means research and/or teaching primarily and substantially aimed at understanding or treating a human disease or health condition. This includes, but is not limited to, projects that use established protocols or research tools that involve the examination of processes or other events that may directly or indirectly impact on the physical and/or mental health of personnel, late pre-clinical or early human trials of a human therapeutic agent, material or diagnostic test or device; or other interventional research involving humans; using material collected from human subjects for the primary purpose of studying the underlying causes, prevalence, epidemiology or mode of inheritance of a disease or human condition; or using established animal models or established cell lines for the purpose of studying the underlying causes, prevalence, epidemiology or mode of inheritance of a human disease or human health condition.
Health research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments. The latter is termed preclinical research if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies.
A new paradigm to biomedical and health research is being termed translational research, which focuses on iterative feedback loops between the basic and clinical research domains to accelerate knowledge translation from the bedside to the bench, and back again.
Most of the research in the field is pursued by biomedical scientists, however significant contributions are made by other biologists, as well as chemists and physicists. Health and medical research, done on humans, has to strictly follow the ethical standards sanctioned in the Declaration of Helsinki, the National Statement on Ethical Conduct in Human Research, and elsewhere. In all cases, the research ethics has to be respected.
Fields of health research common to Defence include:
- Behavioral health
- Preventive medicine
- Public Health
Joint Health Command Low Risk Research Ethical Review Process
Within Joint Health Command (JHC), the low risk review process is managed by the Directorate of Health Research Coordination (DHRC). The steps to these processes are:
- Researchers must submit the Health Research Ethical Review Assessment form electronically to:
- Upon submission of the completed Assessment Form, researchers whose research meets the qualifications for negligible research will receive an exemption confirmation number and the research project will be recorded for reporting purposes.
- In addition to submission of the completed Assessment Form, researchers whose research meets the qualifications for low risk research should submit the JHC Low Risk Research Application for Ethical Review to the address above. An application will not be actioned by the panel if the application itself is incomplete or attachments are missing.
- There is no submission date as applications are reviewed on a continual basis.
- Once a complete application is received, DHRC will ensure the application is in order and confirm the potential for low risk review.
- The Director, Defence Health Research, will circulate the electronic copy of the full application to the low risk review panel members. Additional expertise may be requested as needed.
- Applications will be reviewed in accordance with the standards contained in the National Statement and researchers advised of the results. The possible results are:
- Application approved;
- Application endorsed but subject to conditions that need to be met before approval can be granted;
- Application deferred for further consideration; or
- Application declined (incorporating rationale).
- All approved low risk projects will be allocated a project number which must then be clearly indicated on Participant Information Sheets and Consent Forms used in the research.
Upon submission of the Joint Health Command (JHC) Health Research Ethical Review Assessment Form, JHC may exempt from ethical review research that:
- is negligible risk research and
- involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
Subsequent requirements include:
- A completed Principal Investigator Assurance (prior to commencement of research);
- Annual Progress Reports on 1 June; and
- Final Report upon completion.
Health Research Dissemination
There is a need to disseminate scientific research results widely, not only to provide a sharing of potentially useful information, but also to permit peer review of research processes.
Health researchers who wish to publicly present research findings or publish articles in journals or other publishing forms including submissions as a thesis or treatise, based on information acquired through approved health research involving Defence personnel and/or resources, are first required to obtain approval from JHC.
Researchers must submit the completed JHC Publication and Presentation Application form along with the article and/or abstracts of verbal presentations that are to be published but does not include the verbal presentation per se. In the event of a request for copies of slides or other visual aids used in a verbal presentation, the compliance of the researcher is required. If any doubt exists advice is to be sought from the DDHR. The Directorate of Health Research Coordination will maintain a database of all decisions and copies of all approved publications and presentations.
Where Defence approval has been provided to a draft manuscript and there is a subsequent amendment to the final manuscript to be published, the amended manuscript must be further submitted for Defence approval.
In accordance with the Defence Security Manual (DSM) no classified material is to be included in any manuscript which is to be published as open source material. Defence retains the right to prohibit or place conditions on the publication of a submitted manuscript.
All publications must include the following in the body of the manuscript:
- a detailed statement on relevant Defence ethical approvals;
- an acknowledgment of the use of Defence resources and personnel where appropriate; and
- a disclaimer stating that the opinions expressed therein are those of the author/s and do not necessarily reflect those of Defence or any extant policy.
Manuscripts consequent to the conduct of approved health research are to be submitted in final draft form for approval prior to publication. Manuscripts are to be forwarded, preferably in electronic format, to the DDHR. The DDHR will ensure that the final Defence approval is provided by the relevant one Star equivalent level within JHC.