Ethical, Legal, and Societal Implications (ELSI) Program

In accordance with FAR 5.201, the Department of Health and Human Services (HHS) Advanced Research Projects Agency for Health (ARPA-H) is publicizing its intention to award a non-commercial firm-fixed-price FAR 13.1 purchase order on a non-competitive basis with Johns Hopkins University Baltimore, Maryland to support the ARPA-H Ethical, Legal, and Societal Implications (ELSI) Program. The authority permitting other than full and open competition is FAR Subpart 13.1, 41 U.S.C. 1901. The North American Industry Classification System code for this procurement is 541715 – Research and Development in the Physical, Engineering, and Life Sciences (Except Nanotechnology and Biotechnology). The justification is as follows. ARPA-H is tasked via congressional legislation to collaborate with leaders and experts within the healthcare and biomedical research and development fields to foster the development of novel, breakthrough and broadly applicable capabilities and technologies to accelerate transformative innovation in biomedical science and medicine. Based on this legislation, ARPA-H must also consider throughout the course of each program how these new and innovative capabilities and technologies will positively and negatively impact the general populace, society at large and what ethical implications will be at play. In order to have this capability ARPA-H leadership is seeking support in developing a well-informed, comprehensive but intelligible ELSI framework to help guide, clarify, justify and evaluate its programs as they seek to create and accelerate high-impact health solutions to well-defined problems. Given the unique needs of each future ARPA-H program, and because different topics necessitate distinct approaches, experts, and processes, ELSI questions or concerns will be raised and addressed at various points throughout the program lifecycle, including at the first phase of addressing the Heilmeier questions and several subsequent phases, such as delivering a pitch to the Science and Technical Board and selecting performers. As ARPA-H prepares to launch its first programs and program-related investments in 2023, there is urgency needed to assess program models and frameworks currently in practice within the U.S. government, gather global best practices across sectors, and set an implementation path for ARPA-H’s ELSI program. As a result of this effort, ARPA-H will leverage recommendations and insights from stakeholders, ELSI thought leaders, and subject matter experts to launch its ELSI program within an accelerated timeline to support ARPA-H programs that will be under development within weeks. An ARPA-H unique ELSI program is a key component to ensuring the success of ARPA-H’s mission and therefore must be procured based on urgency to ensure that it is fully functional to support newly created program office. The ELSI program must be established to assist programs function from their initiation and throughout the life cycle of the programs. There would be substantial risk in making ARPA-H investments without an operational ELSI program, because this ELSI program will mitigate potential risks or unintended consequences that may arise from the proposed research. The ELSI program must be established in advance of implementing research so that modifications to mitigate risk can be made before the program begins. Risks that ELSI programs evaluate include, for example, the risk that a program will create perceptions or pose undue risk to vulnerable groups; the risks that a program will have unintended biosafety concerns; and risks to privacy. This ELSI program will lay the groundwork to start the facilitation of development of policies to ensure that the research is equitable and impactful. This notice of intent is not a request for competitive proposals. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. However, all responses received by closing of this notice will be considered by the Government. Interested parties may identify their interest and submit information demonstrating their capability to support the requirement. Interested parties must clearly show the firm's ability to be responsive without compromising the quality, accuracy, and reliability of services provided. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The point of contact for this procurement is Elizabeth Fuller at [email protected].