Partnerships and Collaborations

Transcription

1 Frequently Asked Questions Updated: March 31, 2017 (added Q62 to Process Questions) Table of Contents Partnerships and Collaborations... 1 Topics Questions... 5 Process Questions... 9 Partnerships and Collaborations Prospective proposers that are interested in partnering or collaborating on a specific topic can provide their contact information to be made publicly available in the FAQ. cmmoreno@bcm.edu with your name, , along with topics/areas of interest and subject matter expertise to add your name to this list. Omics capabilities for use during missions 1. Stephanie Duncan sduncan@sparxeng.com, Sparx Engineering in Houston, TX. We are open to collaboration. We are a team of highly skilled electrical, mechanical, software, industrial, and biomedical engineers who can create stand alone and/or design solutions from the ground up. We cumulatively have 30+ years in space flight operations. We are looking for partners in omics, wearables, ratiometric sensing, and manufacturing for space flight. 2. Emmanuel Hilaire, PhD hilairee@njhealth.org (Director, Technology Transfer Office at National Jewish Health, Denver and ex-space scientist in the 90s!). We are the #1 respiratory hospital in the US. Our research expertise is genomics, proteomics, lipidomics, immunology, biomarkers analysis, assay development, respiratory and immune diseases etc. We are experienced in studying the effects of environmental factors on human health. Microgravity is an environmental factor we are interested in exploring. We have strong expertise in microbiome studies as well. Feel free to contact me if you are interested in potentially collaborating with us. Long lasting medications 1. Jonna Ocampo jonnaocampo@gmail.com 2. Danielle Tullman-Ercek ercek@northwestern.edu: I am interested in biomanfucture on demand and looking for collaborators. TRI FAQ-1

2 3. Kemba Lee Please feel free to contact me for pharmaceutical/innovative therapy collaboration. TRI FAQ-2

3 Human brain imaging 1. Morris Vanegas Our MIT/NEU, Cambridge/Boston based team is coupling previous and current experiences in space suit design and digital fabrication, with wearables and computational optics. Open to collaborations. 2. Quan Zhang We are located at Harvard Medical School and Massachusetts General Hospital, and have unique wearable, analog-tested (parabolic flight, HERA) NIRS/DOI capabilities. Let us know if interested in collaboration. Inflight surgical capabilities 1. Stuart Corr (Director Technology Development for Department of Surgery, Baylor College of Medicine) Increase an organism s resistance to radiation 1. Charles Spencer ctspencer@utep.edu, University of Texas at El Paso. We are putting together a proposal to evaluate existing drugs in mitigating space radiation damage. Open to collaborations. Preserve muscle mass with pharmaceuticals 1. Lichar Dillon eldillon@utmb.edu: bed rest + exercise analog 2. Kemba Lee l_kemba@bellsouth.net: Please feel free to contact me for pharmaceutical/innovative therapy collaboration. Inflight production of fresh food 1. Joe Russell jrussell@mriglobal.org: I plan to submit a proposal around an integrated perishable-longevity improving and molecular food testing platform for in-flight food safety and preservation. I am looking to field test in an analog environment such as Aquarius/NEEMO. Please feel free to contact me if you have experience with analog deployments and/or are interested in partnering. TRI FAQ-3

4 Microbiome based therapies for improving health in spaceflight 1. Volgin LLC we're focused on microbiomesupportive foods. 2. Emmanuel Hilaire, PhD (Director, Technology Transfer Office at National Jewish Health, Denver and ex-space scientist in the 90s!). We are the #1 respiratory hospital in the US. Our research expertise is genomics, proteomics, lipidomics, immunology, biomarkers analysis, assay development, respiratory and immune diseases etc. We are experienced in studying the effects of environmental factors on human health. Microgravity is an environmental factor we are interested in exploring. We have strong expertise in microbiome studies as well. Feel free to contact me if you are interested in potentially collaborating with us. Lymphatic imaging in microgravity 1. Quan Zhang We are located at Harvard Medical School and Massachusetts General Hospital, and have unique wearable, analog-tested (parabolic flight, HERA) NIRS/DOI capabilities. Let us know if interested in collaboration. TRI FAQ-4

5 Topics Questions Q62: Can you clarify language on "Inflight production of fresh food regarding growing plants other than typical land green plants used for food? Should we be proposing to grow algae, mushrooms, and seaweed or not? Would you consider vegetable production that does not overlap with VEGGIE? A62: TRI is looking for food production that does not overlap with NASA s VEGGIE project. Plants grown without soil, like algae, mushrooms and seaweed, may be good candidates. We urge you to check for overlap with the VEGGIE project. Q61: Will there be further specifications on common model organisms with regard to age? A61: When working with model organisms, consideration should be given to the fact that astronauts are typically in their late 30s, 40s, and 50s. Therefore for most studies, model organisms should be aged appropriately, such that the age of the model organisms in animal months or years is approximately equivalent to humans that are in their late 30s, 40s or 50s. Q60: Are psychological assessments required for rodent studies? A60: No psychological assessments are required, however, it would be useful to note whether animal behavior changes as a result of the medication or to determine whether cognitive abilities are affected, particularly in cases the drug crosses the blood brain barrier. Q59: Does the pharmaceutical under evaluation need to be FDA approved? A59: TRI prefers that the pharmaceutical be FDA approved in order to reduce subsequent work required for transition to operations. Q58: What duration of disuse atrophy in rodents will be considered relevant to human space travel? A58: See the literature of disuse atrophy in astronauts and extrapolate for rodents. The degree of atrophy matters more than duration of microgravity exposure. See HRP s evidence report for the muscle risk: TRI FAQ-5

6 Q57: What are the weight, size, and power limitations for a future imaging system? A57: We cannot provide hard rules, but mass, volume and power use should be minimized. Anything larger than a big laptop likely would not be selected flight. Q56: It might not be possible to achieve the end result of a flyable MRI (or other imaging) system within the scope of this program; therefore, what would be the expectations of this program to advance towards that goal? How many additional phases/years would be permissible after the end of this program in order to reach the end goal? A56: At this time, MRI is probably the imaging modality least amenable to adaptation for spaceflight. TRI anticipates that a miniaturized MRI may not be suitable for use in space, however investigators may propose this imaging modality if they believe it can work within the power, mass and volume etc. constraints inherent to spaceflight. Q55: Within the Inflight Surgical Capabilities topic area, it states, develop surgical capabilities with the primary capability of achieving hemostasis in the case of trauma, nose bleed, or surgical procedure. More advanced surgical capabilities could include appendectomy or cholecystectomy in cases of acute abdominal pain. Does this mean that a surgical technology primarily addressing the more advanced surgical capabilities mentioned (such as cholecystectomy) must also address external hemostasis (such as in the case of nose bleeds) in addition to focusing on internal bleeding related to the injury or surgery? A55: In microgravity, blood will form a bubble around the vessels that it leaks from, which will obscure a surgeon s field of view. Hemostasis must be considered in order to adequately address more complicated surgical procedures. Q54: For the topic Increase an organism s resistance to radiation, will applications that propose to use a rodent model only be considered? Will applications that propose to use targeted genetic manipulations in rats be considered? A54: TRI will consider projects that use any common model organism, including but not limited to Drosophila, fish, amphibian, mouse or rat. TRI FAQ-6

7 Q53: Can you direct us to current mission architecture planning for long duration exploration missions? A53: The document found at the link has information regarding NASA s design reference missions (DRMs). _requirements_document_rev_g.pdf Q52: Can you elaborate on the use of refrigerated or frozen storage of ingredients for the topic Lab-grown meat or dairy products? A52: Solutions should be mission feasible. Solutions that require refrigerated or frozen storage of ingredients, including culture media, will not be considered. Q51: Would using tardigrades as a model system to study HZE effects be a responsive proposal to the topic regarding radiation resistance? A51: Yes, provided that radiation exposures are space-like. See the Slaba et al NASA technical report GCR Simulator Reference Field and a Spectral Approach for Laboratory Simulation for details on space radiation ( Q50: Can you elaborate on how to address safety and palatability for the topic Lab-grown meat or dairy products? A50: Safety can include laboratory analysis to screen for toxic ingredients, as well as determination of microbiological safety. Palatability could include trials by human tasters. Q49: Does the topic microbiome based therapies for improving health in spaceflight require a flight experiment with an appropriate ground control? A49: TRI will consider proposals that include studies in space flight or a scientifically appropriate analog. All studies should include the necessary controls. Flight studies will be subject to availability of flight, crew time, and other mission resources. TRI cannot ensure that any particular study will be selected for flight. Q48: Would medical devices that assist in maintaining muscle mass be responsive to the topic preserve muscle mass with pharmaceuticals? A48: TRI will not consider these kinds of proposals for this current solicitation, but may call for medical device proposals in the future. TRI FAQ-7

8 Q47: Can compounds in human clinical trials or nutraceuticals be used for the topic preserve muscle mass with pharmaceuticals? A47: TRI will consider proposals that use nutraceuticals or drugs currently in human clinical trials, but note that these proposals may receive a lower feasibility evaluation due to the need for subsequent FDA approval. Q46: Does inflight surgical capability include remote guidance via augmented reality or virtual reality? A46: Ground guidance will be problematic with communication delays up to 20 minutes on some parts of a Mars journey. Any proposal that addresses all the resource restrictions, including the communications delay, could be successful. Q45: Would pre/post-operative management of a casualty, or a virtual anesthesiologist, respond to this call for proposals? A45: Yes. The TRI is seeking a way to enable surgery in the spaceflight environment, which includes microgravity plus inherent limitations on trained clinicians, medical supplies, mass, volume, power, etc. Proposals that enable surgery with these constraints could be successful. Q44: Are high linear energy transfer (LET) effects on tardigrades a potential area of interest? A44: The TRI is interested in the biomedical effects of space-like radiation. See the Slaba et al NASA technical report GCR Simulator Reference Field and a Spectral Approach for Laboratory Simulation for details on space radiation ( TRI FAQ-8

9 Process Questions Q62: What is the time of day are the proposals due by? A62: The deadline for proposals is 11:59 ET on the due date. Q43: Is a separate registration required for the organization itself which includes a designation of the person who will act as the EBPOC? A43: As explained during the organization registration steps: "For security purposes only the Electronic Business Point of Contact (EBPOC) or Alternate EBPOC, as listed for your organization in the Central Contractor Registration (CCR, can register his/her organization. The EBPOC or Alternate EBPOC will be asked to fill in some organizational information, print out the Organization Registration Request and Authorization form, have it signed by the Organization Authorizing Official and send it back to NASA. Upon receipt of this form, your organization's registration will be activated. The person requesting this registration (i.e. EBPOC or alternate EBPOC) will become the Organization's Point of Contact (OPOC) for NSPIRES. The OPOC will be granted all organizational privileges within NSPIRES and can then facilitate in setting up the organization's NSPIRES account / privilege structure to best meet the needs of your Sponsored Research Office personnel." The organization must be registered with NSPIRES for a PI to be able to affiliate with it. Please contact the NSPIRES help desk (NSPIREShelp@nasaprs.com) or read the NSPIRES tutorials for additional information. Q42: Can ESA-affiliated scientists from Europe be included as coinvestigators/pis? A42: In regards to ESA affiliated scientists, yes they can participate as coinvestigators and other roles. See pages of the Appendix D for more information. Principal investigators must be based at U.S.-based institutions (universities, companies, government laboratories). Q41: Should small openly competed (SOC) proposals be aimed as stand-alone studies or targeted for possible inclusion in future or planned campaigns? A41: TRI has no plans to arrange for stand-alone projects to be placed into campaigns at this time. TRI also does not intend to pre-determine which analog is best for an investigator s project. Investigators must choose the appropriate analog for their study. All costs associated with an investigator s proposed analog environment should be included in the budget. TRI FAQ-9

10 Q40: Is there a specified time limit to complete the research? How often are grants re-evaluated? A40: See each individual research topic in Appendix C regarding the funding period (varies between 2-4 years). Projects are assessed for progress via an annual progress report and annual virtual review. See Appendix D pages for more information on reporting requirements. Q39: Is there any down-select based on the LOI? A39: No. 1-3 days following due date of the LOI an automated reply will be sent to each submitter. Proposers may submit full proposals in NSPIRES following receipt of the automated reply. Please feel free to work on your proposal outside of NSPIRES prior to receiving this notification. There will be no extensions given for LOI or proposal submission. Q38: Should the proposal outline the research planned for the first year in detail, and subsequent years broadly? Research plans may change based on results from the first year. A38: Research plans should include all years. Contingency plans could be included in the proposal to account for different results in the first year. Q37: Are biosketches required as part of LOI submission? A37: Submission of 2-page biosketches is required during the proposal submission, not the LOI submission. Q36: Is one individual required to be designated as the AOR during the registration process? A36: Yes. Q35: Must all individuals be registered in NSPIRES before LOI submission? A35: No, but it is recommended to register team members as early as possible. Q34: Can a single institution or company s staff constitute the multiple disciplines requirement? A34: Yes, provided that there is a breadth of skill sets represented on the team. Q33: Does TRI accept modular budgets? A33: No, TRI requires detailed budgets in response to the solicitation. TRI FAQ-10

11 Q32: Can one principal investigator submit more than one proposal? A32: Yes, there is no limit to the number of proposals that a single individual or institution may submit. Q31: Is there a limit to the number of applications that a single institution can propose? A31: There is no limit to the number of applications from any organization. Q30: Does a single investigator opportunity include co-investigators? A30: A single investigator opportunity means a single principal investigator. This type of project could also involve one or more co-investigators, collaborators, or consultants. Q29: In the TCore topic for Long-lasting medications, it is noted that this project will be considered for funding as a TRI Core Research Project (TCore), with a maximum of five individual PIs, but this team approach is not required. Would it be acceptable to submit a single investigator proposal to this topic? A29: It is acceptable to submit a small, openly competed (SOC) grant to this topic. In this case, the award would be up to 3 years with a budget up to $300K a year. Q28: Can TRI facilitate partnership of proposers? A28: TRI will not be responsible for arranging teams this should be investigator driven. Prospective proposers that are interested in partnering or collaborating on a specific topic can provide their contact information to be made publicly available in the FAQ. cmmoreno@bcm.edu with your name, , and along with topics/areas of interest and subject matter expertise to add your name to this list. Q27: Please clarify the statement: "This opportunity is for a single investigator." Does this topic require a PI and co-investigators or a PI and expert consultants? A27: A single investigator opportunity means a single principal investigator. This type of project could also involve one or more co-investigators, collaborators, or consultants. This is in contrast to the TCore opportunities that are similar to NIH Program Projects and have multiple PIs working in an integrated fashion. TRI FAQ-11

12 Q26: Does TRI fund bedrest studies? A26: Yes, TRI will consider proposals that include bedrest studies. The proposer, however, must find a bedrest facility, make arrangements, and include all costs in their proposal budget. Q25: In proposals that utilize bedrest, are the NASA standard measures required? A25: No, this is not a requirement for TRI-funded projects. However, including some NASA standard measures may be seen as beneficial. If standard measures are proposed and there are measures that are too difficult to include, please provide an explanation. See HRP s evidence reports on the muscle and aerobic risks for more information: and Q24: Is the pre-proposal webinar restricted to those who submit questions? A24: The pre-proposal webinar is open to all interested parties. Q23: Is in-kind cost-sharing (including but not limited to personnel effort) acceptable for the 10% cost-sharing requirement? Does the NIH salary cap apply to TRI solicitations? A23: Yes, in-kind cost-sharing does meet TRI s cost-sharing requirement; please provide the cost breakdown in the proposal budget & justification. The NIH salary cap does not apply to TRI s solicitation. Q22: How is cost-sharing handled? Do shared resources across projects suffice for this requirement? A22: Principal Investigators and Co-Principal Investigators will be funded separately at his/her institution. Each funded institution is responsible for cost sharing 10% of the award. Cost sharing requirements can be discussed in further detail directly with TRI finance. Cost-sharing can be handled in a variety of ways, including but not limited to personnel percent effort, purchasing or sharing of equipment and resources, etc. In projects that involve multiple institutions, each institution must cost share. TRI FAQ-12

13 Q21: Are non-profit entities exempt from the cost-sharing requirement? A21: No. Each funded institution is responsible for cost sharing 10% of the award. Cost sharing requirements can be discussed in further detail directly with TRI finance. Q20: What is the formatting requirement for the LOI? A20: The LOI requires no special format; it is submitted via webform on NSPIRES electronic submission system. Please login to NSPIRES to submit an LOI. There is a 4,000 character limit for the central Science-Technical section of a LOI. Q19: I am submitting a proposal that is a flight experiment or requires use of an analog. Where can I find the Analog Study Resource Worksheet or the Flight Experiment Resource Worksheet? A19: The Analog Study Resource Worksheet and the Flight Experiment Resource Worksheet can be found here: =%7bF495C88B-9494-C09F-E E098AA060%7d&path=open Q18: When will the funding decision regarding proposals be made? A18: We plan for funding to begin on or after October 1, Announcement of awards will be made prior to October. Q17: Can research funds be used to fly a payload on a commercial suborbital launch vehicle? A17: Proposers may use any spaceflight analog that is appropriate for their scientific question, which also includes suborbital flight. TRI will only consider proposals that address research emphases stated in the solicitation which meet the budget limitations given for each topic. Schedule is another parameter evaluated in feasibility assessment. Q16: Does cost for beam time need to be allocated in the proposal budget? A16: All costs of the proposed work should be included in the budget which includes all sample treatments, use of analogs or facilities away from the proposer s home institution, as well as any travel or shipping that may be required. Investigators that are unfamiliar with budgeting for beam time may contact TRI for assistance. TRI FAQ-13

14 Q15: Regarding the TCore topic, will TRI need a detailed budget from each partner involved for operations and use the funds? A15: The budgets for TCores must be allocated. Collaborations between universities or other organizations are often best treated as subawards or subcontracts on the NSPIRES budget sheets, with the amounts being used by the parent organization spelled out as normal, regardless of how many investigators are involved from that parent organization. The amount to be given out as subawards must be in the NSPIRES-entered budget and it is encouraged to be included and broken down in the budget justification section. Please see the wording under Instructions for Preparation of Proposals (TRI Proposal Instructions, Section D.5): In addition to the Cover Page online budget forms, proposers are encouraged to provide expanded budgets as needed (i.e., subcontracts) as part of their budget justification (see number 13 below and the Guidebook for proposers). Q14: Can I request an extension for submitting my proposal? A14: Extensions will not be given. It is strongly suggested that you begin your proposal preparation early, familiarize yourself with the solicitation and the proposer s guidebook, and ensure that your authorized organization representative (AOR) is registered with NSPIRES and will be available to submit your proposal by the deadline. Q13: How can I verify that my proposal has been submitted? A13: Once a proposal has been submitted, it no longer appears on the Current proposals/nois screen. Select the Submitted proposals/nois link to the left of the screen. Submitted proposals are displayed here. It is your responsibility, and not TRI s, to verify that your proposal has been officially submitted by the proposal due date. TRI FAQ-14

15 Q12: What do the various proposal status types in NSPIRES mean? A12: There are six different proposal status types. Pending is a proposal cover page that is in process, but not yet linked to an organization. Only the PI (and any team member who has been granted privileges) can edit the cover page or upload documents in this status. Linked is a proposal cover page that is in process, and linked to the organization that is going to submit it. Once a proposal is linked, appropriately privileged personnel in the office who will be submitting the proposal (typically the AOR) will have access to the proposal and can, if necessary, lock the proposal. A locked proposal cannot be edited. A proposal becomes locked when the PI clicks the Release to Org button. A proposal can also be locked by the AOR, who can also unlock a proposal if further editing by the PI is needed. A rejected proposal is returned by the organization to the PI. It can be edited by the PI and re-released to the organization. A submitted proposal has been submitted to NSPIRES by the AOR. Submitted proposals no longer appear on the Active Proposals/NOIs page of a PI s proposals page. Submitted proposals are shown on the Submitted Proposals/NOIs page. A withdrawn proposal is pulled back from NSPIRES by the organization. If this is done prior to the proposal due date, the proposal could be re-submitted (it will be given a new proposal number). After the proposal due date, the proposal cannot be re-submitted. Q11: I receive checks that I am missing proposal components when I submit my proposal. What does this mean? A11: As a courtesy, the NSPIRES system performs a check of the proposal components upon submission. NSPIRES is used by multiple programs for proposal submission and only the components outlined in this solicitation are required for compliance. Checks referring to proposal components not mentioned in the solicitation or requesting proposal components be uploaded separately (such as budget justification) can be ignored. A completed proposal cover page elements and single PDF proposal document as outlined in the solicitation are the only required components for this solicitation. TRI FAQ-15

16 Q10: I ve started the proposal creation/submission process. How do I find what I started and see where it is in the process? A10: In order to see proposals that you have in process, login to your account and select the Proposals link. Below the Active Proposals heading is a list of all proposals that you have started to create as a PI or on which you have been identified as a team member, but which have not yet been submitted. The title of the proposal is a link that will take you to the screen that allows you to edit the various components (note that if you are a team member, you may or may not have editing privileges, depending on if the PI granted them to you or not). The organization to which you have linked your proposal (if any) is shown, as is the PI name, the proposal due date, and the proposal status (see below). Q9: Do I need to list all team members on my LOI cover page? A9: Yes, as completely as possible at the LOI submission. This information is used to arrange review panels; team members identified in the LOI submission will not be asked to join proposal review panels. Teams can change in the final proposal. In the final proposal, a biosketch (2-page preferred) should be included for each team member listed on the cover page. TRI needs a complete and accurate accounting of team member participation on the proposal cover page in order to prevent conflicts of interest during the peer review process. Q8: Some of my team members do not yet have NSPIRES accounts, what do I do? A8: In order to list your team members on the cover page, they must have NSPIRES accounts. You can complete most of your cover page creation and proposal document upload while the individuals are being registered. If an individual has still not created an account when the proposal needs to be submitted, this person should be named in the Proposal upload and an account should be created as soon as possible. Please contact the NSPIRES help desk, NSPIRES-help@nasaprs.com, for any difficulties during registration. TRI FAQ-16

17 Q7: My proposal team includes a NASA civil servant. Are there special instructions for including budget information for a NASA civil servant team member? A7: Proposers are required to enter the NASA civil servant team member name and fraction of FTE (full-time equivalent) involvement in the same field under the Item column in section F Other Direct Costs of the online budget. The funds requested should be entered as the Total Requested Funds for the NASA civil servant, including salary, fringe, materials, travel, etc. Cost-sharing is not required for civil servants. Please see section C.3 of the TRI Proposal Instructions document for details. Proposers with questions on accounting for NASA civil-servant team members are encouraged to contact Benjamin Goodman, Senior Scientist, NASA Research and Education Support Services at bgoodman@nasaprs.com, phone x218. Q6: I received notification to submit a full proposal, but I would like to change my collaborators (Co-I) to different individuals at different Institutions, is this allowed? A6: Yes, this is allowed as long as the basic premise of the work has not changed. The project personnel listed in the LOI are not considered binding and can be adjusted in a full proposal. Q5: Can a foreign citizen who is part of the faculty of a U.S. institution propose to the call for proposals? A5: Yes. The eligibility requirements of the solicitation apply to the proposing organization and not the individual. However, it is possible that export control requirements must be taken into account for members of a proposing organization who are not U.S. citizens or do not have permanent resident status. See additional restrictions regarding Chinese participants in Section C.2.b. of the Proposal Instructions. Q4: I have not received notification to submit my full proposal. When should I expect to be able to begin work in NSPIRES on my full proposal? A4: 1-3 days following due date of the LOI an automated reply will be sent to each submitter. Proposers may submit full proposals in NSPIRES following receipt of the automated reply. Please feel free to work on your proposal outside of NSPIRES prior to receiving this notification. Q3: How can I sign up to attend the pre-proposal webinar? A3: There is no sign-up necessary for the pre-proposal webinar. The login details for the pre-proposal webinar can be found here ( TRI FAQ-17

18 Q2: I cannot find the answers to my questions in the solicitation documents, the guidebook, or this FAQ. Who can I ask for assistance? A2: Please ensure that you read the TRI Research Topics, TRI Proposal Instructions, and this FAQ in their entirety before contacting TRI with questions. For NSPIRES-related questions and the online preparation and submission of your proposals, nspires-help@nasaprs.com or by telephone to (202) Monday through Friday, 8:00 AM 6:00 PM Eastern Time. There is also a Proposal Online Help site at Tutorials of NSPIRES are available at Additional technical information and contact information can be found in both solicitation research appendices. Please reference the solicitation documents. You may contact Dr. Virginia Wotring (virginia.wotring@bcm.edu), TRI Chief Scientist, for other questions. Q1: Where do I find information regarding the research emphases or the process for applying? A1: The research topics are found on NSPIRES in the document NN16ZSA001N-TRIRT and the proposal instructions are found in the document NNJ16ZSA001N-TRIIN. TRI FAQ-18