Pre_sol_Notice_Dec_2023.pdf

Pre-Solicitation Notice Page 1 of 4

SAM.GOV CONTRACT OPPORTUNITIES PRE-SOLICITATION NOTICE

NOTICE ID: 75N91023R00043

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A

SOLICITATION WILL BE ISSUED ON A LATER DATE.

Title: Logistical and IT support for the NCI Central Institutional Review Board (CIRB)

BACKGROUND:

The National Cancer Institute’s (NCI) Central Institutional Review Board (CIRB) is the country’s largest federally funded single/central IRB, and is responsible for the development, implementation, and management of a centralized model of Institutional Review Board (IRB) review for multi-site, NCI-sponsored clinical trials. The goal of this initiative is two-fold: to streamline regulatory compliance and decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide by providing a single, centralized review that can be utilized by local IRBs participating in NCI-sponsored multi-center trials; and to maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level.

The NCI, due to the size, complexity, and public impact of this project, requires that the entire proposed professional team, and the organization as a whole, possess an expert depth of knowledge and documented experience in IRB, federal and other applicable regulations. In addition, the NCI requires that each member of the team demonstrates professional credibility and can represent this project across all stakeholder groups in a way that instills trust and confidence in the NCI’s CIRB.

REQUIREMENTS:

The National Cancer Institute seeks continuation of the Central Institutional Review Board (CIRB) Support Services through full and open competition procedures under NAICS Code 541611 with the size standard of $ 24.5 Million.

Currently, the Initiative involves four CIRBs, the Adult CIRB – Late Phase Emphasis reviewing adult NCI-sponsored primarily Phase 3 treatment trials; the Adult CIRB – Early Phase Emphasis reviewing adult NCI-sponsored Phase 0, 1, 2 treatment trials; the Pediatric CIRB reviewing NCI-sponsored pediatric Phase 0, 1, 2, 3, and pilot treatment trials; and the Division of Cancer Prevention (DCP) reviewing studies to evaluate cancer risk and to find methods to prevent those risks. The CIRB uses an independent model of IRB review where a local institution and principal investigators inform the CIRB about local context considerations, including local laws and requirements, via the submission of annual worksheets. Each CIRB reviews the NCI-sponsored trials within their purview

Pre-Solicitation Notice Page 2 of 4 and additionally reviews the local context considerations for each institution with investigators credentialed to participate in those trials. The NCI recruits and appoints individuals to serve on the CIRB.

The purpose of the contract is to provide the Government with the expertise in IRB and other Federal regulations, IRB operations, ethics, quality, information technology, and program management necessary to manage the NCI CIRB and support the institutions that rely on it.

Some of the major activities the awardee would perform shall include:

1. CIRB Central Operations – The activities required to run the daily operations of the boards and the studies they review. Ensure that the four CIRB boards are populated according to 45 CFR 46.107, are operated according to 45 CFR 46.108, and review research in compliance with CFR 46.109-111, 116 and 21 CFR parts 50 and 56.

2. CIRB Local Operations – Capacity to conduct the activities necessary to ensure that all CIRB-enrolled organizations comply with their Authorization Agreement with the CIRB and have acceptable infrastructure, expertise, support, and oversight to conduct NCI-sponsored research.

3. CIRB Helpdesk – Provide two channels, telephone, and email to service an average of 1,200 contacts/month. The queries come from members of enrolled institutions and are of a technical and often complex nature.

4. Communication and Education – The activities required to provide well planned, clear, and consistent communications, to ensure smooth operations of the program and that government staff are apprised of operational or regulatory issues related to the conduct of boards, support of institutions, or other issues necessary to ensure compliance with IRB regulations.

5. Ensure uninterrupted continuation of the NCI CIRB’s full accreditation status with AAHRPP by complying with all reporting requirements and accreditation standards.

6. Quality Assurance (QA) and Quality Improvement – The activities required to conceptualize and implement a robust quality assurance and continuous quality improvement program.

7. Provide IT software and support for all CIRB activities – The activities required to ensure the continuous operation and security of IT systems that support the Operations Office, the enrolled institutions, the boards, and the NCI. All IT tools must meet Federal IT requirements and are integrated with NCI Systems.

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8. Collaboration with other NCI contractors – The activities required to integrate with NCI processes, collaborate with other NCI contractors to achieve the requirements of the SOW while simultaneously promoting and supporting other NCI contractors to address their requirements.

9. Project Management – The activities required to maintain budget, scope, effectiveness and pace, and have physical documents pertaining to each specific task. The Contractor shall follow the standards and best practices of the Project Management Institute (pmi.org).

10. Every two years, plan and execute CIRB Education Days, based on member evaluations, expressed educational needs, and anticipated new regulatory or ethical issues.

11. Transition Activities: The contractor shall perform Transition-in and Transition-out activities as applicable.

ANTICIPATED PERIOD OF PERFORMANCE:

The NCI Office of Acquisitions intends to issue a solicitation for a contractor to provide Logistical and IT support for the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). It is anticipated that one cost-reimbursement, level of effort contract with an anticipated period of performance with a base period of one (1) year and four (4), one-year option periods, may be awarded, with an anticipated start date of September 1, 2024.

The RFP will be available electronically on or around January 8, 2024, and may be accessed through the Contract Opportunities at https://sam.gov/. PAPER COPIES OF

THIS SOLICITATION WILL NOT BE MADE AVAILABLE. IT IS THE

OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE

FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE

ENCOURAGE ALL RESPONSIBLE SMALL BUSINESSES TO SUBMIT A

PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY.

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.

Primary Point of Contact:

Lydia Castro-Perigo Contract Specialist lydia.perigo@nih.gov Phone: 240-276-5446

Secondary Point of Contact:

https://sam.gov/ mailto:lydia.perigo@nih.gov

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Erin Felent Contracting Officer erin.felent@nih.gov Phone: 240-858-3667 mailto:erin.felent@nih.gov