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New Investigator Award

Submission Guidelines

(Fall 2023 Competition)

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Heart & Stroke

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Table of Contents

A. General Information 4 1) New Investigator Awards 4 2) Application Submission Deadline 4 3) Incomplete/Unacceptable Applications 4 4) Re-Applying to the New Investigator Competition 4 5) Competition Results 4 6) Non-Employee Status 4 7) Public Information 5 8) Ethical Requirements 5 9) Sex and Gender-Based Analysis and Reporting (SGBAR) 5 10) Equity, Diversity and Inclusion (EDI) 6 11) co- Mentorship 7 12) Indirect Costs 7 13) Open Science and Open Access to Research Outputs Policy 7 14) Publications 8 15) Four Themes of Health Research 8 16) Lay Reviewers 9 17) Multiple Submissions 9 18) Transfer of Award 9 19) Status of Publications 9 20) Partial Awards 9 B. Research Integrity Policy 10 C. Specific Program Information 11 1) Description 11 2) Eligibility Criteria 11 3) Evaluation Criteria 12 4) Tenure / Stipend and Allowances 12 4.1 Tenure 12 4.2 Stipend and Allowances 12 5) Application 13 6) Special Awards 14 7) Contact 15 Heart & Stroke

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A. General Information

1) New Investigator Awards

The New Investigator (NI) program is a salary award to support new investigators who have demonstrated excellence in their doctoral and post- doctoral training and wish to establish their own independent research career. Salary awards provide an added incentive for researchers to continue or begin their program of cardiovascular or cerebrovascular research within Canada. 2) Application Submission Deadline

Applications for the New Investigator award must be submitted by 16:00 (EDT) on September 7, 2023, using the Heart & Stroke’s electronic grant management system (CIRCUlink). CIRCUlink will not accept submissions after this deadline. Any applications attempted or submitted after the deadline will NOT be accepted. There will be no appeal process to late submissions. It is the applicant’s responsibility to ensure that a completed application, including letters of support and all required signatures, is submitted online via CIRCUlink prior to the deadline. Applications will not be accepted by email.

Heart & Stroke will decline late or incomplete applications. There will be no appeal process. 3) Incomplete/Unacceptable Applications

All applicants are strongly cautioned to carefully read and follow the instructions and requirements outlined in this guideline document. All submissions are considered final, no alterations or changes will be accepted.

In order to maintain the principle of fairness to all applicants, regulations must be adhered to in the preparation of a New Investigator application. Any infraction of the rules will lead to the truncation or immediate rejection (without appeal) of the application. Any incomplete applications, applications without required signatures or support letters, and/or applications that do not respect the set-page limitations as noted in this guideline document, will not be admissible to the competition.

4) Re-Applying to the New Investigator Competition If three (3) unsuccessful New Investigator applications have been made, a subsequent application will be considered only in unusual circumstances.

5) Competition Results

Early notification (not likely to be funded/may or may not be funded/most likely to be funded) may be sent to applicants in early 2024. The release of early notifications is dependent on funding availability and on the timing of peer review and availability of funding. Applicants will be advised of any changes to program milestones via email.

Official/final notifications will be sent to applicants by the end of May 2024 or an update on notifications will be provided prior to that date.

6) Non-Employee Status

The granting of an award is deemed to establish neither an employer-employee relationship nor a partnership between the grantor and the grantee.

Heart & Stroke

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7) Public Information

Successful applicants need to be aware that the title of their research program and the lay summary will be placed into the public domain or included in Heart & Stroke publications without notification. Applicants are cautioned not to disclose information that could endanger a proprietary position in these sections. Successful applicants may be asked to help us communicate the importance of research to Heart & Stroke donors and the public. Raising funds to support research is difficult and more than ever we need to let our donors and the public know that their donations are being used to support world class research. Applicants are well-positioned to explain the role of research in increasing heart health and reducing the burden of heart disease and stroke and may be asked to serve as a spokesperson or to work with us to profile their research.

8) Ethical Requirements

By signing and submitting applications to Heart & Stroke, applicants undertake the responsibility to ensure any experimentation will be acceptable to the institution on ethical grounds and comply with the following guidelines and host institution research policies, as applicable: Applicants must ensure all experiments comply with the following guidelines and host institution research policies, as applicable:

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans1.

• Good Clinical Practice (GCP).

• Good Laboratory Practice (GLP).

• In the case of laboratory animal experimentation, the guiding principles and standards that have been enunciated by the Canadian Council on Animal Care2.

• Guidelines and standards for biological and chemical hazards as outlined in the Public Health Agency/Canadian Food Inspection Agency’s Canadian Biosafety Standards and Guidelines3.

• Any research involving human pluripotent stem cells must adhere to the CIHR Guidelines for Human Pluripotent Stem Cell Research4. The institution must notify Heart & Stroke as to the results of the review by the CIHR’s Stem Cell Oversight Committee. 9) Sex and Gender-Based Analysis and Reporting (SGBAR) Heart & Stroke has committed to advancing sex and gender-based analysis and reporting (SGBAR) and improving health for all. Applicants are required to integrate SGBAR in their research design. Any application that does not incorporate SGBAR must provide a rationale why it would not be relevant to the project.

All applicants are strongly encouraged to complete CIHR’s Institute of Gender and Health online training modules.

Applicants engaging in clinical trial-based research are also strongly encouraged to complete Women’s College Hospital’s Sex -Specific Analysis and Reporting in Clinical Trials online training module.

Please see resource documents: Glossary of SGBAR & EDI Terminology and List of SGBAR and EDI E- Learning and Resources for Researchers for a glossary of key terminology and additional learning resources, respectively.

1 See www.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ for details. 2 See www.ccac.ca/en_/standards/guidelines for details. 3 See http://canadianbiosafetystandards.collaboration.gc.ca/index-eng.php for details. 4 See http://www.cihr-irsc.gc.ca/e/15255.html for details. Heart & Stroke

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10) Equity, Diversity and Inclusion (EDI)

Heart & Stroke has committed to advancing equity, diversity and inclusion (EDI) and improving health for all. This commitment applies across our organization, including to our research investment and our desire to strengthen the quality and impact of the research we fund and, ultimately, improve health outcomes for all people in Canada.

Equity5 is defined as the removal of systemic barriers and biases, enabling all individuals to have equal opportunity to access and benefit from the research, with a focus on those bearing a disproportionate burden of disease which includes but is not limited to: women, Indigenous peoples, persons with disabilities, members of visible minorities/racialized groups, and members of LGBTQ2+ communities.

Diversity is defined as differences in race, colour, place of origin, religion, immigrant and newcomer status, ethnic origin, ability, sex, sexual orientation, gender identity, gender expression and age.

Inclusion is defined as the practice ensuring that all individuals are valued and respected for their contributions and are equally supported.

To create and sustain positive change in the heart and stroke research ecosystem, principles of EDI need to be integrated across the research system, including in research practice and in research design. Applying an EDI lens enhances the specificity, representativeness, rigour and transparency of research. As part of a larger body of EDI resources being developed across the Tri-Agencies, the Social Sciences Research Council (SSHRC) has developed a robust guideline to support the integration of EDI principles into research. They provide distinct descriptions of what this means in terms of both research practice and research design:

EDI in research practice (EDI-RP) involves promoting diversity in team composition and trainee recruitment; fostering an equitable, inclusive and accessible research work environment for team members and trainees; and highlighting diversity and equity in mentoring, training and access to development opportunities.

EDI in research design (EDI-RD) involves designing research so that it takes EDI into account through approaches that may include intersectionality, sex and gender-based analysis and reporting (SGBAR), anti-racism, and disaggregated data collection and analysis, among others. These approaches necessitate consideration of diversity and identity factors such as, but not limited to: age, culture, disability, education, ethnicity, gender expression and/or gender identity, immigration and/or newcomer status, Indigenous identity, language, neurodiversity, parental status/responsibility, place of origin, religion, race, sexual orientation, and socio-economic status. Applicants are encouraged to describe how EDI considerations have been integrated in their research design (EDI-RD), as appropriate. For example, applicants may elect to provide a description of why specific diversity or identity factors were selected for inclusion and analysis in their research (e.g race, immigration or newcomer status), describe the process of developing and maintaining a respectful relationship with the intended study population, or discuss why they do or do not intend to collect, analyze and report disaggregated data.

5 EDI terminology has been adapted from: Guide to Addressing Equity, Diversity and Inclusion Considerations in Partnership Grant Applications (SSHRC, 2021)

Heart & Stroke

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Indigenous Research (research that is conducted by, grounded in or engaged with First Nations, Inuit, Métis or other Indigenous nations, communities, societies or individuals, and their wisdom, cultures, experiences or knowledge systems, as expressed in their dynamic forms, past and present) must be done with a commitment to respectful relationships with Indigenous Peoples and communities. See List of SGBAR and EDI E-Learning and Resources for Researchers for relevant resources EDI considerations will not be explicitly included in the evaluation criteria in the 2024-2025 competition. Heart & Stroke anticipates further incorporating and formalizing evaluation of EDI considerations into grant review in subsequent competitions. Heart & Stroke is committed to building capacity within the heart and brain health research communities and systems for the integration of EDI into research practice and design. This will be supported though learning and skill building opportunities for trainees and researchers, connecting trainees and researchers to EDI best practice guidelines for research, and through the development of partnerships with other funders and facilitators within the research environment. Applicants are strongly encouraged to complete Women’s College Hospital’s Intersectionality as a Research Lens Training Module and CIHR’s Unconscious Bias in Peer Review Training Video Module.

Please see resource documents: Glossary of SGBAR & EDI Terminology and List of SGBAR and EDI E- Learning and Resources for Researchers for a glossary of key terminology and additional learning resources, respectively.

11) co- Mentorship

Heart & Stroke recognizes that successful mentorship is vital to career development and success. Mentors provide advice, counsel, feedback, and support related to career and personal development. Mentors can also serve as sponsors, collaborators, authors, or coaches. Mentoring can support skill and knowledge development across many domains including, but not limited to, research knowledge, skills, abilities, and techniques; knowledge and skills required to work with others, translate knowledge or widen the impact of research; knowledge of research standards, requirements and practices; and development of personal attributes, skills and characteristics necessary for success. Mentors also provide access to their social networks, providing mentees with research connections that would otherwise be unavailable to them.

Applicants are required to identify a minimum of one mentor and describe, in a co-signed one-page letter, both the mentorship approach for the first year of the award and provide a three-year mentorship plan. Note that Heart & Stroke employees cannot act in this formal mentorship role. 12) Indirect Costs

Heart & Stroke supports only the direct costs of research. No funding is to be used for indirect costs of research. The definition of indirect costs of research for the purposes of this policy is; costs which cannot be directly associated with a particular research program or operating grant, including costs associated with the general operation and maintenance of facilities (from laboratories to libraries); the management of the research process (from grant management to commercialization); and regulation and safety compliance (including human ethics, animal care and environmental assessment); and generic institutional/departmental taxes/tithes related to services. 13) Open Science and Open Access to Research Outputs Policy Open Science6 is the practice of making scientific inputs, outputs and processes freely available to all with minimal restrictions. Scientific research outputs include (i) peer- reviewed science articles and publications, (ii) scientific and research data and (iii) public contribution to and dialogue about science.

6Government of Canada, Roadmap for Open Science, www.ic.gc.ca/eic/site/063.nsf/eng/h_97992.html#8 Heart & Stroke

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Open Science is enabled by people, technology, and infrastructure. It is practiced in full respect of privacy, security, ethical considerations, and appropriate intellectual property protection.

Sharing data, information, tools, resources, and results and eliminating barriers to collaboration will accelerate the creation and exchange of knowledge to improve health. Heart & Stroke requires that all researchers supported in whole or in part through Heart & Stroke make their research outputs publicly available as soon as possible but no later than twelve (12) months after the final publication or availability of results. In this policy, Heart & Stroke defines research outputs as peer- reviewed journal publications, research data, and the results of clinical trials that will not be published in peer-reviewed journals. Compliance with the Open Access to Research Outputs policy is a condition of acceptance of all Heart & Stroke research funding. Please see Heart & Stroke’s Open Access to Research Outputs available at: Open Access to Research Outputs Policy: Guidelines. Heart & Stroke encourages New Investigators to use the open science principles (FAIR: Findable, Accessible, Interoperable, and Reusable) as a guide to sharing outputs and eliminating barriers to collaboration. At this time, proposed Open Science efforts will not be explicitly included in the evaluation criteria. Heart & Stroke anticipates incorporating Open Science into peer review in subsequent competitions.

To learn more about Open Science and the federal government’s Open Science roadmap see https://www.ic.gc.ca/eic/site/063.nsf/eng/h_97992.html. When appropriate researchers are also required to register their projects through the appropriate registration mechanism (i.e. www.clinicaltrials.gov or PROSPERO). 14) Publications

Recipients of Personnel Awards must acknowledge the support of Heart & Stroke in all scientific communications and press releases related to their award with the following wording: “This work was supported by the Heart and Stroke Foundation of Canada”. To facilitate the implementation of Heart & Stroke’s program for knowledge transfer and exchange and to demonstrate accountability for use of research funding, Heart & Stroke must be notified in advance of the publication date of any major publications arising from research funded by Heart & Stroke by email at: ady0an@r.postjobfree.com . 15) Four Themes of Health Research

New Investigator applicants must estimate what proportion of the proposed research falls under the four

(4) health research themes.

The four (4) themes of health research as defined by the CIHR are: Basic Biomedical (I)

Research with the goal of understanding normal and abnormal human function, at the molecular, cellular, organ system and whole-body levels, including the development of tools and techniques to be applied for this purpose; developing new therapies or devices which improve health or the quality of life of individuals, up to the point where they are tested on human subjects. Studies on human subjects that do not have a diagnostic or therapeutic orientation. Clinical (II)

Research with the goal of improving the diagnosis and treatment (including rehabilitation and palliation) of disease and injury; improving the health and quality of life of individuals as they pass through normal life stages. Research on, or for the treatment of, patients. Health Services/Systems (III)

Research with the goal of improving the efficiency and effectiveness of health professionals and the health care system, through changes to practice and policy. Health services research is a Heart & Stroke

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multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviours affect access to health care, the quality and cost of health care, and ultimately our health and well- being.

Social, Cultural, Environmental and Population Health (IV) Research with the goal of improving the health of the Canadian population, or of defined sub- populations, through a better understanding of the ways in which social, cultural, environmental, occupational, and economic factors determine health status. 16) Lay Reviewers

Heart & Stroke incorporates lay reviewers on Scientific Review Committee (SRC) panels to increase accountability and transparency of the Heart & Stroke review process and to ensure the research is aligned with its goals and mission. Heart & Stroke places a high priority on ensuring appropriate lay summaries are submitted as part of each application. If the application is accepted for funding and the lay summary is identified as unsatisfactory, funds will be encumbered pending receipt of a satisfactory lay summary.

Please note that lay reviewers are only provided access to the lay summary of an application, and not an application in its entirety; as such, the lay structured lay summary should include all pertinent information related to the application. The structured lay summary should be written for a patient, caregiver, or community member audience so that it is easily understood by a non-technical audience; it should inspire and speak to relevance and meaningfulness of the work and to the desired outcomes. To ensure that the requirement for readability is met, you are strongly encouraged to use commercially available tools to determine the readability level of your lay summary. 17) Multiple Submissions

Multiple submissions from a single individual for a Heart & Stroke New Investigator Award are not permitted. Where partnership programs are in place, the applicant must contact Heart & Stroke for more information.

18) Transfer of Award

New Investigator Awards may not be assigned or transferred to another individual under any circumstances.

19) Status of Publications

Manuscripts may not be attached unless they have been submitted or accepted to a pre-print server or submitted or accepted for publication in a peer-reviewed journal. Any manuscript included with an application must be accompanied by documentation confirming its status. Any manuscript included with an application must be accompanied by documentation from a journal verifying that the manuscript has been submitted, is accepted for publication, or is in press. Only updates to the three (3) representative publications included with the application will be accepted. Heart & Stroke will not accept letters indicating confirmation of acceptance for publication of a paper after December 1, 2023. 20) Partial Awards

Partial awards of less than one (1) year are not available to New Investigator Award applicants. Heart & Stroke

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B. Research Integrity Policy

The primary objective of Heart & Stroke’s Research Integrity Policy is to protect and defend the integrity of the research process and to deal with allegations of scientific misconduct in a timely and transparent fashion. Responsibilities of researchers, institutions and Heart & Stroke with respect to research integrity are outlined in the Heart & Stroke Framework: Responsible Conduct of Research. As a condition of funding, all Heart & Stroke grant and award recipients agree to comply with the Principles and Responsibilities set out in that policy, and the research misconduct provisions below. Heart & Stroke defines research misconduct to include actions that are inconsistent with “integrity” as defined by the Tri-Agency Framework, and to include such actions as fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.7 Heart & Stroke will deal with allegations of scientific misconduct in the following manner:

• Any allegation of scientific misconduct will be initially reviewed by Heart & Stroke to determine whether an investigation is warranted. If it is felt that an investigation is required, Heart & Stroke may request that this be conducted by the host institution of the individual considered to have performed the alleged misconduct. In allegations specifically related to the peer review process, the investigation may be conducted jointly by the institution and Heart & Stroke.

• Heart & Stroke will not act on verbal allegations of misconduct. All allegations must be submitted in writing. Although the confidentiality of persons who submit an allegation of scientific misconduct will be protected as much as possible, it must be recognized that due process will often result in the identity of this person being released to the investigating institution.

• The institution will be required to submit a written report upon conclusion of the investigation. This report will summarize the findings of the investigation and any future actions that will be undertaken by the institute as a result of the findings.

• In cases where misconduct is concluded to have occurred, Heart & Stroke may apply sanctions against the individual(s) implicated. These sanctions will range from a reprimand letter to a ban from applying for or holding Heart & Stroke funds for a set period of time.

7 Wording adopted from the US Department of Health and Human Services, Public Health Service Policies on Research Misconduct, Final Rule. May 17, 2005. Definitions are available from. https://ori.hhs.gov/definition-misconduct Heart & Stroke

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C. Specific Program Information

1) Description

Heart & Stroke New Investigator Award

The Heart & Stroke New Investigator (NI) award provides salary support to individuals who have clearly demonstrated excellence during their doctoral and post-doctoral training in cardiovascular or cerebrovascular research.

A limited number of New Investigator awards will be supported by the Heart & Stroke at any given time.

All awards become tenable July 1 following the announcement of the competition results. 2) Eligibility Criteria

Equity, diversity, and inclusion (EDI) in research environments enhances excellence, innovation and creativity. Heart & Stroke is committed to excellence through equity and encourages applicants from diverse and equity deserving groups to apply to our funding opportunities. 2.1 General –New Investigator

a. A New Investigator may not be in receipt of another major Personnel award from another national funding agency at the same time as holding a Personnel Award from Heart & Stroke. Likewise, an awardee may not concurrently hold a Canada Research Chair and a Heart & Stroke New Investigator, Alberta New Investigator, or an Ontario Clinician Scientist award. In addition, an awardee may not hold two Heart & Stroke Personnel Awards (national and provincial) concurrently. However, an awardee may accept supplemental funding; no greater than 50% of the value of the Heart & Stroke award if it is from a local or provincial funding source. b. At the time of submission, the applicant must have a full-time appointment at the Assistant Professor level or above in Canada;

c. At the time of submission, and for the duration of the award, award recipients are ineligible if they hold or have already held funding, directly or indirectly, from the tobacco industry. d. The applicant should clearly demonstrate the potential to become an independent investigator. e. At the time of submission, no more than five (5) years may have passed since the date of the first faculty appointment at the Assistant or Clinical Assistant Professor level. This would include Adjunct positions in a research track for which the applicant is eligible to write a Grant-in-Aid as a Principal or Co-Principal Investigator. The date of first faculty appointment will be based on the date listed in the Common CV (i.e., under Employment). f. Applications for this award must be supported by the university or institution at which the applicant will conduct the proposed research program. The university or institution is expected to guarantee the applicant appropriate academic rank and to provide adequate space and facilities for the investigator’s research, commensurate with the status of the individual’s experience and level of support from Heart & Stroke.

g. The applicant must have an MD, PhD, or equivalent degree. h. The Dean and Department Head (or institutional equivalents) must guarantee at least 75% of the applicant’s time will be allocated to the proposed research program. i. The applicant must hold an operating grant in support of the proposed research program at the time of this award; such grant(s) may be from Heart & Stroke and/or other granting agencies. The research grant support has the following additional requirements: i) For each year of the three (3) years of the award, the recipient must be a Principal or Co- Principal Investigator on a peer-reviewed grant originating from a national or provincial funding agency, irrespective of the amount of the grant. ii) The recipient must have at least $30,000 per year of research funding for which the recipient is Principal or Co-Principal Investigator. Heart & Stroke

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iii) Peer reviewed/Non-Peer reviewed funding

• For years one (1) and two (2) of the award, research funding may originate from peer-reviewed and non-peer-reviewed sources.

• For year three (3) of the award, research funding must originate from peer-reviewed sources.

3) Evaluation Criteria

a. All applications undergo peer review by the SRC. b. The major criteria in evaluating the applications will be: i. Academic and research background of the applicant; ii. Research environment; and

iii. The quality of the research program.

4) Tenure / Stipend and Allowances

Award Name Eligibility Value/year Duration

New Investigator

0-5 years $60K* 3 years

* See Special Awards (section 6, page 14)

4.1 Tenure

a. The award will be for a period of three (3) years. The award cannot be renewed for a second term.

b. The recipient will be considered as an employee of the sponsoring university or institution and funds granted will be paid to the institution for payment to the recipient. The recipient will enjoy the benefits of a full-time member of the staff with respect to pension, insurance and other plans according to the university or institution’s policies. c. The recipient may request a leave of absence, details of which are set out in Heart & Stroke Grant Management Guidelines. Leaves of absence must be agreed to by Heart & Stroke and endorsed and supported by the Host Institution.

d. The award may be terminated at any time for good cause by the recipient, the sponsoring institution, or Heart & Stroke.

e. The award commences July 1 and the recipient will devote the ensuing three (3) years to the objectives of the award. This period

Contact this candidate