, the full scientific review may occur at another participating NCI-designated cancer center with an approved PRMS.
All other aspects of the FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Office of Cancer Centers
National Cancer Institute (NCI)
Telephone: 240-276-5600
Email: [email protected]
and Human Services (HHS)
