ResearchNet - RechercheNet

Funding Organization
Canadian Institutes of Health Research
Program Name
Team Grant : Pediatric Rare Disease Clinical Network ARCHIVED
(National Pediatric Rare Disease Clinical Trials and Treatment Network)
Sponsor(s)

CIHR, under the scientific leadership of the CIHR Institute of Genetics, and in partnership with the Government of Canada's National Strategy for Drugs for Rare Diseases.

Program Launch Date
2023-06-13
Deadline Date
TBD

Important Dates

Competition Expression of Interest (202310DCN)
CLOSED
Full Application (202310DCN)
CLOSED
Application Deadline 2023-06-27 2023-10-24
Anticipated Notice of Decision 2023-07-04 2024-02-14
Funding Start Date N/A 2024-01-01

Notices

The content of this funding opportunity has been updated
Date updated: 2023-07-14
Section(s) updated: How to Apply

On July 14, 2023, CIHR introduced the Manage Access task to allow a Nominated Principal Applicant (NPA) to delegate access to individuals on their team to support the completion of their application. Please see the How to Apply Instructions for further details.

Expression of Interest

All applicants interested in submitting, participating in and/or joining an application to this call must submit an Expression of Interest (EOI) by email entitled "EOI: National Pediatric Rare Diseases Clinical Trial and Treatment Network" to support-soutien@cihr-irsc.gc.ca no later than 8:00 p.m. (EDT) on June 27, 2023. Note that this task is mandatory to be eligible to submit a Full Application as a Nominated Principal Applicant. While there will only be one grant awarded, collaborations are highly encouraged. See the How to Apply section for more details.

Collaboration Call

CIHR will schedule a Collaboration Call for July 6, 2023 at 1pm EST, with those who submitted an EOI. The Nominated Principal Applicant (NPA) participation is mandatory. The goals of this call will be to: (1) support participants with the requirements of this funding opportunity; (2) allow participants to explore potential collaborations across teams prior to the submission of the Full Application; and (3) answer questions. A formal meeting invite will be sent by email following the EOI deadline. Note that participating in the collaborative call is mandatory to be eligible to submit a Full Application as a NPA.

Table of Contents

Description


Background

Rare Diseases (RDs) constitute an under-recognized global health priority. In fact, notwithstanding their name, RDs are far from rare. The population prevalence of RDs is reported at 3.5-6.0% and affect as many as 446 million people globallyFootnote 1. By extrapolating data generated in studies conducted in other countries to Canada, we can estimate that most pediatric hospital beds are occupied by rare diseases patients, that a minimum of 5% to 10% of all hospitalization costs in Canada are tied to rare diseasesFootnote 2, that 563,000 to 2,331,000 Canadians are living with rare diseasesFootnote 1 and that, on an annual basis, 14,000 Canadian kids under 15 die from a rare diseaseFootnote 3. Taken collectively, these numbers would make "rare disease land" the world's third most populous country.

Using current clinical diagnostic pathways, a RD takes an average of five years to diagnose, with 2-3 misdiagnoses prior to the correct diagnosis. This diagnostic odyssey, along with social isolation, an absence of care coordination and attendant socio-economic and mental health burdens are too often the norm for those living with RDs. Compounding the situation is the fact that more than two thirds of RDs have a pediatric onsetFootnote 1,Footnote 2,Footnote 4

There is an increased awareness and recognition of the profound morbidity and mortality caused by RDs Footnote 5. In response to the burden posed by RDs, as well as the fundamental inequities faced by those affected, the UN High Commissioner for Human RightsFootnote 6 has designated RDs as a priority for the conceptualization and implementation of Universal Health Coverage. There are medical, economic and human rights imperatives to address these issues.

Purpose

This investment will catalyze the creation of a Pediatric Rare Disease Clinical Network to streamline rare diseases clinical research across Canada and to facilitate the collaboration among researchers across pillars, people with lived and living experience (e.g., patients, family, caregivers), health care providers, industry, policy and regulatory bodies. This Network will maximize synergies to advance discovery across the rare disease continuum from prevention to diagnosis through to treatment and survivorship to improve health outcomes for children and adolescents affected by rare diseases. The aim is to support national and international clinical trials to rapidly advance discoveries to support rare diseases patients and their families across Canada. It will maximize the impact of the Government of Canada's efforts deployed in the regulatory modernization for health products, improve Canada's standing globally, and attract industry dollars for future investments and sustainability.

Role and Contributions of Applicant Partners: CIHR recognizes that a broad range of partners may be relevant to this opportunity and it is expected that applicant(s) describe the role of all applicant partners and how/if they will contribute to research related activities. Any consideration of risk and/or conflict of interest should also be explained, as appropriate.

Funds Available

CIHR and partner(s) financial contributions for this initiative are subject to availability of funds. Should CIHR or partner(s) funding levels not be available or are decreased due to unforeseen circumstances, CIHR and partner(s) reserve the right to reduce, defer or suspend financial contributions to grants received as a result of this funding opportunity.


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Objectives


The specific objectives of this funding opportunity are to:

These objectives are to be supported by the following key design elements/components which must be included in the Network:


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Eligibility


Eligibility to Apply

For an application to be eligible, all the requirements stated below must be met:

  1. The Nominated Principal Applicant (NPA) must be:
    1. an independent researcher affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge translation).
      OR
    2. an individual affiliated with an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate.
      OR
    3. an Indigenous non-governmental organization in Canada with a research and/or knowledge translation mandate.
  2. The NPA must have their substantive role in Canada for the duration of the requested grant term.
  3. The Institution Paid must be authorized to administer CIHR funds before the funding can be released (see Administration of Funds).
  4. The research team must include an Early Career Researcher (ECR) identified as a Principal Applicant (PA).
  5. At least one project participant must be a knowledge user (including but not limited to decision makers, policy-makers, clinician scientists, health professionals) identified as Principal Knowledge User (PKU) or Knowledge User (KU).
  6. In addition to the Nominated Principal Applicant and Knowledge User, at least one Co-Applicant must be a patient.
  7. The applicant team must include at least one applicant who self-identifies as Indigenous (First Nations, Inuit or Métis) and/or provides evidence of having meaningful and culturally safe involvement with Indigenous Peoples.
  8. The applicant team must have a Sex and Gender Champion and an Equity, Diversity and Inclusion (EDI) Champion :
    • Combined, the champions must have experience in (i) sex- and gender-based analysis (SGBA) or with gender diversity in the community; (ii) fostering EDI in research and/or applied settings (e.g., promoting equitable access to research participation or inclusion of typically underrepresented population groups in decision making), and (iii) creating Sex and Gender and EDI plans for diversity of team composition;
    • These individuals may hold other roles within the team in addition to standing as the team's Sex and Gender and EDI champions;
    • The Sex and Gender and EDI champion roles may be served by the same individual or different individuals.
  9. The applicant team must include representation from a minimum of five provinces/territories

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Guidelines


General CIHR Policies

Before submitting an application to this funding opportunity, applicants should review the relevant policies and guidelines on the CIHR Funding Policies page to ensure understanding of their responsibilities and expectations.

Equity, Diversity and Inclusion and Indigenous Rights

CIHR is committed to promoting the inclusion and advancement of groups historically excluded from science as one of the means to enhance excellence in research, training and knowledge mobilization. This means recognizing and reducing systemic barriers, mitigating biases, as well as including and benefiting from the full pool of talented researchers and trainees in the system. CIHR's position on equity, diversity and inclusion (EDI) is available in the Tri Agency Statement on Equity, Diversity and Inclusion.

CIHR recognizes that First Nations, Métis and Inuit are rights-holding as First Peoples of Canada and may not consider themselves to be part of equity-seeking groups (e.g., women, racialized minorities, persons with disabilities and members of 2SLGBTQI+ communities). Taking a rights- and distinctions-based approach to Indigenous self-determination in research is important to reflect this position and to strengthen Indigenous health and well-being. CIHR's commitment to supporting Indigenous self-determination in health research is available in the CIHR Strategic Plan 2021–2031 and the Action Plan: Building a healthier future for First Nations, Inuit, and Métis peoples.

Allowable Costs

Applicants are advised to consult the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Guide on Financial Administration (TAGFA) to determine if an expenditure is an appropriate use of grant funds.

To further clarify, the following expenses are examples of appropriate uses of grant funds, provided they satisfy the principles and pertinent directives of the TAGFA:

Use of Personal Information

Conditions of Funding


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Review Process and Evaluation


Relevance Review Process

CIHR-Institute of Genetics will perform a relevance review to identify applications that are in alignment with all objectives of this funding opportunity.

Applications that are not deemed to be relevant will be withdrawn from the competition.

Review Process

Peer review will be conducted in accordance with the priority-driven initiatives review guidelines.

Iterative review may be implemented at the Full Application stage should the review panel conclude that clarifications and/or adjustments to protocol, outcomes, or other proposal elements are required. The applicants may be asked to meet with the peer review panel if necessary to provide more clarity about their application. The final funding recommendation will take into consideration the answers provided by the applicants.

For information on CIHR's peer review principles, see the Peer Review: Overview section of CIHR's website.

Evaluation Criteria

To support the strategic objectives of this funding opportunity, the following evaluation criteria will be used:

  1. Quality and Feasibility of the Network Approach:
    1. Extent to which the proposal responds to the description, including all six objectives and key design components of this funding opportunity.
    2. Feasibility of the proposed network approach (including timeline, participant and stakeholder engagement, leveraging existing networks nationally and internationally, budget, etc.)
    3. Extent to which there is potential impacts for rare diseases clinical management.
    4. Quality and appropriateness of the applicants' proposed plan for the consideration of EDI at all stages and including the incorporation of biological variables (e.g., sex, age) and/or sociocultural identity factors (e.g., gender, race, ethnicity, language) into the activities proposed, where applicable.
    5.  Are the approaches, methods and integration of sex and gender appropriate to deliver the proposed output(s) and achieve the proposed contribution(s).
    6. Quality and appropriateness of the team's commitment to engaging a diversity of members – including but not limited to Black and other communities impacted by racism, First Nations, Métis and Inuit where issues related to Indigenous health and/or communities are relevant, in particular related to how they will address team composition and recruitment processes; core Network activities; and/or knowledge mobilization activities. Refer to the Best practices in Equity, Diversity and Inclusion in Research for additional guidance
  2. Quality of Applicants:
    1. Relevant track record of team members in providing leadership and successfully engaging a diverse group of collaborators, including patients, to advance a complex entity.
    2. Demonstrated relationships and connections with multiple stakeholders and partners from diverse research areas and sectors involved in clinical trials research, including but not limited to Black and other communities impacted by racism, First Nations, Inuit and Métis communities.
    3. Extent to which the overall team has the necessary knowledge, expertise and experience to work in Indigenous communities in a meaningful and culturally safe way.
    4. Demonstration of the potential for success for those in early career stages or from non-academic backgrounds based on other activities and roles.
    5. Extent to which the team includes pan-Canadian representation.
    6. Appropriateness of information provided to justify team membership, to identify possible gaps in membership, and the plans proposed to fill those gaps.
  3. Governance, Management, and Operations:
    1. Quality and appropriateness of the proposed governance plan.
    2. Appropriateness of the plan to manage sustainability of the Network beyond the funding period, including feasibility and transparency of proposed processes.
    3. Quality and appropriateness of the strategy to engage key stakeholders to develop, implement and maintain a pediatric rare diseases clinical trial network.
    4. Extent to which the Network is positioned to address and respect Indigenous data governance, by applying the First Nations Principles of OCAP® Footnote 1, the CARE Principles, or other principles of Indigenous data governance, if applicable.
    5. Relevance and value of collaborations and partnerships to the objectives of this funding opportunity.
    6. Proactive and meaningful consideration of partnership risks, including the extent of real and/or perceived conflict of interest and appropriateness of its management and mitigation (if applicable).
  4. Impact of Network Activities:
    1. Clear justification for the Network's approach to use funding to enhance coordination, build capacity and make significant contributions to the advancement of pediatric rare disease clinical trials in Canada in support of improving the lives of Canadians.
    2. Quality of the knowledge mobilization plan to accelerate availability of high-quality and real-time evidence for research, policy and/or clinical practice, including ensuring that the evidence is relevant, timely and continues to align with the objectives of this funding opportunity.
    3. Extent to which there is potential impacts for rare diseases clinical management.
    4. Quality of the approach to develop and increase pan-Canadian collaborations and for engaging researchers and/or organizations focusing on clinical trials and care.
    5. Appropriateness of the approach to developing and increasing international linkages, including liaison activities and related knowledge mobilization activities to maximize the impact and international visibility of the Network.
    6. Extent of the role(s) and contribution(s) of all applicant partner(s) in advancing the impact and reach of the Network (if applicable).
  5. Budget:
    1. Appropriateness of the budget and justification for amount requested.
    2. Feasibility of proposed activities based on available budget.

Funding Decision

The names of successfully funded applicants will be published on the CIHR website.

Partner and Internal Collaborator Participation

The opportunity to add new partners and internal collaborators to this funding opportunity may arise after publication. These partners and internal collaborators may not be listed; however, the principles that govern relevance review, including consent to share information and funding decisions, will still apply.


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How to Apply


Step 1 – Expression of Interest (EOI)

The objective of the EOI is to enable applicants to signal interest in submitting, participating and/or joining applications to this call. It will also facilitate participation in the Collaboration Call and subsequent stages of this competition. While there will only be one grant awarded, collaboration is highly encouraged.

Note that this task is mandatory to be eligible to submit a Full application as the Nominated Principal Applicant (NPA).

Step 2 – Collaboration Call

Step 3 – Full Application

Specific instructions to complete your ResearchNet application

Task: Identify Participants

Task: Enter Proposal Information

Task: Complete Summary of Research Proposal

Task: Enter Budget Information

Task: Attach Other Application Materials

Other – attach the following under "Other":

Task: Manage Access (optional)

  • The Nominated Principal Applicant (NPA) can delegate access to a maximum of five individuals to support the completion of the application. Note: A delegate's access does not carry over from one stage of the competition to another (i.e., from the registration to the application stage). The NPA will need to delegate access at each stage of a competition. NPAs should revoke delegates' access prior to completing the Consent and Submit tasks if they do not want them to retain access to submitted applications via their Completed Activities tab. For more information, please see the Frequently Asked Questions (FAQ).(Updated: 2023-07-14)

Task: Print Signature Pages


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Contact Information


For all inquiries, please contact:

CIHR Contact Centre
Telephone: 613-954-1968
Toll Free: 1-888-603-4178
Email: support-soutien@cihr-irsc.gc.ca

For service hours, please consult our Contact us page.


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Sponsor Description


Note: Additional partners/internal collaborators, including from industry and the private sector, may join this funding initiative over the coming year.

Internal Collaborators

Canadian Institutes of Health Research
At the Canadian Institutes of Health Research (CIHR), we know that research has the power to change lives. As Canada's health research investment agency, we collaborate with partners and researchers to support the discoveries and innovations that improve our health and strengthen our health care system.

CIHR – Institute of Genetics
The Institute of Genetics (IG) supports research on the human and model genomes and on all aspects of genetics, basic biochemistry and cell biology related to health and disease, including the translation of knowledge into health policy and practice, and the societal implications of genetic discoveries.


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Additional Information


Administration of Funds

Funds will only be released to the institution or organization identified as the Institution Paid. If the Institution Paid is not already authorized to administer CIHR funds, for the duration of the grant term, it may be required to undergo a financial and eligibility review and sign a funding agreement, or the successful applicant may choose to have their funds administered by a CIHR eligible institution. Please contact the Contact Centre to enquire about the process.

Definitions:


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Date Modified: