Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant

Eligibility

For an application to be eligible:

1. The Nominated Principal Applicant (NPA) must be:
   1. an independent researcher or a knowledge user (including a PWLE) 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) at the time of funding.
      • If the NPA is a knowledge user, there must be at least one Principal Applicant (PA) who is an independent researcher;
      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 (individual) 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 funds can be released (see Administration of Funds).
4. The core leadership of the research team must include at least five Principal Applicants (PAs) / Principal Knowledge Users (PKUs) (the NPA can count as one of these five applicants), covering each of the following categories and should aim to represent the diversity of the Canadian population:
   1. A patient (including PWLE);
   2. Two researchers, including at least one  Early Career Researcher (ECR);
   3. A health care provider (e.g., physician; nurse; occupational therapist; Indigenous Elder, healer or Knowledge Keeper; pharmacist; social worker; physiotherapist; psychologist; or other health professional); and
   4. A health system decision maker (i.e., individual empowered to engage with the research project and serve as a conduit of information to and from their respective health system, health care institution, health care centre [including health or wellness centres on-reserve or in urban centres], etc.).
5. One member of the core leadership team* must have successfully completed one of the sex- and gender-based analysis training modules available online through the CIHR Institute of Gender and Health and submit a Certificate of Completion. Select and complete the training module most applicable to your project. Applicants are encouraged to review the page "How to integrate sex and gender in research" on the CIHR website. See How to Apply for more details.
   *Organizations as NPAs: For organizations applying as the NPA, a representative of the organization must complete the training module on the organization's behalf.
6. The research team must have a Sex and Gender Champion and an Equity, Diversity and Inclusion (EDI) Champion:
   1. Combined, the champions must have experience (i) in 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.
   2. These individuals may hold other roles within the team in addition to standing as the team's Sex and Gender and EDI champions.
   3. The Sex and Gender and EDI champion roles may be served by the same individual or different individuals.
7. For applications with an Indigenous Health Research component, the core leadership of the research team (see bullet 4) must include:
   1.  At least one PA/PKU (may be the NPA) who self-identifies as First Nations, Inuit or Métis and/or can provide evidence of having meaningful and culturally safe involvement with Indigenous Peoples.  A one-page document describing how they meet this requirement must be submitted as an "Other" attachment (see How to Apply section).
8. Applicants must secure partner contributions from non-federal sources to match the CIHR contribution at a minimum 1:1 ratio.
   1. Note that federal sources of funds will be accepted within the context of research in collaboration with Indigenous communities. The amount of matching funding from the federal source must be directed towards and commensurate with the proportion of Indigenous-focused research (for example, if 50% of the research is being conducted with Indigenous communities, then 50% of the matched funding can be from a federal source).
9. An applicant can only submit one application as an NPA but can participate in any number of applications in other applicant roles.

Summary

The innovative Clinical Trials (iCT) Initiative was launched at CIHR through SPOR in 2016; 

iCTs use designs that are alternative to traditional Randomized Controlled Trials (RCTs), with application in areas ranging from product development to health system improvement. For example, innovative clinical trials include the use of seamless trial designs, modelling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit–risk determinations, and other novel designs.

iCT methods can reduce the cost of conducting trials, reduce the amount of time needed to answer research questions, and increase the relevance of research findings to patients, healthcare providers and/or policy makers. iCTs funded through SPOR focus on comparative effectiveness and implementation science research and engage a diverse and inclusive range of patients and other knowledge users as part of a multidisciplinary team in the research process in an accessible manner, among other requirements.

SPOR iCTs need to have a complex trial design and a primary focus in:

• Comparative Effectiveness (CE) research: Compares two or more healthcare options already shown to be efficacious. The healthcare options could include diagnostics, drugs, medical devices, surgeries, complementary medicine, self-care or ways to deliver health care. The findings should be able to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different health care options and other type of interventions.
• Implementation Science (IS) research: Examines interventions that are already shown to work under certain conditions and within certain contexts, which could be defined by demographic, biological, clinical, social, economic, geographic, or other factors. The interventions could include diagnostics, drugs, medical devices, surgeries, complementary medicine, self-care, or ways to deliver health care. Implementation science aims to determine if these interventions can be adapted to other contexts, how they should be adapted and the longer-term effects of implementation.

Note: Proposed projects must be an iCT with a POR approach, and incorporate all three (3) key design elements and address two (2) key design considerations (see below). The proposal must clearly describe these design elements and considerations (as applicable) and the evidence-informed policy or intervention of focus for implementation/comparative effectiveness research and the existing evidence base supporting its effectiveness (i.e., this funding opportunity does not support the development of new or pilot interventions).

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Overhead N/A

Submission Process:

The LOI package, plus approval in RMS will be required by RSO by noon on March 17, 2023. Please be sure to select "Submitted for approvals" (Under Save & Progress) in RMS in good time to allow for approvals from your Department Head and/or ADR prior to the Research Services deadline. Consult your department and faculty for more information on their approval processes and timelines.

Do not submit through ResearchNet until RSO's approval has been granted. 

Institutional signature not required for LOI stage; submit application in ResearchNet by 6:00PM Calgary time on March 22, 2023. 

Full application, plus approvals in RMS, will be required by RSO by noon on Friday, July 7, 2023. Please be sure to select "Submitted for approvals" (Under Save & Progress) in RMS in enough time to allow for approvals from your Department Head and/or ADR prior to the internal RSO deadline. Consult your department and faculty for more information on their approval processes and timelines.

Do not submit through ResearchNet until RSO's signature has been granted!! 

Once institutional signature has been obtained, the NPA will receive an automated message from RMS to their ucalgary email address. A copy of the CIHR signature page will be available via the RMS record, under Documents. Upload the CIHR signature page and routing slip in the Print/Upload Signature Pages task in ResearchNet by 6:00PM Calgary time on Wednesday, July 12, 2023.