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Addendum to the guidelines for the eligibility of applications related to health
Overview
The three federal granting agencies—the Natural Sciences and Engineering Research Council of Canada (NSERC), the
Social Sciences and Humanities Research Council
(SSHRC) and the
Canadian Institutes of Health Research
(CIHR)—have developed guidelines for
Selecting the Appropriate Federal Granting Agency
to help applicants select the appropriate agency when applying for funding. These guidelines describe the eligible and ineligible research subject matter for support from each agency and apply to research, research training, and related activities.
NSERC collaborates closely with the other granting agencies to encourage and promote support to the full range of natural sciences and engineering (NSE) research and research training, including collaboration across disciplines and subject areas.
This is an addendum to the
Selecting the Appropriate Federal Granting Agency
guidelines (specifically the
Guidelines for the Eligibility of Applications Related to Health section) and provides examples of eligible and ineligible research subject matter related to NSERC’s function legislated in the
NSERC Act
.
In addition to reading the guidelines on
Selecting the Appropriate Federal Granting Agency
and this addendum, NSERC encourages applicants to contact the research services or student liaison offices at their institution for guidance.
Applicants may also wish to seek advice from the NSERC program officer of the program to which they are considering applying.
Examples
Some research areas overlap the mandates of both NSERC and CIHR. The following examples illustrate the eligibility of applications related to human health for NSERC funding. These lists are not exhaustive. While the examples are grouped by broad themes, applicants should consider all sections due to their interrelatedness.
Fundamental processes in humans (for all research disciplines)
Research seeking to further our understanding of fundamental processes in humans is eligible for NSERC support. However, research with disease-related goals—including work on the etiology, diagnosis, treatment or prevention of physical or mental disease, abnormality, or dysfunction in humans—is normally not eligible. Research based on an experimental system that represents a state of disease or dysfunction may be eligible when the primary objective is to understand the functioning of the healthy state.
| NSERC eligible | NSERC ineligible |
|---|---|
| Using cancer cells to investigate mechanisms of apoptosis (programmed cell death) in normal cells. | Identifying or validating a target for therapy, or measuring the response to a therapy. |
| Studies aiming to understand contraction, fatigue, load, or recovery cycle of muscle in healthy subjects. | - |
| Research involving the fundamental biochemistry of drug delivery mechanisms (for example, liposome microsphere preparation). | - |
| Modifying gene expression or replication processes and studying the impact of different hormonal levels in healthy state stem cells. | Studying gene replication or cell death in stem cells that have been transformed into cancer cells to learn about cancer treatment or prevention. |
| Developing materials or drug delivery systems/mechanisms, and testing their bio-compatibility, molecular compatibility, release of the API, or degradation rates. | Testing new materials or drug delivery systems/mechanisms for treatment efficiency or improved drug formulation. |
| Studying virus growth and replication, and virus-host interactions within a normal state host immune system. | Studying virus growth and replication in the diseased state to understand disease progression. |
| Studying the immune response of a healthy human host to commensal bacteria, or the response to initial contact with invasive bacteria or viruses. | Studying human immune response under a state of disease caused by an acute or chronic bacterial infection. |
| Studying the mechanisms underlying the inflammatory response in a healthy state by using triggers (for example, physical, psychological, biological, chemical) to induce inflammation. | Testing treatments or therapies for inflammation in a state of disease or dysfunction. |
| Investigating ontogeny of a healthy human immune system. | Studying immune system development in immunodeficiency disorders. |
| Studying the cascade of biological responses during instances of acute pain in healthy organisms. | Researching methods of alleviating, dampening or managing the experience of chronic pain. |
| Using gene editing technology to knock out a pain-related gene in mice for the purposes of studying gene function in vivo in healthy subjects. | Using gene editing technology to rescue pain-related gene transcription to reduce injury-induced pain hypersensitivity. |
| Constructing canine-specific antibodies for the purpose of controlling pain in veterinary patients. | Studying the efficacy of potential human pain therapeutics in animal models. |
| Constructing new compounds and determining their molecular structure and chemical properties. | Testing chemical properties and metabolic roles of possible treatment compounds in a state of disease or dysfunction. |
| Studies aiming to evaluate the pattern of hormonal changes during healthy pregnancy. | Studies aiming to understand pre-eclampsia; studies aiming to treat gestational diabetes. |
| Studying aging processes to understand the fundamental mechanisms of human function or cellular function. | Studying age-related development and mechanisms of osteoarthritis, osteoporosis, Alzheimer’s. |
| Cell motility: understanding the role of pili in plant bacteria motility in agriculture. | Cell motility: cellular and molecular investigation of cancer metastasis. |
| Modeling Avian Influenza Virus transmission between wild geese populations and free ranging poultry farms. | Modeling Avian Influenza genotypes to predict human vaccine components or human epidemics. |
| Analyzing joint mechanical performance under stress in healthy subjects. | Rehabilitation of gait impairment in patients with concussions. |
| Studying micro-level bone/tissue failure and self-repair in a healthy state. | Studying bone/tissue adaptation in a diseased/injured state or following a surgical procedure. |
| Studies aiming to understand the mechanisms of injury in a healthy state (for example, impact loading to understand bone fracture). | Studies aiming to understand the mechanisms of injury in a diseased state or associated with a surgical procedure. |
| Using video tracking, computer simulation, and analysis to assess biomechanics of specific movements (such as throwing, running, kicking) in the healthy state. | Using computer simulation and analysis to assess rehabilitation treatment effects or responses. |
| Developing new mathematical or statistical models, theories, methodologies, or analytical tools that may lead to potential future applications in human health (such as diagnosis or treatment). | Use of already existing mathematical/statistical models, theories, methodologies, analytical tools for disease treatment or diagnosis. |
| Developing mathematical models to evaluate uncertainty. | Applying decision-based mathematical models to predict risk of error by emergency respondents or to predict disease outbreaks. |
Pharmaceuticals, nutraceuticals and functional foods for human use
Research related to pharmaceuticals, nutraceuticals or functional foods has significant grounding in the health sciences and is not eligible under NSERC’s mandate unless the focus is on advancing the NSE.
Research related to developing novel ways of synthesizing active pharmaceutical ingredients (APIs) and analogs or manufacturing vaccines, scaling up production of new APIs or vaccines, and research including bioassays conducted strictly for the purpose of informing the development strategies, may be eligible. Research related to food components, nutraceuticals, or functional foods is eligible if it aims to elucidate the mechanism of action of a dietary component purported to affect a specific structure or physiological function; however, research aiming to determine or validate the effects of such ingredients on health is not eligible.
| NSERC eligible | NSERC ineligible |
|---|---|
| Developing novel biological sources rich in a desired nutraceutical or API of a precursor aimed at production. | Screening compounds for bioactivity (including high throughput assays), building compound libraries for screening purposes, testing drug candidates, nutraceuticals or vaccines for efficacy or determination of pharmacological parameters. |
| Developing novel processes leading to products that contain desired nutraceutical ingredients, including the determination of digestibility and availability of the ingredient. | Gathering information about APIs, vaccines or nutraceutical ingredients for regulatory or marketing purposes. |
| Elucidating the mechanism of action of a nutraceutical on a specific physiological function in the healthy state. | Determining or validating the direct or suspected effects on health of a candidate nutraceutical ingredient or combination. |
| Developing new technology allowing the production of vaccines. | Developing a vaccine for a specific use. |
| Limited biological testing to inform the synthesis/manufacturing development strategy. | Projects where the main focus is on validation through biological testing (in vivo, ex vivo, in vitro, in silico). |
| Developing novel non-active and non-disease specific ingredients used to deliver APIs in biological systems. | Research aimed at delivering a specific API in the context of the development of the drug. |
| Developing new food combining nutraceutical ingredients. | Testing and validating health properties of new food. |
| Using known APIs to investigate fundamental mechanisms in the healthy state. | - |
Medical devices and technologies
NSE research whose primary purpose is to develop medical devices—including monitoring and diagnostic technologies—and devices for treating a disease or physical condition is eligible, unless it is at the validation stage (i.e., pre-clinical in vivo testing, reliability testing, comparison studies and clinical trials).
Research aiming to develop medical devices used to treat a disease or physical condition can have a strong engineering component in the early stages of development and require the skills and expertise of non-medical engineers and/or scientists in their development. A combination of diseased-state and healthy-state are used to verify the performance/utility, and to provide feedback in the device’s development stage. This “non diseased”-focused research is part of NSERC’s mandate.
| NSERC eligible | NSERC ineligible |
|---|---|
| Verifying and evaluating medical devices (in vitro and ex vivo testing, feasibility testing in vivo with a very limited number of subjects). | Validating medical devices (animal or human trials for efficacy testing, reliability testing and comparison studies). |
| Developing methodology for sterilization and fatigue testing of medical devices. | Safety assessment of medical devices. |
| Using biomechanical methods to assess mechanical properties of newly developed biomaterials. | Assessing potential damage or injury associated with a medical procedure. |
| Designing and modeling medical implants on synthetic models (or on a small scale ex vivo) and optimizing placement. | Phase I or large-scale animal trials of new implants. |
| Assessing biocompatibility in the development of new medical devices. | Assessing the biocompatibility of commercially available medical devices. |
| Formulation, conceptualization and/or feasibility of new, or modification of an existing, medical device that clearly demonstrates a research challenge in the NSE. | - |
| Research aiming to develop or optimize a new diagnostic technology based on available data. | Assessing the performance of a newly developed diagnostic technology or focussing on collection of new data. |
| Biomechanical testing of a device on an able bodied person to ensure the components perform as designed. | Biomechanical assessment by a clinician performing a procedure with a medical device. |
| Developing novel imaging methods that may lead to improved diagnosis and treatment of disease. | Using existing imaging methods to determine their efficacy in a clinical setting. |
| Verifying and evaluating the mechanical properties, degradation rates, or biocompatibility of newly developed artificial, bioinspired and/or tissue-engineered biomaterials or scaffolds. | Assessing artificial, bioinspired, and/or tissue-engineered biomaterials or scaffolds treatment efficiency or wound healing in injury or disease states. |
Decision-making and consultation process to determine the eligibility of applications related to human health
For most programs, NSERC is responsible for decision-making about eligibility. Potential applicants are encouraged to contact NSERC staff with any questions regarding subject matter eligibility in advance of submitting their application. Staff will endeavour to provide advice to applicants; however, NSERC only makes a final decision on eligibility once it receives a full application.
NSERC staff also consults, as required, with outside experts and/or with officials at SSHRC or CIHR for input before reaching a decision. NSERC informs applicants in writing if their proposal is deemed ineligible.
Please note that NSERC does not accept appeals on the grounds of subject matter eligibility.