Central Institutional Review Board (CIRB)

HHS-NIH-NCI-ETSB-41001-46 NOTICE INFORMATION Agency/Office: National Institutes of Health Location: National Cancer Institute, Office of Acquisitions Title: 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541611 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $7 Million per annum. Statements 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 concern's name, point of contact, address, and DUNS number. Central Institutional Review Board (CIRB), a project within the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: The NCI is one of the world's largest public sponsors of clinical trials in cancer, supporting a broad range of prevention, diagnostic, imaging, and treatment studies of new drugs, procedures and multi-modality approaches for oncology patients. Developmental work for new treatments (Phase 1 and 2 trials) has traditionally been carried out in a limited number of institutions while definitive studies comparing new treatments to the standard of care (Phase 3 trials) have required multi-center collaborations. The NCI, through its Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD) and other Divisions/Programs (e.g. Division of Cancer Prevention, Cancer Centers Program), supports multiple sites and investigators in North America to collaborate in multi-center trials/studies (e.g. NCI Cooperative Groups Clinical Trials Program for treatment and radiology imaging, Specialized Programs of Research Excellence (SPORES), Community Clinical Oncology Programs (CCOPs), Minority-Based Community Clinical Oncology Programs (MB-CCOPs), Comprehensive/Clinical Cancer Centers Program, and CTEP Phase 1 and 2 Programs). These NCI multi-center programs each maintain the necessary infrastructure (e.g., scientific committees, statisticians, data managers and quality control monitors) needed to successfully perform clinical trials/studies. Purpose and Objectives: The Central Institutional Review Board (CIRB) Initiative is a project of the National Cancer Institute (NCI) to develop and implement a centralized model of IRB review for multi-site, NCI-sponsored clinical trials. The goal of the Initiative is two-fold: A. 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. B. To maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level. Currently, the Initiative involves three 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 and the PedCIRB reviewing NCI-sponsored pediatric Phase 0, 1, 2, 3, and pilot treatment trials. 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 review the local context considerations for each institution with investigators credentialed to participate in those trials. Project Requirements: Organization must be able to complete the following tasks: 1) Initial Transition from current contract to new contract. 2) Manage and provide administrative and regulatory support for three Central Institutional Review Boards (one for adult phase 3 and large phase 2 trials, the second for early phase trials, and the third for pediatric trials of all phases); 3) Establish and support a fourth CIRB for review of DCP trials; 4) Manage and provide administrative and regulatory support for CIRB review of enrolled institution's local context considerations; 5) Support CTEP's requirement for institutions participating in NCI-sponsored trials to enroll in the CIRB Initiative and facilitate integration of these institutions into the CIRB Initiative; 6) Manage and support currently enrolled institutions; 7) Provide informatics systems to support all operations; 8) Communicate with NCI and stakeholders regarding all aspects of the Initiative 9) Implement and manage an Initiative-wide Quality Improvement Plan; 10) Maintain AAHRPP Accreditation per AAHRPP requirements; 11) Phase-Out Transition Anticipated Period of Performance: It is anticipated the services will be acquired through full and open competitive procedures. It is anticipated that a cost reimbursement type contract will be awarded with a six (6) month base plus nine (9) six (6) month option periods beginning on or about June 1, 2014. Capability Statement/Information Sought: To be deemed capable of providing services that meet the CIRB requirements, please submit a written capability statement demonstrating the ability and experience in 1) planning and conducting CIRB meetings, 2) Understanding CIRB regulatory compliance, 3) Developing coordination and liaison with collaborating investigators or institutions as they complete requirements to open a study, 4) Maintaining and improving web design to support operations with information technology (IT) systems to increase efficiency and accuracy, and 5) Developing files and reports of work to allow efficient and easy transfer of data and knowledge. We encourage all responsible sources, particularly small businesses, to submit detailed concise information which will be considered by the agency. Submission Information: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Christopher T. Scott, Contracting Officer, at scottc2@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF), by February 3, 2014 4:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. 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. 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.