Logistical and IT Support for the NCI Central Institutional Review Board (CIRB)

Solicitation #: 75N91019R00002.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.
The Central Institutional Review Board (CIRB) Initiative is a project of the National Cancer Institute (NCI) to develop, implement, and manage a centralized model of IRB review for multi-site, NCI-sponsored clinical trials. The goal of the 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.
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 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 and additionally reviews the local context considerations for each institution with investigators credentialed to participate in those trials.
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. Transition-In (if applicable) - The activities required to conduct a transition-in from the incumbent contractor that ensures an orderly, secure, and efficient transition of all contract activities and materials within 90 days of contract award.

2. CIRB Central Operations - The activities required to run the daily operations of the boards and the studies they review.

3. CIRB Local Operations - The activities necessary to address local context considerations at individual institutions. This function includes enrolling organizations and reviewing local context information.

4. CIRB Helpdesk - The activities required to respond to inquiries via multiple channels of communication (e.g., telephone and email) with an average of 600 contacts/month. Most contacts are from enrolled institutions regarding local context issues.

5. Communication and Education - The activities required to provide well planned, clear and consistent communications, which are essential to ensure smooth operations.

6. Maintain AAHRPP Accreditation - The activities required to complete all requirements to maintain uninterrupted full accreditation status.

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

8. Provide IT software and support for all CIRB activities - The activities required to ensure all IT tools meet Federal IT requirements and are integrated with NCI Systems.

9. Collaboration with other NCI contractors - The activities required to integrate with NCI processes, collaborate with other NCI contractors to achieve the requirements of the Statement of Work while simultaneously promoting and supporting other NCI contractors to address their requirements.

10. 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).

11. Transition-Out - The activities required to transfer policies and procedures; transfer relevant files, records, materials, and data; all source code and object code developed, modified, and/or enhanced under the contract; and transition all activities to a new awardee.

12. Options for Additional Level of Effort - The activities required to provide additional support to cover an expansion of work in the major task areas mentioned in all prior sections of the Statement of Work.

The services will be acquired through full and open competition. It is anticipated that one (1) level of effort cost plus fixed fee type contract will be awarded as a result of the solicitation with a base period of one (1) year plus four (4) additional one-year option periods, and ten (10) options for increased quantities beginning on or about September 1, 2019.

The RFP will be available electronically on or about January 17, 2019 and may be accessed through the FedBizOpps at www.fbo.gov. We encourage all responsible sources, particularly 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. IT IS THE OFFERORS' RESPONSIBILITY TO MONITOR THE ABOVE INTERNET SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.

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