Clinical research is guided by a series of standards specified in national and international documents and regulatory requirements. Key documents are described below.
International Conference of Harmonisation (ICH) Guideline for Good Clinical Practice
The ICH Guideline for Good Clinical Practice provides guidance and principles on how clinical research should be planned, reviewed and conducted to meet international standards. These guidelines have been agreed upon internationally to reduce the differences in technical requirements for drug development.
In a practical sense, this guideline outlines:
- What needs to be covered in a study protocol
- Files need to be generated and kept
- Procedures and processes should be established.
This guideline has been adopted by the Therapeutic Goods Administration, with some additional Australian requirements, in ICH Good Clinical Practice at Therapeutic Goods Administration.
National Health and Medical Research Council (NHMRC) National Statement
This Australian National Statement provides a national reference point for ethical consideration of research in humans. Human Research Ethics Committees use this statement to guide their review of research protocols, so investigators need to ensure that their research protocols comply with its requirements. This statement requires research protocols to conform to the ICH Guideline for Good Clinical Practice where it is relevant.
Importantly, the statement specifically mentions the use of palliative care populations in research. Therefore, investigators need to directly address the key issues in relation to this vulnerable population in any ethics proposal. Such issues relate to the interplay between risks, benefits and burden of the research.
Australian Code for the Responsible Conduct of Research
- The Code provides advice on how to manage research data and materials;
- how to publish and disseminate research findings (including proper attribution of authorship);
- obligations in peer review; how to collaborate across institutions; and how to manage conflicts of interest.
This page was created on 25 March 2008 and is due for review in March 2010