Abstract

Despite the growth of traditional Chinese medicine (TCM) and western herbal medicine (WHM) research in Australia, little is known about how ethics committees (HRECs) assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.

Highlights

  • Complementary Medicine (CM) is an inclusive term that incorporates complementary medicines and complementary therapies. We use this term to include the concepts of health and medical systems, practices and products not currently recognised as part of mainstream conventional or mainstream medicine, alternative medicine (CM used in place of Western medicine), traditional medicine, and integrative medicine (CM used together with mainstream Western medicine) [1]

  • A response was received from 148 committees (66%), of which 20 indicated they had reviewed at least one traditional Chinese medicine (TCM) or western herbal medicine (WHM) application in the previous three years

  • Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers our study did identify some gaps mostly relating to the assessment of risk and risk management prior to approval being given

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Summary

Introduction

Complementary Medicine (CM) is an inclusive term that incorporates complementary medicines and complementary therapies (modalities and or systems) We use this term to include the concepts of health and medical systems, practices and products not currently recognised as part of mainstream conventional or mainstream medicine, alternative medicine (CM used in place of Western medicine), traditional medicine (indigenous medicine and practices), and integrative medicine (CM used together with mainstream Western medicine) [1]. The World Health Organisation estimates that 80% of the world’s population depends on use of CM, including traditional indigenous medicines. A more recent survey of CM use in Australia indicated 46% used vitamins not prescribed by a doctor, 19% used herbal medicines, and 6% traditional Chinese medicine (TCM) [5]

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