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Definition of Medical and Dental Research
In September 2009, the ARC clarified its definition of Medical and Dental Research, in consultation with the National Health and Medical Research Council and stakeholders. This definition retains the original definition, and clarifies and elaborates on it. This definition will apply to all new Funding Rules for ARC
Medical and Dental Research means research and/or training which, in the opinion of the ARC, has a significant focus on near-term clinical medical (including dental) outcomes.
A proposal may be ineligible if it deals substantially with any of the following areas of research. Examples of research that the ARC may consider ineligible are:
- using human subjects to test the clinical efficacy of a diagnostic or therapeutic agent or medically applicable device or material;
- using material collected from human subjects for the purpose of studying disease prevalence, epidemiology or mode of inheritance;
- observation or treatment of human patients for clinical medical or dental purposes; and
- prevention of disease by medical and or dental intervention in human subjects;
where the purposes of the research are for applications solely in a human medical and/or dental context.
The ARC will not recommend for approval, and the Minister will not approve for funding, any Proposal that fails to satisfy the “eligibility criteria” set out in these Funding Rules, including if the ARC determines that a proposed project would fall within the area of Medical and Dental Research.
Frequently Asked Questions are included in the Instructions to Applicants and are critical for clarification and understanding.
Frequently Asked Questions
- Will the ARC consider funding projects which use animal models to undertake medical/dental research, to investigate disease (e.g., pathologies, genetics) to provide the evidence to lead to the human trials which will be funded by NHMRC and not ARC? YES
- Will the ARC support the pre-clinical design and/or development of a diagnostic or therapeutic agent or medically applicable device or material? YES.
- Can human samples be used as controls, even if the main focus is on a non-human species? Some researchers use a non-standard model (e.g., kangaroo) to investigate a mechanism that is related to a human disease. YES
- Does the definition rule out research into diseases using animal models that may have implications for treatment of the disease in humans. NO.
- Does this definition mean that for Linkage Projects the definition would limit some of the research that has been previously conducted through trials that were clearly linked to commercial outcomes? NO.
- Will the ARC consider funding projects which use computer modelling to undertake medical/dental research to get to the stage of possible human trials? YES
- Will the ARC consider funding projects investigating prevalence, incidence, or epidemiology, but not by having human participants as their data source but databases of population spreads and patterns of incidence gathered from addresses and hospital admissions (e.g., as in health economics)? YES
- Will the ARC consider funding public health projects that include a medical component (e.g., immunisation) that incorporate behavioural strategies (e.g., self-management) to ensure the result sought (e.g., increasing the rate of immunisation)? YES.
- Will the ARC support proposals in psychological research which involve observation or treatment of human patients for clinical medical or dental purposes and have the goal of prevention of disease by medical and or dental intervention?; for example, where an application in psychology (e.g., research into memory, pain, etc.) might aim (1) to develop a credible intervention from an experimental paradigm in the laboratory, and (2) to test its efficacy once developed in a clinical sample? YES
- Does the ARC fund health management research (e.g., into information systems, organizational behaviour, economic impact); that is, research assessing current clinical practice and identifying improvements? YES
- Are behavioural, psychological and sociological interfaces with respect to medical and dental research still eligible for the ARC; for example, in relation to substance abuse, risk taking behaviour, lack of exercise, smoking, alcohol addiction or abuse, eating disorders, violence, ageing etc.? YES
- Are behavioural interventions with individuals or groups or community-based education programs for health promotion or injury minimisation (wearing seat belts or bike helmets, safety in the workplace, bullying prevention, effective parenting etc) still eligible to be submitted to the ARC? Yes
- Are programs of a behavioural nature that encourage healthy ageing or therapies such as music therapy still eligible to be submitted to the ARC? YES
- Is research in the area of bioinformatics excluded? Is using human data to develop analytical methods for the purpose of preventing, diagnosing or treating disease ineligible for ARC support? NO
- Is research into therapeutic drug development eligible? For example, research that is undertaken to better understand the biochemical basis of drug action? YES
- Will the ARC consider funding projects which undertake formulation and proof of concept testing of new chemical entities to get to the stage of possible clinical trial? YES
07/10/09
