80JSC023BRR - RFI.pdf

REQUEST FOR INFORMATION

Inviting Comments and Suggestions to Enable Development/Enhancement of a Bedrest Research Facility to support NASA Studies

April 2023

Issued by

Human Research Program, NASA/Johnson Space Center (JSC)

Purpose

The NASA Johnson Space Center Human Research Program (HRP) is interested in establishing a partnership to develop/improve and operate a comprehensive bedrest research facility to support human spaceflight related research studies as well as other multi-discipline research objectives for periods up to 90 days (30-60 days more typically).

Review of this entire Request for Information (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

Previous NASA Bedrest RFIs have focused on full-service bedrest facility capabilities. This RFI opens an opportunity to entities and institutions that have an interest in bedrest research but may not have the current infrastructure to support strict head down tilt bedrest studies to meet the HRP study requirements (duration of bedrest, number of test subjects, facilities, and staffing capabilities). ‘Strict’ head-down tilt entails ensuring adherence to the head-down tilt protocol at all times including dining, personal hygiene activities, sleep, and task/test completion.

NASA research has demonstrated that prolonged bedrest 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. Bedrest studies of 30 to 60 days are currently used to study the onset of Spaceflight Associated Neuro-ocular Syndrome (SANS), impacts on sensorimotor function, and effectiveness of potential countermeasures to mitigate or eliminate risks to astronauts.

Typical HRP bedrest studies require sophisticated infrastructure to support the test subject care and research requirements. Very few facilities in the world can meet all the HRP bedrest study requirements. NASA is interested in enabling additional bedrest research facility capabilities in the U.S.

to support upcoming research pivotal to expanding 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 bedrest 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 bedrest 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 long-duration bedrest research.

It is important to note that experience in bedrest 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 bedrest research capabilities in the future. Importantly, the responses are also expected to identify significant barriers to implementation that must be addressed. For example, future bedrest research aims to increase inclusion of women and people of racial, ethnic, and national origin identities that have been underrepresented in past test subject pools. Since bedrest research involves facilities with complex infrastructure to meet the needs of the test subjects, researchers, and implementers (test subject care and medical staff), the responses are likely to include ideas regarding partnerships that pool resources and capabilities to 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 bedrest facility research opportunities, achieve NASA HRP goals and objectives, leverage significant sources of other funding, obtain essential services that are not available at the investigator’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 SAM.gov. Interested parties are responsible for monitoring this website for the release of any solicitation or synopsis.

Bedrest Facility Requirements

The envisioned facility would be capable of supporting 4 (minimum) to 12 bedrest test subjects for up to 90 days (with 30 to 60-day studies more typical) in strict HDT, with on-site or nearby medical and laboratory facilities. The facility staff would provide test subject recruitment, study planning and implementation, medical monitoring, clinical care of test subjects, hygiene, food and nutrition, 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 bedrest facility and services to fully support HRP research:

1. Facility A. Fundamental bedrest capabilities (core to successfully implementing bedrest):

1) Bed rest facility capable of accommodating 4-12 test subjects simultaneously in strict Head-Down-Tilt (HDT) for periods up to 90 days (30-60 days more normal), with on-site accommodation of pre- and post-HDT training/BDC and recovery periods (up to 1-month pre and post)

2) Access to on-site medical capabilities including clinical, diagnostic monitoring, laboratory services, MRI/fMRI, etc. while maintaining strict HDT

3) Capability to maintain strict HDT within the facility and, if transportation is needed, to off-site facilities

4) Systems for monitoring test subjects, such as audio, camera systems, video capture, private communications, external communications, etc.

5) IT infrastructure and data management capabilities including data storage, transferring secure large datasets, near real time data access, data security

6) Provisions for collecting, storing, processing biological samples

7) Safety provisions for test subjects and staff

8) Availability of food systems for test subject consumption (metabolic kitchen, etc.)

including assessment of nutritional and caloric needs

9) Capability to support continuous monitoring of multiple test subjects simultaneously for specific tests/measures

10) Capability to toilet, shower, and exercise while under strict HDT

11) Capability to support International Bedrest Standard Measures data collection (see attached description of International Bedrest Standard Measures)

12) Access to physiotherapy equipment and expertise

13) Large doorways and areas to allow movement and stationing of test subject beds and equipment

14) Consistent configuration of test subject rooms (single or no more than 2 test subjects per room), including provision of HDT beds, acoustic mitigation (extraneous noise), adjustable lighting capability (timing, intensity/brightness, and color temperature) to support circadian alignment to Earth day/night, and privacy accommodations

15) Separate male and female rooming accommodations

16) Capability for private areas as well as group activities while maintaining strict HDT

17) Accommodation for use of laptops, tablets etc. during HDT

B. Desirable capabilities:

1) Capability to manipulate study or environmental conditions (e.g. CO2 levels, higher noise levels, test subject social isolation, sleep deprivation, limited food system, etc.)

2) Capability to implement countermeasures as part of the research studies

3) Capability to support consecutive bedrest campaigns with minimal reconfiguration time (maximize throughput of test subjects and plan next campaign while implementing current campaign)

4) Capability for climate-controlled storage for research hardware and systems when not in use, including potentially large equipment

5) Capability to perform operational tasks so that spaceflight-relevant individual and team performance measures can be collected during HDT (to add spaceflight mission context and themes to bedrest studies)

6) Open laboratory space for operating study specific hardware systems

2. Staffing A. Fundamental bedrest Staffing capabilities

1) Facility management including development of new capabilities, as needed

2) Test subject monitoring 24/7 for protocol compliance and safety

3) Capability to provide overnight science shifts

4) Science integration expertise, including deconflicting individual study requirements and constraints, and optimizing schedules and impact to the test subjects (ie, shared needle sticks, etc)

5) Implementation/execution of study measures (ie, PI not present to implement) with local expertise

6) Campaign timeline development and detailed implementation plans/schedules

7) Facility maintenance and support prior to and during campaign

8) Process for conducting facility and operational safety reviews

9) Capability for a full Internal Review Board (IRB) campaign level review (Greater Than

Minimal Risk)

10) Test subject recruitment, screening, training pre-HDT, monitoring during HDT, and pre/post HDT baseline data collection (BDC)

11) Clinical care of test subjects – daily housekeeping and patient/test subject care services, nursing care, dietetics, physical therapy

12) Independent medical and psychological monitoring and support for test subjects

13) Access to subject matter experts for implementation of HDT bedrest, medical testing, nutrition, countermeasures, psychology, physical therapy and test subject reconditioning

14) Reporting status throughout the development and implementation of the study

3. Other A. Fundamental bedrest capabilities

1) A capability to implement an experimental study design that includes test subject random assignment to treatment and control groups to ensure the facility can replicate strict HDT bedrest similar to previous facilities and control studies (minimum 30 days)

B. Desirable capabilities:

1) Minority Serving Institution participation

2) Implementation of NASA HRP studies with potential accommodation of partner institution studies on non-interference basis

3) Capability to support testing of pharmaceuticals and nutraceuticals as part of the research studies