Bed-Rest and Isolation Studies 2014

Announcement of Opportunity

Publication date: October 7, 2014

Application deadline: December 8, 2014

1. Introduction

In the future, human exploration of space is expected to extend beyond Low Earth Orbit (LEO) to targets such as Mars or near-Earth objects. The resulting expeditions will require extended periods of exposure to weightlessness and space radiation, with confinement and isolation in the extreme environment of space, all of which are linked to substantial health and performance risks.

The CSA is interested in human spaceflight and maintaining a healthy and highly qualified Canadian astronaut corps capable of participating in space exploration missions. To achieve this, the CSA's Health and Life Sciences (HLS) group conducts activities generating knowledge in fields that sustain human space flights, mitigate health risks and develop countermeasures for those missions. Bed-rest and isolation studies are spaceflight analogues that are valuable for initial validation of new countermeasures and for improving understanding of risks of spaceflight.

Through the CSA's participation in the European Life and Physical Sciences Program (ELIPS-4), Canadian investigators have access to space analogue facilities such as bed rest that are not available in Canada. In October 2013, the ESA released two Announcements of opportunity (AOs) to which Canadian investigators could submit proposals: Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR); and Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia).

Previous bed-rest studies have been direct precursors of Canadian experiments on the International Space Station (ISS), and isolation studies allow for medical, physiological, and psychological research in Isolated and Confined Environments (ICEs) resembling space. The ESA AOs have closed and ESA has completed its review process, resulting in a selection of the experiments that will be part of future bed-rest campaigns and isolation studies.

In order to achieve its program objectives, the CSA HLS group is launching this AO to solicit proposals for funding from investigators who have applied to either the ESA AO for Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR) or the ESA Call for Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia), and have been selected by ESA to participate in their bed-rest studies or their Concordia Antarctic Station research opportunities. In other words, this CSA AO is only open to Canadian researchers whose proposal to ESA in one of the two aforementioned ESA AOs has passed the ESA peer and technical reviews. This CSA AO will lead to funding of the Canadian members of the science teams; infrastructure costs for the bed-rest or isolation campaigns are paid by ESA.

Please read the following AO thoroughly before submitting your application. It has been prepared to assist applicants through the application process, and it outlines important elements including mandatory criteria for eligibility, details on eligible projects and the selection process. In the event of any discrepancies between this AO and the individual funding agreements governing a project(s), the latter document(s) will take precedence.

This AO is consistent with the terms and conditions of the CSA Class Grant and Contribution Program to Support Research, Awareness and Learning in Space Science and Technology – Research Component described on the following page: www.asc-csa.gc.ca/eng/funding-programs/grants-and-contributions-snapshot.asp.

2. AO Objectives

Through this AO, the CSA is seeking to financially support Canadian researchers involved in scientific experiments who have been selected by ESA in either the ESA AO for Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR) or the ESA Call for Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia), to be conducted during one of their bed-rest campaigns or Concordia Antarctic Station research opportunities. No other proposals will be considered for this CSA AO.

Projects selected from this CSA competition will have as their objective to increase the medical, physiological and/or psychological scientific knowledge that will contribute to the efforts toward the understanding, mitigation or elimination of health risks associated with human space exploration and generate scientific insights that will also contribute to applications on Earth.

More specifically, through this AO, the CSA seeks to:

• Provide an opportunity for new space life sciences experiments to be conducted during ESA bed-rest campaigns or Concordia Antarctic Station studies, thus providing new knowledge and insight into the risks of human space flight. It is expected that these studies may inform future ISS research and other space studies. However, such follow-up proposals for ISS research and other space studies are not eligible for funding in this AO.

The total financing amount given in grant for this AO is $1.5 million for a maximum period of three years. It is expected that funding for bed-rest initiatives will cover a maximum period of two years, and a maximum of three years for studies conducted at the Concordia Antarctic Station. The overall number of grants awarded and their level will depend on the budget requested by each proposal and the availability of funds. Proposals will be ranked on the basis of scores obtained in this CSA competition, based on evaluation criteria described in Section 5. The CSA reserves the right not to accept any proposals or to reduce the amount of the grant requested at its entire discretion.

3. Eligibility Criteria

3.1 Eligible Recipients

Eligible recipients (beneficiaries) for grants will be:

• Canadian universities and post-secondary institutions

3.2 Eligible Projects

Projects eligible for funding in this solicitation process are those where Canadian researchers are involved as principal investigator or as co-investigator, and that have been selected based on scientific merit and feasibility through one of the following ESA AOs:

• Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR)
• Call for Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia)

These projects will be performed during an ESA bed-rest campaign or a Concordia Antarctic Isolation Study and must be aligned with the CSA priorities identified in Sections 3.3 and 3.4 of this document.

A project may consist of several activities to attain its objectives or results. Any logical breakdown or combination of these activities can constitute a funded project. However, breaking down a project into numerous activities or sub-activities to obtain more than the maximum grant or contribution funding is not allowed for what is considered to be one project. Furthermore, even if the maximum funding for one project is not reached, the completion of a funded activity does not automatically guarantee funding of the remaining activities of the project. Details of eligible costs of the projects financed under this AO are listed in Section 6.

3.3 Links to CSA Priorities

To be eligible, projects supported under this AO must be aligned with CSA priority outcomes, as stated in the 2014–15 Report on Plans and Priorities. At the highest level, the contribution of Space Exploration "fosters the generation of knowledge as well as technological spin-offs that contribute to a higher quality of life for Canadians." As the CSA continues to collaborate in the European Life and Physical Sciences Program (ELIPS), Canadians have access to space analogue facilities such as bed rest that are not available in Canada. The HLS group of the CSA is sponsoring this AO and will only consider relevant those activities that are aligned with its mandate to "identify, understand, mitigate or eliminate health risks associated with human space flights, and to understand and address the needs of humans during those missions." The most important health risks associated with human space flights (i.e. future long-duration human spaceflight missions) have been identified and are listed in Table 3.1. Proposals that address one or more of the risks listed in this table will be given higher priority for CSA support.

The following table presents the human space flight risks targeted by the CSA for this AO.

3.4 Links to G&C Program Objectives

To be eligible, projects supported under this AO must contribute to the achievement of the following objective:

• To support the development of science and technology relevant to the priorities of the CSA.

4. Applications

4.1 Required Documentation

To satisfy CSA requirements, the application must include the following:

• A completed typed original application form (PDF or Word templates) signed by the duly authorized representative;
• Two (2) hard copies of the complete application to this CSA AO;
• A copy of the document(s) confirming the legal name of the organization (must be confirmed by the Office of Research);
• A copy of the complete application to this CSA AO (identical to the signed paper copy) on a standard electronic media (USB flash drive, CD or DVD);
• A copy of the ESA letter of acceptance to one of the following ESA AOs:
  • Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR)
  • Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia)
• An electronic copy of the proposal package submitted to ESA for the Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR) competition or the Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia) competition;
• A letter signed by the chairperson of the local Institutional Review Board (IRB) regarding approval of the experimental protocol using human subjects will be included with the proposal;
• Letters from other funding contributors confirming their contributions (if applicable);
• Declaration on Confidentiality, Access to Information Act and Privacy Act form signed by the duly authorized representative (see application form); and
• For organizations in Quebec, M-30 Supporting Documentation form completed and signed by the duly authorized representative (see application form).

It is the applicant's responsibility to ensure that the application complies with all relevant Canadian legislation and bylaws (federal, provincial/territorial and municipal). Applications sent by email shall not be accepted and incomplete applications shall not be considered.

Applications must be mailed to the CSA at the following address:

• Proposals must be received at the CSA no later than December 8, 2014, at 4:00 p.m. (EST).
• Applications sent by email shall not be accepted.
• Incomplete applications shall not be considered.

4.2 Service Standards – Complete Applications

Applicants will be notified in writing of decisions regarding their application. Applications that have been selected will be announced on the CSA website on the page for this AO.

The CSA has set service standards related to delays in processing requests, the acknowledgement of receipt, funding decision and payment processes.

Acknowledgement: The CSA's goal is to acknowledge receipt of proposals within 2 weeks of receiving a completed application package.

Decision: The CSA's goal is to respond to the proposal within 10 weeks of receiving a completed application package or closing date of the AO, and to send for signature a grant agreement within 18 weeks after formal approval of the proposal.

Payment:
Grant: The CSA's goal is to issue payments within 4 weeks of the successful fulfillment of requirements outlined in the grant agreement.

Compliance with these service standards is a shared responsibility. The applicant must submit all required documentation in a timely fashion. Service standards may vary by AO.

5. Evaluation

5.1 Eligibility Criteria

• Represents an eligible recipient as defined in Section 3.1
• Represents an eligible project as defined in Section 3.2, 3.3 and 3.4
• Meets program funding provisions (see Section 6)

5.2 Evaluation Criteria

An evaluation committee will assess screened-in applications according to the criteria described below. The eligible projects to be evaluated in this AO will have already been evaluated for scientific merit and feasibility through the ESA AO processes; therefore the CSA will focus its evaluation on the following criteria.

5.2.1 Mandatory Criteria

Each submission will first be evaluated to ensure it meets the mandatory criteria.

5.2.1.1. Eligibility of the applicant

Description: This criterion evaluates whether the application has been submitted from an eligible recipient.

Scoring

5.2.1.2. Eligibility of the project

Description: This criterion evaluates whether the application is an eligible project for this AO.

Scoring

5.2.1.3. Alignment with priorities of the G&C Program

Description: This criterion evaluates how the project will contribute to the Grant and contribution (G&C) Program objectives.

Scoring

5.2.2 Graded Evaluation Criteria

Table 5.1 Summary Table of Graded Evaluation Criteria

Submissions will be evaluated using the following graded criteria. To be considered eligible for funding, they must receive a score greater than 125/200. These criteria and ratings are described in detail below.

Graded Criterion 1. Benefits to Canada

a) Alignment with the priorities of the CSA Space Life Sciences Program

Description: This criterion evaluates whether the proposed research project is aligned with the priorities of the CSA Space Life science program, which are to identify, understand, mitigate or eliminate health risks associated with human space flights, and to understand and address the needs of humans during those missions.

Maximum: 35
Minimum: 25

b) Potential of the work to inform Canadian healthcare practices

Description: This criterion evaluates the proposal's description of the potential of the research to contribute positively to Canada through reducing the costs of Canadian healthcare practices.

Maximum: 35
Minimum: 15

Graded Criterion 2. Project Feasibility, Resources and Risk Assessment

a) Budget and Resources Allocation

Description: This criterion evaluates the adequacy of the budget and resources allocation to tasks, level of efforts and material resources. Applicants need to present an itemized budget describing project expenditures and sources of funding.

• Information should be broken down by project phases (e.g. preparatory phase; campaign / data collection phase; post phase / data analysis; or any other relevant phase breakdown);
• All funding sources and all expenditures must be included from initiation of the project to completion of data analysis;
• Budget must describe and justify project expenditures.

Note: Over-budgeting (i.e. padding) will be penalized, so applicants are encouraged to provide their best estimates of project costs.

Maximum: 15
Minimum: 5

b) Risk Management

Maximum: 15
Minimum: 0

Description: The proposal needs to expose project risk management and mitigation strategies. This criterion evaluates the knowledge of potential pitfalls and obstacles that may occur during project course and adequacy of proposed preventive/remedial measures. The proposal shall in particular address science-related risk and mitigation strategies related to the completion of the project they are presenting, as well as standard project management risks.

Graded Criterion 3. Results

Scientific Merit Review (as assessed by the ESA peer review evaluation process):

Description: This criterion will use the ESA Scientific Merit Review score, which assessed the Study Significance, Approach, Innovation, Personnel, and Institutional Environment.

5.3 Evaluation Process

Only applications that have passed the eligibility criteria listed in Section 3 will be considered further.

Several evaluators could assess each application based on evaluation criteria listed in Section 5. Before a final decision is made, Program Managers may seek input and advice from others, including, but not limited to, federal, provincial/territorial and municipal government agencies, organizations, etc.

The determination of the amount of support will take into consideration CSA availability of funds, the total cost of the project as well as the other confirmed sources of funds invested by other stakeholders and the applicant.

All proposals from bed-rest and isolation studies will be placed in one pool. Proposals will be ranked on the basis of a numerical average of the scores obtained in this CSA competition, and the scores obtained in the ESA peer review.

6. Funding

6.1 Available Funding

The total financing amount given in grant for this AO is $1.5 million for a maximum period of three years. It is expected that funding for bed-rest initiatives will cover a maximum period of two years, and a maximum of three years for studies conducted at the Concordia Antarctic Station. The overall number of grants awarded and their level will depend on the budget requested by each proposal and the availability of funds.

The CSA reserves the right not to accept any proposals or to reduce the amount of the grant requested at its entire discretion.

Approved proposals will be eligible for total government (federal, provincial/territorial and municipal) assistance of up to 100% of total project costs.

Applicants are required to identify all sources of funding in their application and to confirm this information in a funding agreement if the project is selected for funding. In addition, upon completion of a project, the applicant will be required to disclose all sources of funding. To determine the amount of financial support it will offer, the CSA will consider the total project cost and funding from other stakeholders and the applicant.

6.2 Eligible Costs

Eligible costs are direct expenses associated with the delivery of the approved project that is required to achieve the results of the project. Expenses will be covered subject to the applicant signing a funding agreement, in the form of a grant, with the CSA.

Applicants to this CSA AO cannot include as eligible costs any costs related to non-Canadian Co-Investigators or non-Canadian Principal Investigators or their work within the proposal. These costs should be submitted to the appropriate national agency for funding.

Grants

The eligible costs for grants under this AO are the following:

• access fees;
• accommodation and meal allowances;
• acquisition, development and printing of materials;
• acquisition or rental of equipment;
• consultant services;
• costs related to obtaining security clearance;
• data acquisition;
• data management;
• laboratory analysis services;
• license and permit fees;
• marketing and printing services;
• materials and supplies;
• overhead (administrative) costs (not to exceed 20% of eligible costs for universities and 15% for other eligible recipients);
• participation fees at conferences, committees and events;
• PST, HST and GST net of any rebate to which the recipient is entitled and the reimbursement of any taxes for goods and services acquired in a foreign country net of any rebate or reimbursement received in the foreign country;
• publication and communication services;
• registration fees;
• salaries and benefits;
• training;
• translation services;
• travel; and
• tuition fees.

Costs related to the bed-rest facility and subjects are covered by ESA. Some transportation fees for Concordia isolation studies are covered by ESA or third parties, and would therefore not be covered in the CSA funding agreements.

7. Funding Agreements

7.1 Payments

The CSA and the successful applicants (the recipients) will sign a funding agreement. This represents a condition for any payment made by the CSA with respect to the approved project.

For grant agreements, payments will be made in a lump sum or in instalments as described in the signed agreement. Grant funding agreements will include a clause stipulating the obligation for the recipients to confirm, once a year in the case of multi-year agreements, their eligibility to this Program Component and to inform the CSA in writing of any changes to the conditions used in determining their entitlement and eligibility to this Component.

7.2 Conflict of Interest

In the funding agreement, the recipient will certify that any former public office holder or public servant it employs complies with the provisions of the relevant Conflict of Interest and Post-Employment Code for Public Office Holders and the Value and Ethics Code for the Public Sector respectively.

7.3 Intellectual Property

Applicants to this AO should be aware that the ESA Data Policy applies to their project selected either from the ESA AO for Life Science Research Using the Spaceflight Analogue "Bed Rest" (AO-13-BR) or the ESA Call for Medical, Physiological and Psychological Research Using Concordia Antarctic Station as Human Exploration Analogue (AO-13-Concordia). The projects funded through this AO will be conducted during campaigns organized by ESA, and therefore the ESA Data Policy (quoted in ESA's AO documents) has precedence over the other conditions of Intellectual Property stated below.

The CSA funding agreement establishes that all intellectual property developed by the recipient in the course of the project shall vest in the recipient. When applicable, the funding agreement will include a provision granting to the CSA a non-exclusive, irrevocable, world-wide, free and royalty-free licence in perpetuity to use or sub-licence the use of any such Intellectual Property contained in recipient reports for non-commercial governmental purposes.

7.4 Organizations in Quebec

An organization in Quebec whose operations are partially or fully funded by the province of Quebec may be subject to An Act Respecting the Ministère du Conseil exécutif, R.S.Q., Chapter M-30.

Under Sections 3.11 and 3.12 of An Act Respecting the Ministère du Conseil exécutif, R.S.Q., Chapter  M-30 (hereinafter referred to as the Act), certain entities/organizations, as defined in the meaning of the Act, such as municipal bodies, school bodies or public agencies, must obtain an authorization from the Secrétariat aux affaires intergouvernementales canadiennes du Québec (SAIC), as indicated by the Act, before signing any funding agreement with the Government of Canada, its departments or agencies, or a federal public agency.

Consequently, any entity that is subject to the Act is responsible for obtaining such authorization before signing any funding agreement with the Government of Canada.

Applicants from Quebec must complete, sign and include the M-30 Supporting Documentation form with their application.

7.5 Performance Measurement

The CSA will ask the recipients to report on certain elements of projects such as:

Knowledge

• Knowledge Production (including publications)
• Presentations
• Intellectual Property (including patents)

Capacity

• Project's Research Team (including Highly Qualified Personnel supported)

Collaboration

• Partners contributions
• Partnerships
• Multidisciplinarity

As a courtesy, the CSA would like to receive a copy of publications arising from the work and to be informed in advance of significant press releases or media interest resulting from the work.

7.6 Audit

The recipient of a funding agreement shall keep proper records of all documentation related to the funded project, for the duration of the project and for six (6) years after the completion date of the project, in the event of an audit. This documentation shall be available upon request.

8. Privacy Notice Statement

The CSA will comply with the federal Access to Information Act and Privacy Act with respect to applications received under this Component. By submitting your personal information, you are consenting to its collection, use and disclosure in accordance with the following Privacy Notice Statement, which explains how the applicant's information will be managed.

Necessary measures have been taken to protect the confidentiality of the information provided by the applicant. This information is collected under the authority of the CSA Class Grant and Contribution Program to Support Research, Awareness and Learning in Space Science and Technology – Research Component, and will be used for the evaluation and selection of proposals. Personal information (such as contact information and biographical information) included in the rejected proposals will be stored in a Personal Information CSA Bank for five years and then destroyed (Personal Information File no. ASC PPU045). Personal information included in the successful proposals will be retained along with the proposal results for historical purposes. These data are protected under the Privacy Act. According to the Privacy Act, the data linked to one individual and included in the proposal being evaluated can be accessed by the specific concerned individual who has rights with respect to this information. This individual may, upon request,

1. be given access to his/her data and
2. have incorrect information corrected or have a notation attached.

Applicants should note that for all agreements over $25,000, information related to the funding agreement (amount, grant, name of the recipient and project location) through this Component and the purpose of the funding will be made available to the public on the CSA website.

If you need additional information on privacy matters before sending your proposal, contact Danielle Bourgie, Coordinator, Access to Information and Privacy, at the CSA.

Telephone: 450-926-4866
Email: aiprp-atip@asc-csa.gc.ca

9. Frequently Asked Questions (FAQ)

It is the responsibility of the applicants to obtain clarification of the requirements contained herein, if necessary, before submitting an application. At any point of the process, applicants are welcome to share with the CSA their comments or suggestions regarding the AO, the program or the process.

However, during the course of a competitive AO, for reasons of fairness to all competitors, the CSA cannot provide specific information directly to a company or someone about a potential proposal or any other subjects.

Applicants can also use the generic web-based Comments and Suggestions Box available at www.asc-csa.gc.ca/eng/funding-programs/grants-and-contributions-snapshot.asp#comments.

For any questions related to the AO, applicants can either use the web-based Comments and Suggestion Box or email address (lecedessetc-thegandccoe@asc-csa.gc.ca); both tools are anonymous. The questions and answers related to this AO will be posted on the CSA website in the Frequently Asked Questions section of this AO. The CSA will respond to questions received before November 28, 2014, at 4:00 p.m. (EST).