ResearchNet - RechercheNet
Funding Opportunity Details
Important Dates
Competition |
202005CVR
CLOSED |
---|---|
Application Deadline | 2020-05-12 |
Anticipated Notice of Decision | 2020-06-12 |
Funding Start Date | 2020-05-01 |
Notices
The content of this funding opportunity has been updated
Date updated: 2021-09-16
Section(s) updated: Guidelines
The content of this funding opportunity has been updated
Date updated: 2020-05-27
Section(s) updated: Important Dates, Notices/Alerts
CIHR has extended the Anticipated Notice of Decision for this funding opportunity. (Updated: 2020-05-27)
CIHR has extended the submission deadline for this funding opportunity to May 12, 2020. (Updated: 2020-05-08)
CIHR is providing a linkage tool that is intended to facilitate connections and collaborations (domestically and internationally) should there be interest. This is not a mandatory tool. Information is provided on a volunteer basis and does not confer any advantages in the evaluation and funding of applications. Please note that potential applicants are not required to use the linkage tool or contact those who have submitted their information.
If you would like to use this tool, please complete a short form. The information you provide will appear on a public CIHR web page.
Table of Contents
Description
This funding opportunity is part of Government of Canada's continued rapid response to address the health challenges of the COVID-19 pandemic. The funding will enable rapid and timely research responsive to the current phase of COVID-19 pandemic in Canada and around the globe, which is focused on slowing and stopping the spread of SARS-CoV-2, including but not limited to:
- understanding the underlying pathophysiology and immunological response;
- developing and testing therapeutics, vaccines and diagnostics;
- providing evidence for best care strategies to those who are suffering from severe disease;
- creating evidence-based policies to support health workers and health systems as well as those designated as essential services, in coping with the significant burden posed by COVID-19; and
- ongoing, adaptive social and public health responses.
Given the absence of vaccines and effective therapies, the current focus in Canada is reducing transmission of COVID-19 through individual and population-level measures, including personal hygiene, physical distancing, testing, isolating and tracking contacts and travel restrictions. The sharp increase in infections and hospitalizations observed elsewhere, including in low- and middle-income countries, indicate that there is also need for support of health systems and health workers to prevent the system(s) from being overwhelmed.
During the COVID-19 pandemic, domestic and international organizations (e.g., Public Health Agency of Canada, Health Canada, United States National Institutes of Health, and World Health Organization) have played critical roles in providing guidance, sharing data and coordinating the global response. The WHO R&D Blueprint has served as a guiding framework for international coordination, including the preparation of a coordinated Global Research Roadmap. The Government of Canada’s research investments have additionally been informed by its participation in the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), an international organization composed of 28 members that coordinates closely with WHO.
Canada has a rich history of relevant expertise in health research to find solutions to the issues raised by COVID-19, especially through intervention research, health outcomes research and clinical trials. Moreover, research is a critical component of the response to COVID-19 as it informs the evidence base underpinning the effective deployment of these actions.
A broad portfolio of research is needed to effectively mitigate the rapid spread of COVID-19 and minimize its direct and indirect impacts on individuals and communities within and across jurisdictions in Canada and globally. Mitigation strategies require a coherent and integrated response from all Canadians, and especially from health care workers, researchers, public health authorities, industry, policymakers, and the health system. As such, research projects funded through this call are encouraged to amplify existing national and international networks, including in low-and middle- income countries, infrastructures and relationships with partners in order to leverage efforts and increase timeliness, efficiency, and impact of response.
Research areas
The Government of Canada will provide funding for clinical trials, including pragmatic and adaptive trials in addition to amplification of existing trials, trial networks, or platforms to include COVID-19 data elements. This can include the inclusion of Canadian sites for trials being led or funded internationally.
Funding is also available for other epidemiological studies (including observational), implementation science or other relevant study designs to scale-up promising existing projects, reorient current research or platforms, or initiate new rapid response research that can be initiated immediately upon successful application of funds, to address COVID-19 in one of more of the following research areas. (Updated: 2020-04-27)
Understanding the safety, efficacy, effectiveness, ethics, and implementation of:
- Vaccines, diagnostics, or therapeutics, such as but not limited to:
- Examine the enhanced immune disease and Antibody Dependent Enhancement (ADE) aspects of safety of vaccines
- Testing existing therapeutics to prevent and treat COVID-19 infection
- Point of care diagnostics that can be applied at home and/or in remote locations
- Correlates of protection based on sero-surveillance testing data for COVID-19 infection
- Optimization and testing of convalescent sera or other passive antibody transfer protocols
Safety and efficacy studies of vaccines and therapeutics should be sufficiently powered for stratification across relevant subgroups, for example, severity of disease, age, sex, or high risk factors.
- Clinical management and health system interventions, such as but not limited to:
- resource allocation decision-making, including access to equipment such as ventilators and personal protective equipment (PPE) as well as therapeutics
- interventions to plan for, expand on, or redress surge capacity as well as organization of care, and the healthcare workforce
- management of COVID-19 in cases with co-morbidities such as diabetes or cardiorespiratory conditions
- access to and implementation of timely and relevant clinical management approaches, such as virtual care and related guidelines or non-hospitalized care of cases, including in remote locations or Indigenous communities
- infection prevention and control measures
- interventions and strategies to mitigate the impact on non-COVID care
- population level genomics that determine COVID-19 differences in susceptibility and severity
- Social, policy, and public health responses and related indirect consequences, such as but not limited to:
- population-level containment strategies such as physical distancing, quarantine, and travel restrictions
- public health communications and citizen engagement
- impacts of external decisions/measures on self-determination and self-governance of Indigenous Peoples (First Nations, Inuit and Métis)
- scale-up of systems for assessment and diagnostics testing and follow-up
- real-time data development and design for predictive or forecasting models and observational studies that inform policy-making
Projects focused on scale-up or reorientation could include, but not be limited to, projects from the first COVID-19 rapid response competition, as well as efforts to amplify or adapt existing national and international clinical trials and related research networks and platforms. International collaborations and/or multi-site/multi-jurisdictional research is expected.
Proposals are encouraged to consider priority populations that may face unique contexts and/or challenges including:
- older adults
- children and their families
- homeless and underhoused populations
- populations living in institutional or communal settings (including long term care facilities)
- immunocompromised citizens and/or those living with serious chronic conditions
- those who face unintended systematic bias(es) within the healthcare system
- First Nations, Inuit and Métis communities
- populations living in remote settings
- refugees
- people in countries with weaker health systems
For research projects involving First Nations, Inuit and Métis Peoples: Appropriate consideration of TCPS 2: Chapter 9 - Research Involving the First Nations, Inuit and Métis Peoples of Canada, and demonstration of meaningful and culturally safe practices, plans and activities throughout the research project.
A lifecycle approach may be relevant to the research areas outlined above and can be considered in the study design.
Sex and gender differences exist in the research areas above, making sex and/or gender issues an important component of this research initiative. CIHR will require applicants to consider sex as a biological variable and gender as a socio-cultural factor in their research.
Funds Available
Approximately $107.9M of funding is available. The Government of Canada's financial contributions for this initiative are subject to availability of funds. Should the Government of Canada funding levels not be available or are decreased due to unforeseen circumstances, the Government of Canada reserves the right to reduce, defer or suspend financial contributions to grants received as a result of this funding opportunity.
- Of this total amount, there is up to $7,000,000 available over 1 year from IDRC to fund applications with investigators/collaborators from research institutions based in low and middle-income countries.
- Of this total amount, there is $300,000 available over 1 year from the CIHR Institute of Aging to fund research relevant to the areas of interest as outlined in the Sponsor Description section.
- The following provincial research funders have committed funding over 1 year to support applications with principal or co-applicants from research institutions based in their respective provinces:
- Michael Smith Foundation for Health Research (British Columbia) - $150,000
- Alberta Innovates - $100,000
- Saskatchewan Health Research Foundation - $50,000
- Research Manitoba - $100,000
- New Brunswick Health Research Foundation - $100,000
- Research Nova Scotia - $100,000
Note: Partner funding may increase.
The maximum amount per grant that can be requested for clinical trial research is $5,000,000 over 1 year.
The maximum amount per grant that can be requested for all other types of research is $2,500,000 over 1 year.
Please note that the budget amounts have been set at these levels to allow for adequate funding of some of the research projects that could be submitted. However, it is expected that most budgets will be significantly lower than these maximums. All budgets will be subject to rigorous analysis to ensure applicants are requesting appropriate funds for their research.
Partnership approaches, either in-kind or financial, to increase the budget available to projects and/or maximize the impact and reach is encouraged; however, they are not mandatory.
For more information on the appropriate use of funds, refer to Allowable Costs.
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Objectives
- Accelerate the availability of high-quality and real-time evidence to support Canada’s rapid response to the global pandemic in order to better prevent, detect, treat and manage COVID-19;
- Develop, test, and study the implementation of effective interventions to prevent, detect, treat, and manage COVID-19 at the individual and/or population levels by reorienting or amplifying existing research platforms, networks, and trials as well as funding new research projects within existing and established research infrastructure;
- Enable Canadian engagement and coordination in national and international large-scale trials and better enable harmonized data collection, sharing of data, quasi-experimental and observational studies, and rapid large-scale evaluation of impact;
- Provide evidence to inform clinical and health system management and public health response, and/or decision-making and planning within and across jurisdictions in Canada and internationally; and
- Enhance local, national and/or international collaborative efforts, including in low- and middle-income countries, to mitigate the rapid spread of COVID-19 and related negative consequences.
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Eligibility
Eligibility to Apply
For an application to be eligible:
- The Nominated Principal Applicant must be an independent researcher.
- The Nominated Principal Applicant must be appointed at a CIHR eligible institution at the time of application (see the CIHR Application Administration Guide – Part 4).
For an application to be eligible to receive funding from the IDRC:
- The team must include researchers that are based in Canada and researchers that are based in low and middle income countries (LMIC), as defined by the Organisation for Economic Co-operation and Development (OECD) Development Assistance Committee (all countries noted in list).
- For teams in which research will be conducted in more than one LMIC country, there must be at least one researcher listed as a Principal Applicant based in each country.
- For teams involving sub-grantees (indirect beneficiaries of IDRC funds), these sub-grantee institutions must be identified and described by the Principal Applicant.
Applicants are encouraged to consider an appropriate representation of groups underrepresented in science, and a diversity of experiences, on research teams. Additional guidance can be found on the Best practices in Equity, Diversity and Inclusion in Research webpage.
Note: All CIHR eligible institutions are located in Canada.
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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.
As is the case with all Agency-funded research, ethics review in accordance with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) will be required for research involving human participants. Please note that the TCPS addresses research ethics review during publicly declared emergencies – Chapter 6, Section D, Articles 6.21, 6.22, and 6.23. Institutions and REBs are encouraged to refer to this guidance during the current emergency. Should you have any questions about how to interpret this section of the TCPS, please contact the Secretariat at secretariat@srcr-scrr.gc.ca.
Allowable Costs
Applicants should review the Use of Grant Funds section of Tri-Agency Guide on Financial Administration for requirements regarding allowable costs and activities.
The following expenses will be considered eligible for funding received through this funding opportunity:
- The Tri-Council Policy Statement 2 (TCPS 2 - Chapter 9 Research Involving the First Nations, Inuit and Métis Peoples of Canada) recognizes the importance of respecting the culture and traditions of Indigenous Peoples and acknowledges the necessity to incur expenditures in that regard in the conduct of research. As such, the Agency considers these expenditures eligible for payment from the grant holder's grant funds (with appropriate backup documentation);
- Costs related to community mobilization and engagement, including culturally relevant promotional items such as, tobacco, cloth, feasting and gift giving for honoring ceremonies, and cash reimbursements (in a method acceptable to the individual or community being reimbursed) to compensate community participation; and
- Contracts and/or consultant fees for knowledge translation and communication activities for Indigenous Elders, community members, and Indigenous Knowledge Keepers involved in activities related to the Indigenous community.
- Release Time Allowance is an eligible expense to facilitate the participation of knowledge user(s) in a research program.
For recipients of IDRC funding (including sub-grantees), they will comply fully with the policies and guidelines as outlined in the General IDRC Funding Guidelines.
Conditions of Funding
- Given the urgency of this funding competition, there may be additional requirements outside of standard requirements for reporting or participation in activities, such as international coordination activities.
- Applicants will be required to reserve and allocate costs in their budget for up to two (2) team members to participate in two (2) international meetings.
- Within 48 hours of being notified (NOD date), successful applicants must submit a 1- page overview to CIHR with the anticipated timing of their research outputs. CIHR will follow-up with funded applicants with a template and instructions.
- Summaries of the proposed work that is funded will be shared with other funders and other relevant stakeholders.
- Data produced as a result of this funding must be shared in line with the Joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak.
- Data related to research by and with First Nations, Inuit, Métis or Urban Indigenous communities whose traditional and ancestral territories are in Canada must be managed in accordance with data management principles developed and approved by those communities, and on the basis of free, prior and informed consent. This includes, but is not limited to, considerations of Indigenous data sovereignty, as well as data collection, ownership, protection, use, and sharing. (Updated: 2021-09-16)
- All COVID-19 related publications must be open access, in alignment with the call from the Chief Science Advisors.
- The applicant must consent to the use and disclosure of full application and nominative information at the time of application, for purposes of relevance review, funding decisions and analysis.
- The Nominated Principal Applicant will be required to submit an electronic Final Report to CIHR. This online report will be made available to the Nominated Principal Applicant on ResearchNet at the beginning of the grant funding period and can be filled in as the research progresses.
- All reports will be shared with partners supporting the grant.
- The Principal Applicants who are successful in this competition are strongly encouraged to actively participate in peer review, and as members of the CIHR College of Reviewers, when invited.
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Review Process and Evaluation
Relevance Review Process
CIHR will perform a relevance review to identify applications that are in alignment with the objectives and one of the research areas of this funding opportunity. Applications that are not deemed to be relevant to the objectives and research area(s) will be withdrawn from the competition and not proceed to peer review.
In addition, relevant partners and CIHR Institutes will perform a separate review to assess alignment to partner/Institute specific funding requirements.
Review Process
Peer review will be conducted in accordance with CIHR peer review principles.
For information on CIHR's peer review principles, see the Peer Review: Overview section of CIHR's website.
Evaluation Criteria
- Quality of project:
- Extent to which the application responds to the objectives;
- Extent to which the application responds to one or more of the research areas;
- Addresses clear knowledge gap/need and high feasibility;
- Appropriateness of the proposed approach, study design, and populations;
- Quality and appropriateness of the sex- and gender-based analysis+ (SGBA+). SGBA+ refers to the consideration and examination of sex, gender and other identity factors (e.g., age, race, ethnicity, culture, religion, geography, education, disability, income and sexual orientation) at all stages of the research process including planning and implementation of the research project and related activities – please visit How to integrate sex and gender into research and Why Sex and Gender Need to be Considered in COVID-19 Research for additional information;
- For research involving Indigenous Peoples, appropriate consideration of TCPS2: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada, and demonstration of meaningful and culturally safe practices, plans and activities throughout the research project.
- Quality of Applicants:
- Track record of team members in fields related to the proposed research;
- Relevance and value-add of collaborations and partnerships to the research objectives;
- Ability of the project team to carry out the proposed research, including project governance;
- Ability of team to quickly mobilize necessary resources, including by leveraging existing networks and/or research programs;
- For research involving Indigenous Peoples, extent to which the overall research team has the necessary knowledge, expertise and experience in Indigenous health research, and complementarity of expertise and synergistic potential to conduct Indigenous health research.
- Impact of the Research:
- Clear justification for rapid response nature of project including the use of funding to achieve timely impacts and maximize health benefits;
- Quality of the proposed knowledge translation plans to accelerate availability of high quality, real-time evidence for translation of research into policy, practice, and/or clinical guidelines to address the immediate response to the COVID-19 pandemic;
- Potential to contribute to the global response to COVID-19.
- Budget:
- Appropriateness of the budget and justification for amount requested.
All applications that include a clinical trial will also be evaluated on the following additional criteria (note that clinical trial research proposals have an extra page to account for the additional criteria):
- Demonstrated networked capacity to conduct multisite trials, including evidence that relevant trial groups/networks and/or sites are engaged;
- Proposal provides evidence that the trial will be adequately powered and multi-site in order to have greatest potential for generalizability;
- Amplifies current clinical trial activities (nationally or internationally) or is ready to be implemented upon successful receipt of funds;
- Selection of appropriate outcomes with harmonized measures
Funding Decision
Funding decisions will be made in order to balance funding across the research areas while respecting rank order within each research area.
The names of successfully funded applicants as well as project details 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
- The application process for this funding opportunity is comprised ofone step: Full Application.
- Due to the expedited nature of the process, there will be no extensions to the application deadline and late applications will not be accepted.
- To complete your Full Application, follow the instructions in the Grants – Application Guidelines along with any additional instructions found below under "Specific Instructions".
- All participants listed, with the exception of Collaborators, are required to:
- Have/obtain a CIHR PIN.
- Complete the Equity and Diversity Questionnaire.
Specific instructions to complete your ResearchNet application
Task: Identify Participants
- List all participants in the "Identify Participants" task. Consult the Eligibility section and ensure that all requirements are met.
- The Nominated Principal Applicant (NPA) and Principal Applicants (PA) must provide either a CIHR Biosketch CV OR the Applicant Profile CV (a 3-page CV to be uploaded as a PDF).
- The Co-Applicant(s) and Knowledge User(s) are not required to submit CVs but it is encouraged. A CIHR Biosketch CV OR an Applicant Profile CV is acceptable.
- If you're using the Biosketch CV, you must upload it in the Identify Participants task in the “CCV Confirmation Number” textbox. As this CV type is optional, please verify that your CCV has loaded correctly and save this task.
- If you're using the Applicant Profile CV, you must upload the PDF in the Task: Attach Other Application Material under the “Other” attachment type (see below)
Task: Enter Proposal Information
- The Research Proposal must address each of the elements outlined in the evaluation criteria.
- All applications, with the exception of clinical trials, can submit a maximum of 5 pages for English applications and 6 pages for French applications.
- Clinical trial applications can submit a maximum of 6 pages for English applications and 7 pages for French applications.
- Note: Your proposal must include all crucial information (including tables, charts, figures and photographs) that a reviewer will need to read in order to assess your application.
- If you are submitting a clinical trial proposal, you must select “Yes” to the “Is this a Clinical Trial” question in the Enter Proposal Information – Details page. For a definition and more information regarding clinical trials, consult the Policy on trials.
- If you are submitting a randomized control trial, you must select “Yes” to the “Does this application contain a Randomized Control Trial” question in the Enter Proposal Information – Details page.
- In the Descriptors section, you must select at least one “Suggested Institute”.
- Please select the Institute that is most aligned to you research.
- Please also identify all Institutes where the focus of your research is aligned to the Institute(s) specific area(s) of interest as outlined in Funds Available and Sponsor Description sections.
Task: Complete Summary of the Research Proposal
- Summarize your research proposal (maximum 1 page).
Task: Enter Budget Information
- Complete the Budget Module in ResearchNet for the total requested budget.
- Financial Assistance Requested Details:
- Provide a justification how the budget requested is appropriate for the scope of the research proposed.
Task: Attach Other Application Materials
- References (to be loaded under the “Other” attachment type):
- Additional pages for references is permitted.
- Your document must be in PDF form and titled References.
- Applicant Profile CV(s) (to be loaded under the “Other” attachment type):
- Upload any Applicant Profile CVs (maximum three (3) pages).
- Your document must be in PDF form and titled according to the applicant’s CV name and role (i.e., John Smith – Principal Applicant).
- Letters from Collaborators:
- A signed letter is required from all Collaborator(s) listed on the application that outlines their contribution to the research.
- Letters of Support:
- Provide a letter of support from each funding partner, confirming their contribution(s).
- For Release Time Allowance requests, provide a letter of support from the recipient's organization.
Note
- No attachment outside of the ones list above will be considered by reviewers (i.e., they will be deleted from the application prior to being provided to the reviewers).
- For all letter attachments: Original signatures are not required; an email approval will be accepted in lieu. Attach each email approval with each letter.
Task: Complete Peer Review Administration Information
This task collects information used for the purpose of peer review administration and aids CIHR in recruiting appropriate expertise.
- Suggested Reviewers for this Application
Suggest Canadian and/or international reviewers that you think have the expertise to review your application. CIHR reserves the right to make the final selection of reviewers. You should not suggest reviewers in conflict of interest. Consult the Conflict of Interest and Confidentiality Agreement for Peer Reviewers and Peer Review Observers on the CIHR website for more information.
Task: Apply to Priority Announcements / Funding Pools
- In the context of this competition, this task will group applications into the research areas WSC Note: #researchareas listed above.
- The purpose of this grouping is to allow for funding decisions to be balanced across the research areas as well as help with reviewer recruitment and assignment.
- There is no fixed amount of funding for each of the research areas. Rank order will be respected within each research area.
- CIHR reserves the right to determine the appropriate research area for each application.
- Identify a Research Area:
- Select one Research Area title from the list you see in ResearchNet.
- You must select only one research area as the primary research area for your application. If you select more than one, your application will only be considered for the first one identified.
- In the text box provided address how the research proposed is aligned with the objectives of this call and the research area selected.
Task: Print, Scan and Upload Signature Pages
- Required signatures:
- Signatures must be included for all applicants (except Collaborators), and individual(s) with signing authority from the Institution Paid.
- Original signatures are not required. The scanned signed signature pages and the Routing Slip must be uploaded in the Print/Upload Signature Pages task in ResearchNet prior to submitting your application.
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Contact Information
For all inquiries, please contact:
Email: EHTRF-FRNMS@cihr-irsc.gc.ca
For service hours, please consult our Contact us page.
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Sponsor Description
Partners
- Canadian Institutes of Health Research (CIHR)
- International Development Research Centre (IDRC)
- CIHR Institute of Aging (IA): Unlike many other CIHR Institutes, which are focused on particular diseases, IA's mandate is the aging person in an aging society. As such, and in the context of the COVID-19 crisis IA’s focus is specifically centered on the amplified effects of this crisis on older adults. The CIHR Institute of Aging (IA) will provide funding for applications that are determined to be relevant to priorities that are specific to this crisis and are in line with one or more of its Strategic Directions or sub-directions as described in its current 2019-21 Strategic Plan. In particular, IA will contribute funding towards:
- Vaccine-related research that includes older adults as research participants and addresses their specific needs relating to disease and vaccination.
- Research related to treatment and clinical trials that ensure that older adults of both sexes are appropriately represented in clinical trials and that polypharmacology and optimal dosing for older adults are considered when developing new COVID-19 treatments and guidelines.
- Research related to Ethics, Health Services, Public Policy and Population Health focused specifically on the needs of and impact on older adults.
- Michael Smith Foundation for Health Research
- Alberta Innovates
- Saskatchewan Health Research Foundation
- Research Manitoba
- New Brunswick Health Research Foundation
- Research Nova Scotia
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Additional Information
Additional information:
- For more information and resources related to COVID-19, please consult the following CIHR webpage.
- Why Sex and Gender Need to be Considered in COVID-19 Research
A Guide for Applicants and Peer Reviewers
First, sex-disaggregated data reveal that more men are dying from COVID-19 than women. It is not clear if there arebiological factors at play, or if comorbid and behavioural factors are to blame.
Second, pandemics can compound inequalities for girls, women, sexual and gender minorities and other at-risk populations. It is essential that these different subpopulations are considered in order to create effective, equitable policies and interventions.
Applicants and Reviewers should appropriately account for the following in COVID-19 research proposals:
Molecular Mechanisms of Viral Pathogenesis
Include both male and female cells, as the SARS-CoV-2 receptor, ACE2, is X-linked and escapes X chromosome inactivation1. Disaggregate results by sex.
Host Immune Response
Include male and female animals or humans, as sex hormones were shown to regulate the host immune response to SARS-CoV infection in mice2. Disaggregate results by sex.
Diagnostic Tests and Serologic Antibody Testing
Sensitivity and specificity should be tested for males and females separately, as sex differences in viral titers and IgM/IgG antibodies have been reported for viral infections in humans and mice3,4.
Vaccines and Therapeutics
Sex-specific dosing of vaccines and other therapeutics should be tested, as efficacy, safety and toxicity for males and females differences for some drugs, immunotherapies5 and vaccines6.
Clinical Trials
Stratify randomization by sex, as there are known sex-specific differences in the safety and efficacy of drugs and biologics7. Disaggregate results by sex.
Medical Devices and Personal Protective Equipment
Sex-specific anatomical differences and gendered user preferences should be incorporated into the design of medical devices and personal protective equipment for COVID-19.
Social, Behavioural Observational and Seroprevalence Studies
Sex, gender, age and other identity characteristics should be considered in survey questions and sampling strategy. Gendered behaviours should be investigated in studies of disease susceptibility. For example, men are more likely to smoke than women8 and less likely to seek healthcare9, whereas older women are more likely to live alone and experience social isolation.
Gender roles should also be considered. 70% of the paid and unpaid global healthcare workforce are women10, and they face a greater risk of infection being on the frontline of the COVID-19 pandemic.
Gender relations should be factored into research on the impact of the pandemic, as physical distancing puts women and girls at higher risk of domestic violence due to heightened tensions in the household11.
Mental Health
Mental health effects may reasonably vary by sex, gender, sexual orientation and other identity characteristics, as the triggers, causes, signs and symptoms of depression and anxiety may differ 12.
Implementation Science
Sex, gender and other identity characteristics influence the way in which an implementation strategy works, for whom, under what circumstances and why. Messaging should consider how to appropriately include and target different groups according to sex, gender and other identity characteristics 13.
Policy
The unintended outcomes of all COVID-19 policies, especially economic recovery policies, should be considered for groups such as Indigenous Peoples, sexual and gender minorities, racialized individuals, single parents, immigrants, unpaid workers, individuals with precarious work status, people with disabilities, the homeless and those living in rural and remote areas14.
References
- Tukiainen, T et al. Nature 550, 244–248 (2017).
- Channappanavar R et al. The Journal of Immunology. 198:4046-4053 (2017)
- Peretz, J et al. Am. J. Physiol. - Lung Cell. Mol. Physiol. 310, L415–L425 (2016).
- Channappanavar, R. et al. J. Immunol. 198, 4046–4053 (2017).
- Conforti, F. et al. Lancet Oncol. 19, 737–746 (2018).
- Zeng, F. et al. medRxiv (2020) Pre-print at: https://www.medrxiv.org/content/10.1101/2020.03.26.20040709v1
- Tannenbaum, C. & Day, D. Pharmacol. Res. 121, 83–93 (2017).
- WHO: 10 facts on gender and tobacco. (2010): https://www.who.int/gender/documents/10facts_gender_tobacco_en.pdf
- Thompson, AE et al. BMC Fam. Pract. 17, 38 (2016).
- WHO: Gender equity in the health workforce: Analysis of 104 countries: http://www.who.int/hrh/resources/gender_equity-health_workforce_analysis/en/
- UNFPA. COVID-19: A Gender Lens: https://www.unfpa.org/sites/default/files/resource-pdf/COVID-19_A_Gender_Lens_Guidance_Note.pdf
- House of Commons Standing Committee on Health. The Health of LGBTQIA2 Communities in Canada (2019): https://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP10574595/hesarp28/hesarp28-e.pdf
- Tannenbaum, C et al. BMC Med. Res. Methodol. 16, 145 (2016).
- Hankivsky, O. & Kapilashrami, A. Beyond sex and gender analysis: an intersectional view of the COVID-19 pandemic outbreak and response. (2020): https://mspgh.unimelb.edu.au/__data/assets/pdf_file/0011/3334889/Policy-brief_v3.pdf
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- Date Modified: