Guidelines are sets of non-mandatory rules, principles or recommendations for procedures or practices in a particular field. NHMRC guidelines provide information for achieving best practice. They are developed by teams of specialists who follow a rigorous evidence-based approach using a 9-step process, parts of which are specified in the NHMRC Act.
Health professionals are advised to use clinical discretion when applying information contained in NHMRC approved guidelines.
NHMRC does not accept liability for any injury, loss or damage incurred by use of or reliance on the information contained in NHMRC approved guidelines.
NHMRC cannot guarantee and assumes no legal liability or responsibility for the currency, completeness or accuracy of the information contained in NHMRC approved guidelines.
The views and opinions expressed in NHMRC approved guidelines do not necessarily represent those of the Australian Government.
What are guidelines?
Guidelines are sets of non-mandatory rules, principles or recommendations for procedures or practices in a particular field. They only become mandatory if governments turn them into legislation, professional bodies incorporate them into codes of conduct for their members or funding bodies insist on compliance with them.
What are the benefits of having guidelines?
In the health and medical fields, NHMRC guidelines provide the evidence-based information needed to achieve best practice. In regard to ethical issues in those fields, NHMRC guidelines reflect the community's range of attitudes and concerns.
Types of NHMRC guidelines
The National Health and Medical Research Council Act 1992 (NHMRC Act)  requires NHMRC to develop evidence-based guidelines. NHMRC produces them in three broad categories:
- population health – for example, guidelines on drinking water quality, nutrition and alcohol consumption
- ethics – for example, guidelines on organ donation, post coma unresponsiveness and the wellbeing of animals used in research
- clinical practice – for example, guidelines for the treatment of diabetes, breast cancer and stroke rehabilitation and recovery.
Who initiates NHMRC guidelines and their review?
The development of new NHMRC guidelines can be suggested by:
- NHMRC's Chief Executive Officer, Council or its committees
- government agencies
- peak bodies, advocacy groups and other organisations.
However, only NHMRC's CEO can make the decision to initiate development.
Council looks at current guidelines after five years and recommends to NHMRC's CEO if they need to be reviewed. After 10 years, irrespective of whether they were reviewed at five years or not, guidelines are either reviewed and the evidence updated, or revoked.
Who develops NHMRC guidelines?
NHMRC guidelines are developed by teams of specialists following a rigorous evidence-based approach. The specialists include:
- members of working committees that are set up to develop guidelines. Members are high-level experts nominated by NHMRC's CEO and Council as well as relevant organisations such as government agencies, peak professional bodies, advocacy groups and educational institutions
- specialists in evaluating evidence
- professional technical and scientific writers.
Where possible, stakeholders including representatives from the guideline target group are also engaged in the development process.
NHMRC's 9-step guideline development process
NHMRC may oversee the entire guideline development process itself (internal development). Alternatively, it may partner with another organisation such as a professional college, which then carries out much of the development up to and including step 5 below (external development). Either way, the process is substantially the same.
- A working committee is established consistent with the NHMRC Act. The committee provides expert advice to NHMRC during the guideline development process.
- Specialists in evaluating medical evidence carry out a systematic literature review. This is arguably the most important step in the process because one of the main principles of guideline development is that they should be based on the best available evidence.
- Professional technical and scientific writers turn the literature review into a set of draft guidelines.
- The draft guidelines are put out for public consultation, as required by the NHMRC Act.
- NHMRC considers all submissions arising from the public consultations and advises if the guidelines need to be redrafted due to new evidence or concerns raised by stakeholders. If so, the working committee advises the technical and scientific writers about the best way to do this.
- NHMRC subjects the draft (or redrafted) guidelines to review by an independent reviewer who ensures that all the necessary processes have been followed during the guidelines' development.
- NHMRC may choose to have a peer review of the guidelines. If so, they are sent to a number of experts in the subject area for their opinion, primarily on the evidence base used for the guidelines.
- The guidelines go to NHMRC's Council for its consideration. Council can send the guidelines back for further work if, for example, it feels more evidence is required in a particular area. When it is satisfied with the final draft, Council makes a recommendation to NHMRC's CEO, who makes the decision to issue internally-developed guidelines or approve externally-developed ones.
- The guidelines are published and disseminated.
How long does the process take?
The entire process typically takes around 18 months to two years, although it can take less or more time depending on the complexity of the issues being addressed and the number of submissions received during consultation.