Issued by Human Research Program, NASA/Johnson Space Center (JSC) Purpose The NASA Johnson Space Center Human Research Program (HRP) and the Minority University Research and Education Project (MUREP), administered through the NASA’s Office of STEM Engagement (OSTEM) is inviting feedback on the approaches NASA can take to establish university partnerships to develop a world-class bed rest research facility to support multi-discipline research. Review of this entire RFI notice is encouraged to ensure a comprehensive response is prepared and to have a full understanding of how your response will be utilized. Background The Human Research Program (HRP) is interested in exploring options for establishing a partnership to develop/improve and operate a robust bed rest research facility to support 30- to 60-day human spaceflight related research studies as well as other research objectives. Previous NASA Bed Rest RFIs have focused on full-service bed rest facility capabilities. This RFI opens the possibility to entities and institutions that have an interest in bed rest research but may not have the current infrastructure to support bed rest studies of 30 to 60 days in length or with all of the equipment or capabilities required to support the NASA studies. NASA research has demonstrated that prolonged bed rest at 6 degrees strict head-down tilt (HDT) simulates some of the physiological and psychological adaptations experienced by astronauts during spaceflight. To better understand and characterize the impact of extended micro-gravity periods on the human body, the HRP conducts research into areas considered to be of significant risk during spaceflight. Bed rest studies of 30 to 60 days are used to study the onset of Spaceflight Associated Neuro-ocular Syndrome (SANS) as well as impacts on sensorimotor function and potential countermeasures to mitigate or eliminate risks to astronauts. Typical HRP bed rest studies require sophisticated infrastructure to support the subject care and research requirements. Very few facilities in the world can meet all the HRP bed rest study requirements. NASA is interested in developing robust bed rest research facility capabilities in the U.S. to support upcoming research enabling spaceflight travel and operations outside low Earth orbit. Request for Comments To ensure that the broad perspective of the diverse researchers and institutions potentially interested in bed rest research and facilities are considered, this RFI invites stakeholders throughout the scientific research, advocacy, clinical practice, and academic institution communities to comment. Specifically, NASA is interested in comments from academic institutions of all sizes, especially Minority Serving Institutions (MSIs), research faculty, commercial and community partners that have strategies or ideas about how to partner to develop a new bed rest facility (or improve an existing facility) and operate the facility for research purposes including but not limited to NASA HRP funded research. The goal is to create a partnership where all parties contribute expertise and resources to create a comprehensive facility for multi-discipline bed rest research, which allows all the partners to expand their research opportunities beyond their existing capabilities. It is important to note that experience in bed rest studies is not a prerequisite for response to this RFI. NASA is seeking innovative ideas from interested parties across diverse platforms. Responses to this RFI will assist NASA in identifying, developing, and implementing strategies that will enable broad use of U.S. domestic bed rest research capabilities in the future. Importantly, the responses are also expected to identify significant barriers to implementation that must be addressed. For example, future bed rest research aims to include minority and female test subjects that are typically underrepresented as test subject applicants. Additionally, as bed rest research involves facilities with complex infrastructure to meet the needs of the test subjects, researchers, and implementers (subject care and medical staff), the responses are likely to include ideas regarding partnerships that pool resources and capabilities and that share the benefits and outcomes. Moreover, NASA is interested in identifying partnerships that can strengthen and develop the research capacity and infrastructure of MSIs in areas of strategic importance and value to NASA’s mission and national priorities. Responses from interested parties may describe how the collaborations will increase student access to the bed rest facility research opportunities, achieve NASA HRP goals and objectives, leverage significant sources of additional funding, obtain essential services that are not available at the proposer’s home institution, and/or contribute to sustainability. No solicitation exists; therefore, do not request a copy of the solicitation. If a solicitation is released, it will be synopsized on beta.SAM.gov. Interested firms are responsible for monitoring this website for the release of any solicitation or synopsis. All responses shall be submitted electronically via email to Kelle Pido,
[email protected], no later than July 16, 2021 4:30PM Central US Time. Please reference 80JSC021RFIBedRests in any response. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents will not be notified of the results of the evaluation. Bed Rest Facility Requirements The envisioned facility would be capable of supporting 4 (minimum) to 12 bed rest subjects for up to 60 days, with on-site or nearby medical and laboratory facilities. The facility staff would provide subject recruitment, study planning and implementation, medical monitoring, clinical care of subjects, data and sample collection/storage/distribution, and implementation of specific study measures and tests within a safe environment. The following capabilities are required for the bed rest facility and services to fully support HRP research: Facility: Private or semi-private accommodations for 4 to 12 test subjects HDT beds and support equipment – gurneys, shower, etc. Shower/bathroom facilities accommodating HDT use Access to metabolic kitchen to meet subject dietary needs Medical monitoring equipment to support subjects Access to Magnetic Resonance Imaging(MRI), Positron Emission Tomography (PET), Cognitive Therapy (CT) without over road transportation Laboratory facilities Multiple rooms for simultaneous conduct of study specific tests (some private, some group) Physical therapy and rehabilitation equipment Systems for monitoring subjects, such as audio, camera systems, video capture, private communications, external communications, etc. Provisions for collecting, storing, processing biological samples IT infrastructure and data management services (data storage, large file transfer, near real time data access, data security, etc) Services: Recruitment, screening and selection of test subjects according to HRP-supplied criteria Study planning based on HRP-supplied requirements Development of detailed study implementation plan including daily schedule for all measures, data and sample management, communication and reporting plan, risk management, contingency plan, health and safety plan, personnel training and procedures, medical monitoring plan, dietary plan, and rehabilitation plan Training of facility staff to perform the HRP-required tests and measures; support development of study specific procedures Medical monitoring staff – routine medical and psychological monitoring, response to contingency or anomalous conditions; access to medical specialists as required to meet HRP requirements Access to subject matter experts for implementation of medical testing, nutrition, countermeasures, exercise, and head down tilt bed rest Clinical care of subjects – daily housekeeping and patient/subject care services, nursing care, physical therapy Laboratory services Bioethical certification and institutional review board approvals Execution/implementation of every aspect of the bed rest study Implementation of safety provisions for test subjects and staff Additionally, it would be beneficial for the facility to support testing of pharmaceuticals and nutraceuticals as part of the research studies.