Inactive

1.0 GENERAL INFORMATION Title: Centralized Institutional Review Board (CIRB) for Minimal Risk Registry Linkage Studies Contracting Office Address: Department of Health and Human Services, National Ins... 1.0 GENERAL INFORMATION Title: Centralized Institutional Review Board (CIRB) for Minimal Risk Registry Linkage Studies Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892, USA. Description: The National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS) is seeking to contract with a commercial Institutional Review Board (IRB) to serve as a Central IRB (CIRB) for the intake, processing and review of multi-state/site minimal risk registry linkage studies. The CIRB is intended to streamline the IRB application and review process, thereby saving time and resources associated with multiple local IRB approval processes and is a component of the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) workflow. The requesting investigator must provide evidence of Institutional IRB review and approval (or exemption) to initiate the VPR-CLS linkage request process. Aside from VPR-CLS multi-site studies, the CIRB is also intended to review studies funded by and conducted by National Cancer Institute (NCI) staff within the Division of Cancer Control and Population Studies (DCCPS) or other NCI divisions with a related need for a CIRB review for those studies meeting the definition of minimal-risk and eligible for expedited review. National Cancer Institute (NCI) Division of Cancer Control and Population Sciences (DCCPS), Surveillance Research Program (SRP), plans to procure on a sole source basis the services of a commercial IRB to serve as the Centralized IRB. This acquisition will be processed in accordance with FAR Part 12 commercial services using FAR Part 13.5 Simplified procedures for Certain Commercial Products and Commercial Services. The North American Industry Classification System code is 541990 – All Other Professional, Scientific, and Technical Services This is not a small business set aside. Only one (1) award will be made as a result of this solicitation. This will be awarded as a Time and Materials type contract. The Period of Performance is estimated to be a base period of twelve (12) months plus two twelve (12) month option periods from the effective date stated in the award. 2.0 BACKGROUND The Surveillance, Epidemiology, and End Results (SEER) Program provides information on cancer statistics to reduce the cancer burden among the U.S. population and is one of the premier cancer surveillance programs in the world currently composed of population-based central cancer registries covering 48% of the US population. The SEER Program is managed by the Surveillance Research Program (SRP) within the Division of Cancer Control and Population Studies (DCCPS) at the National Cancer Institute (NCI). SRP currently contracts with central cancer registries within the U.S. to provide data and expertise to the SEER Program. Cancer Registry staff annotate the required elements into local systems that are then passed into the SEER Data Management System (SEER*DMS). In addition to the contracts held directly with those central cancer registries, SRP also works in a collaborative fashion with the North American Association of Central Cancer Registries (NAACCR) which is the professional organization that develops and promotes uniform data standards for cancer registration and promotes the use of cancer surveillance data and systems. NCI conducts many large cohort studies that typically rely on self-reported cancer data requiring medical record validation. This medical record validation process is labor-intensive, costly, and prone to underreporting or misreporting of cancer and disparity-related differential response over time. Currently NCI DCCPS supports cohorts that annually follow more than 1.2 million individuals. For most of those, follow up information on the development of cancer, as well as survival and cause of death are essential components. In addition to DCCPS, NCI’s Division of Cancer Prevention and Division of Cancer Epidemiology and Genetics also have large cohort studies that would benefit from cost-efficient methods to acquire follow up information. In response to this unprecedented capacity and opportunity for large scale epidemiologic research, SRP responded to the researchers quest for efficient linkage(s) with multiple cancer registries by collaborating with NAACCR, with NCI’s Biomedical Computing Support contractor, and with U.S. based central cancer registries, and researchers to develop and implement a Virtual Pooled Registry Cancer Linkage System (VPR-CLS). The VPR-CLS leverages decades of investment in U.S. state cancer surveillance systems by facilitating the identification of cancers diagnosed across nearly all U.S. registries. VPR-CLS provides an online system to link cohorts with multiple state cancer registries by: (1) securely transmitting a study file to registries; (2) providing an optimized linkage algorithm to generate preliminary match counts; and (3) providing a streamlined process and templated forms for submitting and tracking data requests for cohort participants that matched with registries. In February 2022, the VPR-CLS had officially launched with 45 registries, covering 95% of the U.S. state populations plus Puerto Rico. To date, including pilot studies, registries have been linked with 15 cohort studies ranging in size from 14,273 to 10.9 million participants. The number of cancer cases in the registry files used for these linkages ranged from 73,500 to 5,500,000. Establishing use of a Centralized IRB (CIRB) is key to the VPR-CLS approach. It is bolstered by the NIH policy, effective May 25, 2017 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html) which sets the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects’ research protocols funded by the NIH that are carried on at more than one site in the United States. It also promotes compliance with the 2019 NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-050.html#:~:text=Several%20provisions%20in%20the%20Revised,clinical%20trial%20informed%20consent%20documents). While researchers submit minimal risk studies for evaluation via the VPR-CLS workflow for CIRB determination, it is expected that the Centralized IRB will also be used for other studies such as other DCCPS-funded studies that use SEER data (i.e., linkage studies) where there may be some risk of re-identifiability. These other DCCPS-funded studies meet the definition of minimal risk and multi-site research (not full board IRB review), so the NIH policy is applicable regardless of sponsor. SEER has developed a tiered-based approach for data release with increasing oversight and requirements as the tier increases, with Tier 4 being the highest Tier requiring IRB review. The studies, that will be proposed by extramural researchers, are minimal risk studies utilizing de-identified or limited datasets of previously linked SEER data with external data sources that could have a more sensitive nature (e.g. genomics) or increased risk of re-identifiability (e.g. multiple dates for service/treatment). A Centralized IRB will not only streamline and speed up the review process but will also eliminate duplicative local IRB review, minimize locally driven modifications to the study protocol, and ensure a standard high-quality patient protection review. 3.0 PURPOSE The purpose of this acquisition is to contract with a commercial Institutional Review Board (IRB) to serve as the Central IRB (CIRB) to intake, process, and review multi-state/site minimal-risk registry linkage studies. The CIRB is intended to streamline the IRB application and review process, thereby saving time and resources associated with multiple local IRB approval processes and is a component of the VPR-CLS workflow. The requesting researcher must provide evidence of IRB review and approval (or exemption) to initiate the VPR-CLS request process. Aside from VPR-CLS multi-site studies, the CIRB is also intended to review studies that are funded by and conducted by NCI staff within DCCPS or other NCI divisions and in which meet the definition of minimal risk and are eligible for expedited determination or exempt review. The term minimal-risk registry linkage study will be used regardless of submission source (VPR-CLS, DCCPS or others). The CIRB is expected to provide a consistent, high quality and expert review process and have the expertise and understanding of issues and challenges specific to cancer registries. The CIRB will primarily be responsible for the review and adjudication of linkage protocols defined as minimal risk studies. The Contractor shall ensure compliance with 45 CFR 46, the Department of Health and Human Services, Office for Human Research Protections which specifies that minimal risk studies may be reviewed under an expedited review process (http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.110).VPR-CLS studies and SEER data release products studied fall, in general, under the definition of expedited review, thus not requiring a full IRB review. Under the work of this SOW, the CIRB will be a critical partner in the advancement of the VPR-CLS efforts and will work collaboratively with the NCI, NAACCR, NCI’s Biomedical Computing Support contractor, registry participants on the VPR-CLS team as well registries that will accept a Centralized IRB as the single IRB (sIRB) of record. Success with the usage of the CIRB within the context of assisting with the VPR-CLS studies will help facilitate high-quality reviews and determinations, among cohort studies, post-marketing surveillance, and clinical trials. Simultaneously it will help the cancer surveillance community and researchers address the myriad of scientific questions related to the cancer problem within the United States. 4.0 TASKS The Contractor shall: 4.1 Develop, Implement, and Maintain CIRB Review Procedures (Labor Hours) 1. Establish a process to contact, discuss, develop, execute and maintain reliance agreements with the U.S. central cancer registries identified by the Contracting Officer’s Representative (COR) (and their IRB, following the kick-off meeting but prior to accepting any researcher applications), outlining – a. the requirements of each registry defining a minimal-risk study (i.e., meeting registry criteria VPR-CLS submission with expedited review); b. when a study request is required to undergo local IRB review (for example if registry staff are involved in the study, state requirements, etc.); c. the type of agreement necessary for the local IRB to accept the CIRB as the IRB of record. The NCI seeks to enter into agreements that address groups or classifications of studies (minimal-risk, multi-site linkage studies) as compared to agreements which must be addressed with each study request; d. local context issues that must be addressed by the CIRB during the review process; e. for IRBs which have not accepted the CIRB as the IRB of record, note those exceptions and ensure that communications for any linkage is addressed appropriately. 2. Fully execute required agreements with local IRBs and revise such agreements as necessary. 3. Develop, maintain and update, as necessary, a plan as part of the CIRB review process for addressing local context issues as applicable. Local context issues are defined as issues pertaining to the review of a study application by a registry’s local IRB not included in the CIRB review which may require reconciliation before approval.. The definition of local context issues may vary by state and the CIRB Contractor shall work with each entity to ensure it is defined and agreed upon when resolving. 4. Work with the COR, NAACCR and DCCPS’ Biomedical Computing Support Services contractor as needed, to understand the VPR-CLS workflow and any associated tools (ex. Match*Pro database) used in the VPR-CLS process. 5. Maintain and update as necessary the Standard Operating Procedures (SOPs) for expedited review, adjudication, and communication of minimal risk studies. These SOPs include: a. utilization of existing systems and services such as the VPR-CLS for the retrieval of the templated application and supporting documents needed to review and adjudicate; b. review submission of minimal risk protocols for cancer registry linkages with cohort studies, clinical trials, or other research applications; c. review processes and timelines for requesting changes to a reviewed minimal risk registry linkage study protocol; d. the processes and timelines for the re-review of modified minimal risk registry linkage study protocol; and e. the processes and timelines for continuing review activities as required. Submissions will be reviewed for completeness and the Contractor shall work with the submitting party to resolve any issues around completeness. SOPs for new or revised processes shall be drafted and updated as required. The Contractor shall ensure that all applicable CIRB SOPs comply with Federal laws and regulations. The Contractor shall consider the VPR-CLS workflows for incorporation into CIRB SOPs. 6. Securely store documents including those downloaded from the VPR-CLS to be used in the review process. The Contractor shall restrict access to CIRB members based on role (to be identified by the CIRB). This includes all associated study review documents including, but not limited to: a. the protocol, b. correspondence between stakeholders, and c. any supporting documentation required to render a review and decision. 7. Recommend and implement tracking statistics for assessing the performance of the CIRB for submitted studies, identifying how and what elements the Contractor can provide. 8. Track CIRB activity related to minimal-risk registry linkage studies and provide regular updates to the VPR-CLS team or as requested. The Contractor shall provide such information with the understanding that the Government or VPR-CLS team will use it when presenting on minimal risk registry linkage study activity to relevant stakeholders at public meetings. 9. Promote or otherwise post information regarding minimal risk registry linkage study activity on the CIRB Contractor’s company website. The Contractor shall work with the COR to determine what information shall be presented on the website. 10. Present on CIRB activities and processes to external audiences (i.e., during NAACCR Summer Forums) as needed 11. Utilize electronic systems and tools to facilitate and conduct the tasks in this SOW. The Government will not be providing such tools, nor will the Government fund the development of new tools for these tasks. 12. Participate in VPR related project calls/meetings. 13. Maintain full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc (AAHRPP) for the duration of this contract. 14. Within the first ten months following contract award, the successful Contractor shall develop and submit a Draft Transition Out plan which will describe the Contractor’s strategy for transferring work from this contractor to a successor contractor, in the event a final transition would be required. The plan must include information on the transfer of policies and procedures; transfer of relevant files, records, materials, and data; transition of all activities as appropriate. The draft transition plan will be revised, if necessary, and the draft transition plan will become the final transition plan upon approval of the COR. The approved final transition plan shall be followed to ensure an orderly, secure, efficient, and expedited transition of all contract activities by the ultimate contract completion date. 4.2 Conduct CIRB Reviews (Firm-Fixed-Price) 1. Create and maintain a review board for the review of minimal risk registry linkage studies. This will include: a. identification of a Chair, b. listing of review board members, c. process steps and timeline for action by the review board for the initial review and, d. any subsequent re-review of minimal risk registry linkage studies. The Contractor shall ensure that the review board membership has adequate expertise to review submitted studies. The Contractor shall appropriately assign reviewers for each review to be conducted including initial review, amendment review, continuing review, etc. While this is not required to be a standing board, the CIRB shall ensure that appropriately qualified members are available without delaying the review. 2. Coordinate, prepare and distribute meeting packets including agenda and related review materials to CIRB members in a timely fashion, as established with the COR. This shall include but not be limited to: a. recording attendance, b. completion of reviewer assignments, c. review board members conflict of interest, recusal, and meeting quorum per the CIRB SOPs. 3. Document all aspects of the review meetings and prepare minutes of review meetings. The Contractor shall make review meetings and related documentation available to the COR at the COR’s request. 4. Prepare all correspondence related to CIRB meeting review outcomes, including, but not limited to, drafting outcome letters and sending the drafted letters to the Chair for signature, distributing the letters to the appropriate study personnel (Study Chair, PI, etc.), copying all relevant staff per request or CIRB SOPs. The Contractor shall also utilize the VPR- CLS to upload relevant review documents (outcome letters, changes to protocols, etc.) which will facilitate the information being disseminated to all necessary parties. 5. Upload study specific documents to the secure system for storage, including those downloaded from the VPR-CLS to be used in the review process. This includes all associated study documents including but not limited to: a. the protocol, b. correspondence between stakeholders, and c. any supporting documentation required to render a review and decision. 6. Develop a plan to accommodate fluctuations in the number of minimal risk studies submitted for CIRB review each year. For estimating purposes only, for the base effort the NCI anticipates the number of studies to be a minimum of 50 reviews/studies per year (expedited review, exempt determination, or amendments such as annual status reports or adding new registries to a study) as the base quantity in every contract year. Given uncertainty in demand, it’s also possible that the volume of studies falls below this estimate. It is also possible that the volume will well exceed this base quantity of reviews per year. In anticipation of that, additional Optional Quantities of reviews will be available to exercise as options and will be used to fund additional reviews over the Base Quantity. The Contractor should plan for this potential variation. 5.0 OTHER UNIQUE REQUIREMENTS OR CONSIDERATIONS The Contractor shall have full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) in order to be considered for award and shall maintain it for the duration of this contract. Evidence of current AAHRPP accreditation shall be provided prior to award. 6.0 PERIOD OF PERFORMANCE One 12-month base period, plus two 12-month Option Periods. See 11.0 “Option to Extend the Term of the Contract”. 7.0 PLACE OF PERFORMANCE All work shall be performed at the Contractor’s facility in the U.S. 8.0 CONTRACT TYPE Time and Materials (T&M) 9.0 PAYMENT SCHEDULE Task 4.1 “Develop, Implement, and Maintain CIRB Review Processes” will be reimbursed on a Labor Hour basis following the terms of FAR Clause 52.232-7 “Payments under Time-and-Materials and Labor- Hour Contracts.” The Contractor shall invoice monthly pursuant to the Invoice Instructions in the contract. Task 4.2 “Conduct CIRB Reviews” will be reimbursed on a Firm-Fixed-Price basis per completed study review. For the purposes of FAR Clause 52.232-7 “Payments under Time-and-Materials and Labor-Hour Contracts” costs associated with “Conducting CIRB Reviews” shall be treated as an Other Direct Cost. The NCI anticipates an estimated 50 reviews/studies during each 12-month period. The NCI may increase the number of studies at the unit price specified as described in Section 11.1 “Option for Increased Quantity”. NET 30 days from date of invoice. Payment shall be made in monthly increments after satisfactory completion and acceptance of the deliverables stated in Section 10.0. The Contractor shall be paid after satisfactory completion and acceptance of work provided. Payment authorization requires submission and approval of invoice to the NCI COR and to the Administrative Officer and NIH OFM Commercial Accounts per the contract’s Invoice and Payment Provisions. A copy of each invoice should be e-mailed to the Administrative Officer and the NCI COR’s contact information on the first page of the order. 10.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE Pursuant to FAR clause 52.212-4 Alternate 1, Contract Terms and Conditions – Commercial Products and Commercial Services, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. SOLE SOURCE JUSTIFICATION The purpose of this acquisition is to contract with a single commercial IRB to serve as a Central IRB (CIRB) for the intake, processing, and review of multi-state/site minimal risk registry linkage studies. Currently NCI funds cohorts that annually follow more than 1.2 million individuals. To respond to the unprecedented capacity and opportunity for large scale epidemiologic research, NCI responded to the researchers quest for efficient linkage(s) with multiple cancer registries by developing and implementing a Virtual Pooled Registry Cancer Linkage System (VPR-CLS) that officially launched in February 2022 with 45 registries, covering 95% of the U.S. state populations plus Puerto Rico. This is a follow-on acquisition to a contract held by Biomedical Research Alliance of NY (BRANY). The tasks outlined in the Contract Requirements require that the contractor maintain reliance agreements with the current 16 central cancer registry IRBs that have ceded their IRB review to BRANY as the current CIRB contractorfor minimal risk linkage studies. Re-establishing these reliance agreements with an alternative contractor is a significant undertaking, leads to substantial duplication of costs, and would not only be an unnecessary expenditure of time and funds but also pose a significant threat to the timely oversight of ongoing NIH-funded research, causing a detrimental and avoidable delay. There is no other organization that can effectively engage without unacceptable and unnecessary delays and cost increases in fulfilling the requirements not only for re-establishing reliance agreements but also re-performing reviews of the 17 existing studies for which BRANY maintains oversight. THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. NCI intends to award a contract to Biomedical Research Alliance of New York, 1981 Marcus Avenue, Suite 210 Lake Success, NY 11042 United States under the authority of FAR 6.302-1. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00 PM ET, April 8, 2024. All responses and questions must be in writing and emailed to Angela Moore, Contracting Officer via electronic mail at Angela.Moore2@nih.gov. Reference ID 75N91024Q00068 on all correspondence. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. 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