SMART IRB Governance, Administration, and Operations Support (GAOS)

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. This notice is being issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. North American Industry Classification System (NAICS) CODE: The NAICS code applicable to this requirement is 541990 - All Other Professional, Scientific and Technical Services($19.5M). Background Information: The National Institutes of Health (NIH) is the nation�s leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. The National Center for Translational Sciences (NCATS) brings together a diverse group of scientists, including medicinal chemists, biologists, toxicologists, clinicians, and engineers to translate basic science conducted elsewhere into products and services that help improve people�s health and lives. NCATS� mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common. 45 C.F.R. Part 46, Protection of Human Subjects, also known as the Common Rule, requires review by an institutional review board (IRB) of any research involving human subjects that is conducted, supported, or regulated by any Federal department or agency. Historically, institutions establish their own IRBs, which for multi-site research could result in multiple IRBs reviewing the same research. However, multi-site research is required by NIH to designate a single IRB (sIRB). See NOT OD-16-094. In addition, the Common Rule requires single IRB review of multi-site research for research supported or conducted by any of the Common Rule signatory agencies. NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is currently administered by a third party and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/. SMART IRB is currently used nationwide by over a thousand institutions. Reliance on and utilization of a sIRB requires that institutions document the reliance on the sIRB. Although the SMART IRB Authorization Agreement eliminates the need to negotiate the terms of the reliance agreement, institutions and IRBs must still document the use of the agreement for specific research. Within the SMART IRB platform, institutions agree to the terms of the SMART IRB agreement by �joining�. The SMART IRB Joinder platform supports the process of joining the SMART IRB agreement, its documentation, and generation of an Institutional Profile documenting key information about the joining institution (and IRBs, where applicable). Institutions that have signed the SMART IRB Agreement through the Joinder platform have access to the SMART IRB Online Reliance System (ORS) to coordinate and document sIRB arrangements with other SMART IRB Participating Institutions. There are some barriers preventing some institutions from using the ORS. The contractor shall support NCATS in making SMART IRB Joinder and ORS processes and workflows more user friendly and responding to documented needs communicated by the existing user community, which will lead to increased use of SMART IRB Framework and allow for more efficient implementation of sIRB and therefore facilitate collaborative research nationwide. Actual website and systems development will be handled outside of this contract. For information technology (IT) related areas, the NCATS Information Technology Resource Branch (ITRB) is responsible for the operating system(s), databases, applications, system architecture, server and the security infrastructure provided and/or hosted by NCATS, while the contractor will be expected to be knowledgeable about and support these tasks and/or responsibilities in collaboration with ITRB. Project Description: NCATS requires a partner to facilitate user administration, process/workflow improvements, content development/moderation, requirements gathering, and dissemination of the SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board) portfolio of services. SMART IRB relies on three systems: (1) the SMARTIRB.org website which is used for content distribution, notification, and educational purposes, (2) Joinder, through which institutions enter institutional information and sign the SMART IRB Authorization Agreement (AA), and (3) the Online Reliance System (ORS), through which IRB reliance arrangements under the SMART IRB Agreement are documented on a study-by-study basis. The selected partner will provide support to aid in the facilitation and growth of SMART IRB. Anticipated period of performance: The anticipated period or performance is one base year, and up to four 1-year option periods for a total contract period of up to five years. Capability Statement / Information Sought: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet the project requirements to the Contract Specialist. In particular, your capability statement should address the following capabilities: Direct experience and knowledge of regulations and guidance relating to reliance agreements. Specific knowledge of SMART IRB reliance agreement, its history, and specific terms of reference. Access to legal counsel to advise on regulatory issues related to IRB and to update the SMART IRB reliance agreement in conformance with regulations, federal policies, and feedback. Established relationships with government agencies (VA, DOE, DOD, NIH, etc.) with the ability to negotiate SMART IRB 3.0. Established relationships and points of contact in the community subject to IRB. A process for developing recommendations to resolve challenges to single IRB processes. An established and vetted system to request public comments on Harmonization Steering Committee recommendations and working groups and for any new amendments or versions of the SMART IRB reliance agreement itself. In-depth knowledge and an established management process to ensure the Online Reliance System and Joinder platform are maintained to appropriate standards. Distributed and national presence of content experts and Ambassadors who serve as practical and available resources for institutions to join, establish and execute successful SMART IRB reliance. An evolving evaluation system that works with single IRB community at large to continuously make improvements, identify best practices, and return results. An active harmonization steering committee of academic, industry, and government member