2: Recommendations of the forum on legal implications of clinical practice guidelines

2. Development of guidelines
In developing guidelines, it is recommended that organisations and individuals conform to the NHMRC's Guidelines for the development and implementation of clinical practice guidelines.1

3. Ratification of guidelines
It was agreed that the process of ratification is fundamental to the value of guidelines as evidence in court, and should be established for Australian conditions. In particular, it was recommended that:

• A rigorous, national process of ratification, which is supported by stakeholders including consumer and professional groups, probably through NHMRC, be agreed;
• Procedures for updating guidelines, and for ensuring these are issued with an expiry date, be included in the ratification process;
• An independent review of the guideline development process be included in the ratification to ensure adherence to the agreed process; and
• The areas of disagreement within the guidelines be noted in the document, along with the groups and individuals who disagreed with specific recommendations.

4. Approaches to expert testimony
It is recommended that different options be explored for the provision of expert medical opinion to judges, including the role of clinical practice guidelines in expert testimony.

5. Practising outside of the guidelines
It was recommended that clinicians who practise outside of accepted guidelines take special care to document the variation in practice and their rationale for choosing not to follow guidelines. This may include strategies such as providing patients with additional documentation, seeking their consent to vary from the guidelines, or assisting the patient to obtain a second opinion. It was also recommended that strategies be developed to enable clinicians practising outside of the guidelines to feed back into the guideline review process.

6. Consumer information
As already required by the NHMRC, it is recommended that consumer guides be developed in conjunction with clinical practice guidelines. Clarification of the concept of "adequately informing" is required, and information should be provided in ways that will best meet the needs of individuals. Alternative strategies, such as taping the consultation, should be explored.

7. Liability of guideline developers
It was agreed that the likelihood of guideline developers and individual members of guideline development committees being held liable will be minimised if the guidelines focus on summaries of evidence and if an appropriate development and ratification process is followed. However, further attention to this issue is required and any precedents should be noted.

8. Continuing legal education
It is recommended that continuing legal education be established cooperatively between health and legal professionals to improve understanding of the role of clinical guidelines and their processes of development and ratification, and of the standing of various types of guidelines.