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

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The requirement is assigned a code of 541611 in the NAICS, and the size standard for such requirement is $15 Million per annum. Responses should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business name, point of contact, address and DUNS number (See Paragraph F. Capability Statement for more information). An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. A. Background In 1997, the NCI Clinical Trials Program Review Group issued recommendations for addressing challenges facing clinical research as a result of "exponential increase in new therapeutics and new technology in a changing fiscal and health care environment." Among its findings, the Armitage Report recommended that NCI "establish a more streamlined IRB process for multi-center, cooperative group or intergroup trials to assure that all patients are treated equally, and are provided the opportunity to participate in research in institutions close to their home." In 2001, in response to the Armitage Report, the NCI launched its CIRB initiative. NCI established a central IRB to review multi-center, late-phase oncology trials in adults: the Adult CIRB, later renamed Adult CIRB-Late Phase Emphasis. In 2004, NCI established the Pediatric CIRB to review cancer treatment, prevention, and control studies in children. In 2012, the NCI CIRB received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). In 2013, NCI established a second CIRB for adult studies: the Adult CIRB-Early Phase Emphasis. Also in 2013, the NCI transitioned to an independent model, in which the NCI CIRB serves as the IRB of record for all studies under their review. All institutions were transitioned to the independent model. In 2015, NCI established a fourth CIRB: the Cancer Prevention and Control CIRB, which is under the Division of Cancer Prevention (DCP), to review studies to evaluate cancer risk. The NCI CIRB was re-accredited by AAHRPP. This acquisition is a re-competition of contract HHSN261201400023C awarded to the EMMES Corporation. A previous contract for this initiative was awarded to the EMMES Corporation under contract HHSN261200800010C (June 20, 2008 to June 19, 2014). Prior to EMMES, the support services contract was held by Capital Technology Information Services under contract HHSN261200522011C (June 20, 2005 to June 19, 2008) and prior to that, was awarded as part of a contract held by Westat. B. Purpose and Objectives 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. C. Project Requirements Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to support this initiative. The Contractor shall perform some or all of the following support activities, as may be specified by the NCI COR, in support of this initiative. 1. CIRB Central Operations Run the daily operations of the boards and the studies that the boards review. This includes but is not limited to the following: A. Staff each board meeting with staff who are qualified to ensure that each board meeting is conducted in accordance with all relevant regulations, standards, policies, and the CIRB SOPs. B. Ensure that the structure, function, and decisions of NCI's CIRBs (boards) are in continuous compliance with all Department of Health and Human Services (DHHS) regulations pertaining to the rights and welfare of subjects (45 CFR 46), U.S. Food and Drug Administration (FDA) regulations pertaining to the rights and welfare of subjects participating in research involving investigational drugs, devices, or biologics (21 CRF 50 and 21 CFR 56), all NIH policies related to the conduct of federally-funded clinical trials, AAHRPP accreditation standards, and the most recent CIRB Standard Operating Procedures located at https://www.ncicirb.org/system/files/CIRB%20SOPs_042518.pdf C. Annually ensure the forms, tools, and processes associated with the Central Operations are assessed and updated to ensure transparency, ease of use, promote efficiency and effectiveness, and regulatory compliance. D. Conduct pre-board meeting management in a manner that will improve efficiency of board reviews. This shall include how the Offeror will ensure an effective and efficient approach that ensures applications are complete, the most appropriate review type is identified, and the informed consent documents adhere to the NCI Informed Consent Template. E. Conduct all CIRB meetings virtually using a web-based board management tool and provide board members with the necessary regulatory expertise, IRB knowledge, meeting facilitation, and procedural skills required for an effective meeting. F. Compile and send board decision letters within a timeframe specified by the COR. G. Complete minutes within 48 hours and distribute within 72 hours of the board meeting. H. Implement automated processes to improve the consistency and efficiency in the creation of meeting minutes and letters. I. Receive, review and report to OHRP and/or FDA unanticipated problems and serious and continuing noncompliance. J. Ensure NCI CIRB SOPs are current, complete and in compliance with all applicable regulations and AAHRPP standards. K. Document internal work processes. L. Comply with NCI business rules that govern processes related to the regulatory requirements that NCI is required to follow, in accordance with established SOPs M. Manage CIRB Board Membership and ensuring the highest quality of board operations. N. Plan, conduct, and evaluate a comprehensive education effort for new and established board members. 2. CIRB Local Operations A. Conduct a comprehensive evaluation of the current Local Operations process and function and propose improvements. B. Capture and evaluate local context information to comply with applicable regulations, AAHRP standards, and CIRB SOPs. Ensure that the CIRB SOPs are complete, correct, and compliant with relevant regulations and accreditation standards; and promote efficiency and effectiveness. Execute a plan to maintain SOP updates. C. Develop, maintain, and update as needed, local context worksheets to ensure continued regulatory compliance and minimize administrative burden. D. Support institutions enrolled or enrolling in the CIRB. E. Continuously analyze the local context experience and report patterns, trends or issues that require SOP changes or stakeholder education. F. Compile and send board decision letters within a timeframe specified by the COR. Letters reporting a board decision of - tabled' shall be sent within a timeframe specified by the COR. G. Complete minutes within 48 hours and distribute within 72 hours of the board meeting. Board minutes shall adhere to the "Minutes of Institutional Review Board Meetings: Guidance for Institutions and IRBs," published by Office of Human Research Protections (OHRP), September 2017. H. Utilize a suitable process for the management, storage, and accessibility of the official records of the CIRB that complies with all applicable regulations and is audit-ready. I. Effectively manage IT and integrate it with NCI infrastructure with attention to ease of use for the end user. 3. CIRB Help Desk A. Staff and operate a multi-channel helpdesk that conforms to industry best practices and standards for accuracy, timeliness, and satisfaction to ensure that CIRB stakeholders receive prompt, accurate, and courteous responses to questions or concerns. B. Propose processes, and staff training that ensures a consistent approach to managing questions and ensures reliability and consistency of responses across staff members. C. Propose appropriate Key Performance Indicators (KPIs), quality targets, and the methods to measure and report performance against these indicators and implement these items upon approval by the COR. D. Design and implement a quarterly survey for user satisfaction. E. Include helpdesk data in the monthly progress report. Specifically, report volume per channel, volume per category, response time, and analysis of new observations or ongoing trends. F. Supply and utilize an IT tool that facilitates achieving the tasks in this section of the SOW. If requested by the COR, adopt and implement NCI-provided helpdesk management software. The Contractor may either develop their own software or tailor the software to meet their needs within any best practices outlined by the NCI. 4. Communication and Education A. Plan, conduct and evaluate tools and mechanisms to ensure that government staff are apprised of operational or regulatory issues related to the conduct of the boards, support of institutions, or other issues necessary to ensure compliance with IRB regulations. B. Serve as content experts for internal NCI meetings as requested. C. Attend local, regional and national meetings (e.g. NCTN Group meetings, NIH conferences, PRIMR, AAHRPP) by delivering presentations or posters, serving as a panelist, and/or staffing a vendor booth. D. Provide management reports and review of processes for continuous quality improvement. E. Maintain the CIRB website and ensure the URL remains compliant with current Federal regulations and that content is current and meets the objectives of the NCI CIRB. F. Update website content quarterly and refresh design/graphics/content every two years beginning at contract award. G. Integrate the website into an overarching communications and education plan and use web site metrics to inform user engagement strategies. H. Implement strategies to effectively communicate new information and keep users engaged. I. Provide an annual assessment of the CIRB website to determine if upgrades are required to meet evolving technical, regulatory, or business needs. 5. Maintain AAHRPP Accreditation A. Complete all requirements to maintain uninterrupted full accreditation status and ensure that CIRB operations, processes, education, and staffing are in continuous compliance with all existing or modified AAHRPP standards. Obtain the necessary data, prepare and submit all required reports, materials, information within the required timeline to ensure the continuous maintenance of accreditation. B. Achieve the standards for AAHRPP recertification, including, but not limited to, conducting meetings to acquire necessary information, preparing participants for interviews, and preparing documentation. 6. Quality Assurance and Quality Improvement A. Conceptualize and implement a robust quality assurance and continuous quality improvement program that: i. Ensures effective program operations by reporting Operations Office compliance with CIRB SOPs and Operational Efficiency Working Group (OEWG) timelines. ii. Promotes effective compliance with IRB regulations. iii. Meets or exceeds regulatory requirements and AAHRPP standards. iv. Reduces the administrative burden on CIRB Board members and individuals from CIRB participating institutions. v. Minimizes timelines vi. Minimizes contractor effort. B. Mines data on processes and/or topics as requested by NCI and analyze the mined data, e.g., local context review or the helpdesk. C. Delivers a quarterly QA report outlining current or potential risks and strategies for risk mitigation and other improvements to accuracy, efficiency, and efficacy for each of the CIRB Operations functional areas. 7. Provide IT software and support for all CIRB activities A. Ensure all IT tools meet Federal IT requirements and shall be integrated with NCI Systems. B. Utilize IRBManager as the repository for the CIRB regulatory documents. Within 90 days of contract award, acquire license for IRBManager and maintain/tailor IRB manager to meet the NCI CIRB's requirements. C. Provide and use a commercial-off-the-shelf (COTS) tool to support the Central Operations activities that meets the requirements of the SOW. 8. Collaboration with other NCI Contractors Collaborate with other NCI contractors to achieve the requirements of the SOW while simultaneously promoting and supporting other NCI contractors to address their requirements by: A. Participating in twice monthly cross-contractor meetings. B. Participating in topic specific working groups as needed. C. Tailoring CIRB IT Systems to integrate with the NCI Systems. D. Tailoring CIRB SOPs to maximize benefit to other CTEP contractors while maintaining the CIRB specific requirements outlined in this SOW. E. Assessing all proposed changes or modifications for impact on CIRB requirements and cost to implement. 9. Project Management Follow the standards and best practices of the Project Management Institute (pmi.org) including, but not limited to: A. Utilizing professionally recognized standard tools and processes to track the progress of all activities. This includes: i. A written plan to meet project requirements and ensure that project requirements are tracked and fulfilled. ii. A visual representation of the plan. iii. A method for evaluating and adjusting the plan. iv. The plan, visual representation and evaluation mechanisms must be completed within 90 days of contract award. All three will be reviewed and modified on a quarterly basis. B. Provide documentation of project requirements and track details of completion. C. Conduct weekly in person meetings and provide written reports that prioritize activities and demonstrate progress of ongoing tasks. D. Ensure responsiveness to NCI CORs: i. 1-hour response to urgent calls or emails ii. 4-hour response to routine calls or emails iii. Establish dedicated email for correspondence from NCI CORs. E. Ensure Operational Efficiency Working Group (OEWG, https://ctep.cancer.gov/protocolDevelopment/OEWG.htm#oewg_timelines_sops) deadlines are met. F. Collaborate as necessary with other components of the NCI Extramural HRPP to ensure smooth and efficient operations. 10. Additional Boards A. Develop a plan to establish a CIRB to review the specialized Board requirements to be determined. The CIRB shall follow the same CIRB SOPs as the existing CIRBs. B. Nominate CIRB members qualified to support the new Board. Final membership list is due to COR 6 weeks prior to the first meeting of this CIRB. C. Arrange for each CIRB member to be oriented to the CIRB processes and meeting management tool at least one week prior to the first CIRB meeting. D. Modify existing CIRB SOPs and technology to support the CIRB. D. Anticipated Period of Performance It is anticipated that one (1) cost-reimbursement level-of-effort 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 beginning on or about September 1, 2019. E. Other Important Considerations Capability Statements must clearly demonstrate the following: A. Personnel: Understanding of the size, complexity, and public impact of this project, and an understanding that the entire proposed professional team should possess an expert depth of knowledge and documented experience in IRB, federal and other applicable regulations B. Technical Approach: Understanding of the scope, purpose, and complexity of the project requirements above and the capability to perform the functions in an effective and efficient manner. There should be demonstration of the regulatory and operational understanding of the "why behind each sub-task. C. Corporation Experience and Management: Successful completion of similar contracts in support of similar projects, technically, administratively, and financially. D. Facilities and Equipment: Acceptable facilities and equipment to provide support to this project. F. Capability Statement We encourage small businesses to submit a capability statement which will be considered by the agency. Small businesses possessing experience and demonstrated capability to accomplish the requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Organizations that submit capability statements in response to this notice shall clearly document and demonstrate capabilities in their technical approach, personnel, corporate experience and management, and facilities and equipment. Capability Statements submitted in response to this notice are not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in a single -space format using 12-point font size minimum. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Responses must reference the sources sought number and include the following: 1. Current certified business status 2. Name and Address of the Company, DUNS number. 2. Point of contact with name, title, address, phone, fax and email. 3. Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; 4. List of organizations to whom similar types of services have been previously provided and the dollar value of that work. G. Information Submission Instructions Please respond by e-mail with a capability statement to Jame Chang at jame.chang@nih.gov by July 5, 2018 at 3:30 PM EST. All capability Statements must be in MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted. H. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. I. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).