National Statement on Ethical
Conduct in Research Involving Humans
Part 13 - Innovative Therapy or Intervention
Clinical research is defined in the Declaration of Helsinki as 'medical research combined with professional care'. This can occur in a number of settings, including public and private hospitals and clinics, other institutions or organisations, community settings, and in general or specialist medical practices.
Clinical research must conform to the requirements of this Statement.
Innovations in clinical practice include the wide range of new diagnostic or therapeutic methods which are aimed at improving health outcomes beyond those of existing methods, but which have not yet been fully assessed for safety and/or efficacy. The spectrum of innovations ranges widely from minor variations of existing methods, or extension of existing methods to new indications, through to completely novel technologies. Whether a change in an individual's investigation or treatment represents such an innovation or whether it constitutes clinical research is a matter for the responsible clinician's judgement.
At the stage at which a specific form of innovative therapy becomes subject to systematic investigation to determine its efficacy and safety in order to decide whether its introduction should be recommended, it should be treated as clinical research requiring formal consideration by a Human Research Ethics Committee.
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]